49. 全身性エリテマトーデス Systemic lupus erythematosus Clinical trials / Disease details


臨床試験数 : 993 薬物数 : 702 - (DrugBank : 184) / 標的遺伝子数 : 116 - 標的パスウェイ数 : 200

  
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PhaseCountries
1NCT05504187
(ClinicalTrials.gov)
October 202315/8/2022Study to Evaluate Safety, Tolerability and Pharmacodynamics of KP104 in Participants With Thrombotic Microangiopathy Secondary to Systemic Lupus ErythematosusAn Open-label, Phase 2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of KP104 in Subjects With Thrombotic Microangiopathy Secondary to Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: KP104Kira Pharmacenticals (US), LLC.NULLNot yet recruiting18 Years65 YearsAll24Phase 2NULL
2NCT05029336
(ClinicalTrials.gov)
September 202324/8/2021Autologous Stem Cell Transplant (ASCT) for Autoimmune DiseasesAutologous Hematopoietic Stem Cell Transplant for Children and Young Adults With Life Threatening Autoimmune DiseasesSystemic Lupus Erythematosus;Systemic SclerosisBiological: Depletion of CD3/CD19 in an autologous stem cell transplantStephan Grupp MD PhDNULLRecruiting8 Years25 YearsAll20Phase 2United States
3NCT04893161
(ClinicalTrials.gov)
June 1, 202316/5/2021A Model About the Response of Belimumab in SLEA Model to Early Predict the Response of Belimumab Treatment in the Patients With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: BelimumabFirst Affiliated Hospital Xi'an Jiaotong UniversityNULLNot yet recruiting18 YearsN/AAll72Phase 4NULL
4NCT05688696
(ClinicalTrials.gov)
March 31, 202310/1/2023Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Systemic Lupus ErythematosusA Phase IIb, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Systemic Lupus ErythematosusSystemic Lupus Erythematosus, SLEDrug: Orelabrutinib (Low Dose);Drug: Orelabrutinib (High Dose);Drug: Orelabrutinib PlaceboBeijing InnoCare Pharma Tech Co., Ltd.NULLNot yet recruiting18 Years75 YearsAll186Phase 2China
5NCT05440422
(ClinicalTrials.gov)
March 22, 202329/6/2022The Role of Anifrolumab in Improving Markers of Vascular Risk in Patients With Systemic Lupus Erythematosus (SLE)The Role of Anifrolumab in Improving Markers of Vascular Risk in Patients With Systemic Lupus ErythematosusSystemic Lupus Erythematosus;Cardiovascular Disease;Premature AtherosclerosisDrug: anifrolumab;Other: PlaceboNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NULLNot yet recruiting18 Years80 YearsAll45Phase 1United States
6NCT05624749
(ClinicalTrials.gov)
March 7, 20237/11/2022Phase 3 Study to Evaluate Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2)A Randomized, Double-blind, Placebo-controlled Multicenter Phase 3 Study to Evaluate Efficacy, Safety and Tolerability of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2)Systemic Lupus ErythematosusDrug: ianalumab;Drug: placeboNovartis PharmaceuticalsNULLNot yet recruiting12 YearsN/AAll280Phase 3NULL
7NCT05639114
(ClinicalTrials.gov)
March 1, 20234/11/2022Phase 3 Study to Evaluate Two Regimens of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 1)A Randomized, Double-blind, Parallel Group, Placebo-controlled Multicenter Phase 3 Study to Evaluate Efficacy, Safety and Tolerability of Two Regimens of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 1)Systemic Lupus ErythematosusDrug: Ianalumab;Drug: PlaceboNovartis PharmaceuticalsNULLNot yet recruiting12 YearsN/AAll406Phase 3NULL
8NCT05638802
(ClinicalTrials.gov)
March 202328/11/2022A Study of DS-7011a in Patients With Systemic Lupus Erythematosus and Cutaneous Lupus ErythematosusA Phase 1b/2, Double-Blind, Placebo-Controlled, Randomized, Parallel-Arm Study to Explore the Safety, Pharmacokinetics, and Proof of Biological Activity of DS-7011a in Patients With Systemic Lupus Erythematosus and Active Cutaneous Lupus ErythematosusSystemic Lupus Erythematosus;Cutaneous Lupus ErythematosusDrug: DS-7011a;Drug: PlaceboDaiichi Sankyo, Inc.NULLNot yet recruiting18 YearsN/AAll24Phase 1/Phase 2NULL
9NCT05765006
(ClinicalTrials.gov)
February 24, 20236/2/2023CD19-CART(Relma-cel) for Moderate to Severe Active Systemic Lupus ErythematosusA Phase I Dose-escalation Study Evaluate the Safety Tolerability Pharmacokinetics(PK) and Pharmacodynamics(PD) of Relma-cel in Subjects With Moderate to Severe Active Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusBiological: Relma-celShanghai Ming Ju Biotechnology Co., Ltd.NULLRecruiting18 Years70 YearsAll24Phase 1China
10EUCTR2022-002691-36-SK
(EUCTR)
07/02/202324/10/2022Phase 3 study to evaluate two regimens of ianalumab on top of standard-of-care therapy in patients with systemic lupus erythematosus (SIRIUS-SLE 1)A randomized, double-blind, parallel group, placebo-controlled multicenter phase 3 study to evaluate efficacy, safety and tolerability of two regimens of ianalumab on top of standard-of-care therapy in patients with systemic lupus erythematosus (SIRIUS-SLE 1) Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ianalumab
Product Code: VAY736
INN or Proposed INN: IANALUMAB
Other descriptive name: VAY736
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
406Phase 3Hungary;United States;Czechia;Japan;Thailand;Portugal;Spain;Canada;Czech Republic;Turkey;China;Brazil;Guatemala;Poland;South Africa;Slovakia;Israel;Bulgaria
11NCT05559671
(ClinicalTrials.gov)
February 7, 202326/9/2022Safety of the Herpes Zoster Subunit Vaccine in LupusA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Non-inferiority Crossover Study Evaluating the Safety and Immunogenicity of the Herpes Zoster Subunit Vaccine in Patients With Systemic Lupus ErythematosusSystemic Lupus ErythematosusBiological: Herpes Zoster Subunit (HZ/su) Vaccine;Biological: PlaceboNYU Langone HealthNULLNot yet recruiting18 Years90 YearsAll224Phase 4United States
12EUCTR2022-002691-36-CZ
(EUCTR)
27/01/202323/11/2022Phase 3 study to evaluate two regimens of ianalumab on top of standard-of-care therapy in patients with systemic lupus erythematosus (SIRIUS-SLE 1)A randomized, double-blind, parallel group, placebo-controlled multicenter phase 3 study to evaluate efficacy, safety and tolerability of two regimens of ianalumab on top of standard-of-care therapy in patients with systemic lupus erythematosus (SIRIUS-SLE 1) Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ianalumab
Product Code: VAY736
INN or Proposed INN: IANALUMAB
Other descriptive name: VAY736
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
406Phase 3Portugal;United States;Czechia;Slovakia;Thailand;Spain;Guatemala;Turkey;Israel;Hungary;Czech Republic;Canada;Brazil;Poland;South Africa;Bulgaria;China;Japan
13NCT05672576
(ClinicalTrials.gov)
January 16, 20233/1/2023A Research Study to Evaluate the Efficacy and Safety of Cenerimod in Subjects Suffering From Systemic Lupus ErythematosusA Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of Cenerimod in Adult Subjects With Moderate-to-severe Systemic Lupus Erythematosus (SLE) on Top of Background TherapyLupus Erythematosus, SystemicDrug: Cenerimod;Drug: PlaceboIdorsia Pharmaceuticals Ltd.NULLRecruiting18 Years75 YearsAll420Phase 3United States
14NCT05620407
(ClinicalTrials.gov)
January 12, 202310/11/2022A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus ErythematosusA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Active Systemic Lupus Erythematosus (SLE) (POETYK SLE-2)Systemic Lupus ErythematosusDrug: Deucravacitinib;Other: PlaceboBristol-Myers SquibbNULLRecruiting18 Years75 YearsAll490Phase 3United States;Argentina;Australia;Brazil;Chile;Czechia;Greece;Hungary;Japan;Mexico;Peru;Poland;Portugal;Singapore;Spain;Taiwan;United Kingdom
15NCT05617677
(ClinicalTrials.gov)
January 12, 20238/11/2022A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Active Systemic Lupus Erythematosus (SLE) (POETYK SLE-1)Systemic Lupus ErythematosusDrug: Deucravacitinib;Other: PlaceboBristol-Myers SquibbNULLRecruiting18 Years75 YearsAll490Phase 3United States;Argentina;Brazil;Bulgaria;Canada;China;Colombia;France;Germany;Hong Kong;Ireland;Italy;Korea, Republic of;Lithuania;Mexico;Peru;Poland;Portugal;Romania
16EUCTR2021-006378-22-NL
(EUCTR)
11/01/202305/10/2022A Study to Evaluate the Continuous Safety and Efficacy of BIIB059 in Adults with Active Systemic Lupus ErythematosusA Multicenter, Randomized, Dose-Blind, Phase 3 Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of BIIB059 in Adult Participants with Active Systemic Lupus Erythematosus - EMERALD Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Not applicable
Product Code: BIIB059
INN or Proposed INN: BIIB059
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
864Phase 3Israel;Chile;Colombia;Italy;France;Puerto Rico;Peru;Australia;Netherlands;China;Korea, Republic of;Czechia;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Romania;Bulgaria;Germany;Japan;Sweden;Serbia;United States;Philippines;Taiwan;Greece;Spain;Russian Federation
17NCT05666336
(ClinicalTrials.gov)
December 31, 20228/12/2022Multi-omics Studies on the Efficacy of Telitacicept in Chinese SLE PatientsProteomics Combined With Metabolomics Studies on the Efficacy of Telitacicept in Chinese Patients of Systemic Lupus ErythematosusSystemic Lupus ErythematosusBiological: Telitacicept;Drug: Hydroxychloroquine;Drug: Prednisone;Drug: Methylprednisolone;Drug: Cyclophosphamide;Drug: Mycophenolate Mofetil;Drug: TacrolimusFen LiNULLNot yet recruiting18 Years75 YearsAll30Phase 4NULL
18EUCTR2022-002691-36-ES
(EUCTR)
22/12/202201/11/2022Phase 3 study to evaluate two regimens of ianalumab on top of standard-of-care therapy in patients with systemic lupus erythematosus (SIRIUS-SLE 1)A randomized, double-blind, parallel group, placebo-controlled multicenter phase 3 study to evaluate efficacy, safety and tolerability of two regimens of ianalumab on top of standard-of-care therapy in patients with systemic lupus erythematosus (SIRIUS-SLE 1) Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ianalumab
Product Code: VAY736
INN or Proposed INN: IANALUMAB
Other descriptive name: VAY736
Novartis Farmacéutica, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
406Phase 3Portugal;United States;Czechia;Slovakia;Spain;Thailand;Guatemala;Turkey;Israel;Hungary;Canada;Brazil;Poland;South Africa;Bulgaria;China;Japan
19NCT05648500
(ClinicalTrials.gov)
December 13, 20225/12/2022A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus ErythematosusA Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of Cenerimod in Adult Subjects With Moderate-to-Severe Systemic Lupus Erythematosus (SLE) on Top of Background TherapyLupus Erythematosus, SystemicDrug: Cenerimod;Drug: PlaceboIdorsia Pharmaceuticals Ltd.NULLRecruiting18 Years75 YearsAll420Phase 3United States
20NCT05458622
(ClinicalTrials.gov)
November 29, 202213/6/20223TR (Taxonomy, Treatment, Targets and Remission) Systemic Lupus Erithematosus Study Protocol3TR (Taxonomy, Treatment, Targets and Remission) Systemic Lupus Erithematosus Study ProtocolSystemic Lupus Erythematosus (SLE)Biological: Blood sample;Biological: Urine sample;Biological: Saliva sample;Biological: Stood sample;Procedure: Tissue sampleUniversity Hospital, BrestNULLRecruiting18 YearsN/AAll25Phase 3France
21NCT05306873
(ClinicalTrials.gov)
October 28, 202211/3/2022Examining Distinct Immunophenotypes to Validate and Enhance Rational Treatment in Systemic LupusA Phase 2, Double-Blind, Placebo-Controlled Trial of Mycophenolate Mofetil Alone or With Voclosporin for Systemic Lupus: Examining Distinct Immunophenotypes to Validate and Enhance Rational Treatment (DIVERT) (ALE10)Systemic Lupus ErythematosusDrug: Mycophenolate Mofetil;Drug: Placebo for Mycophenolate Mofetil;Drug: Voclosporin;Drug: Placebo for VoclosporinNational Institute of Allergy and Infectious Diseases (NIAID)NULLRecruiting18 Years60 YearsAll120Phase 2United States
22NCT05048238
(ClinicalTrials.gov)
September 30, 202231/8/2021Evaluation of Tofacitinib in Prevention of Photosensitivity in LupusEvaluation of Tofacitinib in Prevention of Photosensitivity in Lupus (ALE11)Systemic Lupus Erythematosus;Cutaneous LupusDrug: TofacitinibNational Institute of Allergy and Infectious Diseases (NIAID)NULLRecruiting18 Years65 YearsAll10Phase 1United States
23NCT05540327
(ClinicalTrials.gov)
September 16, 202212/9/2022The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)A Phase II, Double-blind, Dose-Ranging, Parallel, Long-term Extension Study to Evaluate the Safety and Efficacy of Enpatoran in Participants With Subacute Cutaneous Lupus Erythematosus, Discoid Lupus Erythematosus and/or Systemic Lupus Erythematosus Having Completed the WILLOW (MS200569_0003) Study Treatment (WILLOW LTE)Systemic Lupus ErythematosusDrug: M5049 low dose;Drug: M5049 medium dose;Drug: M5049 high dose;Drug: PlaceboMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyNULLRecruiting18 Years76 YearsAll440Phase 2United States;Bulgaria;Japan;Moldova, Republic of;Poland;Argentina;Australia;Brazil;Chile;China;Colombia;Greece;Israel;Korea, Republic of;Mauritius;Mexico;Philippines;Serbia;South Africa;Spain;Taiwan
24EUCTR2019-003409-83-GR
(EUCTR)
12/09/202204/07/2022A Study to evaluate the safety and tolerability of dapirolizumab pegol in study participants with systemic lupus erythematosusA Multicenter, Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of Dapirolizumab Pegol Treatment in Study Participants With Systemic Lupus Erythematosus Systemic lupus erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Dapirolizumab pegol
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
760Phase 3Serbia;Portugal;United States;Philippines;Taiwan;Hong Kong;Greece;Spain;Chile;Colombia;Italy;France;Peru;Australia;Denmark;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan
25NCT05689580
(ClinicalTrials.gov)
September 1, 202210/1/2023The Influence of Ketogenic Diet on Lupus Nephritis Patients' ImmunityThe Influence of Ketogenic Diet on Lupus Nephritis Patients' ImmunitySystemic Lupus Erythematosus;Ketogenic DietingDietary Supplement: Ketogenic diet;Dietary Supplement: Balanced dietChang Gung Memorial HospitalNULLRecruiting20 YearsN/AAll30N/ATaiwan
26EUCTR2019-003407-35-DE
(EUCTR)
22/08/202217/02/2022A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosusA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS FLY Systemic lupus erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Dapirolizumab pegol
Product Code: CDP7657
INN or Proposed INN: dapirolizumab pegol
Other descriptive name: DZP
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3Serbia;Portugal;United States;Czechia;Hong Kong;Taiwan;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;China;Japan
27JPRN-jRCT2031220187
01/08/202207/07/2022Evaluate Efficacy, Safety and Tolerability, PK and PD of Emapalumab in Children and Adults With MAS in Still's or SLEA Two-cohort, Open-label, Single-arm, Multicenter Study to Evaluate Efficacy, Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of Emapalumab in Children and Adults with Macrophage Activation Syndrome (MAS) in Still's Disease (Including Systemic Juvenile Idiopathic Arthritis and Adult Onset Still's Disease) or with MAS in Systemic Lupus Erythematosus - EMERALD Macrophage Activation Syndrome, Secondary Hemophagocytic Lymphohistiocytosis, Still Disease, SLEEmapalumab iv infusion
initial dose: 6 mg/kg
Subsequent doses: 3 mg/kg
Nakaoku TakahiroNULLRecruiting>= 6month old<= 80age oldBoth2Phase 2-3Belgium;Canada;China;Czechia;France;Germany;Italy;Netherlands;Poland;Spain;Sweden;United Kingdom;United States;Japan
28EUCTR2019-003407-35-DK
(EUCTR)
13/07/202217/06/2022A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosusA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS FLY Systemic lupus erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Dapirolizumab pegol
Product Code: CDP7657
INN or Proposed INN: dapirolizumab pegol
Other descriptive name: DZP
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3Serbia;Portugal;United States;Czechia;Hong Kong;Taiwan;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;China;Japan
29NCT05411016
(ClinicalTrials.gov)
July 11, 20226/6/2022A Study of KK4277 in Healthy Volunteers and Patients With Systemic Lupus Erythematosus and Cutaneous Lupus ErythematosusA Phase 1 Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose or Multiple Ascending Dose Study of KK4277 in Healthy Volunteers, Patient With Systemic Lupus Erythematosus, and Patient With Cutaneous Lupus ErythematosusHealthy Volunteers;Systemic Lupus Erythematosus (SLE);Cutaneous Lupus Erythematosus (CLE)Drug: Placebo;Drug: KK4277Kyowa Kirin Co., Ltd.NULLNot yet recruiting18 Years75 YearsAll116Phase 1Japan
30NCT05339217
(ClinicalTrials.gov)
July 1, 20222/4/2022Efficacy and Immunological Evaluation of Telitacicept and Low Dose IL2 in the Treatment of Systemic Lupus ErythematosusEfficacy and Immunological Evaluation of Telitacicept and Low Dose IL2 in the Treatment of Systemic Lupus Erythematosus: a Randomise Prospective StudySystemic Lupus ErythematosusDrug: Telitacicept;Drug: Interleukin-2Peking University People's HospitalNULLRecruiting18 Years65 YearsAll60Phase 3China
31NCT05306574
(ClinicalTrials.gov)
June 20, 202223/3/2022A Study of Telitacicept for the Treatment of Moderately to Severely Active Systemic Lupus ErythematosusA Multicenter, Randomized, Double-Blind, Placebo-Controlled, 2-Stage Trial to Evaluate Efficacy and Safety of Telitacicept Compared to Placebo in Patients With Moderately to Severely Active Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: Telitacicept;Drug: PlaceboRemeGen Co., Ltd.NULLRecruiting12 Years70 YearsAll341Phase 3United States;Bulgaria;Colombia;Poland;Puerto Rico
32NCT05433857
(ClinicalTrials.gov)
June 10, 202217/6/2022Probiotics in Systemic Lupus ErythematosusEvaluation of the Clinical Outcome of Probiotics in Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: Lacteol forte capsulesAin Shams UniversityNULLRecruiting18 Years65 YearsAll40Phase 2Egypt
33NCT05352919
(ClinicalTrials.gov)
June 10, 202225/4/2022A Study to Evaluate the Continuous Safety and Efficacy of BIIB059 (Litifilimab) in Adults With Active Systemic Lupus ErythematosusA Multicenter, Randomized, Dose-Blind, Phase 3 Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of BIIB059 in Adult Participants With Active Systemic Lupus ErythematosusSystemic Lupus Erythematosus (SLE)Drug: BIIB059 (litifilimab);Drug: PlaceboBiogenNULLRecruiting18 YearsN/AAll864Phase 3United States;Argentina;Australia;Belgium;Brazil;Bulgaria;Canada;Chile;China;Colombia;Czechia;France;Germany;Greece;Hungary;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Peru;Philippines;Poland;Puerto Rico;Romania;Russian Federation;Serbia;Spain;Sweden;Taiwan;United Kingdom
34NCT05430854
(ClinicalTrials.gov)
June 1, 202220/6/2022Study of Daxdilimab (HZN-7734) for the Treatment of Systemic Lupus Erythematosus in an Open-label Extension StudyAn Open-Label Extension Study To Evaluate The Long- Term Safety And Tolerability Of Daxdilimab (Hzn-7734) In Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusBiological: DaxdilimabHorizon Therapeutics Ireland DACNULLEnrolling by invitation18 Years72 YearsAll156Phase 2United States;Argentina;Greece;India;Mexico;Poland;Serbia;Spain;Taiwan
35NCT05392790
(ClinicalTrials.gov)
May 23, 202223/5/2022Progressive Resisted Exercise Plus Aerobic Exercise on Osteoporotic Systemic Lupus ErythmatosusProgressive Resisted Exercise Program Combined With Aerobic Exercise on Osteoporotic Systemic Lupus Erythmatosus Patients, Randomized Controlled TrialSystemic Lupus ErythematosusOther: Progressive resisted exercise training;Drug: Calcium and Vit D;Other: Aerobic exercisesCairo UniversityNULLRecruiting30 Years50 YearsFemale80N/AEgypt
36NCT05247203
(ClinicalTrials.gov)
May 17, 202226/1/2022Telitacicept Study in Chinese Subjects With Systemic Lupus ErythematosusA Phase I, Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Telitacicept in Chinese Subjects With Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusBiological: Telitacicept;Drug: standard therapyRemeGen Co., Ltd.NULLRecruiting18 Years65 YearsAll75Phase 1China
37EUCTR2020-004529-22-DE
(EUCTR)
21/04/202223/09/2021Subcutaneous Anifrolumab in Adult Patients with Systemic Lupus ErythematosusA Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Subcutaneous Anifrolumab in Adult Patients with Systemic Lupus Erythematosus - Tulip SC Moderate-to-severe Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Anifrolumab
Product Code: MEDI-546
INN or Proposed INN: ANIFROLUMAB
Other descriptive name: ANIFROLUMAB
AstraZenecaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 3United States;Spain;Ukraine;Chile;Russian Federation;Colombia;United Kingdom;Hungary;Mexico;Argentina;Poland;Peru;Bulgaria;Germany;Japan
38EUCTR2020-005776-35-DE
(EUCTR)
20/04/202201/10/2021A Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of CareA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care systemic lupus erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Not applicable
Product Code: BIIB059
INN or Proposed INN: Not applicable
Other descriptive name: Humanised IgG1 monoclonal antibody against blood dendritic cell antigen 2
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
540Phase 3Serbia;United States;Czechia;Israel;Colombia;United Kingdom;Italy;Hungary;Canada;Argentina;Belgium;Romania;Germany;Netherlands;China;Japan
39NCT05278663
(ClinicalTrials.gov)
April 14, 20224/3/2022A Study to Assess the Safety, Tolerability, and Pharmacokinetics of E6742 in Systemic Lupus Erythematosus ParticipantsA Randomized, Double-Blind, Placebo-Controlled, Multi-center, Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of E6742 in Systemic Lupus Erythematosus PatientsLupus Erythematosus, SystemicDrug: E6742;Other: PlaceboEisai Co., Ltd.NULLRecruiting18 Years75 YearsAll24Phase 1/Phase 2Japan
40NCT05262686
(ClinicalTrials.gov)
April 1, 202222/2/2022Efficacy and Immunological Evaluation of Belimumab Plus Low Dose IL-2 in the Treatment of Systemic Lupus ErythematosusEfficacy and Immunological Evaluation of Belimumab Plus Low Dose IL-2 in the Treatment of Systemic Lupus Erythematosus: a Randomised Prospective StudySystemic Lupus ErythematosusDrug: Belimumab;Drug: Interleukin-2Peking University People's HospitalNULLRecruiting18 Years70 YearsAll10Phase 3China
41EUCTR2020-005775-12-FR
(EUCTR)
01/04/202226/08/2021A Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of CareA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care systemic lupus erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Not applicable
Product Code: BIIB059
INN or Proposed INN: Not applicable
Other descriptive name: Humanised IgG1 monoclonal antibody against blood dendritic cell antigen 2
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
540Phase 3United States;Philippines;Taiwan;Greece;Spain;Chile;Russian Federation;France;Mexico;Brazil;Poland;Australia;Peru;Bulgaria;Sweden;Korea, Republic of
42NCT05162586
(ClinicalTrials.gov)
March 31, 20228/12/2021The WILLOW Study With M5049 in SLE and CLE (SCLE and/or DLE) (WILLOW)A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging, Parallel and Adaptive Study to Evaluate the Efficacy and Safety of Enpatoran in SLE and in CLE (SCLE and/or DLE) Participants Receiving Standard of Care (WILLOW)Systemic Lupus ErythematosusDrug: Enpatoran low dose;Drug: Enpatoran medium dose;Drug: Enpatoran high dose;Drug: PlaceboEMD Serono Research & Development Institute, Inc.Merck KGaA, Darmstadt, GermanyRecruiting18 Years75 YearsAll440Phase 2United States;Argentina;Australia;Bulgaria;Chile;China;Colombia;Greece;Japan;Korea, Republic of;Mauritius;Mexico;Moldova, Republic of;Philippines;Poland;South Africa;Spain;Taiwan;Germany
43NCT00775476
(ClinicalTrials.gov)
March 31, 202217/10/2008Treatment of Systemic Lupus Erythematosus (SLE) With N-acetylcysteineTreatment of Systemic Lupus Erythematosus (SLE) With N-acetylcysteine (NAC) (SNAC)Systemic Lupus ErythematosusDrug: N-acetylcysteine;Drug: PlaceboState University of New York - Upstate Medical UniversityNULLRecruiting18 YearsN/AAll290Phase 2United States
44EUCTR2021-004648-27-ES
(EUCTR)
21/03/202219/11/2021A Study of Enpatoran in Patients With Systemic Lupus Erythematosus andCutaneous Lupus ErythematosusA Phase II, Randomized, Double-Blind, Placebo Controlled Dose-Ranging, Parallel and Adaptive Study to Evaluate the Efficacy and Safety of Enpatoran in Systemic Lupus Erythematosus and in Cutaneous Lupus Erythematosus (Subacute Cutaneous Lupus Erythematosus and/or Discoid Lupus Erythematosus) Participants Receiving Standard of Care - WILLOW Systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE)
MedDRA version: 21.1;Level: PT;Classification code 10056509;Term: Cutaneous lupus erythematosus;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 21.1;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.1;Classification code 10057903;Term: Subacute cutaneous lupus erythematosus;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Enpatoran 25mg
Product Code: M5049
INN or Proposed INN: Enpatoran
Merck Healthcare KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
440Phase 2United States;Serbia;Philippines;Greece;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Mexico;Mauritius;Argentina;Poland;Brazil;Australia;Bulgaria;South Africa;China;Japan;Moldova, Republic of
45NCT05203419
(ClinicalTrials.gov)
March 15, 202210/1/2022Multiple Ascending Dose Study of MHS552 in Adults Participants With Systemic Lupus Erythematosus (SLE)A Two-part, Randomized, Investigator- and Participant- Blinded, Placebo-controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MHS552 in Adult Participants With Systemic Lupus Erythematosus (SLE)Lupus Erythematosus, SystemicDrug: MHS552;Drug: PlaceboNovartis PharmaceuticalsNULLRecruiting18 Years65 YearsAll28Phase 1Germany
46EUCTR2019-003407-35-ES
(EUCTR)
09/03/202217/01/2022A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosusA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS FLY Systemic lupus erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Dapirolizumab pegol
Product Code: CDP7657
INN or Proposed INN: dapirolizumab pegol
Other descriptive name: DZP
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Serbia;Portugal;Czechia;Taiwan;Hong Kong;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Poland;Belgium;Denmark;Bulgaria;Germany;Japan;China
47EUCTR2019-003406-27-DK
(EUCTR)
09/03/202204/03/2021A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosusA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS GO Systemic lupus erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Dapirolizumab pegol
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Serbia;Portugal;Philippines;Taiwan;Greece;Spain;Chile;Colombia;Italy;France;Peru;Australia;Denmark;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany
48NCT05236491
(ClinicalTrials.gov)
March 9, 202210/2/2022COvid-19 Vaccine Booster in Immunocompromised Rheumatic DiseasesCOvid-19 Vaccine Booster in Immunocompromised Rheumatic DiseasesRheumatoid Arthritis;Autoimmune Rheumatologic Disease;Systemic Lupus Erythematosus;Systemic Vasculitis;Systemic Sclerosis;Scleroderma;Undifferentiated Connective Tissue Diseases;Overlap Connective Tissue Disease;ImmunosuppressionBiological: COVID-19 vaccinePaul R FortinCanadian Institutes of Health Research (CIHR)Recruiting18 YearsN/AAll287Phase 2/Phase 3Canada
49NCT05123586
(ClinicalTrials.gov)
March 7, 202216/11/2021A IMMA Master Protocol: A Study of LY3361237 in Participants With at Least Moderately Active Systemic Lupus ErythematosusA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Two-Arm, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of LY3361237 as a Treatment for Adults With At Least Moderately Active Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: LY3361237;Drug: PlaceboEli Lilly and CompanyNULLRecruiting18 Years65 YearsAll90Phase 2United States;Argentina;Czechia;France;Mexico;Poland;Puerto Rico;Taiwan;Russian Federation;Ukraine
50JPRN-jRCT2071210076
03/03/202215/10/2021A Multicenter, Randomized, Double-Blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus ErythematosusThe purpose of this study is evaluating the efficacy and safety of SC antifrolumab in adult patients with moderate -to-severe SLE despite receiving standard therapy - Tulip SC Systemic Lupus ErythematosusApproximately 360 patients are planned to be randomly assigned in a 1:1 ratio (180 patients
per treatment group) to receive either a fixed SC dose of anifrolumab or placebo once weekly (QW).
Hibi KazushigeNULLRecruiting>= 18age old<= 70age oldBoth36Phase 3United States;Argentina;Bulgaria;Chile;Colombia;Hungary;Mexico;Peru;Poland;Russia;Ukraine;United Kingdom;Germany;Spain;Japan
51EUCTR2020-004047-86-HU
(EUCTR)
28/02/202223/12/2021A Study of ALPN-101 in Active LupusA Randomised, Double-Blind, Placebo-controlled study of ALPN-101 in Systemic Lupus Erythematosus Systemic lupus erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042946;Term: Systemic lupus erythematosus rash;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 21.1;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.1;Level: LLT;Classification code 10042948;Term: Systemic lupus erythematosus syndrome aggravated;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Classification code 10029142;Term: Nephritis systemic lupus erythematosus;System Organ Class: 100000004857
MedDRA version: 20.1;Classification code 10067657;Term: Systemic lupus erythematosus disease activity index increased;System Organ Class: 10022891 - Investigations
MedDRA version: 20.0;Classification code 10067658;Term: Systemic lupus erythematosus disease activity index decreased;System Organ Class: 10022891 - Investigations
MedDRA version: 20.1;Classification code 10067659;Term: Systemic lupus erythematosus disease activity index abnormal;System Organ Class: 10022891 - Investigations
MedDRA version: 21.0;Classification code 10080670;Term: Systemic lupus erythematosus reactivation;Classification code 10073694;Term: Lupus pleurisy;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 21.1;Classification code 10040968;Term: SLE arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: ALPN-101
INN or Proposed INN: Acazicolcept
Other descriptive name: ALPN-101
Alpine Immune Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 2France;United States;Taiwan;Hungary;Spain;Poland;Russian Federation;Germany;Korea, Republic of
52EUCTR2021-004648-27-BG
(EUCTR)
24/02/202212/01/2022A Study of Enpatoran in Patients With Systemic Lupus Erythematosus and Cutaneous Lupus ErythematosusA Phase II, Randomized, Double-Blind, Placebo Controlled Dose-Ranging, Parallel and Adaptive Study to evaluate the Efficacy and Safety of Enpatoran in Systemic Lupus Erythematosus and in Cutaneous Lupus Erythematosus (Subacute Cutaneous Lupus Erythematosus and/or Discoid Lupus Erythematosus) Participants Receiving Standard of Care - WILLOW Systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE)
MedDRA version: 21.1;Level: PT;Classification code 10056509;Term: Cutaneous lupus erythematosus;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 21.1;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.1;Classification code 10057903;Term: Subacute cutaneous lupus erythematosus;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Enpatoran 25mg
Product Code: M5049
INN or Proposed INN: Enpatoran
Merck Healthcare KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
440Phase 2United States;Serbia;Philippines;Greece;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Mexico;Mauritius;Argentina;Poland;Brazil;Australia;South Africa;Bulgaria;China;Japan;Moldova, Republic of
53JPRN-jRCT2011210069
15/02/202205/02/2022A Study Evaluating the Efficacy and Safety of Afimetoran Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Afimetoran in Participants With Active Systemic Lupus Erythematosus Systemic Lupus ErythematosusArm A: Afimetoran 30mg QD
Arm B: Afimetoran 10mg QD
Arm C: Afimetoran 2.5mg QD
Arm D: Placebo QD
Ranganathan UshaNULLRecruiting>= 18age old<= 70age oldBoth20Phase 2Argentina;Australia;Brazil;Chile;Colombia;France;Germany;Ireland;Mexico;Poland;Romania;Spain;Taiwan;USA;United Kingdom;Japan
54EUCTR2020-005776-35-RO
(EUCTR)
10/02/202229/04/2022A Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of CareA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care systemic lupus erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Not applicable
Product Code: BIIB059
INN or Proposed INN: Not applicable
Other descriptive name: Humanised IgG1 monoclonal antibody against blood dendritic cell antigen 2
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
540Phase 3Serbia;United States;Czechia;Israel;Colombia;Italy;United Kingdom;Hungary;Canada;Argentina;Belgium;Romania;Germany;Netherlands;China;Japan
55JPRN-jRCT2041210058
04/02/202220/08/2021A Study of Nipocalimab in Adult Participants with Active Systemic Lupus ErythematosusA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Nipocalimab in Adult Participants with Active Systemic Lupus Erythematosus Systemic Lupus ErythematosusGroup 1_Placebo:Participants will receive placebo intravenously (IV) every two weeks (q2w) through Week 50 along with standard-of-care treatments (that is, immunomodulators, antimalarial drugs and Glucocorticoids [GCs]).
Group 2_Nipocalimab Dose 1: Participants will receive nipocalimab dose 1 intravenously (IV) q2w through Week 50 along with standard-of-care treatments (that is, immunomodulators, antimalarial drugs and GCs).
Group 3_Nipocalimab Dose 2: Participants will receive nipocalimab dose 2 intravenously (IV) q2w through Week 50 along with standard-of-care treatments (that is, immunomodulators, antimalarial drugs and GCs).
Numaguchi HirotakaNULLRecruiting>= 18age old<= 65age oldBoth225Phase 2Bulgaria;Colombia;Germany;Spain;Hungary;Poland;Taiwan, Province Of China;Ukraine;United States OfAmerica;South Africa;Japan
56EUCTR2021-001406-30-PL
(EUCTR)
02/02/202212/01/2022A study investigating the treatment of Systemic Lupus Erythematosus with LY3361237A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Two Arm, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of LY3361237 to Treat Adults with At Least Moderately Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: LY3361237
INN or Proposed INN: LY3361237
Other descriptive name: LY3361237
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 2United States;Czechia;Mexico;Puerto Rico;Argentina;Poland;Ukraine;Russian Federation
57NCT05203692
(ClinicalTrials.gov)
February 2, 202220/1/2022A Study of a Single Ascending Dose Study of DS-7011a in Healthy SubjectsA Phase 1, Subjects- and Investigator-Blinded, Sponsor-Unblinded, Placebo-Controlled, Randomized, Sequential Cohort Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending Intravenous and Subcutaneous Doses of DS-7011a in Healthy SubjectsSystemic Lupus ErythematosusDrug: DS-7011a;Drug: PlaceboDaiichi Sankyo, Inc.NULLActive, not recruiting18 Years45 YearsAll80Phase 1United States
58EUCTR2019-003409-83-DE
(EUCTR)
17/01/202226/07/2021A Study to evaluate the safety and tolerability of dapirolizumab pegol in study participants with systemic lupus erythematosusA Multicenter, Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of Dapirolizumab Pegol Treatment in Study Participants With Systemic Lupus Erythematosus Systemic lupus erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Dapirolizumab pegol
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
760Phase 3Serbia;Portugal;United States;Philippines;Taiwan;Hong Kong;Greece;Spain;Chile;Colombia;Italy;France;Peru;Australia;Denmark;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan
59NCT05155345
(ClinicalTrials.gov)
January 11, 202210/12/2021A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered Mosunetuzumab to Participants With Systemic Lupus ErythematosusA Phase Ib, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered Mosunetuzumab to Participants With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: Mosunetuzumab;Drug: TocilizumabHoffmann-La RocheNULLRecruiting18 Years75 YearsAll50Phase 1United States;Georgia;Moldova, Republic of;Poland;Ukraine
60NCT05140824
(ClinicalTrials.gov)
December 30, 20214/11/2021A Study to Evaluate the Safety, Tolerability, and PK Profile of Single and Multiple Doses TJ202 in Patient With Systemic Lupus ErythematosusA Multicenter, Randomized, Double-blind, Placebo-Controlled, Phase 1 Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of Single and Multiple Doses of TJ202 in Patients With Systemic Lupus ErythematosusSystemic Lupus Erythematosus (SLE)Drug: Placebo;Biological: TJ202 injectionI-Mab Biopharma Co. Ltd.NULLTerminated18 Years65 YearsAll1Phase 1China
61EUCTR2020-005776-35-NL
(EUCTR)
24/12/202113/09/2021A Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of CareA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care systemic lupus erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Not applicable
Product Code: BIIB059
INN or Proposed INN: Not applicable
Other descriptive name: Humanised IgG1 monoclonal antibody against blood dendritic cell antigen 2
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
540Phase 3Serbia;United States;Czechia;Israel;Colombia;United Kingdom;Italy;Hungary;Canada;Argentina;Belgium;Romania;Netherlands;Germany;China;Japan
62EUCTR2019-004021-25-IE
(EUCTR)
17/12/202108/10/2021A Study Evaluating the Efficacy and Safety of Afimetoran Compared With Placebo in Participants With ActiveSystemic Lupus Erythematosus (SLE)A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Afimetoran in Participants with Active Systemic Lupus Erythematosus. Active Systemic Lupus Erythematosus.
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Afimetoran (2.5mg)
Product Code: BMS-986256
INN or Proposed INN: Afimetoran
Other descriptive name: BMS-986256-06, TLR7/8 Antagonist
Product Name: Afimetoran (10mg)
Product Code: BMS-986256
INN or Proposed INN: Afimetoran
Other descriptive name: BMS-986256-06, TLR7/8 Antagonist
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 2United States;Taiwan;Spain;Ireland;Chile;Colombia;United Kingdom;France;Mexico;Argentina;Brazil;Poland;Romania;Australia;Germany;Japan
63NCT05001737
(ClinicalTrials.gov)
December 15, 202116/6/2021Evaluate Efficacy, Safety and Tolerability, PK and PD of Emapalumab in Children and Adults With MAS in Still's or SLEA Two-cohort, Open-label, Single Arm, Multicenter Study to Evaluate Efficacy, Safety and Tolerability, PK and PD, of Emapalumab in Children and Adults With MAS in Still's Disease or With MAS in Systemic Lupus ErythematousMacrophage Activation Syndrome;Secondary Hemophagocytic Lymphohistiocytosis;Still Disease;Systemic Lupus Erythematosus;SJIA;AOSD;MASDrug: EmapalumabSwedish Orphan BiovitrumNULLRecruiting6 Months80 YearsAll41Phase 3United States;Belgium;Canada;China;Czechia;France;Germany;Italy;Japan;Netherlands;Poland;Spain;Sweden;United Kingdom
64EUCTR2019-004021-25-ES
(EUCTR)
14/12/202125/08/2021A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of BMS-986256 in Participants with Active Systemic Lupus Erythematosus. A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of BMS-986256 in Participants with Active Systemic Lupus Erythematosus. Active Systemic Lupus Erythematosus.
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: TLR7/8 Antagonist (2.5mg)
Product Code: BMS-986256
INN or Proposed INN: Not available
Other descriptive name: BMS-986256-06, TLR7/8 Antagonist
Product Name: TLR7/8 Antagonist (10mg)
Product Code: BMS-986256
INN or Proposed INN: Not available
Other descriptive name: BMS-986256-06, TLR7/8 Antagonist
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 2United States;Taiwan;Spain;Ireland;Chile;Colombia;United Kingdom;France;Mexico;Argentina;Brazil;Poland;Romania;Australia;Germany;Japan
65NCT04702256
(ClinicalTrials.gov)
December 9, 202130/11/2020Induction Therapy for Lupus Nephritis With no Added Oral Steroids: A Trial Comparing Oral Corticosteroids Plus Mycophenolate Mofetil (MMF) Versus Obinutuzumab and MMFInduction Therapy for Lupus Nephritis With no Added Oral Steroids: An Open Label Randomised Multicentre Controlled Trial Comparing Oral Corticosteroids Plus Mycophenolate Mofetil (MMF) Versus Obinutuzumab and MMFLupus Nephritis;Systemic Lupus Erythematosus (SLE)Drug: Obinutuzumab administration;Drug: Administration of Methylprednisolone + Prednisone + Mycophenolate mofetil;Drug: Administration of methylprednisolone, paracetamol and dexchlorpheniramineAssistance Publique - Hôpitaux de ParisRoche Pharma AGRecruiting14 YearsN/AAll196Phase 3France
66ChiCTR2100052342
2021-12-012021-10-24A clinical study on drug reduction and withdrawal initiated by investigators in the treatment of SLE patients with belyumumab for injectionA clinical study on drug reduction and withdrawal initiated by investigators in the treatment of SLE patients with belyumumab for injection systemic lupus erythematosusstandard treatment group:standard treatment ;Belimumab + standard therapy group 1:Belimumab(5mg/kg.m)+ standard therapy;Belimumab + standard therapy group 2:Belimumab(10mg/kg.m)+standard therapy;Belimumab + standard of care group 3:Belimumab(10mg/kg.2m)+standard of care group;Affiliated Hospital of Guilin Medical CollegeNULLRecruiting1665Bothstandard treatment group:25;Belimumab + standard therapy group 1:25;Belimumab + standard therapy group 2:25;Belimumab + standard of care group 3:25;Phase 4China
67EUCTR2020-005569-14-BG
(EUCTR)
12/11/202129/09/2021A Clinical Study of Nipocalimab in Adult Participants with Active Systemic Lupus ErythematosusA Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Nipocalimab in Adult Participants with Active Systemic Lupus Erythematosus Active Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nipocalimab
Product Code: JNJ-80202135
INN or Proposed INN: Nipocalimab
Other descriptive name: M281
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
225Phase 2United States;Hong Kong;Taiwan;Spain;Ukraine;Russian Federation;Colombia;Hungary;Argentina;Poland;Bulgaria;South Africa;Germany;Japan
68EUCTR2020-005776-35-HU
(EUCTR)
10/11/202108/10/2021A Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of CareA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care systemic lupus erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Not applicable
Product Code: BIIB059
INN or Proposed INN: Not applicable
Other descriptive name: Humanised IgG1 monoclonal antibody against blood dendritic cell antigen 2
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
540Phase 3Serbia;United States;Czechia;Israel;Colombia;United Kingdom;Italy;Hungary;Canada;Argentina;Belgium;Romania;Germany;Netherlands;China;Japan
69NCT05039840
(ClinicalTrials.gov)
November 10, 20211/9/2021Efficacy and Safety of SAR441344 in the Treatment of Systemic Lupus ErythematosusEfficacy and Safety of SAR441344 in the Treatment of Systemic Lupus Erythematosus: A Randomized, Double Blind, Placebo-controlled, Phase 2, Proof of Concept StudySystemic Lupus ErythematosusDrug: SAR441344 IV;Drug: SAR441344 SC;Drug: Placebo IV;Drug: Placebo SCSanofiNULLRecruiting18 Years70 YearsAll116Phase 2United States;Argentina;Brazil;Chile;Greece;Italy;Mauritius;Mexico;Russian Federation;Spain;Turkey;Ukraine
70NCT05328557
(ClinicalTrials.gov)
November 7, 202130/3/2022A Phase Ia Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered CUG252 in Normal Healthy VolunteersPhase Ia, Randomized Double-Blinded, Placebo-Controlled Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered CUG252 Following a Single Dose Administration in Normal Health Volunteers.Systemic Lupus ErythematosusDrug: CUG252;Drug: PlaceboCugene Inc.NULLActive, not recruiting18 Years65 YearsAll32Phase 1United States
71JPRN-jRCT2011210019
06/11/202130/06/2021Phase 2 double blind study of cenerimodA randomized, double-blind, parallel-group, multicenter, phase 2 study to investigate the safety and PD of cenerimod in Japanese subjects with moderate to severe systemic lupus erythematosus (SLE) Systemic lupus erythematosusAdministration of two doses of cenerimod (2 and 4 mg) given orally once daily for 3 months in adult subjects with moderate to severe SLE concurrently receiving SLE background treatmentYokoyama YoshinariNULLNot Recruiting>= 18age old<= 75age oldBoth16Phase 2Japan
72NCT05261529
(ClinicalTrials.gov)
November 3, 20218/2/2022Effects of an Intervention With EVOO and Physical Activity in Patients With Systemic Lupus ErythematosusEffects of a Nutricional Intervention With EVOO Oil and Physical Activity in Patients With Systemic Lupus Erythematosus: Effect on Clinical Course, Epigenetic and MicrobiomeLupus Erythematosus, SystemicDietary Supplement: Extra Virgin Olive Oil (EVOO);Behavioral: Physical Exercise ProgramUniversidad de GranadaConsejería de Economía, Innovación y Ciencia. Proyectos de I+D+I en el marco operativo Feder Andalucía 2014-2020Recruiting18 Years70 YearsFemale90N/ASpain
73EUCTR2020-005775-12-GR
(EUCTR)
02/11/202113/09/2021A Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of CareA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care systemic lupus erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Not applicable
Product Code: BIIB059
INN or Proposed INN: Not applicable
Other descriptive name: Humanised IgG1 monoclonal antibody against blood dendritic cell antigen 2
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
540Phase 3United States;Philippines;Taiwan;Greece;Spain;Chile;Russian Federation;France;Mexico;Poland;Brazil;Australia;Peru;Bulgaria;Sweden;Korea, Republic of
74EUCTR2020-005776-35-IT
(EUCTR)
02/11/202127/01/2022A Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of CareA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care - . systemic lupus erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Not applicable
Product Code: [BIIB059]
INN or Proposed INN: HA 1A ANTICORPO MONOCLONALE UMANO CLASSE IGM
BIOGEN IDEC RESEARCH LIMITEDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
540Phase 3United States;Czechia;Israel;Colombia;United Kingdom;Italy;Hungary;Canada;Argentina;Belgium;Romania;Germany;Netherlands;China;Japan
75NCT05019950
(ClinicalTrials.gov)
October 28, 202116/8/2021Safety Tolerability and Pharmacokinetics of Oral LABP-104 in Healthy Adult Male and Female VolunteersA Randomized, Placebo-Controlled, Double-Blind, Single-Center Study to Evaluate Safety Tolerability and Pharmacokinetics of Oral LABP-104 in Healthy Adult Male and Female VolunteersSystemic Lupus ErythematosusDrug: LABP-104 250mg;Drug: PlaceboLandos Biopharma Inc.NULLCompleted18 Years64 YearsAll56Phase 1Australia
76EUCTR2021-001802-30-DE
(EUCTR)
28/10/202102/09/2021Efficacy of the drug Benlysta (active ingredient: belimumab) to improve cardiac abnormalities in patients with systemic lupus erythematosus (BeCarma)Efficacy of belimumab to improve subclinical cardiovascular abnormalitiesusing imaging endpoints with cardiac magnetic resonance in patients withsystemic lupus erythematosus (BeCarma) - BeCarma Efficacy of belimumab to improve subclinical cardiovascular abnormalities using imaging endpoints with cardiac magnetic resonance in patients with systemic lupus erythematosus;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Benlysta®Fraunhofer Institut für Translationale Medizin und Pharmakologie (ITMP)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
56Phase 4Germany
77EUCTR2019-004021-25-PL
(EUCTR)
27/10/202124/09/2021A Study Evaluating the Efficacy and Safety of Afimetoran Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Afimetoran in Participants with Active Systemic Lupus Erythematosus. Active Systemic Lupus Erythematosus.
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Afimetoran (2.5mg)
Product Code: BMS-986256
INN or Proposed INN: Afimetoran
Other descriptive name: BMS-986256-06, TLR7/8 Antagonist
Product Name: Afimetoran (10mg)
Product Code: BMS-986256
INN or Proposed INN: Afimetoran
Other descriptive name: BMS-986256-06, TLR7/8 Antagonist
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 2United States;Taiwan;Spain;Ireland;Chile;Colombia;United Kingdom;France;Mexico;Argentina;Poland;Brazil;Romania;Australia;Germany;Japan
78NCT04963296
(ClinicalTrials.gov)
October 26, 20217/7/2021A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus ErythematosusA Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy And Safety of Obinutuzumab in Patients With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: Obinutuzumab;Drug: Placebo;Drug: Acetaminophen/Paracetamol;Drug: Diphenhydramine hydrochloride;Drug: MethylprednisoloneHoffmann-La RocheNULLRecruiting18 Years75 YearsAll200Phase 3United States;Argentina;Brazil;France;Italy;Mexico;New Zealand;Peru;Poland;Russian Federation;South Africa;Spain;United Kingdom
79EUCTR2020-005760-57-PL
(EUCTR)
25/10/202121/09/2021A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Patients with Systemic Lupus ErythematosusA PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OBINUTUZUMAB IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Gazyvaro
INN or Proposed INN: OBINUTUZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3United States;Spain;Russian Federation;Italy;United Kingdom;France;Mexico;Argentina;Poland;Brazil;Australia;Peru;South Africa;New Zealand
80EUCTR2021-001567-25-IT
(EUCTR)
22/10/202112/10/2021Efficacy and safety of SAR441344 in the treatment of Systemic Lupus ErythematosusEfficacy and safety of SAR441344 in the treatment of Systemic Lupus Erythematosus: A randomized, double blind, placebo-controlled, Phase 2, proof of concept study - APATURA Systemic lupus erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: SAR441344
Product Code: [SAR441344]
INN or Proposed INN: NON APPLICABILE
Other descriptive name: SAR441344
SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENTNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
166Phase 2United States;Mexico;Greece;Argentina;Spain;Ukraine;Turkey;Russian Federation;Chile;Germany;Italy
81NCT04908865
(ClinicalTrials.gov)
October 21, 202126/5/2021Open-label Study of Belimumab Plus Standard Therapy in Chinese Pediatric Participants With Active Systemic Lupus Erythematosus (SLE)A Multi-Center, Open-Label Study to Evaluate Safety, Efficacy and Pharmacokinetics of Belimumab Plus Standard Therapy in Chinese Paediatric Patients With Active Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: Belimumab;Drug: Standard therapyGlaxoSmithKlineNULLRecruiting5 Years17 YearsAll65Phase 4China
82EUCTR2020-003509-72-FR
(EUCTR)
21/10/202110/03/2021Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic LupusErythematosusA Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy Active Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Efavaleukin Alfa
Product Code: AMG 592
INN or Proposed INN: EFAVALEUKIN ALFA
Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN
Amgen Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 2United States;Hong Kong;Taiwan;Greece;Spain;Turkey;Austria;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Mexico;Canada;Poland;Bulgaria;Japan
83EUCTR2019-003409-83-HU
(EUCTR)
15/10/202101/09/2021A Study to evaluate the safety and tolerability of dapirolizumab pegol in study participants with systemic lupus erythematosusA Multicenter, Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of Dapirolizumab Pegol Treatment in Study Participants With Systemic Lupus Erythematosus Systemic lupus erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Dapirolizumab pegol
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
760Phase 3Portugal;Serbia;United States;Philippines;Hong Kong;Taiwan;Greece;Spain;Chile;Colombia;Italy;France;Peru;Australia;Denmark;Korea, Republic of;Czechia;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan
84JPRN-jRCTs021210042
14/10/202114/10/2021Randomized , double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of belimumab for early systemic lupus erythematosusRandomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of belimumab for early systemic lupus erythematosus - BEFORE-S Systemic Lupus Erythematosus : SLE
Systemic Lupus Erythematosus, SLE;D008180
Group A to which the test drug is administered and Group B to which the placebo is administered will be set.
Group A: In addition to the usual treatment, belimumab (GlaxoSmithKline Co., Ltd., trade name Benlysta) will be administered subcutaneously once a week at 200 mg. Administration will be continued for 24 weeks.
Group B: Placebo will be administered and standard of care will be performed.
Both groups will receive a combination of hydroxychloroquine unless there is a reason not to use hydroxychloroquine as usual treatment.
If the attending physician determines that it is not appropriate to administer the study drug, the attending physician will not administer the study drug during the week and will record the reason
Ishii TomonoriNULLRecruiting>= 20age old< 80age oldBoth30N/AJapan
85EUCTR2019-004021-25-FR
(EUCTR)
13/10/202113/08/2021A Study Evaluating the Efficacy and Safety of BMS-986256 Compared With Placebo in Participants With ActiveSystemic Lupus Erythematosus (SLE)A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of BMS-986256 in Participants with Active Systemic Lupus Erythematosus. Active Systemic Lupus Erythematosus.
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: TLR7/8 Antagonist (2.5mg)
Product Code: BMS-986256
INN or Proposed INN: Not available
Other descriptive name: BMS-986256-06, TLR7/8 Antagonist
Product Name: TLR7/8 Antagonist (10mg)
Product Code: BMS-986256
INN or Proposed INN: Not available
Other descriptive name: BMS-986256-06, TLR7/8 Antagonist
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 2United States;Taiwan;Spain;Ireland;Chile;Colombia;United Kingdom;France;Mexico;Argentina;Brazil;Poland;Romania;Australia;Germany;Japan
86EUCTR2021-001567-25-DE
(EUCTR)
11/10/202129/07/2021Efficacy and safety of SAR441344 in the treatment of Systemic Lupus ErythematosusEfficacy and safety of SAR441344 in the treatment of Systemic Lupus Erythematosus: A randomized, double blind, placebo-controlled, Phase 2, proof of concept study - APATURA Systemic lupus erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: SAR441344
Product Code: SAR441344
INN or Proposed INN: Not Applicable
Other descriptive name: SAR441344
Sanofi-Aventis Recherche et DéveloppementNULLNot RecruitingFemale: yes
Male: yes
166Phase 2United States;Mexico;Greece;Argentina;Spain;Ukraine;Turkey;Russian Federation;Chile;Germany;Italy
87NCT04895696
(ClinicalTrials.gov)
October 11, 202119/5/2021A Study Evaluating the Efficacy and Safety of Afimetoran Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Afimetoran in Participants With Active Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: Afimetoran;Other: PlaceboBristol-Myers SquibbNULLRecruiting18 Years70 YearsAll344Phase 2United States;Argentina;Australia;Brazil;Chile;China;Colombia;France;Germany;Ireland;Japan;Mexico;Poland;Puerto Rico;Romania;Spain;Taiwan;United Kingdom
88EUCTR2020-005775-12-ES
(EUCTR)
05/10/202108/07/2021A Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of CareA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care systemic lupus erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Not applicable
Product Code: BIIB059
INN or Proposed INN: Not applicable
Other descriptive name: Humanised IgG1 monoclonal antibody against blood dendritic cell antigen 2
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
540Phase 3United States;Philippines;Taiwan;Greece;Spain;Chile;Russian Federation;France;Mexico;Poland;Brazil;Australia;Peru;Bulgaria;Sweden;Korea, Republic of
89NCT05326841
(ClinicalTrials.gov)
October 3, 202123/3/2022Effect of Cholecalciferol Supplementation on Disease Activity and Quality of Life of Systemic Lupus Erythematosus Patients .Effect of Cholecalciferol Supplementation on Disease Activity and Quality of Life of Systemic Lupus Erythematosus PatientsLupus Erythematosus, Systemic;Cholecalciferol Supplementation;Disease Activity;Quality of LifeDrug: Vitamin D3Dr Cipto Mangunkusumo General HospitalNULLCompleted18 Years60 YearsFemale60Phase 3Indonesia
90NCT04486118
(ClinicalTrials.gov)
October 1, 202128/10/2019Centrally Acting ACE Inhibition in SLEA Novel Phase 2 Double-blind, Randomized, Controlled Clinical Trial to Evaluate the Efficacy of Centrally Acting, Non-toxic ACE Inhibition in Cognitive Impairment Associated With SLESystemic Lupus ErythematosusDrug: Lisinopril Pills;Drug: Benazepril PillNorthwell HealthLupus Research AllianceRecruiting18 Years55 YearsAll36Phase 2United States
91EUCTR2021-001567-25-ES
(EUCTR)
22/09/202127/07/2021Efficacy and safety of SAR441344 in the treatment of Systemic Lupus ErythematosusEfficacy and safety of SAR441344 in the treatment of Systemic Lupus Erythematosus: A randomized, double blind, placebo-controlled, Phase 2, proof of concept study - APATURA Systemic lupus erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: SAR441344
Product Code: SAR441344
INN or Proposed INN: Not Applicable
Other descriptive name: SAR441344
Sanofi-Aventis Recherche et DéveloppementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
166Phase 2United States;Mexico;Greece;Argentina;Spain;Ukraine;Turkey;Russian Federation;Chile;Germany;Italy
92EUCTR2019-003409-83-BG
(EUCTR)
21/09/202129/06/2021A Study to evaluate the safety and tolerability of dapirolizumab pegol in study participants with systemic lupus erythematosusA Multicenter, Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of Dapirolizumab Pegol Treatment in Study Participants With Systemic Lupus Erythematosus Systemic lupus erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Dapirolizumab pegol
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
760Phase 3Serbia;United States;Portugal;Philippines;Taiwan;Hong Kong;Greece;Spain;Chile;Colombia;Italy;France;Peru;Australia;Denmark;Korea, Republic of;Czechia;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan
93NCT05057481
(ClinicalTrials.gov)
September 15, 202116/9/2021Reappraisal of the Therapies of Refractory Autoimmune Hemolytic Anemia in Systemic Lupus ErythematosusReappraisal of Second-line Therapies of Refractory Autoimmune Hemolytic Anemia in Systemic Lupus ErythematosusAutoimmune Hemolytic Anemia;Systemic Lupus ErythematosusDrug: Mycophenolate Mofetil 500mg;Drug: RituximabAssiut UniversityNULLActive, not recruiting18 YearsN/AAll30Phase 3Egypt
94NCT04931563
(ClinicalTrials.gov)
September 13, 202129/4/2021Anifrolumab Asian PhIII Efficacy Study for Systemic Lupus Erythematosus (SLE)A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Anifrolumab in Asian Participants With Active Systemic Lupus ErythematosusActive Systemic Lupus ErythematosusBiological: Anifrolumab;Drug: placeboAstraZenecaNULLRecruiting18 Years70 YearsAll328Phase 3China;Hong Kong;Korea, Republic of;Philippines;Taiwan;Thailand
95NCT05030779
(ClinicalTrials.gov)
September 10, 202118/8/2021A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Systemic Lupus ErythematosusClinical Trial for the Safety and Efficacy of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Systemic Lupus ErythematosusSystemic Lupus Erythematosus;Autoimmune DiseasesBiological: Assigned Interventions CD19/BCMA CAR T-cellsZhejiang UniversityYake Biotechnology Ltd.RecruitingN/AN/AAll9Early Phase 1China
96EUCTR2020-004529-22-BG
(EUCTR)
10/09/202123/07/2021Subcutaneous Anifrolumab in Adult Patients with Systemic Lupus ErythematosusA Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Subcutaneous Anifrolumab in Adult Patients with Systemic Lupus Erythematosus - Tulip SC Moderate-to-severe Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Anifrolumab
Product Code: MEDI-546
INN or Proposed INN: ANIFROLUMAB
Other descriptive name: ANIFROLUMAB
AstraZenecaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 3United States;Spain;Ukraine;Chile;Russian Federation;Colombia;United Kingdom;Hungary;Mexico;Argentina;Poland;Peru;Bulgaria;Germany;Japan
97EUCTR2020-005760-57-IT
(EUCTR)
09/09/202112/10/2021A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Patients with Systemic Lupus ErythematosusA PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OBINUTUZUMAB IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS - ALLEGORY Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Gazyvaro
Product Name: Gazyvaro
Product Code: [na]
INN or Proposed INN: OBINUTUZUMAB
F. HOFFMANN - LA ROCHE LTD.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3United States;Spain;Russian Federation;Italy;United Kingdom;France;Mexico;Argentina;Brazil;Poland;Australia;Peru;South Africa;New Zealand
98ChiCTR2100050041
2021-09-012021-08-16A national multicentre retrospective study of beliuzumab in the treatment of Chinese children with systemic lupus erythematosusA national multicentre retrospective study of beliuzumab in the treatment of Chinese children with systemic lupus erythematosus systemic Lupus Erythematosus in childrenbelimumab group :treated with belimumab;Dmards group:treated with Dmards ;Guangzhou Women's and Children's Medical CenterNULLRecruiting518Bothbelimumab group :137;Dmards group:50;China
99NCT04736953
(ClinicalTrials.gov)
September 1, 20214/12/2020Sirolimus Treatment Of Patients With SLESirolimus Treatment of Patients With Systemic Lupus ErythematosusLupus Erythematosus, SystemicDrug: Sirolimus;Other: PlaceboState University of New York - Upstate Medical UniversityNULLNot yet recruiting18 YearsN/AAll220Phase 2NULL
100EUCTR2020-003509-72-BG
(EUCTR)
31/08/202101/06/2021Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic LupusErythematosusA Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy Active Systemic Lupus Erythematosus;Therapeutic area: Body processes [G] - Immune system processes [G12]Product Name: Efavaleukin Alfa
Product Code: AMG 592
INN or Proposed INN: EFAVALEUKIN ALFA
Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN
Amgen Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 2United States;Hong Kong;Taiwan;Greece;Spain;Turkey;Austria;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Mexico;Canada;Poland;Bulgaria;Japan
101EUCTR2020-004529-22-HU
(EUCTR)
24/08/202118/06/2021Subcutaneous Anifrolumab in Adult Patients with Systemic Lupus ErythematosusA Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Subcutaneous Anifrolumab in Adult Patients with Systemic Lupus Erythematosus - Tulip SC Moderate-to-severe Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Anifrolumab
Product Code: MEDI-546
INN or Proposed INN: ANIFROLUMAB
Other descriptive name: ANIFROLUMAB
AstraZenecaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 3United States;Spain;Ukraine;Chile;Russian Federation;Colombia;United Kingdom;Hungary;Mexico;Argentina;Poland;Peru;Bulgaria;Germany;Japan
102EUCTR2020-005569-14-HU
(EUCTR)
24/08/202109/07/2021A Clinical Study of Nipocalimab in Adult Participants with Active Systemic Lupus ErythematosusA Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Nipocalimab in Adult Participants with Active Systemic Lupus Erythematosus Active Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nipocalimab
Product Code: JNJ-80202135
INN or Proposed INN: Nipocalimab
Other descriptive name: M281
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
225Phase 2United States;Hong Kong;Taiwan;Spain;Ukraine;Russian Federation;Colombia;Hungary;Argentina;Poland;South Africa;Bulgaria;Germany;Japan
103NCT04882878
(ClinicalTrials.gov)
August 20, 20217/5/2021A Study of Nipocalimab in Adult Participants With Active Systemic Lupus ErythematosusA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Nipocalimab in Adult Participants With Active Systemic Lupus ErythematosusSystemic Lupus ErythematosusOther: Placebo;Drug: Nipocalimab;Drug: Standard-of-care treatmentJanssen Research & Development, LLCNULLRecruiting18 Years65 YearsAll225Phase 2United States;Argentina;Bulgaria;Colombia;Germany;Hungary;Japan;Poland;South Africa;Spain;Taiwan;Ukraine;Hong Kong;Russian Federation
104EUCTR2020-005528-12-ES
(EUCTR)
17/08/202118/08/2021A Phase 2 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of VIB7734 for the Treatment of Moderate to Severely Active Systemic Lupus ErythematosusA Phase 2 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of VIB7734 for the Treatment of Moderate to Severely Active Systemic Lupus Erythematosus - RECAST SLE Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: VIB7734
Product Code: VIB7734
INN or Proposed INN: VIB7734
Other descriptive name: VIB7734, MEDI7734
Viela Bio, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
195Phase 2United States;Serbia;Taiwan;Mexico;Greece;Argentina;Poland;Spain;Ukraine;Russian Federation;India
105NCT05000216
(ClinicalTrials.gov)
August 13, 20216/8/2021COVID-19 Booster Vaccine in Autoimmune Disease Non-RespondersBooster Effects With Autoimmune Treatments in Patients With Poor Response to Initial COVID-19 Vaccine (ACV01)Rheumatoid Arthritis (RA);Systemic Lupus Erythematosus (SLE);Pemphigus Vulgaris;Multiple Sclerosis (MS);Systemic Sclerosis (SSc);Pediatric SLE;Juvenile Idiopathic Arthritis (JIA);Juvenile Dermatomyositis (JDM);Pediatric-Onset Multiple Sclerosis (POMS)Biological: Moderna mRNA-1273;Biological: BNT162b2;Biological: Ad26.COV2.S;Drug: Continue IS (MMF or MPA);Drug: Continue IS (MTX);Biological: Continue IS (B cell depletion therapy);Biological: Monovalent [B.1.351] CoV2 preS dTM-AS03;Drug: Withhold IS (MMF or MPA);Drug: Withhold IS (MTX);Drug: Withhold IS (B cell depletion therapy);Biological: Moderna mRNA-1273, Bivalent;Biological: BNT162b2, BivalentNational Institute of Allergy and Infectious Diseases (NIAID)Autoimmunity Centers of Excellence;Rho Federal Systems Division, Inc.Recruiting2 YearsN/AAll2340Phase 2United States
106EUCTR2018-004175-12-IT
(EUCTR)
13/08/202117/08/2021A Phase 2b multicenter dose ranging study to evaluate efficacy and safety of PF-06700841 in systemic lupus erythematosus.A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) - - Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: PF-06700841
Product Code: [PF-06700841 5 mg]
INN or Proposed INN: brepocitinib
Product Name: PF-06700841
Product Code: [PF-06700841 25mg]
INN or Proposed INN: brepocitinib
Other descriptive name: PF-06700841-15
PFIZER INCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
448Phase 2United States;Serbia;Portugal;Taiwan;Greece;Spain;Ukraine;Colombia;Italy;France;Australia;China;Korea, Republic of;Czechia;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan
107EUCTR2020-005569-14-ES
(EUCTR)
13/08/202113/08/2021A Clinical Study of Nipocalimab in Adult Participants with Active Systemic Lupus ErythematosusA Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Nipocalimab in Adult Participants with Active Systemic Lupus Erythematosus Active Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nipocalimab
Product Code: JNJ-80202135
INN or Proposed INN: Nipocalimab
Other descriptive name: M281
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
225Phase 2United States;Hong Kong;Taiwan;Spain;Ukraine;Russian Federation;Colombia;Hungary;Argentina;Poland;South Africa;Bulgaria;Germany;Japan
108EUCTR2020-003509-72-AT
(EUCTR)
12/08/202111/05/2021Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic LupusErythematosusA Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy Active Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Efavaleukin Alfa
Product Code: AMG 592
INN or Proposed INN: EFAVALEUKIN ALFA
Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN
Amgen Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 2United States;Hong Kong;Taiwan;Greece;Spain;Turkey;Austria;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Mexico;Canada;Poland;Bulgaria;Japan;Korea, Republic of
109EUCTR2020-004047-86-ES
(EUCTR)
11/08/202123/06/2021A Study of ALPN-101 in Active LupusA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ALPN-101 IN SYSTEMIC LUPUS ERYTHEMATOSUS Systemic lupus erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042946;Term: Systemic lupus erythematosus rash;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 21.1;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.1;Level: LLT;Classification code 10042948;Term: Systemic lupus erythematosus syndrome aggravated;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Classification code 10029142;Term: Nephritis systemic lupus erythematosus;System Organ Class: 100000004857
MedDRA version: 20.1;Classification code 10067657;Term: Systemic lupus erythematosus disease activity index increased;System Organ Class: 10022891 - Investigations
MedDRA version: 20.0;Classification code 10067658;Term: Systemic lupus erythematosus disease activity index decreased;System Organ Class: 10022891 - Investigations
MedDRA version: 20.1;Classification code 10067659;Term: Systemic lupus erythematosus disease activity index abnormal;System Organ Class: 10022891 - Investigations
MedDRA version: 21.0;Classification code 10080670;Term: Systemic lupus erythematosus reactivation;Classification code 10073694;Term: Lupus pleurisy;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 21.1;Classification code 10040968;Term: SLE arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: ALPN-101
INN or Proposed INN: Acazicolcept
Other descriptive name: ALPN-101
Alpine Immune Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 2France;United States;Poland;Spain;Russian Federation;Germany;Korea, Republic of
110EUCTR2020-005760-57-ES
(EUCTR)
30/07/202123/06/2021A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Patients with Systemic Lupus ErythematosusA PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OBINUTUZUMAB IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Gazyvaro
INN or Proposed INN: OBINUTUZUMAB
Roche Farma S. A. U. que realiza el ensayo en España y que actúa como representante F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3United States;Spain;Russian Federation;Italy;United Kingdom;France;Mexico;Argentina;Brazil;Poland;Australia;Peru;South Africa;New Zealand
111EUCTR2020-003509-72-IT
(EUCTR)
27/07/202117/08/2021Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic Lupus ErythematosusA Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy - NA Active Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Efavaleukin Alfa
Product Code: [AMG 592]
INN or Proposed INN: EFAVALEUKIN ALFA
Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN
AMGEN INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 2United States;Hong Kong;Taiwan;Greece;Spain;Turkey;Austria;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Mexico;Canada;Poland;Bulgaria;Japan
112NCT04976322
(ClinicalTrials.gov)
July 27, 202114/7/2021A Study to Evaluate the Safety and Tolerability of Dapirolizumab Pegol in Study Participants With Systemic Lupus ErythematosusA Multicenter, Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of Dapirolizumab Pegol Treatment in Study Participants With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: Dapirolizumab pegolUCB Biopharma SRLNULLEnrolling by invitation16 YearsN/AAll760Phase 3Germany;Greece;Hungary;Mexico;Poland;Romania;Serbia;Spain;Taiwan;United States;Argentina;Belgium;Bulgaria;Canada;Chile;Colombia;Czechia
113ChiCTR2100048635
2021-07-192021-07-12The Impact of low-dose prednisone withdrawal on disease flare and organ damage in SLE patients: a randomized clinical trialThe Impact of low-dose prednisone withdrawal on disease flare and organ damage in SLE patients: a randomized clinical trial Systemic Lupus ErythematosusWithdrawal group:withdraw low dose prednisone;maintanence group:maintain low dose prednisone;Peking University First HospitalNULLPendingBothWithdrawal group:92;maintanence group:92;China
114NCT04961567
(ClinicalTrials.gov)
July 16, 20215/7/2021A Study to Evaluate the Efficacy and Safety of BIIB059 (Litifilimab) in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of CareA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of CareLupus Erythematosus, SystemicDrug: BIIB059 (litifilimab);Drug: PlaceboBiogenNULLRecruiting18 YearsN/AAll540Phase 3United States;Argentina;Belgium;Canada;China;Colombia;Czechia;Germany;Hungary;Israel;Italy;Japan;Netherlands;Puerto Rico;Romania;Serbia;United Kingdom;Bulgaria
115EUCTR2019-003409-83-ES
(EUCTR)
15/07/202114/06/2021A Study to evaluate the safety and tolerability of dapirolizumab pegol in study participants with systemic lupus erythematosusA Multicenter, Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of Dapirolizumab Pegol Treatment in Study Participants With Systemic Lupus Erythematosus Systemic lupus erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Dapirolizumab pegol
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
760Phase 3Serbia;United States;Portugal;Philippines;Taiwan;Hong Kong;Greece;Spain;Chile;Colombia;Italy;France;Peru;Australia;Denmark;Korea, Republic of;Czechia;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan
116ChiCTR2100048796
2021-07-152021-07-16A prospective non-randomized controlled study of integrated traditional Chinese and western medicine for moderately active systemic lupus erythematosusA prospective cohort study of integrated traditional Chinese and western medicine for moderately active systemic lupus erythematosus Systemic lupus erythematosusExperimental group:Western medicine + Jiedu Quyu Zishen Fang's modified treatment based on syndrome differentiation;Control Group:Western Medicine (glucocorticoid, hydroxychloroquine, methotrexate, azathioprine or cyclophosphamide);Zhejiang Chinese Medical UniversityNULLPending1865FemaleExperimental group:264;Control Group:264;N/AChina
117ITMCTR2100005063
2021-07-152021-07-16A prospective non-randomized controlled study of integrated traditional Chinese and western medicine for moderately active systemic lupus erythematosusA prospective cohort study of integrated traditional Chinese and western medicine for moderately active systemic lupus erythematosus Systemic lupus erythematosusExperimental group:Western medicine + Jiedu Quyu Zishen Fang's modified treatment based on syndrome differentiation;Control Group:Western Medicine (glucocorticoid, hydroxychloroquine, methotrexate, azathioprine or cyclophosphamide);Zhejiang Chinese Medical UniversityNULLPending1865FemaleExperimental group:264;Control Group:264;N/AChina
118EUCTR2020-004047-86-PL
(EUCTR)
14/07/202109/06/2021A Study of ALPN-101 in Active LupusA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ALPN-101 IN SYSTEMIC LUPUS ERYTHEMATOSUS Systemic lupus erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042946;Term: Systemic lupus erythematosus rash;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 21.1;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.1;Level: LLT;Classification code 10042948;Term: Systemic lupus erythematosus syndrome aggravated;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Classification code 10029142;Term: Nephritis systemic lupus erythematosus;System Organ Class: 100000004857
MedDRA version: 20.1;Classification code 10067657;Term: Systemic lupus erythematosus disease activity index increased;System Organ Class: 10022891 - Investigations
MedDRA version: 20.0;Classification code 10067658;Term: Systemic lupus erythematosus disease activity index decreased;System Organ Class: 10022891 - Investigations
MedDRA version: 20.1;Classification code 10067659;Term: Systemic lupus erythematosus disease activity index abnormal;System Organ Class: 10022891 - Investigations
MedDRA version: 21.0;Classification code 10080670;Term: Systemic lupus erythematosus reactivation;Classification code 10073694;Term: Lupus pleurisy;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 21.1;Classification code 10040968;Term: SLE arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: ALPN-101
INN or Proposed INN: Acazicolcept
Other descriptive name: ALPN-101
Alpine Immune Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 2United States;France;Taiwan;Hungary;Spain;Poland;Russian Federation;Germany;Korea, Republic of
119NCT03684564
(ClinicalTrials.gov)
July 9, 202113/8/2018RIvaroxaban for Stroke Patients With AntiPhospholipid SyndromeRivaroxaban Versus Warfarin for Stroke Patients With Antiphospholipid Syndrome, With or Without SLE (RISAPS): a Randomised, Controlled, Open Label, Phase II/III, Non-inferiority TrialAntiphospholipid Syndrome;Systemic Lupus Erythematosus;Stroke;Ischemic Stroke;Brain IschemiaDrug: Rivaroxaban;Drug: WarfarinUniversity College, LondonUniversity College London Hospitals;Barking, Havering and Redbridge University Hospitals NHS Trust;Hammersmith Hospitals NHS Trust;Epsom and St Helier University Hospitals NHS Trust;Barts & The London NHS Trust;King's College Hospital NHS Trust;Versus Arthritis (Funder)Recruiting18 YearsN/AAll140Phase 2/Phase 3United Kingdom
120EUCTR2021-000962-14-DE
(EUCTR)
02/07/202119/04/2021A drug trial to evaluate the safety and efficacy of daratumumab, an agent already approved for other diseases, in combination with standard background anti-rheumatic therapy in patients with moderate-to-severe systemic lupus erythematosusA Monocenter, Open Label Study to Evaluate the Safety and Efficacy of Daratumumab in Combination with Standard Background Therapy in Participants with Moderate to Severe Systemic Lupus Erythematosus - DARALUP Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Darzalex
Product Name: Daratumumab
Product Code: JNJ-54767414
Charité - Universitätsmedizin BerlinNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
10Phase 2Germany
121ChiCTR2100048082
2021-07-012021-06-30Identification of Serum and Exosome Markers in Lupus NephritisDevelopment and Application of an Early Diagnosis Scheme for Lupus Nephritis Based on Serum Noncoding Small RNA Systemic Lupus ErythematosusGold Standard:The SLE classification standard revised by the American Academy of Rheumatology in 1997 and the SLE classification standard revised by the American Academy of Rheumatology in 2009;Index test:serum and exosome markers;The Affiliated Drum Tower Hospital of Nanjing University Medical SchoolNULLRecruitingBothTarget condition:100;Difficult condition:100China
122NCT04750057
(ClinicalTrials.gov)
July 1, 20219/2/2021Anifrolumab Early Access ProgramAn Early Access Program for Anifrolumab Treatment in Adult Patients With Active Systemic Lupus Erythematosus - AMANASystemic Lupus ErythematosusDrug: AnifrolumabAstraZenecaClinigen, Inc.No longer available18 YearsN/AAllNULL
123NCT04810754
(ClinicalTrials.gov)
June 30, 202111/3/2021An Open Label Study to Evaluate Daratumumab in Participants With Moderate to Severe Systemic Lupus ErythematosusA Monocenter, Open Label Study to Evaluate the Safety and Efficacy of Daratumumab in Combination With Standard Background Therapy in Participants With Moderate to Severe Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: Daratumumab InjectionCharite University, Berlin, GermanyJanssen-Cilag G.m.b.H;Labor Berlin-Charité Vivantes G.m.b.H;Deutsches Rheuma-Forschungszentrum Berlin (DRFZ);Charité Clinical Trial Office (CTO)Not yet recruiting18 Years60 YearsAll10Phase 2NULL
124NCT04925934
(ClinicalTrials.gov)
June 24, 20214/5/2021Study of VIB7734 for the Treatment of Moderate to Severely Active SLEA Phase 2 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of VIB7734 for the Treatment of Moderate to Severely Active Systemic Lupus ErythematosusLupus Erythematosus, SystemicDrug: VIB7734;Other: PlaceboViela Bio (acquired by Horizon Therapeutics)NULLActive, not recruiting18 Years70 YearsAll214Phase 2United States;Argentina;Greece;India;Mexico;Poland;Russian Federation;Serbia;Spain;Taiwan;Ukraine
125NCT04835441
(ClinicalTrials.gov)
June 22, 20215/4/2021ALPN-101 (Acazicolcept) in Systemic Lupus ErythematosusA Randomized, Double-blind, Placebo-controlled Study of ALPN-101 in Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: ALPN-101;Drug: PlaceboAlpine Immune Sciences, Inc.NULLRecruiting18 Years70 YearsAll130Phase 2United States;France;Hungary;Korea, Republic of;Poland;Spain;Taiwan
126EUCTR2020-003509-72-GR
(EUCTR)
17/06/202122/04/2021A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy Active Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Efavaleukin Alfa
Product Code: AMG 592
INN or Proposed INN: EFAVALEUKIN ALFA
Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN
Amgen Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 2United States;Taiwan;Hong Kong;Greece;Spain;Turkey;Austria;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Mexico;Canada;Poland;Bulgaria;Japan
127EUCTR2020-003509-72-ES
(EUCTR)
17/06/202111/06/2021Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic Lupus ErythematosusA Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy Active Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Efavaleukin Alfa
Product Code: AMG 592
INN or Proposed INN: EFAVALEUKIN ALFA
Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN
Amgen Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 2United States;Hong Kong;Taiwan;Greece;Spain;Turkey;Austria;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Mexico;Canada;Poland;Bulgaria;Japan
128NCT05260255
(ClinicalTrials.gov)
June 15, 202112/5/2021Effect of Vitamin D Supplement on Disease Activity in SLEThe Effect of Vitamin D Supplementation on Disease Activity of Systemic Lupus Erythematosus Patients: A Randomized Clinical Trial in Rajavithi HospitalVitamin D Deficiency;Hypocalcemia;Hyperparathyroidism;Systemic Lupus Erythematosus (Disorder)Drug: vitamin D2 ( calciferol );Drug: PlaceboRajavithi HospitalNULLRecruiting18 YearsN/AAll100N/AThailand
129EUCTR2019-002205-22-NL
(EUCTR)
15/06/202111/02/2020Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment.A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 23.1;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Branebrutinib
Product Code: BMS-986195
INN or Proposed INN: Branebrutinib
Other descriptive name: BMS986195
Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: ORENCIA
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
185Phase 2France;United States;Mexico;Argentina;Spain;Poland;Belgium;Germany;Netherlands;United Kingdom
130EUCTR2019-000328-16-GR
(EUCTR)
10/06/202112/05/2021Safety and Efficacy of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE)A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Rozibafusp Alfa (AMG 570) in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy - Safety and Efficacy of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) Active Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: AMG 570
INN or Proposed INN: AMG 570
Other descriptive name: AMG 570
Product Code: AMG 570
INN or Proposed INN: AMG 570
Other descriptive name: AMG 570
Product Code: AMG 570
INN or Proposed INN: AMG 570
Other descriptive name: AMG 570
Amgen IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 2Portugal;United States;Czechia;Hong Kong;Greece;Spain;Russian Federation;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Australia;Bulgaria;Germany;Japan;Korea, Republic of
131NCT04877691
(ClinicalTrials.gov)
June 8, 20214/5/2021Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus ErythematosusA Multicenter, Randomized, Double-Blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: Medi-546;Drug: PlaceboAstraZenecaIqvia Pty LtdRecruiting18 Years70 YearsAll360Phase 3United States;Argentina;Bulgaria;Chile;Colombia;Germany;Hungary;Japan;Mexico;Peru;Poland;Russian Federation;Spain;Ukraine;United Kingdom
132NCT04643067
(ClinicalTrials.gov)
June 3, 202112/11/2020Phase 1b/2a Study to Evaluate Safety and Efficacy of KPG-818 in SLEA Phase 1b/2a Multicenter Study to Assess the Safety and Tolerability, Pharmacokinetics, and Preliminary Efficacy of KPG-818 in Patients With Systemic Lupus ErythematosusSLE; DrugDrug: 0.15mg KPG-818 dose;Drug: 0.6mg KPG-818 dose;Drug: 2mg KPG-818 dose;Drug: PlaceboKangpu Biopharmaceuticals, Ltd.NULLRecruiting18 YearsN/AAll60Phase 1/Phase 2United States
133NCT04902807
(ClinicalTrials.gov)
June 202121/5/2021Conception of a Diagnosis, Prognosis and Therapeutic Decision Tool for Patients With Autoimmunity and InflammationConception of a Diagnosis, Prognosis and Therapeutic Decision Tool for Patients With Autoimmunity and InflammationAutoimmune Lymphoproliferative Syndrome;Autoimmune Cytopenia;Autoimmune Diseases;Autoimmune Anemia;Autoimmune Thrombocytopenia;Autoimmune Hepatitis;Autoimmune Diabetes;Autoimmune Rheumatologic Disease;Systemic Lupus Erythematosus;Juvenile Idiopathic Arthritis;Hemophagocytic Lymphohistiocytoses;EBV Lymphoproliferation;RAS-Associated Autoimmune Leucoproliferative Disease;Primary Immunodeficiency;APECED;IPEX;BENTA;Enteropathy, Autoimmune;Combined Immunodeficiency;IBDBiological: Collection of samplesInstitut National de la Santé Et de la Recherche Médicale, FranceNULLNot yet recruiting1 Year18 YearsAll500NULL
134NCT04895241
(ClinicalTrials.gov)
May 25, 202117/5/2021A Study to Evaluate the Efficacy and Safety of BIIB059 (Litifilimab) in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of CareA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of CareLupus Erythematosus, SystemicDrug: BIIB059 (litifilimab);Drug: PlaceboBiogenNULLRecruiting18 YearsN/AAll540Phase 3Australia;Bulgaria;Chile;United States;France;Greece;Korea, Republic of;Mexico;Poland;Spain;Sweden;Taiwan;China
135EUCTR2020-003509-72-PL
(EUCTR)
21/05/202111/05/2021Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic LupusErythematosusA Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy Active Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Efavaleukin Alfa
Product Code: AMG 592
INN or Proposed INN: EFAVALEUKIN ALFA
Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN
Amgen Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 2Russian Federation;Chile;Colombia;Italy;Switzerland;France;Mexico;Canada;Poland;Bulgaria;Japan;Korea, Republic of;Spain;Turkey;Austria;United States;Hong Kong;Taiwan;Greece
136NCT04680637
(ClinicalTrials.gov)
May 6, 202118/12/2020Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus ErythematosusA Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care TherapyActive Systemic Lupus ErythematosusDrug: Efavaleukin Alfa;Drug: Placebo;Other: Standard of CareAmgenNULLRecruiting18 Years75 YearsAll320Phase 2United States;Austria;Bulgaria;Canada;Chile;Colombia;France;Greece;Hong Kong;Italy;Japan;Korea, Republic of;Mexico;Poland;Russian Federation;Spain;Switzerland;Taiwan;Turkey
137JPRN-jRCT2041210076
06/05/202101/10/2021Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus ErythematosusA Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy Active Systemic Lupus ErythematosusPlacebo Comparator: Placebo + Standard of Care
Interventions: Drug: Placebo
Other: Standard of Care
Experimental: Efavaleukin Alfa Dose Level One + Standard of Care
Interventions: Drug: Efavaleukin Alfa
Other: Standard of Care
Experimental: Efavaleukin Alfa Dose Level Two + Standard of Care
Interventions: Drug: Efavaleukin Alfa
Other: Standard of Care
Experimental: Efavaleukin Alfa Dose Level Three + Standard of Care
Interventions: Drug: Efavaleukin Alfa
Other: Standard of Care
Hama YorikoNULLRecruiting>= 18age old<= 75age oldBoth320Phase 2United States;Korea, Republic of;Poland;Turkey;Greece,;Spain;Japan
138EUCTR2020-001690-72-BG
(EUCTR)
23/04/202111/03/2021A Study to Investigate the Long-Term Safety and Efficacy of ABBV-599 (ABBV-105 and ABT-494 Given Alone or in Combination) in Participants with Moderately to Severely Active Systemic Lupus Erythematosus who have completed Study M19-130.A Phase 2, Long-Term Extension (LTE) Study with Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus Who Have Completed the M19-130 Phase 2 Randomized Controlled Trial (RCT) - A Phase 2, Long-Term Extension (LTE) Study in Subjects with Moderately to Severely Active SLE Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Elsubrutinib
Product Code: ABBV-105
INN or Proposed INN: Elsubrutinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: UPADACITINIB
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: UPADACITINIB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
260Phase 2United States;Taiwan;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Australia;Bulgaria;Netherlands;Germany;China;Japan;Korea, Republic of
139NCT04516408
(ClinicalTrials.gov)
April 20, 202113/8/2020Recombinant Zoster Vaccine in Stable SLE PatientsEfficacy and Safety of Recombinant Zoster Vaccine in Stable SLE Patients(Vtrial)Herpes Zoster;Recombinant Zoster Vaccine;Systemic Lupus ErythematosusBiological: Recombinant zoster vaccine;Biological: PlaceboRenJi HospitalNULLRecruiting50 YearsN/AAll464N/AChina
140ChiCTR2100043138
2021-04-012021-02-05Efficacy of belimumab combined with standard of care in patients with untreated systemic lupus erythematosusEfficacy of belimumab combined with standard of care in patients with untreated systemic lupus erythematosus Systemic lupus erythematosusBelimumab+SoC group:Belimumab+SoC;SoC group:SoC;Affiliated Hospital of Guilin Medical CollegeNULLRecruiting1665BothBelimumab+SoC group:40;SoC group:40;Phase 4China
141EUCTR2019-003406-27-CZ
(EUCTR)
23/03/202123/12/2020A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosusA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS GO Systemic lupus erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Dapirolizumab pegol
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Serbia;Portugal;Philippines;Taiwan;Greece;Spain;Chile;Colombia;Italy;France;Peru;Australia;Denmark;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany
142NCT04515719
(ClinicalTrials.gov)
March 19, 202113/8/2020Efficacy and Safety of Belimumab in SLE PatientsEfficacy and Safety of Belimumab for Prevention of Disease Flares in SLE Patients With Low Disease ActivitySystemic Lupus ErythematosusBiological: Belimumab;Biological: PlaceboRenJi HospitalNULLRecruiting18 Years70 YearsAll334Phase 4China
143EUCTR2020-001690-72-DE
(EUCTR)
02/03/202115/01/2021A Study to Investigate the Long-Term Safety and Efficacy of ABBV-599 (ABBV-105 and ABT-494 Given Alone or in Combination) in Participants with Moderately to Severely Active Systemic Lupus Erythematosus who have completed Study M19-130.A Phase 2, Long-Term Extension (LTE) Study with Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus Who Have Completed the M19-130 Phase 2 Randomized Controlled Trial (RCT) - A Phase 2, Long-Term Extension (LTE) Study in Subjects with Moderately to Severely Active SLE Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Elsubrutinib
Product Code: ABBV-105
INN or Proposed INN: Elsubrutinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: UPADACITINIB
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: UPADACITINIB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
260Phase 2United States;Taiwan;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Australia;Bulgaria;Netherlands;Germany;China;Japan;Korea, Republic of
144EUCTR2020-001177-78-FR
(EUCTR)
25/02/202109/04/2020Certolizumab to Prevent Pregnancy Complications in High-Risk Patients with Antiphospholipid syndrome (APS) or systemic lupus erythematosus (SLE)Certolizumab to Prevent Pregnancy Complications in High-Risk Patients with APS or SLE - IMPACT Pregnant women with Antiphospholipid Syndrom (APS) and Lupus Antocoagulant (LAC)
MedDRA version: 20.0;Level: PT;Classification code 10002817;Term: Antiphospholipid syndrome;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10058347;Term: Lupus anticoagulant positive;System Organ Class: 100000004848
MedDRA version: 20.0;Classification code 10058355;Term: Lupus anticoagulant;System Organ Class: 100000004848;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
Trade Name: CIMZIA
Product Name: Certolizumab
INN or Proposed INN: CERTOLIZUMAB PEGOL
University of UtahNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: no
50Phase 2United States;France
145NCT04839315
(ClinicalTrials.gov)
February 15, 20215/4/2021COVID-19 Vaccination in Rheumatic Disease PatientsImmunological Consequences of COVID-19 Vaccination in Patients With Rheumatic DiseasesSystemic Lupus Erythematosus;Sjogren's Syndrome;Inflammatory Myositis;Psoriatic Arthritis;Gout;Ankylosing Spondylitis;Arthritis of Multiple Sites Associated With Inflammatory Bowel Disease (Diagnosis);OsteoarthritisBiological: mRNA COVD19 vaccineMayo ClinicNULLTerminated18 YearsN/AAll58Early Phase 1United States
146EUCTR2019-003323-38-DE
(EUCTR)
21/01/202103/07/2020A study to determinate the safety and efficacy of LY3471851 in Adult Patients with Systemic Lupus ErythematosusA Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of LY3471851 (NKTR-358) in Adults with Systemic Lupus Erythematosus - ISLAND-SLE Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: LY3471851
Product Code: LY3471851
INN or Proposed INN: Not Applicable
Other descriptive name: LY3471851
Eli Lilly & CompanyNULLNot RecruitingFemale: yes
Male: yes
280Phase 2Argentina;Russian Federation;Romania;Hungary;United States;Japan;Ukraine;United Kingdom;India;Spain;Canada;Czech Republic;Taiwan;Korea, Republic of;Poland;Mexico;Israel;Australia;Germany
147NCT04726553
(ClinicalTrials.gov)
January 20, 202122/1/2021Nature of Anifrolumab Impact on Vaccine-Emergent Immunity in SLENature of Anifrolumab Impact on Vaccine-Emergent Immunity in Patients With Moderately to Severely Active Systemic Lupus Erythematosus: A Multi-Centre Open Label Parallel Group Trial:Systemic Lupus Erythematosus (SLE)Drug: Anifrolumab;Drug: Standard of CareOklahoma Medical Research FoundationNYU Langone Health;Yale University;Piedmont Heart Institute, Inc., Atlanta, GA;Columbia UniversityRecruiting18 Years70 YearsAll20Early Phase 1United States
148ChiCTR2200055471
2021-01-012022-01-10Efficacy and safety of low-dose CTX combined with belimumab based on B/T cell balance in the treatment of moderate to severe systemic lupus erythematosus: a medical record-based studyEfficacy and safety of low-dose CTX combined with belimumab based on B/T cell balance in the treatment of moderate to severe systemic lupus erythematosus Systemic Lupus Erythematosus (SLE)belimumab group:Low-dose cyclophosphamide combined with belimumab;cyclophosphamide group:Standard dose cyclophosphamide;The Second Hospital of Shanxi Medical UniversityNULLRecruiting1880Bothbelimumab group:40;cyclophosphamide group:42;China
149NCT04570306
(ClinicalTrials.gov)
December 31, 202019/6/2020Transcriptional and Immine Parameters of Response to BelinumabWhole Blood Transcriptional and Mass Cytometry Immune Profiling in Systemic Lupus Erythematosus (SLE) Patients to Discern the Salutary Effects of Belimumab on Halting Disease Progression and Flares Without Compromising Host FitnessSystemic Lupus ErythematosusDrug: BelimumabBiomedical Research Foundation, Academy of AthensNULLNot yet recruiting18 Years65 YearsAll80NULL
150NCT04700267
(ClinicalTrials.gov)
December 28, 20206/1/2021A Study Evaluating the Effects of GLPG3970 Given as Oral Treatment for 12 Weeks in Adults With Systemic Lupus ErythematosusA Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Orally Administered GLPG3970 for 12 Weeks in Adult Subjects With Active Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: GLPG3970 film-coated tablet;Drug: Placebo film-coated tabletGalapagos NVNULLTerminated18 Years65 YearsAll11Phase 1Bulgaria;Moldova, Republic of;Poland;Spain;Ukraine
151EUCTR2020-001690-72-IT
(EUCTR)
22/12/202024/05/2021A Study to Investigate the Long-Term Safety and Efficacy of ABBV-599 (ABBV-105 and ABT-494 Given Alone or in Combination) in Participants with Moderately to Severely Active Systemic Lupus Erythematosus who have completed Study M19-130.A Phase 2, Long-Term Extension (LTE) Study with Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus Who Have Completed the M19-130 Phase 2 Randomized Controlled Trial (RCT) - A Phase 2, Long-Term Extension (LTE) Study in Subjects with Moderately to Severely Active SLE Systemic Lupus Erythematosus (SLE)E.1.1.1.IT - Condizione clinica in un linguaggio facilmente comprensibile Il lupus eritematoso sistemico (LES) è una patologia cronica in cui il sistema immunitario dell’organismo può attaccare la pelle, le articolazioni, i reni, il cervello e/o altri organi dell’organismo stesso. Spesso colpisce con maggiore frequenza le donne e le persone di origine africana.
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Elsubrutinib
Product Code: [ABBV-105]
INN or Proposed INN: Elsubrutinib
Product Name: Upadacitinib
Product Code: [ABT-494]
INN or Proposed INN: UPADACITINIB
Product Name: Upadacitinib
Product Code: [ABT-494]
INN or Proposed INN: UPADACITINIB
ABBVIE DEUTSCHLAND GMBH & CO. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
260Phase 2United States;Taiwan;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Australia;Bulgaria;Netherlands;Germany;China;Japan;Korea, Republic of
152EUCTR2020-001690-72-NL
(EUCTR)
21/12/202010/09/2020A Study to Investigate the Long-Term Safety and Efficacy of ABBV-599 (ABBV-105 and ABT-494 Given Alone or in Combination) in Participants with Moderately to Severely Active Systemic Lupus Erythematosus who have completed Study M19-130.A Phase 2, Long-Term Extension (LTE) Study with Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus Who Have Completed the M19-130 Phase 2 Randomized Controlled Trial (RCT) - A Phase 2, Long-Term Extension (LTE) Study in Subjects with Moderately to Severely Active SLE Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Elsubrutinib
Product Code: ABBV-105
INN or Proposed INN: Elsubrutinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: UPADACITINIB
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: UPADACITINIB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
260Phase 2United States;Taiwan;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Australia;Bulgaria;Netherlands;Germany;China;Japan;Korea, Republic of
153NCT04647708
(ClinicalTrials.gov)
December 16, 202023/11/2020Study of M5049 in CLE and SLE ParticipantsA Phase Ib, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Safety and Pharmacokinetics of Multiple Ascending Doses of M5049 Administered Orally in SLE and CLE Participants Treated With Standard of CareSystemic Lupus Erythematosus;Cutaneous Lupus ErythematosusDrug: M5049;Drug: PlaceboMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyNULLRecruiting18 Years65 YearsAll44Phase 1Bulgaria;Germany;Moldova, Republic of;North Macedonia;Spain;Ukraine
154EUCTR2019-003406-27-PT
(EUCTR)
14/12/202029/06/2020A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS GO A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS GO Systemic lupus erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Dapirolizumab pegol
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Serbia;Portugal;Philippines;Taiwan;Greece;Spain;Chile;Colombia;Italy;France;Peru;Australia;Denmark;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany
155EUCTR2019-000638-20-BG
(EUCTR)
09/11/202014/08/2020A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus ErythematosusA Phase 2 Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Elsubrutinib
Product Code: ABBV-105
INN or Proposed INN: ELSUBRUTINIB
Other descriptive name: ABBV-105
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: UPADACITINIB
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: UPADACITINIB
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
325Phase 2United States;Taiwan;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Australia;Bulgaria;Netherlands;Germany;New Zealand;China;Japan;Korea, Republic of
156EUCTR2019-003323-38-GB
(EUCTR)
06/11/202013/10/2020A study to determinate the safety and efficacy of LY3471851 in Adult Patients with Systemic Lupus ErythematosusA Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of LY3471851 (NKTR-358) in Adults with Systemic Lupus Erythematosus - ISLAND-SLE Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: LY3471851
Product Code: LY3471851
INN or Proposed INN: Not applicable
Other descriptive name: LY3471851
Eli Lilly & CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
280Phase 2United States;Taiwan;Spain;Ukraine;Russian Federation;Israel;United Kingdom;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Australia;Germany;Japan;Korea, Republic of
157EUCTR2019-003323-38-HU
(EUCTR)
04/11/202010/09/2020A study to determinate the safety and efficacy of LY3471851 in Adult Patients with Systemic Lupus ErythematosusA Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of LY3471851 (NKTR-358) in Adults with Systemic Lupus Erythematosus - ISLAND-SLE Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: LY3471851
Product Code: LY3471851
INN or Proposed INN: Not applicable
Other descriptive name: LY3471851
Eli Lilly & CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
280Phase 2United States;Taiwan;Spain;Ukraine;Russian Federation;Israel;United Kingdom;India;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Romania;Australia;Germany;Japan;Korea, Republic of
158NCT04582136
(ClinicalTrials.gov)
November 20203/10/2020Efficacy and Safety of Sirolimus in Active Systemic Lupus ErythematosusEfficacy and Safety of Sirolimus in Patients With Active Systemic Lupus Erythematosus Despite Standard of Care: a Multi-center, Double Blinded, Randomized, Placebo-controlled, Phase 2 TrialSystemic Lupus ErythematosusDrug: Sirolimus;Drug: PlaceboChinese SLE Treatment And Research GroupBeijing Municipal Science & Technology Commission;North China Pharmaceutical Group CorporationNot yet recruiting18 Years65 YearsAll146Phase 2NULL
159NCT04440566
(ClinicalTrials.gov)
October 13, 202017/6/2020O-GlcNAcylation Role in the Pathophysiology of Systemic Lupus ErythematosusO-GlcNAcylation Role in the Pathophysiology of Systemic Lupus ErythematosusSystemic Lupus ErythematosusBiological: blood sampleUniversity Hospital, BordeauxNULLRecruiting18 YearsN/AAll100N/AFrance
160EUCTR2019-003323-38-PL
(EUCTR)
09/10/202007/10/2020A study to determinate the safety and efficacy of LY3471851 in Adult Patients with Systemic Lupus ErythematosusA Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of LY3471851 (NKTR-358) in Adults with Systemic Lupus Erythematosus - ISLAND-SLE Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: LY3471851
Product Code: LY3471851
INN or Proposed INN: Not applicable
Other descriptive name: LY3471851
Eli Lilly & CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
280Phase 2United States;Czechia;Taiwan;Spain;Ukraine;Israel;Russian Federation;United Kingdom;India;Hungary;Mexico;Canada;Argentina;Poland;Romania;Australia;Germany;Japan;Korea, Republic of
161EUCTR2019-003406-27-IT
(EUCTR)
07/10/202021/01/2021A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosusA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - - Systemic lupus erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Dapirolizumab pegol
Product Code: [CDP7657]
INN or Proposed INN: Dapirolizumab pegol
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3Portugal;Serbia;United States;Philippines;Taiwan;Estonia;Slovakia;Greece;Spain;Chile;Colombia;Switzerland;Italy;France;Denmark;Peru;Australia;Netherlands;Korea, Republic of;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Sweden
162ChiCTR2000038519
2020-10-012020-09-23A study of T lymphocyte subsets in children with systemic lupus erythematosusA study of T lymphocyte subsets in children with systemic lupus erythematosus systemic lupus erythematosus in childrenGold Standard:anti-nuclear antibodies;Index test:WBC, CD4+T cells, CD4+CCR7+CD95+T cells, CD4+CD45RA-CCR7+T cells, CD4+CD45RA-CCR7-Tcells;Tianjin Children's HospitalNULLPending817BothTarget condition:100;Difficult condition:50N/AChina
163EUCTR2019-002205-22-FR
(EUCTR)
01/10/202013/01/2020Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment.A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Branebrutinib
Product Code: BMS-986195
INN or Proposed INN: Branebrutinib
Other descriptive name: BMS986195
Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: ORENCIA
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
185Phase 2United States;France;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom
164EUCTR2020-001690-72-HU
(EUCTR)
28/09/202010/09/2020A Study to Investigate the Long-Term Safety and Efficacy of ABBV-599 (ABBV-105 and ABT-494 Given Alone or in Combination) in Participants with Moderately to Severely Active Systemic Lupus Erythematosus who have completed Study M19-130.A Phase 2, Long-Term Extension (LTE) Study with Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus Who Have Completed the M19-130 Phase 2 Randomized Controlled Trial (RCT) - A Phase 2, Long-Term Extension (LTE) Study in Subjects with Moderately to Severely Active SLE Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Elsubrutinib
Product Code: ABBV-105
INN or Proposed INN: Elsubrutinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: UPADACITINIB
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: UPADACITINIB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
260Phase 2United States;Taiwan;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Australia;Bulgaria;Netherlands;Germany;China;Japan;Korea, Republic of
165EUCTR2017-005028-11-NL
(EUCTR)
23/09/202002/07/2020A study of Baricitinib in patients with LupusA Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3United States;Serbia;Philippines;Taiwan;Greece;Spain;Chile;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
166EUCTR2019-003406-27-DE
(EUCTR)
17/09/202015/04/2020A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosusA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS GO Systemic lupus erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Dapirolizumab pegol
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3Portugal;Serbia;United States;Philippines;Taiwan;Estonia;Slovakia;Greece;Spain;Chile;Colombia;Switzerland;Italy;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Sweden
167EUCTR2019-003323-38-RO
(EUCTR)
16/09/202020/05/2022A study to determinate the safety and efficacy of LY3471851 in Adult Patients with Systemic Lupus ErythematosusA Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of LY3471851 (NKTR-358) in Adults with Systemic Lupus Erythematosus - ISLAND-SLE Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: LY3471851
Product Code: LY3471851
INN or Proposed INN: Not applicable
Other descriptive name: LY3471851
Eli Lilly & CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
280Phase 2United States;Czechia;Taiwan;Spain;Ukraine;Russian Federation;Israel;United Kingdom;India;Hungary;Mexico;Canada;Argentina;Poland;Romania;Australia;Germany;Japan;Korea, Republic of
168EUCTR2019-003406-27-AT
(EUCTR)
11/09/202029/05/2020A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosusA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS GO Systemic lupus erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Dapirolizumab pegol
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3Portugal;Serbia;United States;Philippines;Taiwan;Estonia;Slovakia;Greece;Spain;Chile;Colombia;Switzerland;Italy;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Bulgaria;Germany;Norway;Sweden
169EUCTR2019-003406-27-GB
(EUCTR)
09/09/202015/07/2020A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosusA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus Systemic lupus erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Dapirolizumab pegol
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Serbia;Portugal;Philippines;Taiwan;Estonia;Slovakia;Greece;Spain;Chile;Colombia;Switzerland;Italy;France;Australia;Peru;Netherlands;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Norway;Sweden
170NCT04447053
(ClinicalTrials.gov)
September 202023/6/2020Sequential Belimumab and T-cell Based Therapy in SLESequential Belimumab Followed by T-cell Based Therapy in the Treatment of Systemic Lupus Erythematosus (SUBTLE) - a Preliminary Proof-of-concept Mechanistic StudySystemic Lupus ErythematosusDrug: Belimumab Injection [Benlysta]National University Hospital, SingaporeGlaxoSmithKlineNot yet recruiting21 Years70 YearsAll80Phase 4Singapore
171NCT04127747
(ClinicalTrials.gov)
August 18, 202014/10/2019Efficacy of Individualized Rituximab in Maintaining Remission of Moderate and Severe Systemic Lupus ErythematosusA Multicenter, Randomized Controlled Clinical Study About Efficacy and Safety of Standard Dose and Individualized Dose of Rituximab in Maintaining Remission in Patients With Moderate to Severe Systemic Lupus ErythematosusAutoimmune DiseasesDrug: Standard dose of rituximab;Drug: Individualized dose of rituximabSecond Affiliated Hospital, School of Medicine, Zhejiang UniversityNULLRecruiting18 Years65 YearsAll110Phase 4China
172NCT04294667
(ClinicalTrials.gov)
August 12, 202027/2/2020A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus ErythematosusA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: DZP;Other: PlaceboUCB Biopharma SRLNULLRecruiting16 YearsN/AAll450Phase 3United States;Argentina;Australia;Austria;Belgium;Bulgaria;Canada;Chile;Colombia;Czechia;Denmark;France;Germany;Greece;Hong Kong;Hungary;Italy;Korea, Republic of;Mexico;Peru;Philippines;Poland;Portugal;Romania;Serbia;Spain;Taiwan;United Kingdom
173EUCTR2019-002205-22-DE
(EUCTR)
12/08/202007/07/2020Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment.A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 23.1;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Branebrutinib
Product Code: BMS-986195
INN or Proposed INN: Branebrutinib
Other descriptive name: BMS986195
Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: ORENCIA
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
185Phase 2United States;France;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom
174EUCTR2019-003406-27-GR
(EUCTR)
30/07/202002/06/2020A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosusA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS GO Systemic lupus erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Dapirolizumab pegol
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Serbia;Portugal;Philippines;Taiwan;Greece;Spain;Chile;Colombia;Italy;France;Peru;Australia;Denmark;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany
175EUCTR2018-001808-11-GR
(EUCTR)
29/07/202016/07/2020A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus diseaseA Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE) - CARE: Cenerimod Assessing S1P1 Receptor modulation in Systemic Lupus Erythematosus Moderate to severe systemic lupus erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Other descriptive name: ACT-334441
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Other descriptive name: ACT-334441
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Other descriptive name: ACT-334441
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Other descriptive name: ACT-334441
Idorsia Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
325Phase 2United States;Czechia;Philippines;Taiwan;Greece;Spain;Thailand;Ukraine;Turkey;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Mexico;Poland;Romania;Bulgaria;Georgia;Germany;China
176EUCTR2019-003406-27-HU
(EUCTR)
28/07/202020/05/2020A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosusA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus Systemic lupus erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Dapirolizumab pegol
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
450Phase 3Portugal;United States;Serbia;Philippines;Taiwan;Estonia;Slovakia;Greece;Spain;Chile;Colombia;Switzerland;Italy;France;Denmark;Peru;Australia;Netherlands;Korea, Republic of;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Norway;Sweden
177NCT04451772
(ClinicalTrials.gov)
July 27, 202029/6/2020A Study of the Safety of Oral Elsubrutinib Capsules and Oral Upadacitinib Tablets Given Alone or in Combination (ABBV-599) for Adult Participants With Moderately to Severely Active Systemic Lupus Erythematosus to Assess Change in Disease StateA Phase 2, Long-Term Extension (LTE) Study With Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599) in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus Who Have Completed the M19-130 Phase 2 Randomized Controlled Trial (RCT)Systemic Lupus Erythematosus (SLE)Drug: Elsubrutinib;Drug: Placebo for Elsubrutinib;Drug: Upadacitinib;Drug: Placebo for UpadacitinibAbbVieNULLActive, not recruiting18 Years65 YearsAll260Phase 2United States;Argentina;Australia;Bulgaria;China;Colombia;Germany;Hungary;Italy;Japan;Korea, Republic of;Mexico;New Zealand;Poland;Puerto Rico;Spain;Taiwan;United Kingdom;Canada;Netherlands
178NCT05659407
(ClinicalTrials.gov)
July 24, 202013/12/2022BAFF-var as a Biomarker of Response to B-depletive Treatment in Systemic Lupus Erythematosus and Rheumatoid ArthritisThe BAFF-var Polymorphism as a Biomarker of Response to B-depletive Treatment in Patients Affected by Systemic Lupus Erythematosus and Rheumatoid Arthritis: a Prospective StudySystemic Lupus Erythematosus;Rheumatoid Arthritis;BLyS PolymorphismDrug: Belimumab in SLE patients / Rituximab in RA patientsUniversity of CagliariAzienda Ospedaliero Universitaria di CagliariRecruiting18 YearsN/AAll60Italy
179JPRN-jRCT2031210119
17/07/202028/05/2021[M20-186] A Phase 2, Long-Term Extension (LTE) Study With Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599) in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus Who Have Completed the M19-130 Phase 2 Randomized Controlled Trial (RCT)[M20-186] A Phase 2, Long-Term Extension (LTE) Study With Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599) in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus Who Have Completed the M19-130 Phase 2 Randomized Controlled Trial (RCT) Systemic Lupus ErythematosusDrug: Elsubrutinib
Oral; Capsule
Other Name: ABBV-105

Drug: Placebo for Elsubrutinib
Oral; Capsule

Drug: Upadacitinib
Oral; Tablet
Other Names:ABT-494, RINVOQ

Drug: Placebo for Upadacitinib
Oral; Tablet
Yamazaki HayatoNULLRecruiting>= 18age old<= 65age oldBoth260Phase 2Argentina;Bulgaria;China;Germany;Hungary;Mexico;Netherlands;Poland;Puerto Rico;Spain;Taiwan;United States;Japan
180NCT04060888
(ClinicalTrials.gov)
July 14, 202016/8/2019A Study of Ustekinumab in Chinese Participants With Active Systemic Lupus ErythematosusA Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Chinese Subjects With Active Systemic Lupus ErythematosusLupus Erythematosus, SystemicDrug: Ustekinumab (approximately 6 mg/kg);Drug: Ustekinumab 90 milligram (mg);Drug: PlaceboJanssen Research & Development, LLCNULLWithdrawn18 Years75 YearsAll0Phase 3China
181NCT04305197
(ClinicalTrials.gov)
July 9, 202010/3/2020A Study of ICP-022 in Patients With Systemic Lupus Erythematosus (SLE)A Phase Ib/IIa Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerance, Pharmacokinetics/ Pharmacodynamics(PK/PD) of ICP-022 in Patients With Mild and Moderate Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: ICP-022;Drug: PlacebosBeijing InnoCare Pharma Tech Co., Ltd.NULLCompleted18 Years75 YearsAll60Phase 1/Phase 2China
182EUCTR2019-003406-27-BG
(EUCTR)
09/06/202021/04/2020A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosusA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS GO Systemic lupus erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Dapirolizumab pegol
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3Portugal;Serbia;United States;Philippines;Taiwan;Estonia;Slovakia;Greece;Spain;Chile;Colombia;Switzerland;Italy;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Sweden
183EUCTR2017-005028-11-HR
(EUCTR)
05/06/202023/11/2020A study of Baricitinib in patients with LupusA Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3United States;Serbia;Philippines;Taiwan;Greece;Spain;Chile;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
184EUCTR2019-003406-27-ES
(EUCTR)
02/06/202028/05/2020A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosusA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus Systemic lupus erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Dapirolizumab pegol
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Serbia;Portugal;Philippines;Taiwan;Estonia;Slovakia;Greece;Spain;Chile;Colombia;Switzerland;Italy;France;Australia;Peru;Netherlands;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Norway;Sweden
185EUCTR2017-005028-11-GR
(EUCTR)
20/05/202026/11/2019A study of Baricitinib in patients with LupusA Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3United States;Serbia;Philippines;Taiwan;Greece;Spain;Chile;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
186EUCTR2018-003471-35-ES
(EUCTR)
06/05/202010/05/2020Long-Term Safety and Efficacy of BMS-986165 in Subjects with Systemic Lupus ErythematosusA Multi-Center Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects with Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: LLT;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 2United States;Taiwan;Spain;Russian Federation;Israel;Colombia;France;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Australia;Germany;Korea, Republic of
187EUCTR2019-002205-22-BE
(EUCTR)
05/05/202021/01/2020Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment.A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 23.1;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Branebrutinib
Product Code: BMS-986195
INN or Proposed INN: Branebrutinib
Other descriptive name: BMS986195
Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: ORENCIA
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
185Phase 2France;United States;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom
188EUCTR2019-002205-22-GB
(EUCTR)
01/05/202007/01/2020Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment.A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Branebrutinib
Product Code: BMS-986195
INN or Proposed INN: Branebrutinib
Other descriptive name: BMS986195
Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: ORENCIA
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
185Phase 2United States;France;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom
189EUCTR2019-002205-22-ES
(EUCTR)
06/04/202023/01/2020Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment.A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Branebrutinib
Product Code: BMS-986195
INN or Proposed INN: Branebrutinib
Other descriptive name: BMS986195
Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: ORENCIA
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
185Phase 2United States;France;Mexico;Argentina;Poland;Belgium;Spain;Netherlands;Germany;United Kingdom
190ChiCTR2000030342
2020-04-012020-02-29Treatment of connective tissue diseases (including systemic lupus erythematosus, primary Sjogren's syndrome, etc.) by intensive immunosuppressive therapy combined with targeted drugs(PAH targeted therapy)——A double center clinical observation study of pulmonary hypertensionTreatment of connective tissue diseases (including systemic lupus erythematosus, primary Sjogren's syndrome, etc.) by intensive immunosuppressive therapy combined with targeted drugs(PAH targeted therapy)——A double center clinical observation study of pulmonary hypertension Connective tissue diseaseCase series:immunosuppressive and PAH target therapy;Guangdong Provincial People's HospitalNULLPending1875BothCase series:20;N/AChina
191EUCTR2019-002205-22-PL
(EUCTR)
29/03/202007/02/2020Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment.A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 23.1;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Branebrutinib
Product Code: BMS-986195
INN or Proposed INN: Branebrutinib
Other descriptive name: BMS986195
Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: ORENCIA
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
185Phase 2France;United States;Mexico;Argentina;Belgium;Spain;Poland;Germany;Netherlands;United Kingdom
192JPRN-jRCTs011190011
13/03/202013/03/2020Steroid-Independent protocol using BELImumab for disease flare in patients with systemic lupUS erythematosusSteroid-Independent protocol using BELImumab for disease flare in patients with systemic lupUS erythematosus - Sibelius Study Systemic lupus erythematosus
Systemic lupus erhythematosus;D008180
Subjects who have met the entry criteria will be randomly to one of the two treatment groups based on a computer-generated randomization schedule as follows: 1) BEL group and 2) CS increased group using standard CS therapy (CS group) .

1. Subjects in BEL group will receive BEL 200 mg weekly SC on Day 0, and then every 7 days through week 24 or BEL 10mg/kg IV on Day 0, 14, 28 and every 1 month.
2. Subjects in CS group will receive prednisolone (All subjects will start treatment with MMF oral 1g/day
In both groups, if subjects are not on treatment with HCQ, their drug will be started at a dose individually adjusted on basis of the patient's height (from 200 to 400mg/day).
In the BEL group, the baseline dose of CS
Atsumi TatsuyaNULLRecruiting>= 18age oldNot applicableBoth48Phase 4Japan
193NCT04233164
(ClinicalTrials.gov)
March 4, 202016/1/2020Genomic Effects of Glucocorticoids in Patients With Systemic Lupus ErythematosusGenomic Effects of Glucocorticoids in Patients With Systemic Lupus ErythematosusSystemic Lupus Erythematous (SLE)Drug: SOLU-MEDROLNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NULLActive, not recruiting18 Years80 YearsAll47Early Phase 1United States
194EUCTR2019-000328-16-PT
(EUCTR)
02/03/202009/08/2019A Study to Evaluate the Efficacy and Safety of Rozibafusp Alfa (AMG 570) in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) TherapyA Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Rozibafusp Alfa (AMG 570) in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy - Safety and Efficacy of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) Active Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: AMG 570
INN or Proposed INN: AMG 570
Other descriptive name: AMG 570
Product Code: AMG 570
INN or Proposed INN: AMG 570
Other descriptive name: AMG 570
Product Code: AMG 570
INN or Proposed INN: AMG 570
Other descriptive name: AMG 570
Amgen IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 2Portugal;United States;Czechia;Greece;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Poland;Australia;Bulgaria;Germany;Japan;Korea, Republic of
195ChiCTR2000030247
2020-03-012020-02-26Clinical study of guanxining tablet in the treatment of rheumatoid arthritis with cardiovascular damageClinical study of guanxining tablet in the treatment of rheumatoid arthritis with cardiovascular damage Systemic lupus erythematosusexperimental group:Integrative MTX with Guanxinning;control group:MTX;Zhejinag University of f Chinese MedicineNULLRecruitingBothexperimental group:30;control group:30;China
196ITMCTR2000003055
2020-03-012020-02-26Clinical study of guanxining tablet in the treatment of rheumatoid arthritis with cardiovascular damageClinical study of guanxining tablet in the treatment of rheumatoid arthritis with cardiovascular damage Systemic lupus erythematosusexperimental group:Integrative MTX with Guanxinning;control group:MTX;Zhejinag University of f Chinese MedicineNULLRecruitingBothexperimental group:30;control group:30;China
197NCT04058028
(ClinicalTrials.gov)
February 19, 202030/7/2019Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE)A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Rozibafusp Alfa (AMG 570) in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) TherapySystemic Lupus Erythematosus (SLE)Drug: Rozibafusp Alfa;Drug: Placebo for Rozibafusp AlfaAmgenNULLActive, not recruiting18 Years75 YearsAll320Phase 2United States;Argentina;Australia;Bulgaria;Canada;Czechia;France;Germany;Greece;Hong Kong;Hungary;Italy;Japan;Korea, Republic of;Mexico;Poland;Portugal;Russian Federation;Spain
198EUCTR2019-000638-20-NL
(EUCTR)
07/02/202009/12/2019A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of ABBV-105 and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus ErythematosusA Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Code: ABBV-105
INN or Proposed INN: N/A
Other descriptive name: ABBV-105
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: UPADACITINIB
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: UPADACITINIB
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
325Phase 2United States;Czechia;Taiwan;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Romania;Australia;Bulgaria;Netherlands;Germany;New Zealand;China;Japan;Korea, Republic of
199EUCTR2018-004645-16-NL
(EUCTR)
29/01/202029/10/2019A study of belimumab in children with lupusA Multi-Center, Open-Label Trial to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Subcutaneously Administered Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Participants with Systemic Lupus Erythematosus (SLE) - Ph 2,Benlysta, PLUTO-SC, PK-PD study in pediatric patients with SLE Lupus - SLE
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Trade Name: Benlysta
Product Name: Belimumab
Product Code: GSK1550188
INN or Proposed INN: BELIMUMAB
Other descriptive name: LymphoStat-B®, monoclonal anti-BLyS, LSB, BENLYSTA®
GlaxoSmithKline Research & Development LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
24Phase 2United States;Mexico;Argentina;Spain;Germany;Netherlands;Japan
200EUCTR2019-000638-20-DE
(EUCTR)
22/01/202009/09/2019A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus ErythematosusA Phase 2 Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Elsubrutinib
Product Code: ABBV-105
INN or Proposed INN: Elsubrutinib
Other descriptive name: ABBV-105
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: UPADACITINIB
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: UPADACITINIB
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
325Phase 2United States;Taiwan;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Puerto Rico;Argentina;Poland;Australia;Bulgaria;Netherlands;Germany;China;Japan;New Zealand;Korea, Republic of
201NCT04186871
(ClinicalTrials.gov)
January 7, 202028/11/2019Study to Assess Safety and Effectiveness of Branebrutinib Treatment in Participants With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Study Participants With Active Rheumatoid ArthritisA Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects With Active Rheumatoid ArthritisAutoimmune Disorder;Rheumatoid Arthritis;Systemic Lupus Erythematosus;Primary Sjögren's SyndromeDrug: branebrutinib;Drug: abatacept;Drug: branebrutinib placeboBristol-Myers SquibbNULLCompleted18 Years75 YearsAll112Phase 2United States;Argentina;Belgium;France;Germany;Mexico;Netherlands;Poland;Spain;United Kingdom;Australia
202EUCTR2018-003471-35-RO
(EUCTR)
31/12/201907/03/2022Long-Term Safety and Efficacy of BMS-986165 in Subjects with Systemic Lupus ErythematosusA Multi-Center Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects with Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: LLT;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 2United States;Taiwan;Spain;Israel;Russian Federation;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Australia;Germany;Korea, Republic of
203EUCTR2018-004175-12-GB
(EUCTR)
30/12/201923/07/2019A Phase 2b multicenter dose ranging study to evaluate efficacy and safety of PF-06700841 in systemic lupus erythematosusA PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: PF-06700841
Product Code: PF-06700841 5mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Product Name: PF-06700841
Product Code: PF-06700841 25mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Pfizer Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
448Phase 2Hong Kong;Greece;Spain;Ukraine;Colombia;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Germany;Japan;China;Korea, Republic of;United States;Serbia;Portugal;Taiwan
204EUCTR2018-004645-16-DE
(EUCTR)
27/12/201918/09/2019A study of belimumab in children with lupusA Multi-Center, Open-Label Trial to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Subcutaneously Administered Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Participants with Systemic Lupus Erythematosus (SLE) - Ph 2,Benlysta, PLUTO-SC, PK-PD study in pediatric patients with SLE Lupus - SLE
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Trade Name: Benlysta
Product Name: Belimumab
Product Code: GSK1550188
INN or Proposed INN: BELIMUMAB
Other descriptive name: LymphoStat-B®, monoclonal anti-BLyS, LSB, BENLYSTA®
GlaxoSmithKline Research & Development LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
24Phase 2United States;Mexico;Argentina;Spain;Netherlands;Germany;Japan
205EUCTR2019-000328-16-FR
(EUCTR)
20/12/201916/07/2019A Study to Evaluate the Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) TherapyA Phase 2 Dose Ranging Study to Evaluate the Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy - Safety and Efficacy of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) Active Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: AMG 570
INN or Proposed INN: AMG 570
Other descriptive name: AMG 570
Product Code: AMG 570
INN or Proposed INN: AMG 570
Other descriptive name: AMG 570
Product Code: AMG 570
INN or Proposed INN: AMG 570
Other descriptive name: AMG 570
Amgen IncNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noPortugal;United States;Austria;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Canada;Poland;Australia;Bulgaria;Germany;Japan;Korea, Republic of
206EUCTR2017-005028-11-IT
(EUCTR)
19/12/201922/01/2021A study of Baricitinib in patients with LupusA Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) - NA Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: [LY3009104]
INN or Proposed INN: Baricitinib
Other descriptive name: Baricitinib
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: [LY3009104]
INN or Proposed INN: Baricitinib
Other descriptive name: Baricitinib
ELI LILLY & COMPANY, LILLY CORPORATE CENTERNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Serbia;United States;Philippines;Taiwan;Greece;Spain;Ukraine;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Australia;Netherlands;China;Korea, Republic of;Czechia;Korea, Democratic People's Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
207EUCTR2018-004645-16-ES
(EUCTR)
16/12/201911/11/2019A study of belimumab in children with lupusA Multi-Center, Open-Label Trial to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Subcutaneously Administered Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Participants with Systemic Lupus Erythematosus (SLE) - Ph 2,Benlysta, PLUTO-SC, PK-PD study in pediatric patients with SLE Lupus - SLE
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Trade Name: Benlysta
Product Name: Belimumab
Product Code: GSK1550188
INN or Proposed INN: BELIMUMAB
Other descriptive name: LymphoStat-B®, monoclonal anti-BLyS, LSB, BENLYSTA®
GlaxoSmithKline, S.A.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
24 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Mexico;Argentina;Spain;Netherlands;Germany;Japan
208NCT04179032
(ClinicalTrials.gov)
November 28, 201925/11/2019Study of Subcutaneous (SC) Belimumab in Pediatric Participants With Systemic Lupus Erythematosus (SLE)A Multi-Center, Open-Label Trial to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Subcutaneously Administered Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Participants With Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusCombination Product: BelimumabGlaxoSmithKlineNULLActive, not recruiting5 Years17 YearsAll30Phase 2United States;Argentina;Germany;Japan;Mexico;Netherlands;Spain
209EUCTR2018-004175-12-PT
(EUCTR)
25/11/201930/07/2019A Phase 2b multicenter dose ranging study to evaluate efficacy and safety of PF-06700841 in systemic lupus erythematosusA PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: PF-06700841
Product Code: PF-06700841 5mg
INN or Proposed INN: brepocitinib
Other descriptive name: PF-06700841-15
Product Name: PF-06700841
Product Code: PF-06700841 25mg
INN or Proposed INN: brepocitinib
Other descriptive name: PF-06700841-15
Pfizer Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
448Phase 2United States;Serbia;Portugal;Hong Kong;Taiwan;Greece;Spain;Ukraine;Colombia;Italy;France;Australia;Netherlands;China;Korea, Republic of;Czechia;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan
210EUCTR2018-004175-12-ES
(EUCTR)
12/11/201911/11/2019A Phase 2b multicenter dose ranging study to evaluate efficacy and safety of PF-06700841 in systemic lupus erythematosusA PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: PF-06700841
Product Code: PF-06700841 5mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Product Name: PF-06700841
Product Code: PF-06700841 25mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Pfizer Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
448 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Portugal;Serbia;Taiwan;Hong Kong;Greece;Spain;Ukraine;Colombia;France;Australia;Netherlands;China;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan
211NCT04136145
(ClinicalTrials.gov)
October 28, 201921/10/2019Single Dose Study to Investigate the Pharmacokinetics (PK) and Safety of Belimumab 200 Milligrams (mg) Intravenous and 200 mg Subcutaneous Via Auto-injector in Chinese Healthy SubjectsAn Open-label, Randomized, Parallel Group, Single Dose Study to Investigate the PK and Safety of Belimumab 200 mg Intravenous and 200 mg Subcutaneous Via Auto-injector in Chinese Healthy ParticipantsSystemic Lupus ErythematosusDrug: Belimumab for IV;Drug: Belimumab for SCGlaxoSmithKlineNULLCompleted18 Years45 YearsAll36Phase 1China
212EUCTR2017-005028-11-GB
(EUCTR)
24/10/201918/03/2019A study of Baricitinib in patients with LupusA Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1100Phase 3United States;Serbia;Philippines;Taiwan;Spain;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Australia;South Africa;China;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Germany;Japan
213EUCTR2017-005026-37-HR
(EUCTR)
24/10/201920/01/2020A study of Baricitinib in patients with LupusA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
825Phase 3United States;Taiwan;Greece;Ukraine;Austria;Russian Federation;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;Belgium;Brazil;Croatia;Australia;Netherlands;Germany;China
214EUCTR2019-000638-20-IT
(EUCTR)
22/10/201917/06/2021A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus ErythematosusA Phase 2 Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus - na Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Elsubrutinib
Product Code: [ABBV-105]
INN or Proposed INN: Elsubrutinib
Product Name: Upadacitinib
Product Code: [ABT-494]
INN or Proposed INN: UPADACITINIB
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: [ABT-494]
INN or Proposed INN: UPADACITINIB
ABBVIE DEUTSCHLAND GMBH & CO. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
325Phase 2United States;Czechia;Taiwan;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Puerto Rico;Argentina;Poland;Romania;Australia;Bulgaria;Netherlands;Germany;China;Japan;New Zealand;Korea, Republic of
215NCT04275193
(ClinicalTrials.gov)
October 22, 201912/2/2020The Safety and Efficacy of Zishenqing in Subjects With Active Systemic Lupus ErythematosusThe Safety and Efficacy of the Traditional Chinese Medicine Zishenqing in Subjects With Active Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: Zishenqing;Drug: PlaceboShanghai University of Traditional Chinese MedicineRenJi HospitalRecruiting18 Years65 YearsAll118Phase 2/Phase 3China
216EUCTR2018-004175-12-RO
(EUCTR)
17/10/201926/07/2019A Phase 2b multicenter dose ranging study to evaluate efficacy and safety of PF-06700841 in systemic lupus erythematosusA PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: PF-06700841
Product Code: PF-06700841 5mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Product Name: PF-06700841
Product Code: PF-06700841 25mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Pfizer Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
448Phase 2United States;Serbia;Portugal;Taiwan;Hong Kong;Greece;Spain;Ukraine;Colombia;Italy;France;Australia;Netherlands;China;Korea, Republic of;Czechia;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan
217NCT04082416
(ClinicalTrials.gov)
October 16, 20191/9/2019Study of Recombinant Human B Lymphocyte(RC18) Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE)A Phase III, Placebo-Controlled ,Multi-Center, Randomized, Double-Blind, Dose-exploring Trial of RC18,a Recombinant Human B Lymphocyte Stimulating Factor Receptor-Antibody Fusion Protein in Subjects With Systemic Lupus Erythematosus (SLE).Systemic Lupus ErythematosusBiological: Placebo plus standard therapy;Biological: RC18 160 mg plus standard therapyRemeGen Co., Ltd.NULLActive, not recruiting18 Years65 YearsAll335Phase 3China
218EUCTR2018-004175-12-BG
(EUCTR)
11/10/201930/07/2019A Phase 2b multicenter dose ranging study to evaluate efficacy and safety of PF-06700841 in systemic lupus erythematosusA PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: PF-06700841
Product Code: PF-06700841 5mg
INN or Proposed INN: brepocitinib
Other descriptive name: PF-06700841-15
Product Name: PF-06700841
Product Code: PF-06700841 25mg
INN or Proposed INN: brepocitinib
Other descriptive name: PF-06700841-15
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
350Phase 2United States;Portugal;Taiwan;Hong Kong;Greece;Spain;Ukraine;Colombia;Italy;France;Australia;China;Korea, Republic of;Czechia;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Serbia
219EUCTR2018-004175-12-DE
(EUCTR)
08/10/201902/08/2019A Phase 2b multicenter dose ranging study to evaluate efficacy and safety of PF-06700841 in systemic lupus erythematosusA PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: PF-06700841
Product Code: PF-06700841 5mg
INN or Proposed INN: brepocitinib
Other descriptive name: PF-06700841-15
Product Name: PF-06700841
Product Code: PF-06700841 25mg
INN or Proposed INN: brepocitinib
Other descriptive name: PF-06700841-15
Pfizer Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
448Phase 2Serbia;United States;Portugal;Taiwan;Hong Kong;Greece;Spain;Ukraine;Colombia;Italy;France;Australia;Netherlands;China;Korea, Republic of;Czechia;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan
220EUCTR2018-001808-11-DE
(EUCTR)
04/10/201918/10/2018A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus diseaseA Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE) - CARE: Cenerimod Assessing S1P1 Receptor modulation in Systemic Lupus Erythematosus Moderate to severe systemic lupus erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Idorsia Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
500Phase 2United States;Taiwan;Thailand;Spain;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Poland;Romania;Bulgaria;Georgia;Germany;China
221EUCTR2019-000328-16-IT
(EUCTR)
01/10/201915/06/2021A Study to Evaluate the Efficacy and Safety of Rozibafusp Alfa (AMG 570) in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) TherapyPhase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Rozibafusp Alfa (AMG 570) in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy - Safety and Efficacy of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) Active Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: AMG 570
Product Code: [AMG 570]
Other descriptive name: AMG 570
Product Name: AMG 570
Product Code: [AMG 570]
Other descriptive name: AMG 570
Product Name: AMG 570
Product Code: [AMG 570]
Other descriptive name: AMG 570
AMGEN INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 2Portugal;United States;Czechia;Greece;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Poland;Australia;Bulgaria;Germany;Japan;Korea, Republic of
222NCT04128579
(ClinicalTrials.gov)
October 1, 201930/9/2019Study of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative NephritisA Phase 1b Multiple Ascending-dose Study of EQ001 in Subjects With Systemic Lupus Erythematosus With or Without Active Proliferative Lupus NephritisLupus Erythematosus;Lupus NephritisDrug: Itolizumab [Bmab 600]EquilliumBiocon LimitedRecruiting18 Years75 YearsAll55Phase 1United States;India;Poland
223EUCTR2018-000305-23-RO
(EUCTR)
30/09/201909/06/2022NoA Randomized Double-Blind Phase 1b/2 Combined Staggered Multiple Dose Escalation Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of Care Systemic lupus erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: BOS161721
Product Code: BOS161721
INN or Proposed INN: Not known
Other descriptive name: IMMUNOGLOBULIN G
Boston Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
156Phase 2United States;Philippines;Hungary;Mexico;Argentina;Poland;Ukraine;Romania;Peru;Georgia;Bulgaria;Colombia
224NCT04835883
(ClinicalTrials.gov)
September 26, 20196/4/2021Exploring the Efficacy and Safety of CS20AT04 (Allogenic Bone Marrow-Derived Stem Cell) in Systemic Lupus Erythematosus PatientsOpen-label, Single-arm, 24-week Investigator Study to Evaluate the Efficacy and Safety of CS20AT04 (HLA-haplo Matched Allogenic Bone Marrow-Derived Stem Cells) Administered in Patients With Lupus Nephritis or Lupus CytopeniaSystemic Lupus ErythematosusBiological: CS20AT04 (allogenic bone marrow derived mesenchymal stem cell)Hanyang University Seoul HospitalCorestem, Inc.;Ministry of Health & Welfare, KoreaRecruiting18 Years70 YearsAll10Phase 2Korea, Republic of
225EUCTR2018-004175-12-HU
(EUCTR)
23/09/201923/07/2019A Phase 2b multicenter dose ranging study to evaluate efficacy and safety of PF-06700841 in systemic lupus erythematosusA PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: PF-06700841
Product Code: PF-06700841 5mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Product Name: PF-06700841
Product Code: PF-06700841 25mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Pfizer Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
448Phase 2United States;Portugal;Serbia;Taiwan;Hong Kong;Greece;Spain;Ukraine;Colombia;France;Australia;Netherlands;China;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan
226EUCTR2019-000328-16-HU
(EUCTR)
23/09/201916/07/2019A Study to Evaluate the Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) TherapyA Phase 2 Dose Ranging Study to Evaluate the Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy - Safety and Efficacy of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) Active Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: AMG 570
INN or Proposed INN: AMG 570
Other descriptive name: AMG 570
Product Code: AMG 570
INN or Proposed INN: AMG 570
Other descriptive name: AMG 570
Product Code: AMG 570
INN or Proposed INN: AMG 570
Other descriptive name: AMG 570
Amgen IncNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noPortugal;United States;Austria;Russian Federation;Switzerland;United Kingdom;Italy;France;Hungary;Czech Republic;Mexico;Canada;Poland;Australia;Bulgaria;Germany;Japan;Korea, Republic of
227EUCTR2019-000638-20-HU
(EUCTR)
18/09/201902/10/2019A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus ErythematosusA Phase 2 Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Elsubrutinib
Product Code: ABBV-105
INN or Proposed INN: ELSUBRUTINIB
Other descriptive name: ABBV-105
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: UPADACITINIB
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: UPADACITINIB
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
325Phase 2United States;Taiwan;Spain;Colombia;United Kingdom;Italy;France;Hungary;Czech Republic;Mexico;Puerto Rico;Canada;Argentina;Poland;Romania;Australia;Bulgaria;Netherlands;Germany;New Zealand;China;Japan;Korea, Republic of
228EUCTR2019-000328-16-DE
(EUCTR)
17/09/201911/07/2019A Study to Evaluate the Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) TherapyA Phase 2 Dose Ranging Study to Evaluate the Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy - Safety and Efficacy of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) Active Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: AMG 570
INN or Proposed INN: AMG 570
Other descriptive name: AMG 570
Product Code: AMG 570
INN or Proposed INN: AMG 570
Other descriptive name: AMG 570
Product Code: AMG 570
INN or Proposed INN: AMG 570
Other descriptive name: AMG 570
Amgen IncNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noPortugal;United States;Austria;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Canada;Poland;Australia;Bulgaria;Germany;Japan;Korea, Republic of
229NCT03562065
(ClinicalTrials.gov)
September 11, 201922/5/2018Treatment of Refractory Systemic Lupus Erythematosus by Allogeneic Mesenchymal Stem Cells Derived From the Umbilical CordTreatment of Refractory Systemic Lupus Erythematosus by Injection of Allogeneic Mesenchymal Stem Cells Derived From the Umbilical CordLupus Erythematosus;Stem Cell TransplantBiological: mesenchymal stem cellsAssistance Publique - Hôpitaux de ParisNULLRecruiting18 Years70 YearsAll10Phase 1/Phase 2France
230NCT04077684
(ClinicalTrials.gov)
September 10, 20191/9/2019Efficacy and Safety of Low-dose IL-2 in Patients With SLE: a Multicenter, Randomised, Placebo-controlled TrialEfficacy and Safety of Low-dose Interleukin-2 in Patients With Systemic Lupus Erythematosus: a Multicenter, Randomised, Placebo-controlled TrialSystemic Lupus ErythematosusDrug: Interleukin-2Peking University People's HospitalNULLRecruiting18 Years75 YearsAll500Phase 2China
231EUCTR2019-000638-20-ES
(EUCTR)
09/09/201927/09/2019A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of ABBV-105 and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus ErythematosusA Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Code: ABBV-105
INN or Proposed INN: ABBV-105
Other descriptive name: ABBV-105
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: UPADACITINIB
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: UPADACITINIB
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
325 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Taiwan;Spain;Colombia;Italy;United Kingdom;France;Czech Republic;Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Romania;Australia;Germany;New Zealand;Japan;China;Korea, Republic of
232NCT03843125
(ClinicalTrials.gov)
September 9, 201914/2/2019A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE)A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients With Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: BaricitinibEli Lilly and CompanyIncyte CorporationTerminated18 YearsN/AAll1156Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Chile;China;Colombia;Croatia;Czechia;France;Germany;Greece;Hungary;India;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Philippines;Poland;Romania;Russian Federation;Serbia;South Africa;Spain;Switzerland;Taiwan;United Kingdom
233EUCTR2018-004175-12-PL
(EUCTR)
03/09/201906/08/2019A Phase 2b multicenter dose ranging study to evaluate efficacy and safety of PF-06700841 in systemic lupus erythematosusA PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: PF-06700841
Product Code: PF-06700841 5mg
INN or Proposed INN: brepocitinib
Other descriptive name: PF-06700841-15
Product Name: PF-06700841
Product Code: PF-06700841 25mg
INN or Proposed INN: brepocitinib
Other descriptive name: PF-06700841-15
Pfizer Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
448Phase 2United States;Serbia;Portugal;Taiwan;Hong Kong;Greece;Spain;Ukraine;Colombia;Italy;France;Australia;Netherlands;China;Korea, Republic of;Czechia;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan
234ChiCTR1900025376
2019-09-012019-08-25Lenalidomide in Treatment-Refractory Lupus-Associated Skin Lesions in Systemic Lupus Erythematosus: A Single-Center, Randomized, Double-Blinded, Placebo-Controlled Clinical TrialLenalidomide in Treatment-Refractory Lupus-Associated Skin Lesions in Systemic Lupus Erythematosus: A Single-Center, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial systemic lupus erythematosusintervention group:lenalidomide 10mg qd;control group:placebo 10mg qd;Chinese Academy of Medical Sciences Peking Union Medical College HospitalNULLRecruiting1870Bothintervention group:15;control group:15;Phase 4China
235EUCTR2018-004175-12-CZ
(EUCTR)
21/08/201925/07/2019A Phase 2b multicenter dose ranging study to evaluate efficacy and safety of PF-06700841 in systemic lupus erythematosusA PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: PF-06700841
Product Code: PF-06700841 5mg
INN or Proposed INN: brepocitinib
Other descriptive name: PF-06700841-15
Product Name: PF-06700841
Product Code: PF-06700841 25mg
INN or Proposed INN: brepocitinib
Other descriptive name: PF-06700841-15
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
350Phase 2Serbia;United States;Portugal;Taiwan;Hong Kong;Greece;Spain;Ukraine;Colombia;Italy;France;Australia;Netherlands;China;Korea, Republic of;Czechia;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan
236EUCTR2017-005026-37-NL
(EUCTR)
06/08/201913/05/2019A study of Baricitinib in patients with LupusA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
825Phase 3United States;Czechia;Taiwan;Greece;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;Brazil;Belgium;Croatia;Australia;Germany;Netherlands;China
237EUCTR2017-005026-37-GR
(EUCTR)
26/07/201903/05/2019A study of Baricitinib in patients with LupusA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
825Phase 3United States;Taiwan;Greece;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;Belgium;Brazil;Croatia;Australia;Germany;Netherlands;China
238NCT03978520
(ClinicalTrials.gov)
July 25, 20193/6/2019A Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)A Phase 2 Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects With Moderately to Severely Active Systemic Lupus ErythematosusSystemic Lupus Erythematosus (SLE)Drug: Elsubrutinib;Drug: Placebo for Elsubrutinib;Drug: Upadacitinib;Drug: Placebo for upadacitinibAbbVieNULLCompleted18 Years65 YearsAll341Phase 2United States;Argentina;Australia;Bulgaria;Canada;China;Colombia;France;Germany;Hungary;Italy;Japan;Korea, Republic of;Mexico;Netherlands;New Zealand;Poland;Puerto Rico;Spain;Taiwan;United Kingdom
239NCT03951259
(ClinicalTrials.gov)
July 24, 201914/5/2019Safety and Efficacy of SM934 Compared to Placebo in Adult Subjects With Active Systemic Lupus ErythematosusA Randomised, Double-blind, Placebo-controlled, Phase 2 Study Evaluating the Safety and Efficacy of SM934 in Adult Subjects With Active Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: SM934;Drug: PlacebosRenJi HospitalJiangsu ZuoYou Medicine Co., Ltd.Recruiting18 Years70 YearsAll48Phase 2China
240EUCTR2017-005028-11-RO
(EUCTR)
22/07/201915/03/2022A study of Baricitinib in patients with LupusA Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Serbia;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Colombia;Switzerland;Italy;India;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
241EUCTR2017-005028-11-PL
(EUCTR)
05/07/201923/04/2019A study of Baricitinib in patients with LupusA Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-TermSafety and Efficacy of Baricitinib in Patients with Systemic LupusErythematosus (SLE) Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3United States;Serbia;Philippines;Taiwan;Greece;Spain;Chile;Russian Federation;Colombia;Italy;Switzerland;India;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
242NCT04184258
(ClinicalTrials.gov)
July 1, 20191/12/2019Treatment of Systemic Lupus Erythematosus With Pooled Allogenic Mesenchymal Stem CellsTreatment of Systemic Lupus Erythematosus With Pooled Allogenic Olfactory Mucosa Derived Mesenchymal Stem CellsSystemic Lupus ErythematosusBiological: Pooled mesenchymal stem cell;Other: Standard treatment according to the Clinical protocolsInstitute of Biophysics and Cell Engineering of National Academy of Sciences of BelarusBelarusian State Medical UniversityCompleted18 Years75 YearsAll7Phase 1/Phase 2Belarus
243EUCTR2018-001735-49-GB
(EUCTR)
01/07/201922/01/2019RIvaroxaban for Stroke patients with AntiPhospholipid SyndromeRivaroxaban versus warfarin for stroke patients with antiphospholipid syndrome, with or without SLE (RISAPS): a randomised, controlled, open-label, phase II/III, non-inferiority trial - RIvaroxaban for Stroke patients with AntiPhospholipid Syndrome Patients with stroke or other ischaemic brain injury who have antiphospholipid syndrome (APS), with or without systemic lupus erythematosus (SLE)
MedDRA version: 20.0;Level: PT;Classification code 10002817;Term: Antiphospholipid syndrome;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: Rivaroxaban
Product Name: Rivaroxaban
INN or Proposed INN: Rivaroxaban
Other descriptive name: Trade Name Xarelto
Trade Name: Warfarin Sodium
Product Name: Warfarin Sodium
INN or Proposed INN: Warfarin sodium
University College LondonNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 2;Phase 3United Kingdom
244NCT03984227
(ClinicalTrials.gov)
July 201928/5/2019New Signaling Pathway Targeting Systemic Lupus ErythematosusStudying of New Signaling Pathway Targeting Systemic Lupus ErythematosusSLEGenetic: Taking peripheral blood samplesAssiut UniversityNULLNot yet recruiting18 Years60 YearsAll60NULL
245NCT03656627
(ClinicalTrials.gov)
June 27, 201931/8/2018Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune DiseaseSafety, Activity, and Pharmacology of Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune DiseaseAutoimmune Diseases;Non-small Cell Lung Cancer;Rheumatoid Arthritis;Psoriasis;Giant Cell Arteritis;Polymyalgia Rheumatica;Systemic Lupus Erythematosus;Crohn Disease;Multiple Sclerosis;Ulcerative ColitisDrug: NivolumabAlliance Foundation Trials, LLC.Bristol-Myers SquibbTerminated18 YearsN/AAll7Phase 1United States
246ChiCTR1900022934
2019-06-202019-05-04Study for the metabolic mechanism of Langchuangjing granule in the treatment of systemic lupus erythematosusinStudy for the metabolic mechanism of Langchuangjing granule in the treatment of systemic lupus erythematosusin Systemic Lupus ErythematosusExperimental group:Langchuangjing granule + Prednisone acetate tablets, Hydroxychloroquine;control group:Prednisone acetate tablets?Hydroxychloroquine;healthy control group:nothing;Nanjing University of Chinese Medicine Affiliated HospitalNULLPendingBothExperimental group:20;control group:20;healthy control group:20;Phase 1China
247ITMCTR1900002316
2019-06-202019-05-04Study for the metabolic mechanism of Langchuangjing granule in the treatment of systemic lupus erythematosusinStudy for the metabolic mechanism of Langchuangjing granule in the treatment of systemic lupus erythematosusin Systemic Lupus Erythematosushealthy control group:nothing;control group:Prednisone acetate tablets\Hydroxychloroquine;Experimental group:Langchuangjing granule + Prednisone acetate tablets, Hydroxychloroquine;Nanjing University of Chinese Medicine Affiliated HospitalNULLPendingBothhealthy control group:20;control group:20;Experimental group:20;Phase 1China
248EUCTR2017-001203-79-ES
(EUCTR)
11/06/201930/04/2019A clinical study to test the efficacy and safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus.A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: LLT;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
360 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Taiwan;Spain;Russian Federation;Israel;Colombia;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Australia;Germany;Japan;Korea, Republic of
249EUCTR2017-005028-11-AT
(EUCTR)
02/06/201928/03/2019A study of Baricitinib in patients with LupusA Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Serbia;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Colombia;Switzerland;Italy;India;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
250NCT03804723
(ClinicalTrials.gov)
June 201911/1/2019Glucocorticoids Withdrawal in Early Systemic Lupus ErythematosusGlucocorticoids Withdrawal in Early Systemic Lupus Erythematosus: a Randomized Placebo-controlled Equivalence TrialSystemic Lupus Erythematosus;Glucocorticoids;Therapy WithdrawalDrug: oral Prednisone 5mgUniversity of PisaNULLNot yet recruiting18 Years85 YearsAll321N/ANULL
251EUCTR2017-005028-11-ES
(EUCTR)
30/05/201931/05/2019A study of Baricitinib in patients with LupusA Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) Systemic Lupus Erythematosus (SLE)
MedDRA version: 20.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3United States;Serbia;Philippines;Taiwan;Greece;Spain;Ukraine;Chile;Russian Federation;Colombia;Italy;Switzerland;India;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
252EUCTR2018-003471-35-HU
(EUCTR)
29/05/201902/04/2019Long-Term Safety and Efficacy of BMS-986165 in Subjects with Systemic Lupus ErythematosusA Multi-Center Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects with Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: LLT;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 2United States;Taiwan;Spain;Russian Federation;Colombia;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Japan;Korea, Republic of
253NCT03933943
(ClinicalTrials.gov)
May 21, 201930/4/2019A Study of LY3361237 in Participants With Systemic Lupus ErythematosusA Phase 1, Randomized, Placebo-Controlled, Multiple- Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous LY3361237 in Patients With Systemic Lupus ErythematosusLupus Erythematosus, SystemicDrug: LY3361237;Drug: PlaceboEli Lilly and CompanyNULLCompleted18 Years70 YearsAll28Phase 1United States
254EUCTR2017-005028-11-HU
(EUCTR)
20/05/201902/04/2019A study of Baricitinib in patients with LupusA Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) Systemic Lupus Erythematosus (SLE)
MedDRA version: 20.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3United States;Serbia;Philippines;Taiwan;Greece;Spain;Chile;Russian Federation;Colombia;Italy;Switzerland;India;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
255EUCTR2018-001808-11-PL
(EUCTR)
17/05/201915/05/2019A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus diseaseA Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE) - CARE: Cenerimod Assessing S1P1 Receptor modulation in Systemic Lupus Erythematosus Moderate to severe systemic lupus erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Idorsia Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
325Phase 2Georgia;Germany;Romania;Bulgaria;United States;Philippines;Czechia;Taiwan;Greece;Spain;Thailand;Ukraine;Turkey;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Mexico;Poland
256EUCTR2017-005028-11-DE
(EUCTR)
10/05/201928/03/2019A study of Baricitinib in patients with LupusA Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3China;United States;Serbia;Philippines;Taiwan;Greece;Spain;Chile;Russian Federation;Colombia;Italy;Switzerland;India;France;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
257EUCTR2018-003471-35-PL
(EUCTR)
04/05/201903/04/2019Long-Term Safety and Efficacy of BMS-986165 in Subjects with Systemic Lupus ErythematosusA Multi-Center Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects with Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: LLT;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 2United States;Taiwan;Spain;Russian Federation;Israel;Colombia;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Japan;Korea, Republic of
258NCT03949426
(ClinicalTrials.gov)
May 1, 20198/5/2019Safety, Tolerability and Pharmacokinetics of KPG-818 in Healthy SubjectsA First-in-Human, Randomized, Double-blind, Placebo-controlled, Sequential Parallel Group, Single Ascending Dose Study in Healthy Participants to Evaluate the Safety, Tolerability and Pharmacokinetics of KPG-818Systemic Lupus ErythematosusDrug: KPG-818Kangpu Biopharmaceuticals, Ltd.NULLCompleted18 Years55 YearsAll40Phase 1United States
259NCT03845517
(ClinicalTrials.gov)
April 18, 201915/2/2019A DOSE-RANGING STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-06700841 IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)Systemic Lupus ErythematosusDrug: Placebo;Drug: PF-06700841 15 mg;Drug: PF-06700841 30 mg;Drug: PF-06700841 45 mgPfizerNULLActive, not recruiting18 Years75 YearsAll346Phase 2United States;Argentina;Australia;Belgium;Bulgaria;Canada;China;Colombia;Czechia;France;Germany;Greece;Hong Kong;Hungary;Italy;Japan;Korea, Republic of;Mexico;Poland;Portugal;Romania;Serbia;Spain;Taiwan;Ukraine;United Kingdom
260EUCTR2017-005028-11-CZ
(EUCTR)
08/04/201928/03/2019A study of Baricitinib in patients with LupusA Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3United States;Serbia;Philippines;Taiwan;Greece;Spain;Chile;Russian Federation;Colombia;Italy;Switzerland;India;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
261NCT03816345
(ClinicalTrials.gov)
April 4, 201924/1/2019Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable CancerA Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)Advanced Malignant Solid Neoplasm;Autoimmune Disease;Crohn Disease;Dermatomyositis;Hematopoietic and Lymphoid Cell Neoplasm;Inflammatory Bowel Disease;Metastatic Malignant Solid Neoplasm;Multiple Sclerosis;Psoriasis;Psoriatic Arthritis;Rheumatoid Arthritis;Sjogren Syndrome;Systemic Lupus Erythematosus;Systemic Scleroderma;Ulcerative Colitis;Unresectable Malignant Solid NeoplasmProcedure: Biospecimen Collection;Biological: NivolumabNational Cancer Institute (NCI)NULLRecruiting18 YearsN/AAll300Phase 1United States;Canada
262NCT03917797
(ClinicalTrials.gov)
April 2, 20192/4/2019Mesenchymal Stromal Cells (MSC´s) in Renal LupusDose-response and Efficacy of Umbilical Cord-derived Mesenchymal Stromal Cells in Renal Systemic Lupus ErythematosusLupus Erythematosus, Systemic;Lupus GlomerulonephritisBiological: MSC treatment;Drug: Standard of Care;Drug: PlaceboUniversidad de los Andes, ChileNULLRecruiting18 Years75 YearsAll39Phase 2Chile
263EUCTR2017-005026-37-GB
(EUCTR)
27/03/201919/09/2018A study of Baricitinib in patients with LupusA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
825Phase 3United States;Taiwan;Greece;Ukraine;Austria;Russian Federation;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;Belgium;Brazil;Croatia;Australia;Netherlands;Germany;China
264NCT03920267
(ClinicalTrials.gov)
March 26, 201927/3/2019Long-Term Safety and Efficacy Study of Deucravacitinib in Participants With Systemic Lupus ErythematosusA Multi-Center Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: BMS-986165Bristol-Myers SquibbNULLActive, not recruiting18 Years75 YearsAll261Phase 2United States;Argentina;Brazil;Canada;Colombia;Hungary;Japan;Korea, Republic of;Mexico;Poland;Romania;Russian Federation;Spain;Taiwan;Australia;Germany;Israel
265EUCTR2018-000305-23-BG
(EUCTR)
20/03/201912/11/2018A Phase 1b/2 Study of BOS161721 in Systemic Lupus Erythematosus (SLE) PatientsA Randomized Double-Blind Phase 1b/2 Combined Staggered Multiple Dose Escalation Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of Care Systemic lupus erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: BOS161721
Product Code: BOS161721
INN or Proposed INN: Not known
Other descriptive name: IMMUNOGLOBULIN G
Boston Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
156Phase 2United States;Philippines;Hungary;Mexico;Argentina;Poland;Ukraine;Romania;Peru;Georgia;Bulgaria;Colombia
266EUCTR2018-001808-11-BG
(EUCTR)
20/03/201906/12/2018A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus diseaseA Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE) - CARE: Cenerimod Assessing S1P1 Receptor modulation in Systemic Lupus Erythematosus Moderate to severe systemic lupus erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Idorsia Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
325Phase 2United States;Philippines;Czechia;Taiwan;Greece;Spain;Thailand;Ukraine;Turkey;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Mexico;Poland;Romania;Bulgaria;Georgia;Germany
267NCT03771885
(ClinicalTrials.gov)
March 16, 201910/12/2018BI 705564 in Patients With Systemic Lupus Erythematosus (SLE)A Phase Ib, Multicentre, Randomised, Double-blind, Placebo Controlled, 8 Week Crossover Study to Assess the Safety, Tolerability and Pharmacokinetics of Orally Administered BI 705564 in Patients With Systemic Lupus Erythematosus.Lupus Erythematosus, SystemicDrug: BI 705564;Drug: PlaceboBoehringer IngelheimNULLWithdrawn18 YearsN/AAll0Phase 1NULL
268ChiCTR1900020803
2019-03-012019-01-19Efficacy of Melatonin in patients with stable systemic lupus erythematosus complicated with insomnia: a single-center, randomized, double-blind, placebo-controlled clinical trialEfficacy of Melatonin in patients with stable systemic lupus erythematosus complicated with insomnia: a single-center, randomized, double-blind, placebo-controlled clinical trial systemic lupus erythematosusintervention group:melatonin 6mg qn;control group:placebo qn;Chinese Academy of Medical Sciences Peking Union Medical College HospitalNULLPending1865Bothintervention group:88;control group:88;Phase 4China
269EUCTR2018-001808-11-HU
(EUCTR)
08/02/201922/11/2018A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus diseaseA Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE) Moderate to severe systemic lupus erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Idorsia Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
500Phase 2United States;Taiwan;Thailand;Spain;Ukraine;Turkey;Lithuania;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Mexico;Poland;Romania;Bulgaria;Georgia;Germany;China
270EUCTR2018-000305-23-HU
(EUCTR)
07/02/201928/11/2018NoA Randomized Double-Blind Phase 1b/2 Combined Staggered Multiple Dose Escalation Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of Care Systemic lupus erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: BOS161721
Product Code: BOS161721
INN or Proposed INN: Not known
Other descriptive name: IMMUNOGLOBULIN G
Boston Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
156Phase 2United States;Philippines;Hungary;Mexico;Argentina;Poland;Ukraine;Romania;Peru;Georgia;Bulgaria;Colombia
271EUCTR2018-001808-11-IT
(EUCTR)
07/02/201928/01/2021A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus diseaseA Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE) - CARE:Cenerimod Assessing S1P1 Receptor modulation in Systemic Lupus Erythematosus Moderate to severe systemic lupus erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Cenerimod
Product Code: [ACT-334441]
INN or Proposed INN: Cenerimod
Product Name: Cenerimod
Product Code: [ACT-334441]
INN or Proposed INN: Cenerimod
Product Name: Cenerimod
Product Code: [ACT-334441]
INN or Proposed INN: Cenerimod
Product Name: Cenerimod
Product Code: [ACT-334441]
INN or Proposed INN: Cenerimod
IDORSIA PHARMACEUTICALS LTDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
500Phase 2United States;Czechia;Philippines;Taiwan;Greece;Spain;Thailand;Ukraine;Turkey;Chile;Israel;Russian Federation;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Poland;Romania;Bulgaria;Georgia;Germany;China
272EUCTR2018-001508-12-FR
(EUCTR)
05/02/201913/11/2018Study the efficacy and safety of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE) A placebo-controlled, patient and investigator blinded, randomized parallel cohort study to assess pharmacodynamics, pharmacokinetics, safety, tolerability and preliminary clinical efficacy of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE) Systemic lupus erythematosus (SLE)
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: VAY736
INN or Proposed INN: ianalumab
Other descriptive name: VAY736
Product Code: CFZ533
INN or Proposed INN: iscalimab
Other descriptive name: CFZ533
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
120 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noTaiwan;Spain;Thailand;Russian Federation;Israel;France;Czech Republic;Hungary;Argentina;Poland;Australia;Germany;China;Japan;Korea, Republic of
273EUCTR2017-001489-53-PT
(EUCTR)
04/02/201908/11/2018Study of Ustekinumab in Subjects with Active Systemic Lupus ErythematosusA Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus - LOTUS Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Stelara
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: Stelara
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Janssen-Cilag International NVNULLNot RecruitingFemale: yes
Male: yes
500Phase 3United States;Serbia;Portugal;Taiwan;Ecuador;Thailand;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Canada;Argentina;Poland;South Africa;Bulgaria;Germany;China;Japan;Korea, Republic of
274ChiCTR1800020286
2019-02-012018-12-22Clinical evaluation of the application of Langchuangjing granule in the treatment of systemic lupus erythematosusEfficacy and safety of Langchuangjing granule in the treatment of systemic lupus erythematosus: a clinical evaluation Systemic Lupus ErythematosusGroup 2:Langchuangjing granule + Prednisone acetate tablets, hydroxychloroquine and other Western medicines for 12 weeks.;Group 1:Prednisone acetate tablets, hydroxychloroquine and other Western medicines for 12 weeks.;Nanjing University of Chinese Medicine Affiliated HospitalNULLPendingBothGroup 2:40;Group 1:20;I (Phase 1 study)China
275EUCTR2018-001808-11-ES
(EUCTR)
24/01/201916/11/2018A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus diseaseA Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE) Moderate to severe systemic lupus erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Idorsia Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
500 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Hong Kong;Taiwan;Spain;Thailand;Ukraine;Lithuania;Turkey;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Mexico;Poland;Romania;Bulgaria;Georgia;Germany;China
276EUCTR2018-001808-11-FR
(EUCTR)
14/01/201931/08/2018A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus diseaseA Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE) Moderate to severe systemic lupus erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Idorsia Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
500Phase 2United States;Taiwan;Thailand;Spain;Ukraine;Turkey;Lithuania;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Poland;Romania;Bulgaria;Georgia;Germany;China
277NCT03742037
(ClinicalTrials.gov)
December 21, 201812/11/2018Efficacy and Safety of Four Doses of Cenerimod Compared to Placebo in Adult Subjects With Active Systemic Lupus ErythematosusA Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Cenerimod in Subjects With Moderate to Severe Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: Cenerimod 0.5 mg;Drug: Cenerimod 1 mg;Drug: Cenerimod 2 mg;Drug: Cenerimod 4 mg;Drug: PlaceboIdorsia Pharmaceuticals Ltd.NULLCompleted18 Years75 YearsAll427Phase 2United States;Bulgaria;Chile;Czechia;France;Georgia;Greece;Hungary;Israel;Italy;Mexico;Philippines;Poland;Romania;Russian Federation;Spain;Taiwan;Thailand;Turkey;Ukraine;United Kingdom;Germany;Lithuania
278EUCTR2017-005027-25-IT
(EUCTR)
20/12/201822/01/2021A study of Baricitinib in patients with LupusA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus - - Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Olumiant - EU/1/16/1170/009-016
Product Name: Baricitinib
Product Code: [LY3009104]
INN or Proposed INN: Baricitinib
Trade Name: Olumiant - EU/1/16/1170/001-008
Product Name: Baricitinib
Product Code: [LY3009104]
INN or Proposed INN: Baricinitib
ELI LILLY & COMPANY, LILLY CORPORATE CENTERNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
825Phase 3Serbia;United States;Philippines;Spain;Chile;Colombia;Italy;India;France;Argentina;Poland;Romania;South Africa;Japan;Korea, Republic of
279NCT03618056
(ClinicalTrials.gov)
December 19, 20181/8/2018Evaluating HIV-1 Neutralization Antibody Breadth in Response to HIV gp120 Protein Vaccine in HIV-uninfected Adults With Quiescent Systemic Lupus ErythematosusA Phase 1b Open Label Clinical Trial to Evaluate HIV-1 Neutralization Antibody Breadth in Response to HIV gp120 Protein Vaccine in HIV-uninfected Adults With Quiescent Systemic Lupus ErythematosusHIV Infections;Systemic Lupus ErythematosusBiological: AIDSVAX® B/ENational Institute of Allergy and Infectious Diseases (NIAID)NULLCompleted18 Years50 YearsAll1Phase 1United States
280NCT03656562
(ClinicalTrials.gov)
December 19, 201819/7/2018Study the Efficacy and Safety of VAY736 and CFZ533 in SLE PatientsA Placebo-controlled, Patient and Investigator Blinded, Randomized Parallel Cohort Study to Assess Pharmacodynamics, Pharmacokinetics, Safety, Tolerability and Preliminary Clinical Efficacy of VAY736 and CFZ533 in Patients With Systemic Lupus Erythematosus (SLE)Systemic Lupus Erythematosus (SLE)Drug: VAY736;Drug: VAY736 Placebo;Drug: CFZ533;Drug: CFZ533 PlaceboNovartis PharmaceuticalsNULLActive, not recruiting18 Years75 YearsAll107Phase 2Spain;Taiwan;Thailand;Argentina;Australia;China;Czechia;France;Germany;Hungary;Israel;Japan;Korea, Republic of;Poland;Russian Federation;United States
281EUCTR2017-005026-37-AT
(EUCTR)
18/12/201825/09/2018A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
825Phase 3United States;Czechia;Taiwan;Greece;Ukraine;Austria;Russian Federation;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;Brazil;Belgium;Croatia;Australia;Netherlands;Germany;China
282EUCTR2017-005026-37-BE
(EUCTR)
17/12/201825/09/2018A study of Baricitinib in patients with LupusA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Taiwan;Greece;Ukraine;Austria;Russian Federation;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;Belgium;Brazil;Croatia;Australia;Netherlands;Germany;China
283EUCTR2018-001808-11-GB
(EUCTR)
17/12/201817/09/2018A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus diseaseA Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE) - CARE: Cenerimod Assessing S1P1 Receptor modulation in Systemic Lupus Erythematosus Moderate to severe systemic lupus erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Other descriptive name: ACT-334441
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Other descriptive name: ACT-334441
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Other descriptive name: ACT-334441
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Other descriptive name: ACT-334441
Idorsia Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
325Phase 2United States;Czechia;Philippines;Taiwan;Greece;Spain;Thailand;Ukraine;Turkey;Chile;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Mexico;Poland;Romania;Georgia;Bulgaria;Germany
284NCT03817424
(ClinicalTrials.gov)
December 13, 201822/1/2019A Study to Evaluate VIB7734 in Participants With Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE), Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and DermatomyositisA Phase 1 Randomized, Placebo-Controlled, Blinded, Multiple Ascending Dose Study to Evaluate VIB7734 in Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus, Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and DermatomyositisSystemic Lupus Erythematosus;Cutaneous Lupus Erythematosus;Sjogren's Syndrome;Systemic Sclerosis;Polymyositis;DermatomyositisDrug: VIB7734;Drug: PlaceboViela BioNULLCompleted18 Years75 YearsAll31Phase 1United States;Poland;Spain
285EUCTR2018-001508-12-ES
(EUCTR)
12/12/201809/10/2018Study the efficacy and safety of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE) A placebo-controlled, patient and investigator blinded, randomized parallel cohort study to assess pharmacodynamics, pharmacokinetics, safety, tolerability and preliminary clinical efficacy of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE) Systemic lupus erythematosus (SLE)
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: VAY736
INN or Proposed INN: ianalumab
Other descriptive name: VAY736
Product Code: CFZ533
INN or Proposed INN: iscalimab
Other descriptive name: CFZ533
Novartis Farmacéutica, S.A.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
120 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noTaiwan;Spain;Thailand;Russian Federation;Israel;France;Czech Republic;Hungary;Argentina;Poland;Australia;Germany;China;Japan;Korea, Republic of
286EUCTR2017-001203-79-DE
(EUCTR)
12/12/201827/02/2018A clinical study to test the efficacy and safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus.A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: LLT;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
360Phase 2United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Australia;Germany;Japan;Korea, Republic of
287EUCTR2018-001508-12-DE
(EUCTR)
05/12/201828/08/2018Study the efficacy and safety of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE)A placebo-controlled, patient and investigator blinded, randomized parallelcohort study to assess pharmacodynamics, pharmacokinetics, safety,tolerability and preliminary clinical efficacy of VAY736 and CFZ533 inpatients with systemic lupus erythematosus (SLE) Systemic lupus erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: VAY736
INN or Proposed INN: ianalumab
Other descriptive name: VAY736
Product Code: CFZ533
INN or Proposed INN: iscalimab
Other descriptive name: CFZ533
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
135Phase 2United States;Czechia;Taiwan;Spain;Thailand;Israel;Russian Federation;France;Czech Republic;Hungary;Argentina;Poland;Australia;Germany;China;Japan;Korea, Republic of
288NCT02525835
(ClinicalTrials.gov)
December 1, 201813/8/2015Tissue Sodium in Autoimmune DiseaseTissue Sodium in Autoimmune DiseaseSystemic Lupus ErythematosusDietary Supplement: Low Dietary Sodium;Dietary Supplement: High Dietary SodiumVanderbilt UniversityNULLWithdrawn18 YearsN/AAll0N/AUnited States
289NCT03878303
(ClinicalTrials.gov)
November 28, 20185/3/2019Study of AC0058TA in Patients With Systemic Lupus Erythematosus (SLE)A Phase 1b Double-Blind, Randomized, Placebo-Controlled Study of the Safety, Pharmacokinetics and Pharmacodynamics of AC0058TA in Patients With Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: AC0058TA;Drug: Placebo AC0058TAACEA Therapeutics, Inc.Hangzhou ACEA Pharmaceutical Research Co., Ltd.Recruiting18 Years75 YearsAll32Phase 1United States
290NCT03724916
(ClinicalTrials.gov)
November 26, 201818/10/2018A Study to Evaluate the Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of TAK-079 in Combination With Standard Background Therapy in Participants With Moderate to Severe Systemic Lupus Erythematosus (SLE)A Phase 1b Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TAK-079 in Combination With Standard Background Therapy in Patients With Moderate to Severe Systemic Lupus ErythematosusSystemic Lupus Erythematosus;Lupus Erythematosus, SystemicDrug: TAK-079;Drug: TAK-079 PlaceboMillennium Pharmaceuticals, Inc.NULLCompleted18 Years75 YearsAll58Phase 1United States
291EUCTR2017-005026-37-HU
(EUCTR)
19/11/201825/09/2018A study of Baricitinib in patients with LupusA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
825Phase 3United States;Taiwan;Greece;Ukraine;Austria;Russian Federation;United Kingdom;Switzerland;Hungary;Czech Republic;Mexico;Belgium;Brazil;Croatia;Australia;Netherlands;Germany;China
292ChiCTR1800019308
2018-11-122018-11-04Efficacy and tolerability of multitarget therapy with NHMX for systemic lupus erythematosusEfficacy and tolerability of multitarget therapy with NHMX for systemic lupus erythematosus systemic lupus erythematosusNHMX:One kind of non-steroid anti-inflammatory drugs combines with hydroxychloroquine sulfate(=200mg/bid) and methotrexate(7.5-20mg/w), with addition of glucocorticoid (=0.5mg/kg·d) or cyclosporine (maintaining the drug concentration between 30-90ug/l);control:hydroxychloroquine sulfate(=200mg/bid) and methotrexate(7.5-20mg/w), with addition of glucocorticoid (=0.5mg/kg·d) or cyclosporine(maintaining the drug concentration between 30-90ug/l);The Third Affiliated Hospital, Southern Medical UniversityNULLRecruiting1865BothNHMX:75;control:75;China
293EUCTR2017-005026-37-CZ
(EUCTR)
12/11/201826/10/2018A study of Baricitinib in patients with LupusA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
825Phase 3United States;Taiwan;Greece;Ukraine;Austria;Russian Federation;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;Belgium;Brazil;Croatia;Australia;Netherlands;Germany;China
294EUCTR2018-001508-12-CZ
(EUCTR)
02/11/201828/08/2018Study the efficacy and safety of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE)A placebo-controlled, patient and investigator blinded, randomized parallelcohort study to assess pharmacodynamics, pharmacokinetics, safety,tolerability and preliminary clinical efficacy of VAY736 and CFZ533 inpatients with systemic lupus erythematosus (SLE) Systemic lupus erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: VAY736
INN or Proposed INN: ianalumab
Other descriptive name: VAY736
Product Code: CFZ533
INN or Proposed INN: iscalimab
Other descriptive name: CFZ533
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
135Phase 2Argentina;Russian Federation;Hungary;Japan;Thailand;Spain;Czech Republic;China;Taiwan;Korea, Republic of;Poland;Israel;Australia;France;Germany
295NCT02633163
(ClinicalTrials.gov)
October 26, 201815/12/2015Phase 2 Trial of Mesenchymal Stem Cells in Systemic Lupus Erythematosus (MiSLE)A Phase II Controlled Trial of Allogeneic Mesenchymal Stem Cells for the Treatment of Refractory LupusSystemic Lupus ErythematosusDrug: Low Dose Mesenchymal Stem Cells (MSCs);Drug: High Dose Mesenchymal Stem Cells (MSCs);Drug: Placebo InfusionMedical University of South CarolinaNULLRecruiting18 Years65 YearsAll81Phase 2United States
296NCT03626311
(ClinicalTrials.gov)
October 23, 20186/6/2018Omega-3 Replacement With Krill Oil in Disease Management of SLEA Double-Blind, Placebo-Controlled Randomized, Multicenter Study to Assess Changes in Omega-3 Index in Erythrocytes and Health Benefit After 24 Weeks of Daily Consumption of AKBM-3031 (Omega-3 Phospholipids From Krill), Followed by a 24 Week Open-Label Extension, in Patients With Systemic Lupus Erythematosus (SLE)Systemic Lupus Erythematosus (SLE)Dietary Supplement: AKBM-3031;Other: PlaceboAker Biomarine Antarctic ASAmpel BioSolutions, LLCCompleted18 YearsN/AAll76N/AUnited States;Canada
297NCT03747159
(ClinicalTrials.gov)
October 1, 201812/10/2018Synergetic B-cell Immunomodulation in SLE - 2nd Study.A Randomized Trial to Investigate the Reset of Humoral Autoimmunity by Combining Belimumab With Rituximab in Severe Systemic Lupus ErythematosusLupus Erythematosus, SystemicDrug: Belimumab InjectionLeiden University Medical CenterDutch Kidney Foundation;GlaxoSmithKlineRecruiting18 YearsN/AAll70Phase 2Netherlands
298EUCTR2018-001392-21-NL
(EUCTR)
25/09/201825/09/2018Synergetic B-cell immunomodulation in SLE – 2nd studyA randomized trial to investigate the reset of humoral autoimmunity by combining belimumab with rituximab in severe systemic lupus erythematosus systemic lupus erythematosus
MedDRA version: 21.1;Level: LLT;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10029142;Term: Nephritis systemic lupus erythematosus;System Organ Class: 100000004857
MedDRA version: 21.1;Classification code 10042948;Term: Systemic lupus erythematosus syndrome aggravated;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: belimumab or benlysta
Trade Name: anti-CD20 B cell depletion with Truxima
Product Name: truxima
Leiden University Medical CenterNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 2;Phase 3Netherlands
299EUCTR2017-001489-53-PL
(EUCTR)
24/09/201823/07/2018Study of Ustekinumab in Subjects with Active Systemic Lupus ErythematosusA Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus - LOTUS Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Stelara
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: Stelara
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Janssen-Cilag International NVNULLNot RecruitingFemale: yes
Male: yes
500Phase 3United States;Serbia;Portugal;Taiwan;Thailand;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Canada;Argentina;Poland;South Africa;Bulgaria;Germany;China;Japan;Korea, Republic of
300EUCTR2017-005027-25-ES
(EUCTR)
21/09/201824/09/2018A study of Baricitinib in patients with LupusA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3Study of Baricitinib in Patients with Systemic Lupus Erythematosus Systemic Lupus Erythematosus (SLE)
MedDRA version: 20.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
750Phase 3Serbia;United States;Philippines;Spain;Chile;Colombia;Argentina;Poland;Romania;South Africa;Japan;Korea, Republic of;Italy;India;France
301NCT03575156
(ClinicalTrials.gov)
September 20, 20187/6/2018Microparticles's Role in the Pathophysiology of Systemic Lupus Erythematosus and Systemic SclerosisMicroparticles's Role in the Pathophysiology of Systemic Lupus Erythematosus and Systemic SclerosisSystemic Lupus Erythematosus;Systemic SclerodermaBiological: blood sample;Biological: urine sampleUniversity Hospital, BordeauxNULLCompleted18 YearsN/AAll208N/AFrance
302ChiCTR1800017540
2018-09-012018-08-03A randomized controlled trial for the long-term outcomes of MMF on new onset SLE patients with high titers of anti-dsDNA antibody for reducing main organ involvementA randomized controlled trial for the long-term outcomes of MMF on new onset SLE patients with high titers of anti-dsDNA antibody for reducing main organ involvement systemic lupus erythematosus1:Hydroxychloroquine (5mg/kg/day) plus prednisone (0.5mg/kg/day);2:Hydroxychloroquine (5mg/kg/day) plus prednisone (0.5mg/kg/day) plus Mycophenolate Mofetil 500mg bid;Ruijin HospitalNULLCompleted1865Both1:65;2:65;Phase 4China
303NCT03527472
(ClinicalTrials.gov)
August 23, 20183/5/2018Memantine for the Treatment of Cognitive Impairment in Systemic Lupus ErythematosusA Randomized Placebo-controlled, Double Blind Phase 2 Clinical Trial of Memantine for the Treatment of Cognitive Impairment in Systemic Lupus ErythematosusLupus Erythematosus, SystemicDrug: Memantine;Drug: PlaceboVanderbilt University Medical CenterKleberg FoundationRecruiting18 Years70 YearsAll80Phase 2United States
304JPRN-JapicCTI-183973
16/8/201829/05/2018A Study of Ustekinumab in Participants with Active Systemic Lupus ErythematosusA Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus Lupus Erythematosus, SystemicIntervention name : Ustekinumab
INN of the intervention : Ustekinumab
Dosage And administration of the intervention : Participants will receive ustekinumab approximately 6 milligram per kilogram (mg/kg) intravenously (IV) based on body weight-range at Week 0 followed by 90 mg ustekinumab subcutaneously (SC) at Week 8 and every 8 weeks (q8w) thereafter through Week 48 during double-blind period. Eligible participants who will enter the extension period will continue to receive 90 mg ustekinumab SC q8w through Week 160
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Participants will receive matching placebo to ustekinumab IV at Week 0, followed by matching placebo to ustekinumab SC at Week 8 and q8w thereafter through Week 48 during double-blind period. Eligible participants who will enter the extension period will cross-over to receive 90 mg ustekinumab SC q8w through Week 160.
Janssen Pharmaceutical K.K.NULLcomplete1675BOTH500Phase 3Japan, Asia except Japan, North America, South America, Europe, Africa
305NCT03312335
(ClinicalTrials.gov)
August 8, 201829/9/2017Low-dose Interleukin-2 for Treatment of Systemic Lupus ErythematosusOpen-label, Monocentric, Phase II, Investigator-initiated Clinical Trial on Unbiased Characterization of Immunological Parameters in Interleukin-2-treated Systemic Lupus ErythematosusLupus Erythematosus, SystemicDrug: Low-dose Aldesleukin (Proleukin®)Onur Boyman, MDNULLCompleted18 YearsN/AAll16Phase 2Switzerland
306NCT03616912
(ClinicalTrials.gov)
August 2, 20181/8/2018A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus ErythematosusA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: Baricitinib;Drug: PlaceboEli Lilly and CompanyIncyte CorporationTerminated18 YearsN/AAll830Phase 3United States;Australia;Austria;Belgium;Brazil;China;Croatia;Czechia;Germany;Greece;Hungary;Israel;Mexico;Netherlands;Russian Federation;Switzerland;Taiwan;United Kingdom;Ukraine
307NCT03616964
(ClinicalTrials.gov)
August 2, 20181/8/2018A Study of Baricitinib in Participants With Systemic Lupus ErythematosusA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: Baricitinib;Drug: PlaceboEli Lilly and CompanyIncyte CorporationCompleted18 YearsN/AAll777Phase 3United States;Argentina;Chile;Colombia;France;India;Italy;Japan;Korea, Republic of;Philippines;Poland;Romania;Serbia;South Africa;Spain
308EUCTR2017-001489-53-BG
(EUCTR)
27/06/201828/03/2018Study of Ustekinumab in Subjects with Active Systemic Lupus ErythematosusA Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus - LOTUS Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Stelara
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: Stelara
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Janssen-Cilag International NVNULLNot RecruitingFemale: yes
Male: yes
500Phase 3United States;Serbia;Portugal;Taiwan;Thailand;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Canada;Argentina;Poland;South Africa;Bulgaria;Germany;China;Japan;Korea, Republic of
309EUCTR2017-001489-53-HU
(EUCTR)
14/06/201803/04/2018Study of Ustekinumab in Subjects with Active Systemic Lupus ErythematosusA Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus - LOTUS Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Stelara
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: Stelara
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Janssen-Cilag International NVNULLNot RecruitingFemale: yes
Male: yes
500Phase 3Portugal;United States;Serbia;Philippines;Taiwan;Ecuador;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Argentina;Poland;Romania;Australia;Peru;South Africa;Bulgaria;Germany;China;Japan;Korea, Republic of
310EUCTR2017-001489-53-ES
(EUCTR)
12/06/201814/03/2018Study of Ustekinumab in Subjects with Active Systemic Lupus ErythematosusA Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus - LOTUS Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Stelara
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: Stelara
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Janssen-Cilag International NVNULLNot RecruitingFemale: yes
Male: yes
500Phase 3Portugal;United States;Serbia;Philippines;Taiwan;Ecuador;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Argentina;Poland;Romania;Australia;Peru;South Africa;Bulgaria;Germany;China;Japan;Korea, Republic of
311NCT03541564
(ClinicalTrials.gov)
May 30, 201817/5/2018An Investigational Study of Experimental Medication BMS-986165 in Healthy Participants to Study Electrocardiogram EffectsA Randomized, Double-Blind, Positive-Controlled, Placebo-Controlled, 4-Period Crossover Study to Investigate the Electrocardiographic Effects of BMS-986165 in Healthy SubjectsSystemic Lupus Erythematosus;Healthy ParticipantsDrug: BMS-986165;Drug: Moxifloxacin;Other: PlaceboBristol-Myers SquibbNULLCompleted18 Years50 YearsAll84Phase 1United States
312EUCTR2016-000488-17-FR
(EUCTR)
16/05/201819/03/2019A study to evaluate the effectiveness and safety of the study drug, when patients are given dosage of ILT-101 with active moderate to severe systemic lupus erythematosus(SLE)A Phase II, multi-centre, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety and pharmacokinetics of ILT-101 in patients with active moderate to severe systemic lupus erythematosus (SLE) Systematic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: ILT-101
Product Code: ILT-101
INN or Proposed INN: Aldesleukin
Other descriptive name: INTERLEUKIN-2
ILTOO PHARMANULLNot RecruitingFemale: yes
Male: yes
100Phase 2Portugal;France;Mexico;Spain;Austria;Bulgaria;Italy
313EUCTR2017-001764-37-PT
(EUCTR)
14/05/201812/10/2017An Extension Study of Patients Previously Enrolled in Study GA30044 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients with Moderate to Severe Active Systemic Lupus ErythematosusA PHASE II, OPEN-LABEL EXTENSION STUDY OF PATIENTS PREVIOUSLY ENROLLED IN STUDY GA30044 TO EVALUATE THE LONG-TERMSAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: GDC-0853
Product Code: RO7010939/F13
INN or Proposed INN: not available yet
Other descriptive name: GDC-0853 RO7010939
Genentech, Inc.NULLNot RecruitingFemale: yes
Male: yes
240Phase 2Portugal;United States;Taiwan;Spain;Chile;Colombia;United Kingdom;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of
314EUCTR2017-001489-53-DE
(EUCTR)
08/05/201823/03/2018Study of Ustekinumab in Subjects with Active Systemic Lupus ErythematosusA Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus - LOTUS Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Stelara
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: Stelara
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
500Phase 3United States;Serbia;Portugal;Taiwan;Thailand;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Canada;Argentina;Poland;South Africa;Bulgaria;Germany;China;Japan;Korea, Republic of
315EUCTR2017-001489-53-LT
(EUCTR)
07/05/201819/03/2018Study of Ustekinumab in Subjects with Active Systemic Lupus ErythematosusA Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus - LOTUS Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Stelara
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: Stelara
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Janssen-Cilag International NVNULLNot RecruitingFemale: yes
Male: yes
500Phase 3United States;Serbia;Portugal;Taiwan;Thailand;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Canada;Argentina;Poland;South Africa;Bulgaria;Germany;China;Japan;Korea, Republic of
316NCT03556007
(ClinicalTrials.gov)
April 18, 20187/5/2018A Study of NKTR-358 (LY3471851) in Participants With Systemic Lupus Erythematosus (SLE)A Phase 1, Double-blind, Randomized, Placebo-controlled, Ascending Multiple-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous NKTR-358 in Patients With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: LY3471851;Drug: PlaceboEli Lilly and CompanyNektar TherapeuticsCompleted18 Years70 YearsAll48Phase 1United States
317NCT03517722
(ClinicalTrials.gov)
April 16, 201813/4/2018A Study of Ustekinumab in Participants With Active Systemic Lupus ErythematosusA Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects With Active Systemic Lupus ErythematosusLupus Erythematosus, SystemicDrug: Placebo;Drug: Ustekinumab (approximately 6 mg/kg);Drug: Ustekinumab 90 mgJanssen Research & Development, LLCNULLTerminated16 Years75 YearsAll516Phase 3United States;Argentina;Bulgaria;Canada;China;Colombia;Germany;Hungary;Japan;Korea, Republic of;Lithuania;Poland;Portugal;Russian Federation;Serbia;South Africa;Spain;Taiwan;Thailand;Ukraine;Australia;Ecuador;France;Peru;Philippines;Romania
318NCT03492255
(ClinicalTrials.gov)
April 12, 201816/3/2018CYCLONES - CYClophosphamide LOw Dose and No Extra SteroidCYCLONES - CYClophosphamide LOw Dose and No Extra SteroidSystemic Lupus Erythematosus (SLE)Drug: Cyclophosphamide;Drug: Methylprednisolone;Drug: Prednisone;Drug: Mycophenolate MofetilUniversity of Sao Paulo General HospitalFundação de Amparo à Pesquisa do Estado de São PauloTerminated18 YearsN/AAll49N/ABrazil
319NCT03451422
(ClinicalTrials.gov)
April 10, 20181/2/2018Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Efavaleukin Alfa in Participants With Systemic Lupus ErythematosusA Randomized, Double-blind, Placebo-controlled Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Multiple Ascending Subcutaneous Doses of Efavaleukin Alfa in Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: Efavaleukin Alfa;Drug: PlaceboAmgenNULLCompleted18 Years70 YearsAll35Phase 1United States;France;Germany;Poland
320EUCTR2017-002564-40-DE
(EUCTR)
10/04/201804/12/2017Safety and Efficacy of AMG 592 in Subjects With Active Systemic Lupus ErythematosusA Phase 1b/2a Study to Evaluate the Safety and Efficacy of AMG 592 in Subjects With Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy. Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: AMG592
Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN
Amgen IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 1;Phase 2United States;France;Poland;Germany
321EUCTR2017-001400-29-FR
(EUCTR)
16/03/201831/07/2018Treatment of systemic lupus erythematosus by injection iv of mesenchymal stem cells (MSC-LES)Treatment of severe refractory systemic lupus erythematosus by injection of allogeneic mesenchymal stem cells derived from the umbilical cord - MSC SLE - MSC-LES Treatment of Systemic Lupus Erythematosus refractory to standard treatments.
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ALLOGENEIC MESENCHYMAL STROMAL CELLS DERIVED FROM THE UMBILICAL CORD
Product Code: 0
INN or Proposed INN: 0
Other descriptive name: CSM allogéniques issues de cordons ombilicaux ( MTI-PP)
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
10Phase 1;Phase 2France
322EUCTR2017-004060-35-HU
(EUCTR)
12/03/201810/01/2018An open-label study to evaluate the safety and tolerability of 200-mcg Dose of IPP-201101 in Patients With SLEAn open-label study of the safety and tolerability of repeated administration of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: IPP-201101
Product Code: IPP-201101
INN or Proposed INN: IPP-201101
ImmuPharmaNULLNot Recruiting Female: yes
Male: yes
75 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Hungary;Mauritius
323NCT03393013
(ClinicalTrials.gov)
March 7, 201821/12/2017A Study of KZR-616 in Patients With SLE With and Without Lupus NephritisA Phase 1b/2 Study of KZR-616 in Patients With Systemic Lupus Erythematosus With and Without NephritisLupus Nephritis;Systemic Lupus ErythematosusDrug: KZR-616Kezar Life Sciences, Inc.NULLCompleted18 Years75 YearsAll69Phase 1/Phase 2United States;Australia;Colombia;Mexico;Peru;Poland;Russian Federation;Ukraine
324NCT03312907
(ClinicalTrials.gov)
March 1, 201813/10/2017A Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination With Rituximab to Adult Subjects With Systemic Lupus Erythematosus (SLE) - BLISS-BELIEVEA Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 104-Week Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination With Rituximab to Adult Subjects With Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: Belimumab;Drug: Rituximab;Drug: Rituximab-placebo;Drug: Standard therapy (Including Immunosuppressants);Drug: Standard therapy (Excluding Immunosuppressants);Drug: Steroid TaperGlaxoSmithKlineNULLCompleted18 YearsN/AAll292Phase 3United States;Argentina;Brazil;Canada;France;Germany;Korea, Republic of;Mexico;Netherlands;Russian Federation;Spain
325NCT03480529
(ClinicalTrials.gov)
March 1, 201821/3/2018Monitoring the IMmUological TOXicity of DrugsMonitoring the IMmUological TOXicity of DrugsArthritis;Systemic Lupus Erythematosus;Rheumatoid Arthritis;Capillary Leak Syndrome;HepatitisDrug: drug inducing arthritis, lupus, hepatitis, or capillary leak syndromGroupe Hospitalier Pitie-SalpetriereInstitut National de la Santé Et de la Recherche Médicale, FranceCompleted18 YearsN/AAll662France
326ChiCTR1800015030
2018-03-012018-03-01A Clinical Trial on Safety and effect of Dapagliflozin to Control Blood Glucose Levels in Systemic Lupus ErythematosusThe Safety of SGLT2-i Dapagliflozin on Treating Blood Glucose Levels in SLE Systemic Lupus ErythematosusCase series:add-on or replace dapagliflozin;Dept. Rheumatology, Renji Hospital South CampusNULLPending1870BothCase series:35;4 (Phase 4 study)China
327NCT03396393
(ClinicalTrials.gov)
March 20184/1/2018Exploratory Study of DHA in Systemic Lupus Erythematosus PatientsA Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety, Pharmacokinetics and Efficacy of Dihydroartemisinin Tablets in Patients With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: Dihydroartemisinin tablet;Drug: Placebo tabletKunming Pharmaceuticals, Inc.NULLNot yet recruiting18 Years65 YearsAll120Phase 2NULL
328NCT03427151
(ClinicalTrials.gov)
February 27, 20188/12/2017Study of Repeated Administration of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus ErythematosusAn Open-label Study of the Safety and Tolerability of Repeated Administration of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus ErythematosusLupus Erythematosus, SystemicDrug: IPP-201101ImmuPharmaNULLCompleted18 YearsN/AAll62Phase 3United States;Czechia;France;Germany;Hungary;Mauritius;Puerto Rico;Poland
329EUCTR2016-003050-32-NL
(EUCTR)
16/02/201824/10/2017A Phase 3 Study to Evaluate the Efficacy and Safety of BelimumabAdministered in Combination with Rituximab to Adult Subjects with Systemic LupusErythematosus (SLE) – BLISS-BELIEVEA Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 104-Week Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination with Rituximab to Adult Subjects with Systemic Lupus Erythematosus (SLE) Systemic Lupus Erythematosus (SLE) or Lupus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: MabThera (Rituximab)
Product Name: MabThera (Rituximab)
INN or Proposed INN: RITUXIMAB
Trade Name: Benlysta (Belimumab)
Product Name: Benlysta (Belimumab)
INN or Proposed INN: BELIMUMAB
Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
280Phase 3United States;Mexico;Canada;Argentina;Spain;Brazil;Russian Federation;Germany;Netherlands;Korea, Republic of
330NCT03371251
(ClinicalTrials.gov)
February 7, 20188/12/2017Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of CareA Randomized Double-Blind Phase 1b/2 Combined Staggered Multiple Dose Escalation Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of CareSystemic Lupus ErythematosusDrug: BOS161721;Drug: PlaceboBoston PharmaceuticalsNULLCompleted18 Years70 YearsAll143Phase 1/Phase 2United States;Argentina;Bulgaria;Colombia;Georgia;Hungary;Mexico;Peru;Philippines;Poland;Romania;Ukraine
331NCT03370263
(ClinicalTrials.gov)
January 15, 20186/12/2017BENLYSTA® Special Drug Use InvestigationBENLYSTA for Intravenous Injection / Subcutaneous Injection Special Drug Use InvestigationSystemic Lupus ErythematosusDrug: BenlystaGlaxoSmithKlineNULLRecruitingN/AN/AAll600Japan
332NCT03407482
(ClinicalTrials.gov)
January 9, 201815/1/2018An Extension Study of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus ErythematosusA Phase II, Open-Label Extension Study of Patients Previously Enrolled in Study GA30044 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients With Moderate to Severe Active Systemic Lupus ErythematosusLupus Erythematosus, SystemicDrug: GDC-0853Genentech, Inc.NULLCompleted18 Years76 YearsAll160Phase 2United States;Argentina;Brazil;Bulgaria;Chile;Colombia;Korea, Republic of;Mexico;Spain;Taiwan;United Kingdom;Germany;Portugal
333EUCTR2016-003050-32-DE
(EUCTR)
09/01/201821/06/2017A Phase 3 Study to Evaluate the Efficacy and Safety of BelimumabAdministered in Combination with Rituximab to Adult Subjects with Systemic LupusErythematosus (SLE) – BLISS-BELIEVEA Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 104-Week Study to Evaluate the Efficacy and Safety of BelimumabAdministered in Combination with Rituximab to Adult Subjects with Systemic LupusErythematosus (SLE) Systemic Lupus Erythematosus (SLE) or Lupus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: MabThera (Rituximab)
Product Name: MabThera (Rituximab)
INN or Proposed INN: RITUXIMAB
Trade Name: Benlysta (Belimumab)
Product Name: Benlysta (Belimumab)
INN or Proposed INN: BELIMUMAB
Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
280Phase 3United States;Mexico;Canada;Argentina;Spain;Brazil;Russian Federation;Netherlands;Germany;Korea, Republic of
334EUCTR2017-001203-79-PL
(EUCTR)
05/01/201803/11/2017A clinical study to test the efficacy and safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus.A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: LLT;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
360Phase 2United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Australia;Germany;Japan;Korea, Republic of
335NCT03030118
(ClinicalTrials.gov)
December 28, 201715/1/2017Study of Anti-Malarials in Incomplete Lupus ErythematosusStudy of Anti-Malarials in Incomplete Lupus ErythematosusSystemic Lupus ErythematosusDrug: Hydroxychloroquine;Drug: Placebo Oral CapsuleMilton S. Hershey Medical CenterNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Active, not recruiting15 Years49 YearsAll187Phase 2United States
336NCT03093402
(ClinicalTrials.gov)
December 21, 201721/2/2017JBT-101 in Systemic Lupus Erythematosus (SLE)A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Efficacy, Safety, and Tolerability of JBT-101 in Systemic Lupus ErythematosusSystemic Lupus Erythematosus;SLE;LupusDrug: JBT-101;Drug: PlaceboNational Institute of Allergy and Infectious Diseases (NIAID)Corbus Pharmaceuticals Inc.;Autoimmunity Centers of Excellence;Rho Federal Systems Division, Inc.Completed18 Years70 YearsAll109Phase 2United States
337EUCTR2017-001764-37-BG
(EUCTR)
15/12/201716/10/2017An Extension Study of Patients Previously Enrolled in Study GA30044 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients with Moderate to Severe Active Systemic Lupus ErythematosusA PHASE II, OPEN-LABEL EXTENSION STUDY OF PATIENTS PREVIOUSLY ENROLLED IN STUDY GA30044 TO EVALUATE THE LONG-TERMSAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: GDC-0853
Product Code: RO7010939/F13
INN or Proposed INN: not available yet
Other descriptive name: GDC-0853 RO7010939
Genentech, Inc.NULLNot RecruitingFemale: yes
Male: yes
240Phase 2Portugal;United States;Taiwan;Spain;Chile;Colombia;United Kingdom;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of
338EUCTR2016-003050-32-ES
(EUCTR)
05/12/201701/12/2017A Phase 3 Study to Evaluate the Efficacy and Safety of BelimumabAdministered in Combination with Rituximab to Adult Subjects with Systemic Lupus Erythematosus (SLE) – BLISS-BELIEVEA Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 104-Week Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination with Rituximab to Adult Subjects with Systemic Lupus Erythematosus (SLE). Systemic Lupus Erythematosus (SLE) or Lupus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: MabThera (Rituximab)
Product Name: MabThera (Rituximab)
INN or Proposed INN: RITUXIMAB
Trade Name: Benlysta (Belimumab)
Product Name: Benlysta (Belimumab)
INN or Proposed INN: BELIMUMAB
Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA
GlaxoSmithKline, S.A.NULLNot RecruitingFemale: yes
Male: yes
200Phase 3United States;Mexico;Canada;Argentina;Brazil;Spain;South Africa;Russian Federation;Netherlands;Germany;Korea, Republic of
339EUCTR2017-001203-79-HU
(EUCTR)
04/12/201704/10/2017A clinical study to test the efficacy and safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus.A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: LLT;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 100000017968;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Bristol-Myers Squibb international CorporationNULLNot RecruitingFemale: yes
Male: yes
400Phase 2United States;Taiwan;Spain;Ukraine;Russian Federation;Israel;Colombia;France;Hungary;Mexico;Argentina;Brazil;Poland;Romania;Peru;Bulgaria;Germany;Japan;Korea, Republic of
340EUCTR2016-004574-17-FR
(EUCTR)
30/11/201728/11/2018A study to measure how safe CC-220 is and how well CC-220 works in people with lupus.A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLEBLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS SYSTEMIC LUPUS ERYTHEMATOSUS
MedDRA version: 20.0;Level: LLT;Classification code 10025134;Term: Lupus erythematosus;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: CC-220
INN or Proposed INN: CC-220
Other descriptive name: CC-220
Product Code: CC-220
INN or Proposed INN: CC-220
Other descriptive name: CC-220
Product Code: CC-220
INN or Proposed INN: CC-220
Other descriptive name: CC-220
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
280 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;United States;Spain;Russian Federation;Colombia;Italy;France;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Germany
341NCT03334851
(ClinicalTrials.gov)
November 17, 20173/11/2017Safety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid ArthritisA PHASE 1, RANDOMIZED, MULTI-CENTER, DOUBLE-BLIND, SPONSOR OPEN, PLACEBO-CONTROLLED, SINGLE AND MULTIPLE DOSE-ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF PF-06835375 IN SUBJECTS WITH SEROPOSITIVE SYSTEMIC LUPUS ERYTHEMATOSUS OR RHEUMATOID ARTHRITISSystemic Lupus Erythematosus;Rheumatoid ArthritisDrug: PF-06835375;Drug: PlaceboPfizerNULLCompleted18 Years70 YearsAll74Phase 1United States;Puerto Rico
342EUCTR2016-004574-17-BE
(EUCTR)
14/11/201707/06/2017A study to measure how safe CC-220 is and how well CC-220 works in people with lupus.A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLEBLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS SYSTEMIC LUPUS ERYTHEMATOSUS
MedDRA version: 20.0;Level: LLT;Classification code 10025134;Term: Lupus erythematosus;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: CC-220
INN or Proposed INN: CC-220
Other descriptive name: CC-220
Product Code: CC-220
INN or Proposed INN: CC-220
Other descriptive name: CC-220
Product Code: CC-220
INN or Proposed INN: CC-220
Other descriptive name: CC-220
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
280Phase 2United States;Serbia;Spain;Russian Federation;Colombia;Italy;France;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Germany
343EUCTR2017-001764-37-GB
(EUCTR)
14/11/201715/08/2017An Extension Study of Patients Previously Enrolled in Study GA30044 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients with Moderate to Severe Active Systemic Lupus ErythematosusA PHASE II, OPEN-LABEL EXTENSION STUDY OF PATIENTS PREVIOUSLY ENROLLED IN STUDY GA30044 TO EVALUATE THE LONG-TERMSAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: GDC-0853
Product Code: RO7010939/F13
INN or Proposed INN: not available yet
Other descriptive name: GDC-0853 RO7010939
Genentech, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 2United States;Portugal;Taiwan;Spain;Chile;Colombia;United Kingdom;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of
344EUCTR2017-001764-37-ES
(EUCTR)
07/11/201718/09/2017An Extension Study of Patients Previously Enrolled in Study GA30044 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients with Moderate to Severe Active Systemic Lupus ErythematosusA PHASE II, OPEN-LABEL EXTENSION STUDY OF PATIENTS PREVIOUSLY ENROLLED IN STUDY GA30044 TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: GDC-0853
Product Code: RO7010939/F13
INN or Proposed INN: not available yet
Other descriptive name: GDC-0853 RO7010939
Roche Farma, S.A por delegación de Genentech, Inc.NULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Portugal;Taiwan;Spain;Chile;Colombia;United Kingdom;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of
345EUCTR2016-004574-17-DE
(EUCTR)
27/09/201721/04/2017A study to measure how safe CC-220 is and how well CC-220 works in people with lupus.A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLEBLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS SYSTEMIC LUPUS ERYTHEMATOSUS
MedDRA version: 20.0;Level: LLT;Classification code 10025134;Term: Lupus erythematosus;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: CC-220
INN or Proposed INN: CC-220
Other descriptive name: CC-220
Product Code: CC-220
INN or Proposed INN: CC-220
Other descriptive name: CC-220
Product Code: CC-220
INN or Proposed INN: CC-220
Other descriptive name: CC-220
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
280Phase 2United States;Serbia;Spain;Russian Federation;Colombia;Italy;France;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Germany
346ChiCTR-IOR-17012802
2017-09-262017-09-26Synergy effects and health regulation effect of oxygen-ozone therapy on systemic lupus erythematosus (SLE)Synergy effects and health regulation effect of oxygen-ozone therapy on systemic lupus erythematosus (SLE) systemic lupus erythematosus (SLE)the Controled Group:basic oral therapy;the Treated Group:basic oral therapy + Autologous blood transfusion with oxygen-ozone + acupoint injection with oxygen-ozone on ST 36;Guangdong Provincial Hospital of Chinese MedicineNULLRecruiting1865Boththe Controled Group:30;the Treated Group:30;China
347NCT03054259
(ClinicalTrials.gov)
September 21, 201717/1/2017Rituximab Objective Outcome Measures Trial in SLEA Feasibility Randomised Placebo-controlled Trial With Objective Outcome Measures to Evaluate the Efficacy of Biosimilar Rituximab in Musculoskeletal and Mucocutaneous Systemic Lupus ErythematosusSystemic Lupus Erythematosus ArthritisDrug: Rituximab;Drug: Methylprednisolone;Drug: Normal SalineUniversity of LeedsNULLRecruiting18 Years99 YearsAll30Phase 2United Kingdom
348NCT03252587
(ClinicalTrials.gov)
September 21, 201715/8/2017An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus ErythematosusA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: BMS-986165;Other: PlaceboBristol-Myers SquibbNULLActive, not recruiting18 Years75 YearsAll363Phase 2United States;Argentina;Australia;Brazil;Canada;Colombia;Germany;Hungary;Israel;Japan;Korea, Republic of;Mexico;Poland;Romania;Russian Federation;Spain;Taiwan;Bulgaria;France;Peru;Ukraine
349NCT03254784
(ClinicalTrials.gov)
September 13, 201717/8/2017A Study to Evaluate BMS-986165 Tablet Formulation Relative to BMS-986165 Capsule Formulation and the Effect of a High-Fat/ High-Calorie Meal and Increased Gastric pH on the BMS-986165 Tablet FormulationA Phase 1, Randomized, Open-Label, Single-Dose, Crossover Study To Evaluate the Bioavailability of BMS-986165 Tablet Formulation Relative To BMS-986165 Capsule Formulation and the Effect of a High-Fat/ High-Calorie Meal And Increased Gastric pH on the Bioavailability of BMS-986165 Tablet Formulation in Healthy SubjectsSystemic Lupus Erythematosus;Arthritic Psoriasis;Psoriasis;Inflammatory Bowel DiseasesDrug: BMS-986165 Capsule;Drug: BMS-986165 TabletBristol-Myers SquibbNULLCompleted18 Years50 YearsAll49Phase 1United States;Netherlands
350NCT03098823
(ClinicalTrials.gov)
September 12, 201721/3/2017A Crossover Study to Compare RAYOS to IR Prednisone to Improve Fatigue and Morning Symptoms for SLEA Randomized, Double-Blind, Active Comparator-Controlled, Crossover Study to Assess the Capacity of RAYOS® Compared to Immediate-Release Prednisone to Improve Fatigue and Control Morning Symptoms in Subjects With Systemic Lupus ErythematosusLupus Erythematosus, Systemic;Lupus Erythematosus;FatigueDrug: RAYOS;Drug: PrednisoneAmpel BioSolutions, LLCNULLCompleted18 Years99 YearsAll62Phase 4United States
351NCT03262727
(ClinicalTrials.gov)
September 1, 201724/8/2017The Effect of BMS-986165 Combined With an Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female PatientsThe Effect of BMS-986165 on the Pharmacokinetics of a Combined Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female SubjectsSystemic Lupus Erythematosus;Arthritic Psoriasis;Psoriasis;Inflammatory Bowel DiseasesDrug: BMS-986165;Drug: Loestrin 1.5/30 (1.5 mg norethindrone acetate/30 µg ethinyl estradiol)Bristol-Myers SquibbNULLCompleted18 Years40 YearsFemale49Phase 1United States
352NCT03260166
(ClinicalTrials.gov)
August 31, 201710/8/2017Nicotinamide Treatment for Lupus-associated Skin Lesions in Lupus ErythematosusAn Open-label Study for Assessing the Efficacy and Safety of Nicotinamide Treatment for Lupus-associated Skin Lesions in Patients With Cutaneous Lupus Erythematosus or Systemic Lupus ErythematosusCutaneous Lupus Erythematosus;Systemic Lupus Erythematosus RashDrug: nicotinamideSecond Xiangya Hospital of Central South UniversityNational Natural Science Foundation of China;Hunan Provincial Natural Science Foundation of China;National Key Clinical Specialty Construction Project of ChinaActive, not recruiting18 Years65 YearsAll40Phase 2China
353NCT03288324
(ClinicalTrials.gov)
August 23, 201729/8/2017Open-label Study of Tofacitinib for Moderate to Severe Skin Involvement in Young Adults With LupusA 3-part Open-label Study Assessing Safety, Tolerability, Pharmacokinetic and -Dynamic Profiles, and Efficacy of Tofacitinib in Young Adults From Age 18 to 45 With Moderate to Severe Skin Involvement Due to LupusCutaneous Lupus;Systemic Lupus ErythematosusDrug: TofacitinibChildren's Hospital Medical Center, CincinnatiPfizerCompleted18 Years45 YearsAll13Phase 1/Phase 2United States
354NCT03219801
(ClinicalTrials.gov)
August 1, 201710/7/2017Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Systemic Lupus ErythematosusEvaluation of Safety and Efficacy in Patients With Systemic Lupus Erythematosus by Transplantation of Umbilical Cord Derived Mesenchymal Stem CellsSystemic Lupus ErythematosusBiological: mesenchymal stem cellsHebei Medical UniversityNULLNot yet recruiting14 Years60 YearsAll10Early Phase 1China
355NCT03161483
(ClinicalTrials.gov)
July 6, 201718/5/2017A Study to Evaluate the Efficacy and Safety of CC-220 in Subjects With Active Systemic Lupus ErythematosusA PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUSLupus Erythematosus, SystemicDrug: CC-220;Other: PlaceboCelgeneNULLActive, not recruiting18 YearsN/AAll289Phase 2United States;Argentina;Belgium;Brazil;Canada;Colombia;France;Germany;Hungary;Italy;Mexico;Poland;Russian Federation;Serbia;Spain
356NCT03189017
(ClinicalTrials.gov)
July 3, 201712/6/2017A Phase I Study of ICP-022 in Healthy SubjectsA Phase I Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Trial in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ICP-022 Following Single and Multiple Escalating DoseSystemic Lupus Erythematosus;Rheumatoid ArthritisDrug: ICP-022;Drug: PlacebosInnocare Pharma Australia Pty LtdNULLCompleted18 Years55 YearsMale64Phase 1Australia
357NCT02920424
(ClinicalTrials.gov)
June 30, 201729/9/2016A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-56022473 in Subjects With Systemic Lupus ErythematosusA Phase 1b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-56022473 in Subjects With Systemic Lupus ErythematosusLupus Erythematosus, SystemicDrug: JNJ-56022473;Drug: PlaceboJanssen Research & Development, LLCNULLWithdrawn18 Years65 YearsAll0Phase 1Germany
358EUCTR2016-002950-19-DE
(EUCTR)
19/06/201712/04/2017A Phase II Study of M2951 in SLE A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects with Systemic Lupus Erythematosus (SLE) - N/A Systemic Lupus Erythematosus (SLE)
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Evobrutinib
Product Code: M2951
INN or Proposed INN: Evobrutinib
Other descriptive name: M2951
Merck KGaANULLNot Recruiting Female: yes
Male: yes
468 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Philippines;Taiwan;Russian Federation;Chile;Colombia;Italy;Mexico;Mauritius;Argentina;Poland;Brazil;Malaysia;Romania;Peru;South Africa;Bulgaria;Germany;Japan;Korea, Republic of
359EUCTR2016-004574-17-HU
(EUCTR)
19/06/201713/04/2017A study to measure how safe CC-220 is and how well CC-220 works in people with lupus.A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLEBLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS SYSTEMIC LUPUS ERYTHEMATOSUS
MedDRA version: 21.1;Level: LLT;Classification code 10025134;Term: Lupus erythematosus;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: CC-220
INN or Proposed INN: CC-220
Other descriptive name: CC-220
Product Code: CC-220
INN or Proposed INN: CC-220
Other descriptive name: CC-220
Product Code: CC-220
INN or Proposed INN: CC-220
Other descriptive name: CC-220
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
280Phase 2Serbia;United States;Spain;Russian Federation;Colombia;Italy;France;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany
360EUCTR2015-004359-32-PL
(EUCTR)
10/06/201724/04/2017Study to Evaluate BIIB059 in CLE with or without SLEA 2-Part Phase 2 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of BIIB059 in Subjects with Systemic Lupus Erythematosus and Active Skin Manifestations and in Subjects with Active Cutaneous Lupus Erythematosus with or without Systemic Manifestations. Systemic Lupus Erythematosus (SLE) with Active Skin Manifestations and Active Cutaneous Lupus Erythematosus (CLE) with or without Systemic Manifestations
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BIIB059
Product Code: BIIB059
INN or Proposed INN: Not Available
Other descriptive name: anti-blood dendritic cell antigen 2
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
320Phase 2United States;Serbia;Philippines;Taiwan;Mexico;Argentina;Thailand;Poland;Israel;Bulgaria;Colombia;Korea, Republic of
361EUCTR2016-004574-17-ES
(EUCTR)
08/06/201707/04/2017A study to measure how safe CC-220 is and how well CC-220 works in people with lupus.A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLEBLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS SYSTEMIC LUPUS ERYTHEMATOSUS
MedDRA version: 19.1;Level: LLT;Classification code 10025134;Term: Lupus erythematosus;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: CC-220
INN or Proposed INN: CC-220
Other descriptive name: CC-220
Product Code: CC-220
INN or Proposed INN: CC-220
Other descriptive name: CC-220
Product Code: CC-220
INN or Proposed INN: CC-220
Other descriptive name: CC-220
Celgene CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
280Phase 2Serbia;United States;Spain;Russian Federation;Colombia;Italy;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Germany
362NCT03122431
(ClinicalTrials.gov)
June 5, 201717/4/2017Relevance of Monitoring Blood and Salivar Levels of Drugs Used in Rheumatic Autoimmune DiseasesRelevance of Monitoring Blood Levels Compared to Salivar Levels of Drugs Used in Rheumatic Autoimmune Diseases: Adherence and Understanding the Possible Underlying Mechanisms Involved in Effectiveness and in Adverse EffectsSystemic Lupus Erythematosus (SLE);Juvenile SLE;Cutaneous LupusDrug: Thalidomide;Drug: Hydroxychloroquine reduced;Drug: standard dose of HCQUniversity of Sao Paulo General HospitalFundação de Amparo à Pesquisa do Estado de São PauloCompleted5 Years64 YearsAll93Phase 4Brazil
363ChiCTR-INC-17011497
2017-05-252017-05-26Canceled by the investigator The efficacy and safety of metformin hydrochloride combined with atorvastatin in the treatment of moderate to severe activity systemic lupus erythematosusThe efficacy and safety of metformin hydrochloride combined with atorvastatin in the treatment of moderate to severe activity systemic lupus erythematosus moderate to severe active systemic lupus erythematosusImmunomodulation combined with traditional DMARDS treatment group:Immunomodulation combined with traditional DMARDS group: On the basis of glucocorticoid and traditional DMARDS treatment, metformin hydrochloride tablets 250mg, 3 times / day, oral; atorvastatin tablets 10mg, 1 times / day; in the first 4 weeks , 12 weeks and 24 weeks to assess the SELSNA-SLEDAI score table,traditional DMARDS treatment group:Traditional DMARDS treatment group: the use of glucocorticoid and traditional DMARDS treatment. The SELSNA-SLEDAI score table, BILAG worksheet, SLE damage index score were assessed at week 4, week 12 and week 24, and serum Th17, Treg and Th17 / Treg ratios were measured.;The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and TechnologyNULLPendingBothImmunomodulation combined with traditional DMARDS treatment group:60;traditional DMARDS treatment group:60;China
364ChiCTR-INR-17011495
2017-05-252017-05-26Canceled by the investigator The efficacy and safety of metformin hydrochloride combined with atorvastatin in the treatment of primary mild to moderate systemic syThe efficacy and safety of metformin hydrochloride combined with atorvastatin in the treatment of primary mild to moderate systemic systemic lupus erythematosus Primary mild to moderate systemic systemic lupus erythematosusImmunomodulatory treatment group:The level of SELSNA-SLEDAI was evaluated at week 4, week 12 and week 24, the BILAG table, the SLE lesion index, and the SLE damage index were measured at 4 weeks, 12 weeks and 24 weeks. The levels of Th17, Treg and Th17 / Treg were measured.;Leflunomide treatment group:Leflunomide tablets 10m, 1 times / day, orally. The SELSNA-SLEDAI score table, BILAG worksheet, SLE damage index score were assessed at week 4, week 12 and week 24, and serum Th17, Treg and Th17 / Treg ratios were measured.;Immunomodulatory treatment group and Leflunomide treatment group :0 weeks to give prednisone acetate tablets 0.5-1mg / kg.d (or patients can choose to take the same dose of methylprednisolone tablets), 4 weeks after the beginning of the dose by 2 weeks to reduce the regular dose of 10% Reduction to prednisone acetate tablets 10mg / day to maintain.;Immunomodulatory treatment group and Leflunomide treatment group:All patients without contraindications plus hydroxychloroquine tablets 0.2,2 / day, orally; and according to the condition plus calcium (800-1200mg / day), vitamin D (200-800IU / day) and other treatment.;The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and TechnologyNULLRecruitingBothImmunomodulatory treatment group:15;Leflunomide treatment group:15;Immunomodulatory treatment group and Leflunomide treatment group :30;Immunomodulatory treatment group and Leflunomide treatment group:30;China
365EUCTR2016-000625-39-BG
(EUCTR)
17/05/201708/03/2017A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus ErythematosusA Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus - Tulip SLE LTE Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Anifrolumab
Product Code: MEDI-546
INN or Proposed INN: Anifrolumab
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
575Phase 3United States;Taiwan;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Japan;New Zealand
366NCT03171194
(ClinicalTrials.gov)
April 27, 20174/5/2017Pilot Trial of Mesenchymal Stem Cells for Systemic Lupus ErythematosusA Phase I Safety Trial of Allogeneic Mesenchymal Stem Cells for Systemic Lupus ErythematosusSystem; Lupus ErythematosusDrug: Low Dose Mesenchymal Stem Cells (MSCs)Medical University of South CarolinaNULLCompleted18 Years65 YearsAll6Phase 1United States
367EUCTR2016-002950-19-BG
(EUCTR)
27/04/201727/03/2017A Phase II Study of M2951 in SLEA Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects with Systemic Lupus Erythematosus (SLE) - N/A Systemic Lupus Erythematosus (SLE)
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Evobrutinib
Product Code: M2951
INN or Proposed INN: Evobrutinib
Other descriptive name: M2951
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
468Phase 2United States;Philippines;Taiwan;Russian Federation;Chile;Colombia;Italy;Mexico;Mauritius;Argentina;Poland;Brazil;Malaysia;Romania;Peru;South Africa;Bulgaria;Germany;Japan;Korea, Republic of
368JPRN-JapicCTI-173544
26/4/201723/03/2017TULIP SLE LTEA Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus Active Systemic Lupus ErythematosusIntervention name : Anifrolumab
INN of the intervention : anifrolumab
Dosage And administration of the intervention : Anifrolumab IV administration every 4 weeks from Week 0 to Week 152 for a total of 39 doses
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Placebo IV administration every 4 weeks from Week 0 to Week 152 for a total of 39 doses
AstraZenecaNULLcomplete18BOTH50Phase 3Japan, Asia except Japan, North America, South America, Europe, Oceania
369EUCTR2016-002950-19-PL
(EUCTR)
25/04/201728/03/2017A Phase II Study of M2951 in SLEA Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects with Systemic Lupus Erythematosus (SLE) - N/A Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Evobrutinib
Product Code: M2951
INN or Proposed INN: Evobrutinib
Other descriptive name: M2951
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
468Phase 2United States;Philippines;Taiwan;Russian Federation;Chile;Colombia;Italy;Mexico;Mauritius;Argentina;Poland;Brazil;Malaysia;Romania;Peru;South Africa;Bulgaria;Germany;Japan;Korea, Republic of
370EUCTR2015-001341-86-BG
(EUCTR)
10/04/201716/02/2017Phase IIb study of IFN-K in Systemic Lupus ErythematosusA Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Neutralization of the Interferon Gene Signature and the Clinical Efficacy of IFNa-Kinoid in Adult Subjects with Systemic Lupus Erythematosus - Phase IIb study of IFN-K in Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 19.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: IFN-Kinoid
Product Code: IFN-K
INN or Proposed INN: Not yet assigned
Other descriptive name: IFN-Kinoid Drug Substance
Neovacs S.A.NULLNot RecruitingFemale: yes
Male: yes
178Phase 2United States;Serbia;Philippines;Taiwan;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Peru;Tunisia;Moldova, Republic of;Korea, Republic of;Mexico;Argentina;Belgium;Poland;Croatia;Bulgaria;Georgia;Germany
371NCT03355482
(ClinicalTrials.gov)
April 10, 201722/11/2017MRI Evaluation Assessing Synovitis to Address the Unmet Need for Reliable Endpoints in SLEMRI Evaluation Assessing Synovitis to Address the Unmet Need for Reliable Endpoints in SLESystemic Lupus Erythematosus ArthritisDrug: Methylprednisolone;Drug: PlacebosOklahoma Medical Research FoundationBristol-Myers SquibbRecruiting18 Years70 YearsAll40Phase 2United States
372NCT03125486
(ClinicalTrials.gov)
April 7, 201718/4/2017Compassionate Use for Subcutaneous (SC) BelimumabCompassionate Use for Subcutaneous (SC) BelimumabSystemic Lupus ErythematosusDrug: SC belimumab 200 mgGlaxoSmithKlineNULLNo longer available18 YearsN/AAllUnited States
373NCT03159936
(ClinicalTrials.gov)
April 3, 20172/5/2017Oral Tofacitinib in Adult Subjects With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE)Open Label Phase 2 Pilot Trial of Oral Tofacitinib in Adult Subjects With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE)Discoid Lupus Erythematosus;Systemic Lupus ErythematosusBiological: Tofacitinib citrateTufts Medical CenterPfizerRecruiting18 Years65 YearsAll12Early Phase 1United States
374EUCTR2016-001039-11-DE
(EUCTR)
03/04/201722/12/2016A Study of the Safety and Efficacy of GDC 0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: GDC-0853
Product Code: RO7010939/F13
INN or Proposed INN: not available yet
Other descriptive name: GDC-0853 RO7010939
Genentech, Inc.NULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Portugal;Taiwan;Spain;Chile;Colombia;United Kingdom;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of
375EUCTR2016-000488-17-BG
(EUCTR)
27/03/201713/02/2017A study to evaluate the effectiveness and safety of the study drug, when patients are given dosage of ILT-101 with active moderate to severe systemic lupus erythematosus(SLE)A Phase II, multi-centre, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety and pharmacokinetics of ILT-101 in patients with active moderate to severe systemic lupus erythematosus (SLE) Systematic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: ILT-101
Product Code: ILT-101
INN or Proposed INN: Aldesleukin
Other descriptive name: INTERLEUKIN-2
ILTOO PHARMANULLNot RecruitingFemale: yes
Male: yes
100Phase 2Portugal;France;Mexico;Spain;Romania;Austria;Bulgaria;Germany;Italy
376EUCTR2016-000488-17-IT
(EUCTR)
02/03/201710/05/2019A study to evaluate the effectiveness and safety of the study drug, when patients are given dosage of ILT-101 with active moderate to severe systemic lupus erythematosus(SLE)A Phase II, multi-centre, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety and pharmacokinetics of ILT-101 in patients with active moderate to severe systemic lupus erythematosus (SLE) - A study to evaluate the effectiveness and safety of the study drug, when patients are given dosage o Systematic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: ILT-101
Product Code: ILT-101
INN or Proposed INN: ALDESLEUCHINA
Other descriptive name: ALDESLEUCHINA
ILTOO PHARMANULLNot RecruitingFemale: yes
Male: yes
100Phase 2France;Portugal;Spain;Austria;Bulgaria;Italy
377NCT03042260
(ClinicalTrials.gov)
March 1, 201710/1/2017Prophylactic Trimethoprim/Sulfamethoxazole to Prevent Severe Infections in Patients With Lupus ErythematousProphylactic Trimethoprim-Sulfamethoxazole for the Prevention of Serious Infections in Patients With Systemic Lupus Erythematosus: a Randomized Placebo Controlled TrialLupus Erythematosus, SystemicDrug: Trimethoprim-Sulfamethoxazole;Drug: Placebo Oral TabletInstituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranNational Council of Science and Technology, MexicoRecruiting18 YearsN/AAll310Phase 4Mexico
378EUCTR2015-001341-86-ES
(EUCTR)
01/03/201727/12/2016Phase IIb study of IFN-K in Systemic Lupus ErythematosusA Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Neutralization of the Interferon Gene Signature and the Clinical Efficacy of IFNa-Kinoid in Adult Subjects with Systemic Lupus Erythematosus - Phase IIb study of IFN-K in Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: IFN-Kinoid
Product Code: IFN-K
INN or Proposed INN: Not yet assigned
Other descriptive name: IFN-Kinoid Drug Substance
Neovacs S.A.NULLNot RecruitingFemale: yes
Male: yes
178Phase 2United States;Serbia;Philippines;Taiwan;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Peru;Tunisia;Moldova, Republic of;Korea, Republic of;Mexico;Argentina;Belgium;Poland;Croatia;Bulgaria;Georgia;Germany
379NCT03030976
(ClinicalTrials.gov)
March 201722/1/2017A Study of CD19 Redirected Autologous T Cells for CD19 Positive Systemic Lupus Erythematosus (SLE)An Open-labeled, Uncontrolled, Single-arm Pilot Study to Evaluate Cellular Immunotherapy Using CD19-targeted Chimeric Antigen Receptor Engineered T Cells in Patients With CD19+ B Cell Systemic Lupus Erythematosus (SLE)Systemic Lupus Erythematosus (SLE)Drug: cyclophosphamide;Drug: anti-CD19-CAR-T cellsShanghai GeneChem Co., Ltd.RenJi HospitalRecruiting18 Years69 YearsAll5Phase 1China
380EUCTR2016-001039-11-BG
(EUCTR)
20/02/201708/11/2016A Study of the Safety and Efficacy of GDC 0853 in Patients With Moderate to Severe Active Systemic Lupus ErythematosusA PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITHMODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: GDC-0853
Product Code: RO7010939/F13
INN or Proposed INN: not available yet
Other descriptive name: GDC-0853 RO7010939
Genentech, Inc.NULLNot RecruitingFemale: yes
Male: yes
240Phase 2United States;Portugal;Taiwan;Spain;Chile;Colombia;United Kingdom;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of
381NCT02962960
(ClinicalTrials.gov)
February 14, 201723/9/2016A Study to Characterize the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab in Adult Type I Interferon Test High Systemic Lupus Erythematosus Subject With Active Skin ManifestationsA Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Characterizing the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab Following Subcutaneous Administration in Adult Systemic Lupus Erythematosus Subjects With Type I Interferon Test High Result and Active Skin Manifestations.Systemic Lupus ErythematosusDrug: Anifrolumab;Drug: PlaceboAstraZenecaNULLCompleted18 Years70 YearsAll36Phase 2United States;Hungary;Korea, Republic of;Poland
382EUCTR2016-001039-11-ES
(EUCTR)
07/02/201726/10/2016A Study of the Safety and Efficacy of GDC 0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS Systemic Lupus Erythematosus
MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: GDC-0853
Product Code: RO7010939/F13
INN or Proposed INN: not available yet
Other descriptive name: GDC-0853 RO7010939
Genentech, Inc.NULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noPortugal;United States;Taiwan;Spain;Chile;Colombia;United Kingdom;France;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of
383EUCTR2015-004359-32-BG
(EUCTR)
01/02/201703/11/2016Study to Evaluate BIIB059 in CLE with or without SLEA 2-Part Phase 2 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of BIIB059 in Subjects with Systemic Lupus Erythematosus and Active Skin Manifestations and in Subjects with Active Cutaneous Lupus Erythematosus with or without Systemic Manifestations. Systemic Lupus Erythematosus (SLE) with Active Skin Manifestations and Active Cutaneous Lupus Erythematosus (CLE) with or without Systemic Manifestations
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BIIB059
Product Code: BIIB059
INN or Proposed INN: Not Available
Other descriptive name: anti-blood dendritic cell antigen 2
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
320Phase 2United States;Serbia;Philippines;Taiwan;Mexico;Argentina;Thailand;Poland;Israel;Bulgaria;Colombia;Korea, Republic of
384EUCTR2016-001039-11-PT
(EUCTR)
30/01/201723/09/2016A Study of the Safety and Efficacy of GDC 0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: GDC-0853
Product Code: RO7010939/F13
INN or Proposed INN: not available yet
Other descriptive name: GDC-0853 RO7010939
Genentech, Inc.NULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noPortugal;United States;Taiwan;Spain;Chile;Colombia;United Kingdom;France;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of
385EUCTR2016-003246-93-PL
(EUCTR)
26/01/201713/12/2016A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Characterizing the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab following subcutaneous administration in Adult Systemic Lupus Erythematosus Subjects with Type I Interferon test high result and active skin manifestations A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Characterizing the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab following subcutaneous administration in Adult Systemic Lupus Erythematosus Subjects with Type I Interferon test high result and active skin manifestations Systemic Lupus Erythematosus;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Anifrolumab
Product Code: MEDI-546
INN or Proposed INN: ANIFROLUMAB
Other descriptive name: Immunoglobulin G1, anti-(human type I interferon receptor) (human monoclonal MEDI-546 heavy chain), disulfide with human monoclonal MEDI-546-chain, dimer
Astrazeneca ABNULLNot RecruitingFemale: yes
Male: yes
32Phase 2United States;Hungary;Poland;Korea, Republic of
386NCT02880852
(ClinicalTrials.gov)
January 23, 201723/8/2016Belimumab Phase I Study in Chinese Subjects With Systemic Lupus ErythematosusA Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK1550188 in Chinese Subjects With Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: BelimumabGlaxoSmithKlineNULLCompleted18 YearsN/AAll20Phase 1China
387JPRN-JapicCTI-183957
20/1/201714/05/2018A Phase II Study of M2951 in Systemic Lupus Erythematosus (SLE)A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects With Systemic Lupus Erythematosus (SLE) Systemic Lupus ErythematosusIntervention name : M2951 (Other Name: Evobrutinib)
INN of the intervention : -
Dosage And administration of the intervention : M2951 low dose will be administered for 52 weeks in double-blind treatment period.

Intervention name : M2951 (Other Name: Evobrutinib)
INN of the intervention : -
Dosage And administration of the intervention : M2951 mid dose will be administered for 52 weeks in double-blind treatment period.

Intervention name : M2951 (Other Name: Evobrutinib)
INN of the intervention : -
Dosage And administration of the intervention : M2951 high dose will be administered for 52 weeks in double-blind treatment period.
Intervention name : M2951 (Other Name: Evobrutinib)
INN of the intervention : -
Dosage And administration of the intervention : M2951 will be administered for 104 weeks in open-lable extension period at a dose of 50 milligrams twice a day.
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Placebo matched to M2951 will be administered for 52 weeks in double-blind treatment period.
Merck Biopharma Co., LtdMerck KGaAcomplete1875BOTH480Phase 2Japan, Asia except Japan, North America, South America, Europe, Africa
388NCT02908100
(ClinicalTrials.gov)
January 19, 201714/9/2016A Study of the Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus ErythematosusA Phase II, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of GDC-0853 in Patients With Moderate to Severe Active Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: GDC-0853;Drug: PlaceboGenentech, Inc.NULLCompleted18 Years75 YearsAll260Phase 2United States;Argentina;Brazil;Bulgaria;Chile;Colombia;Germany;Korea, Republic of;Mexico;Spain;Taiwan;United Kingdom;France;Portugal;Thailand
389NCT02955615
(ClinicalTrials.gov)
January 18, 201717/10/2016ILT-101 in Patients With Active Moderate to Severe Systemic Lupus Erythematosus (SLE)A Phase II, Multi-centre, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of ILT-101 in Patients With Active Moderate to Severe Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: ILT-101;Drug: PlaceboIltoo PharmaNULLCompleted18 YearsN/AAll100Phase 2Austria;Bulgaria;France;Germany;Italy;Mauritius;Mexico;Portugal;Romania;Spain
390NCT02975336
(ClinicalTrials.gov)
January 4, 201723/11/2016A Phase II Study of M2951 in Systemic Lupus Erythematosus (SLE)A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects With Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: Placebo;Drug: M2951EMD Serono Research & Development Institute, Inc.Merck KGaA, Darmstadt, GermanyTerminated18 Years75 YearsAll480Phase 2United States;Argentina;Bulgaria;Chile;Colombia;Germany;Italy;Japan;Korea, Republic of;Malaysia;Mauritius;Mexico;Peru;Philippines;Poland;Romania;Russian Federation;South Africa;Taiwan
391NCT02953821
(ClinicalTrials.gov)
December 16, 20161/11/2016Acthar Gel for Active Systemic Lupus Erythematosus (SLE)A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of Acthar Gel in Subjects With Persistently Active Systemic Lupus Erythematosus Despite Moderate Dose CorticosteroidsLupus Erythematosus, SystemicDrug: Acthar Gel;Drug: Placebo GelMallinckrodtNULLCompleted18 YearsN/AAll172Phase 4United States;Argentina;Chile;Mexico;Peru;Colombia
392EUCTR2016-000625-39-DE
(EUCTR)
13/12/201605/07/2016A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus ErythematosusA Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus - Tulip SLE LTE Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Anifrolumab
Product Code: MEDI-546
INN or Proposed INN: Anifrolumab
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
575Phase 3United States;Taiwan;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;France;Peru;Australia;South Africa;Korea, Republic of;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan
393EUCTR2016-003246-93-HU
(EUCTR)
06/12/201619/10/2016 The purpose of this study is to investigate how a new experimental medication called anifrolumab is distributed in the body when given as subcutaneous (under the skin) injections to subjects with the autoimmune disease called Systemic Lupus Erythematosus (SLE), also known as Lupus. The study will also explore if anifrolumab may improve Lupus skin symptoms. A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Characterizing the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab following subcutaneous administration in Adult Systemic Lupus Erythematosus Subjects with Type I Interferon test high result and active skin manifestations Systemic Lupus Erythematosus;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Anifrolumab
Product Code: MEDI-546
Astrazeneca ABNULLNot Recruiting Female: yes
Male: yes
32 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Hungary;Poland;Korea, Republic of
394EUCTR2016-000488-17-ES
(EUCTR)
21/11/201618/11/2016A study to evaluate the effectiveness and safety of the study drug, when patients are given dosage of ILT-101 with active moderate to severe systemic lupus erythematosus(SLE)A Phase II, multi-centre, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety and pharmacokinetics of ILT-101 in patients with active moderate to severe systemic lupus erythematosus (SLE) Systematic Lupus Erythematosus
MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: ILT-101
Product Code: ILT-101
INN or Proposed INN: Aldesleukin
Other descriptive name: INTERLEUKIN-2
ILTOO PHARMANULLNot Recruiting Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Portugal;Mexico;Spain;Austria;Bulgaria;Italy
395EUCTR2016-001039-11-GB
(EUCTR)
16/11/201624/08/2016A Study of the Safety and Efficacy of GDC 0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: GDC-0853
Product Code: RO7010939/F13
INN or Proposed INN: not available yet
Other descriptive name: GDC-0853 RO7010939
Genentech, Inc.NULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Portugal;Taiwan;Spain;Chile;Colombia;United Kingdom;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of
396EUCTR2015-004457-40-PL
(EUCTR)
04/11/201602/09/2016A clinical trial undertaken around the world in adult patients with lupus erythematosus currently havingsymptoms. These patients are randomly (like flipping a coin) given a drug (at 3 different doses) or aninactive drug in addition to their usual medication given for lupus. Neither the sponsor nor the doctornor the patient will know which additional treatment is given.A MULTI-CENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY FOLLOWED BY AN OBSERVATIONAL PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF DAPIROLIZUMAB PEGOL IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS SUBJECTSWITH MODERATELY TO SEVERELY ACTIVE SYSTEMICLUPUS ERYTHEMATOSUS
MedDRA version: 20.0;Level: LLT;Classification code 10040967;Term: SLE;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Dapirolizumab pegol (DZP)
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
160Phase 2United States;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Germany
397EUCTR2016-000625-39-LT
(EUCTR)
03/11/201617/08/2016A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus ErythematosusA Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus - Tulip SLE LTE Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Anifrolumab
Product Code: MEDI-546
INN or Proposed INN: Anifrolumab
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
575Phase 3South Africa;Korea, Republic of;Lithuania;United States;Taiwan;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;France;Peru;Australia;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan
398ChiCTR-IPR-16009451
2016-11-012016-10-16The Efficacy and Safety of Low Dose IL-2 Conbined Rapamycin Therapy in Chinese Over-treated Patients with Systemic Lupus ErythematosusThe Efficacy and Safety of Low Dose IL-2 Conbined Rapamycin Therapy in Chinese Over-treated Patients with Systemic Lupus Erythematosus Systemic Lupus ErythematosusIL-2 group:IL-2;IL-2 + Rapamycin group :IL-2 and Rapamycin;non IL-2 or IL-6 antagonist group :Glucocorticoids and DMARDs;the Second Hospital of Shanxi Medical UniversityNULLPending1880BothIL-2 group:20;IL-2 + Rapamycin group :20;non IL-2 or IL-6 antagonist group :20;China
399EUCTR2016-000488-17-PT
(EUCTR)
24/10/201628/07/2016A study to evaluate the effectiveness and safety of the study drug, when patients are given dosage of ILT-101 with active moderate to severe systemic lupus erythematosus(SLE)A Phase II, multi-centre, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety and pharmacokinetics of ILT-101 in patients with active moderate to severe systemic lupus erythematosus (SLE) Systematic Lupus Erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: ILT-101
Product Code: ILT-101
INN or Proposed INN: Aldesleukin
Other descriptive name: INTERLEUKIN-2
ILTOO PHARMANULLNot Recruiting Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Portugal;Mexico;Mauritius;Spain;Romania;Austria;Bulgaria;Germany;Italy
400NCT02847598
(ClinicalTrials.gov)
October 20, 20166/6/2016Study to Evaluate BIIB059 in Cutaneous Lupus Erythematosus (CLE) With or Without Systemic Lupus Erythematosus (SLE)A 2-Part Phase 2 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of BIIB059 in Subjects With Systemic Lupus Erythematosus and Active Skin Manifestations and in Subjects With Active Cutaneous Lupus Erythematosus With or Without Systemic ManifestationsSystemic Lupus Erythematosus;Active Cutaneous Lupus ErythematosusDrug: BIIB059;Drug: PlaceboBiogenNULLCompleted18 Years75 YearsAll264Phase 2United States;Argentina;Bulgaria;Colombia;Israel;Korea, Republic of;Mexico;Philippines;Poland;Serbia;Taiwan;Thailand
401EUCTR2015-003341-25-GB
(EUCTR)
17/10/201622/09/2016A study to evaluate the effectiveness and safety of the study drug, when patients are given a 200-mcg dosage of IPP-201101 plus standard of care in patients with systemic lupus erythematosus.A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus - A study to evaluate the effectiveness and safety of the study drug for patients with SLE. Systemic Lupus Erythematosus
MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Code: IPP-201101
INN or Proposed INN: IPP-201101
ImmuPharma SANULLNot Recruiting Female: yes
Male: yes
200 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Hungary;Germany;United Kingdom
402EUCTR2015-004457-40-ES
(EUCTR)
10/10/201605/08/2016A clinical trial undertaken around the world in adult patients with lupus erythematosus currently havingsymptoms. These patients are randomly (like flipping a coin) given a drug (at 3 different doses) or aninactive drug in addition to their usual medication given for lupus. Neither the sponsor nor the doctornor the patient will know which additional treatment is given.A MULTI-CENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY FOLLOWED BY AN OBSERVATIONAL PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF DAPIROLIZUMAB PEGOL IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS. SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS.
MedDRA version: 19.0;Level: LLT;Classification code 10040967;Term: SLE;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Dapirolizumab pegol (DZP)
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657
Product Name: Dapirolizumab pegol (DZP)
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657
Product Name: Dapirolizumab pegol (DZP)
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
160Phase 2United States;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Germany
403NCT02842814
(ClinicalTrials.gov)
October 20163/6/2016Prediction of Relapse Risk in Stable Systemic Lupus ErythematosusEvaluation and Prediction of Relapse Risk After Glucocorticoid Withdrawal in Patients With Stable Systemic Lupus Erythematosus: An Open-labeled Multi-centric Randomized Controlled Study From ChinaSystemic Lupus ErythematosusOther: Drug free;Drug: HCQ;Drug: GC+HCQPeking Union Medical College HospitalXiangya Hospital of Central South University;Shengjing Hospital;People's Hospital of Xinjiang Uygur Autonomous Region;Anhui Provincial Hospital;Beijing HospitalCompleted18 Years60 YearsAll333N/AChina
404NCT02779153
(ClinicalTrials.gov)
October 201618/5/2016Acthar SLE (Systemic Lupus Erythematosus)Efficacy, Safety, and Steroid Sparing Effect of Acthar in Patients With Hematologic Manifestations of Systemic Lupus ErythematosusSystemic Lupus Erythematosus (SLE);Repository Corticotropin InjectionDrug: Acthar low dose (40 U);Drug: Acthar high dose (80 U)NYU Langone HealthMallinckrodtWithdrawn18 YearsN/AAll0Phase 4United States
405EUCTR2015-004457-40-HU
(EUCTR)
20/09/201613/07/2016 A clinical trial undertaken around the world in adult patients with lupus erythematosus currently having symptoms. These patients are randomly (like flipping a coin) given a drug (at 3 different doses) or an inactive drug in addition to their usual medication given for lupus. Neither the sponsor nor the doctor nor the patient will know which additional treatment is given.A MULTI-CENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY FOLLOWED BY AN OBSERVATIONAL PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF DAPIROLIZUMAB PEGOL IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS
MedDRA version: 19.0;Level: LLT;Classification code 10040967;Term: SLE;System Organ Class: 100000004859 ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Dapirolizumab pegol (DZP)
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657
Product Name: Dapirolizumab pegol (DZP)
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657
Product Name: Dapirolizumab pegol (DZP)
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657
UCB Biopharma SPRLNULLNot Recruiting Female: yes
Male: yes
160 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Germany
406EUCTR2015-004457-40-DE
(EUCTR)
19/09/201622/06/2016 A clinical trial undertaken around the world in adult patients with lupus erythematosus currently having symptoms. These patients are randomly (like flipping a coin) given a drug (at 3 different doses) or an inactive drug in addition to their usual medication given for lupus. Neither the sponsor nor the doctor nor the patient will know which additional treatment is given.A MULTI-CENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY FOLLOWED BY AN OBSERVATIONAL PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF DAPIROLIZUMAB PEGOL IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS
MedDRA version: 20.0;Level: LLT;Classification code 10040967;Term: SLE;System Organ Class: 100000004859 ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Dapirolizumab pegol (DZP)
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657
UCB Biopharma SPRLNULLNot Recruiting Female: yes
Male: yes
160 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Germany
407EUCTR2015-004457-40-BG
(EUCTR)
13/09/201603/08/2016 A clinical trial undertaken around the world in adult patients with lupus erythematosus currently having symptoms. These patients are randomly (like flipping a coin) given a drug (at 3 different doses) or an inactive drug in addition to their usual medication given for lupus. Neither the sponsor nor the doctor nor the patient will know which additional treatment is given.A MULTI-CENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY FOLLOWED BY AN OBSERVATIONAL PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF DAPIROLIZUMAB PEGOL IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS
MedDRA version: 19.1;Level: LLT;Classification code 10040967;Term: SLE;System Organ Class: 100000004859 ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Dapirolizumab pegol (DZP)
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657
UCB Biopharma SPRLNULLNot Recruiting Female: yes
Male: yes
160 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Germany
408NCT02080195
(ClinicalTrials.gov)
September 13, 201628/2/2014Nonmyeloablative Conditioning and Transplantation for Patients With Refractory Systemic Lupus Erythematosus (SLE)A Phase I/II Study of Nonmyeloablative Conditioning and Transplantation of Human Leukocyte Antigen (HLA)-Matched, Partially HLA-mismatched, HLA-haploidentical or Matched Unrelated Bone Marrow for Patients With Refractory SLELupus Erythematosus;Graft-versus-host DiseaseDrug: Cyclophosphamide;Drug: Fludarabine;Drug: Tacrolimus;Drug: Mycophenolate Mofetil;Drug: Rabbit antithymocyte globulin;Radiation: Total body irradiation;Biological: Allogeneic bone marrow transplantSidney Kimmel Comprehensive Cancer Center at Johns HopkinsMaryland Stem Cell Research FundTerminated18 Years75 YearsAll1Phase 1/Phase 2United States
409EUCTR2016-000625-39-ES
(EUCTR)
24/08/201615/07/2016A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus ErythematosusA Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus - Tulip SLE LTE Systemic Lupus Erythematosus
MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Anifrolumab
Product Code: MEDI-546
INN or Proposed INN: Anifrolumab
AstraZeneca ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
575Phase 3United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Peru;Australia;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Germany;Japan;New Zealand
410EUCTR2016-000625-39-HU
(EUCTR)
18/08/201623/06/2016A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus ErythematosusA Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus - Tulip SLE LTE Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Anifrolumab
Product Code: MEDI-546
INN or Proposed INN: Anifrolumab
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
575Phase 3United States;Taiwan;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Japan;New Zealand
411EUCTR2016-000488-17-AT
(EUCTR)
08/08/201621/07/2016A study to evaluate the effectiveness and safety of the study drug, when patients are given dosage of ILT-101 with active moderate to severe systemic lupus erythematosus(SLE)A Phase II, multi-centre, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety and pharmacokinetics of ILT-101 in patients with active moderate to severe systemic lupus erythematosus (SLE) Systematic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: ILT-101
Product Code: ILT-101
INN or Proposed INN: Aldesleukin
Other descriptive name: INTERLEUKIN-2
ILTOO PHARMANULLNot Recruiting Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noPortugal;France;Mexico;Mauritius;Spain;Romania;Austria;Bulgaria;Germany;Italy
412EUCTR2015-003341-25-DE
(EUCTR)
29/07/201617/03/2016A study to evaluate the effectiveness and safety of the study drug, when patients are given a 200-mcg dosage of IPP-201101 plus standard of care in patients with systemic lupus erythematosus.A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus - A study to evaluate the effectiveness and safety of the study drug for patients with SLE. Systemic Lupus Erythematosus
MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Code: IPP-201101
INN or Proposed INN: IPP-201101
ImmuPharma SANULLNot Recruiting Female: yes
Male: yes
200 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Hungary;Germany;United Kingdom
413EUCTR2015-005543-14-GB
(EUCTR)
19/07/201619/11/2018Safety and efficacy of Belimumab After B cell depletion therapy in systemic LUPUS erythematosus – BEAT LUPUSSafety and efficacy of Belimumab After B cell depletion therapy in systemic LUPUS erythematosus - BEAT LUPUS Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Belimumab
Product Name: Belimumab
University College LondonNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 2United Kingdom
414EUCTR2015-003341-25-IT
(EUCTR)
06/07/201619/01/2021Uno studio per valutare l'efficacia e la sicurezza del farmaco in studio, quando ai pazienti ¿ dato un dosaggio di 200 mcg di IPP-201101 pi¿ standard di cura, in pazienti con lupus eritematoso sistemico.A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus - A study to evaluate the effectiveness and safety of the study drug for patients with SLE. Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Code: IPP-201101IMMUPHARMANULLNot RecruitingFemale: yes
Male: yes
200Phase 3France;Hungary;Germany;United Kingdom;Italy
415NCT02794285
(ClinicalTrials.gov)
June 30, 20166/6/2016Long Term Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus ErythematosusA Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus.Active Systemic Lupus ErythematosusBiological: Anifrolumab;Drug: PlaceboAstraZenecaPRA Health SciencesCompleted18 Years70 YearsAll559Phase 3United States;Argentina;Australia;Bulgaria;Canada;Chile;Colombia;France;Germany;Hungary;Israel;Japan;Korea, Republic of;Lithuania;Mexico;Peru;Poland;Romania;Russian Federation;South Africa;Spain;Taiwan;Ukraine;United Kingdom;Belgium;Brazil;Czech Republic;Czechia;Italy;New Zealand;Singapore
416NCT03155477
(ClinicalTrials.gov)
June 10, 201613/5/2017Effect Of Curcuma Xanthorrhiza and Vitamin D3 Supplementation in SLE Patients With Hypovitamin DEffect Of Curcuma Xanthorrhiza Supplementation In Systemic Lupus Erythematosus Patients (SLE) With Hypovitamin D Which Were Given Vitamin D3 Towards Disease Activity (SLEDAI), Interleukin-6 (IL-6) And Tumor Growth Factor-ß1 (TGF-ß1) SerumSLEDietary Supplement: Cholecalciferol and C. Xanthorrhiza;Dietary Supplement: Cholecalciferol and placeboSaiful Anwar HospitalNULLCompleted18 Years45 YearsFemale39N/ANULL
417NCT02804763
(ClinicalTrials.gov)
June 2, 201614/6/2016A Phase 2 Efficacy and Safety Study of Dapirolizumab Pegol (DZP) in Systemic Lupus ErythematosusA Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study Followed by an Observational Period to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Subjects With Moderately to Severely Active Systemic Lupus ErythematosusSystemic Lupus Erythematosus (SLE)Drug: Placebo;Drug: Dapirolizumab pegol (DZP)UCB Biopharma S.P.R.L.NULLCompleted18 YearsN/AAll182Phase 2United States;Bulgaria;Chile;Colombia;Germany;Hungary;Mexico;Peru;Poland;Romania;Russian Federation;Spain;Ukraine
418NCT02514967
(ClinicalTrials.gov)
June 201631/7/2015CHABLIS7.5: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without NephritisA Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With Systemic Lupus Erythematosus With or Without NephritisSystemic Lupus ErythematosusDrug: Blisibimod;Drug: PlaceboAnthera PharmaceuticalsNULLTerminated18 YearsN/AAll3Phase 3Georgia
419NCT02741960
(ClinicalTrials.gov)
May 24, 20167/4/2016The Effect of Metformin on Reducing Lupus FlaresA Multicenter, Randomised, Double-blind Placebo Controlled Trial on the Efficacy and Safety of add-on Metformin to Conventional Immunosuppressants in Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: metformin;Drug: placeboRenJi HospitalNULLCompleted18 Years70 YearsAll180Phase 4China
420NCT02932137
(ClinicalTrials.gov)
May 5, 20168/10/2016Anti-infection of Low-does IL-2 in SLEPotential Effect of Anti-infection by Low-dose IL-2 in Treatment of SLESystemic Lupus ErythematosusDrug: Interleukin-2Peking University People's HospitalNULLCompleted18 Years60 YearsAll30N/AChina
421EUCTR2015-003341-25-HU
(EUCTR)
02/05/201607/03/2016A study to evaluate the effectiveness and safety of the study drug, when patients are given a 200-mcg dosage of IPP-201101 plus standard of care in patients with systemic lupus erythematosus.A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus - A study to evaluate the effectiveness and safety of the study drug for patients with SLE. Systemic Lupus Erythematosus
MedDRA version: 18.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Code: IPP-201101
INN or Proposed INN: IPP-201101
ImmuPharma SANULLNot RecruitingFemale: yes
Male: yes
200Phase 3France;United States;Hungary;Germany
422EUCTR2015-004404-35-ES
(EUCTR)
29/04/201604/04/2016A study in LupusA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) Patients with Systemic Lupus Erythematosus (SLE)
MedDRA version: 18.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Lilly S.A.NULLNot RecruitingFemale: yes
Male: yes
300Phase 2France;United States;Taiwan;Mexico;Argentina;Poland;Spain;Romania;Austria;Japan;Korea, Republic of
423JPRN-JapicCTI-153064
27/4/201611/11/2015TULIPA Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus Active Systemic Lupus ErythematosusIntervention name : anifrolumab
INN of the intervention : anifrolumab
Dosage And administration of the intervention : Intravenous infusion (IV)
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Intravenous infusion (IV)
AstraZenecaNULLcomplete1870BOTH60Phase 3Japan, Asia except Japan, North America, South America, Europe, Africa
424EUCTR2015-004404-35-RO
(EUCTR)
18/04/201622/06/2016A study in LupusA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) Patients with Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
300Phase 2France;United States;Taiwan;Mexico;Argentina;Spain;Poland;Romania;Austria;Japan;Korea, Republic of
425EUCTR2015-004404-35-PL
(EUCTR)
12/04/201631/03/2016A study in LupusA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) Patients with Systemic Lupus Erythematosus (SLE)
MedDRA version: 19.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
300Phase 2France;United States;Taiwan;Mexico;Argentina;Spain;Poland;Romania;Austria;Japan;United Kingdom;Korea, Republic of
426EUCTR2015-004404-35-FR
(EUCTR)
12/04/201604/05/2016A study in LupusA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) Patients with Systemic Lupus Erythematosus (SLE)
MedDRA version: 19.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
300Phase 2United States;France;Taiwan;Mexico;Argentina;Poland;Spain;Romania;Austria;Japan;United Kingdom;Korea, Republic of
427EUCTR2015-004404-35-AT
(EUCTR)
06/04/201624/03/2016A study in LupusA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) Patients with Systemic Lupus Erythematosus (SLE)
MedDRA version: 18.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
300Phase 2France;United States;Taiwan;Mexico;Argentina;Poland;Spain;Romania;Austria;Japan;Korea, Republic of
428NCT02331810
(ClinicalTrials.gov)
April 20165/12/2014Pharmacodynamics Assessment Study After Single Subcutaneous Dose Of SAR113244 Versus Placebo In Lupus Male And Female PatientsA Randomized, Double-blind, Placebo-controlled Study Of Safety, Tolerability, And Pharmacokinetics Of Repeated Ascending Subcutaneous Doses Of SAR113244 And Pharmacodynamics Of Single Dose Of SAR113244 In Male And Female Lupus PatientSystemic Lupus ErythematosusDrug: SAR113244;Drug: placeboSanofiNULLWithdrawn18 Years75 YearsBoth0Phase 1NULL
429NCT02618967
(ClinicalTrials.gov)
March 28, 201613/10/2015Single Ascending Dose Study of AMG 570 in Healthy SubjectsA Randomized, Double Blind Placebo Controlled, First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Subcutaneous Doses of AMG 570 in Healthy SubjectsSystemic Lupus ErythematosusBiological: AMG 570;Biological: AMG 570 Matching PlaceboAmgenNULLCompleted18 Years65 YearsAll56Phase 1United States
430NCT02708095
(ClinicalTrials.gov)
March 24, 201610/3/2016A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (SLE)A Randomized, Double-Blind, Placebo-Controlled, Parallel- Group, Phase 2 Study of Baricitinib in Patients With Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: Baricitinib;Drug: PlaceboEli Lilly and CompanyNULLCompleted18 YearsN/AAll314Phase 2United States;Argentina;Austria;France;Japan;Korea, Republic of;Mexico;Poland;Puerto Rico;Romania;Spain;Taiwan
431JPRN-JapicCTI-163359
01/3/2016A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (SLE)-I4V-MC-JAHHA Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (SLE)-I4V-MC-JAHH Systemic Lupus Erythematosus (SLE)Intervention name : Baricitinib
INN of the intervention : Baricitinib
Dosage And administration of the intervention : Baricitinib given orally once a day for 24 weeks
Control intervention name : Placebo
Dosage And administration of the control intervention : Placebo given orally once a day for 24 weeks
Eli Lilly Japan K.K.NULL18BOTHPhase 2NULL
432NCT02711813
(ClinicalTrials.gov)
March 201614/3/2016TAB08 in Patients With Systemic Lupus Erythematosus (SLE), Not Adequately Controlled With Current TreatmentStudy to Assess Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of TAB08 in Patients With Systemic Lupus Erythematosus, Not Adequately Controlled With Current Concomitant TherapyLupus Erythematosus, SystemicDrug: TAB08;Other: PlaceboTheramab LLCNULLTerminated18 Years60 YearsAll60Phase 2Russian Federation
433EUCTR2015-003341-25-FR
(EUCTR)
24/02/201620/04/2016A study to evaluate the effectiveness and safety of the study drug, when patients are given a 200-mcg dosage of IPP-201101 plus standard of care in patients with systemic lupus erythematosus.A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus - A study to evaluate the effectiveness and safety of the study drug for patients with SLE. Systemic Lupus Erythematosus
MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Code: IPP-201101
INN or Proposed INN: IPP-201101
ImmuPharma SANULLNot RecruitingFemale: yes
Male: yes
200Phase 3United States;France;Hungary;Germany
434NCT02725515
(ClinicalTrials.gov)
February 16, 20168/1/2016A Study of the Effect of XmAb®5871 in Patients With Systemic Lupus ErythematosusA Randomized, Double-Blinded, Placebo-Controlled Study of the Effect of XmAb®5871 on Systemic Lupus Erythematosus Disease ActivitySystemic Lupus ErythematosusBiological: XmAb5871;Biological: Placebo to match XmAb5871Xencor, Inc.PPD;ICON plcCompleted18 Years65 YearsAll105Phase 2United States
435NCT02660944
(ClinicalTrials.gov)
January 3, 201616/1/2016A Phase 2a of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE)A Phase 2a, Double-blind, Placebo-Controlled Study of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: RSLV-132;Drug: PlaceboResolve TherapeuticsNULLCompleted18 Years70 YearsAll64Phase 2United States
436NCT02483624
(ClinicalTrials.gov)
January 201623/6/20153,3'-Diindolylmethane in Patients With Systemic Lupus ErythematosusA Single-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of 3,3'-Diindolylmethane (BR-DIM) in Patients With Systemic Lupus Erythematosus (SLE)SLEDrug: BR-DIM;Drug: PlaceboNorth Shore Long Island Jewish Health SystemNULLTerminated18 Years50 YearsFemale6Phase 1NULL
437NCT02677688
(ClinicalTrials.gov)
January 201628/1/2016Autologous EBV-specific Cytotoxic T Cells for the Treatment of Systemic Lupus Erythematosus (SLE)Restauration of EBV Control in SLE Phase 1-2 Trial Evaluating Adoptive Transfer of Autologous EBV- Specific Cytotoxic T Lymphocytes in SLE TreatmentSerologically Active Adult Systemic Lupus ErythematosusBiological: Autologous EBV specific CTL infusionNantes University HospitalNULLTerminated18 YearsN/AAll9Phase 1/Phase 2France
438EUCTR2014-002184-14-NL
(EUCTR)
22/12/201503/09/2015Safety and Efficacy Study of a Biologic to Treat Systemic Lupus ErythomatosusA Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of lulizumab pegol vs. Placebo on a Background of Limited Standard of care in the Treatment of Subjects with Active Systemic Lupus Erythematosus Active Systemic Lupus Erythematosus
MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: lulizumab pegol
Product Code: BMS-931699
INN or Proposed INN: lulizumab pegol
Other descriptive name: Anti-CD28dAb
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
350Phase 2United States;Taiwan;Spain;Chile;Colombia;Italy;France;Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Brazil;Romania;South Africa;Netherlands;Germany;Korea, Republic of
439EUCTR2014-004632-19-BG
(EUCTR)
11/12/201527/10/2015A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus ErythematosusA Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Anifrolumab
INN or Proposed INN: Anifrolumab
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
360Phase 3Argentina;Russian Federation;Singapore;United States;Spain;Canada;Czech Republic;Belgium;Brazil;Korea, Republic of;Mexico;South Africa;Bulgaria;France;Lithuania;Germany
440JPRN-UMIN000025328
2015/12/0525/12/2016A Randomized Open-label Study to Evaluate the Efficacy and Safety of Tacrolimus and Corticosteroids in Comparison With Mycophenolate Mofetil and Corticosteroids in Subjects With Class III/IV+/-V Lupus NephritisA Randomized Open-label Study to Evaluate the Efficacy and Safety of Tacrolimus and Corticosteroids in Comparison With Mycophenolate Mofetil and Corticosteroids in Subjects With Class III/IV+/-V Lupus Nephritis - Efficacy and Safety of Tacrolimus Versus Mycophenolate in Lupus Nephritis systemic lupus erythematosusTacrolimus
Mycophenolate Mofetil
The University of Hong KongNULLRecruiting18years-old75years-oldMale and Female200Not selectedJapan,Asia(except Japan)
441ChiCTR-ONC-15007547
2015-12-052015-12-04Clinical theraputic effect of traditional Chinese medicine on systemic lupus erythematosus: a multicenter prospective cohort studyStudy of the clinical theraputic effect of traditional Chinese medicine on systemic lupus erythematosus systemic lupus erythematosusThe combination of Chinese and western group:Traditional Chinese medicine combined western medicine;Treating by Western Medicine group:Treating by Western medicine (sugar cortical hormone, hydroxychloroquine, and methotrexate, azathioprine, or cyclophosphamide);Zhejiang Chinese Medical UniversityNULLRecruiting1860BothThe combination of Chinese and western group:264;Treating by Western Medicine group:264;China
442NCT02885610
(ClinicalTrials.gov)
December 201526/8/2016Study of RC18 Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE)A Phase IIb , Placebo-Controlled ,Multi-Center, Randomized, Double-Blind, Dose-explorating Trial of RC18,a Recombinant Human B Lymphocyte Stimulating Factor Receptor-Antibody Fusion Protein in Subjects With Systemic Lupus Erythematosus (SLE).Systemic Lupus ErythematosusBiological: Placebo plus standard therapy;Biological: RC18 80 mg plus standard therapy;Biological: RC18 160 mg plus standard therapy;Biological: RC18 240 mg plus standard therapyRemeGenNULLCompleted18 Years65 YearsAll249Phase 2China
443NCT02074020
(ClinicalTrials.gov)
December 201526/2/2014CHABLIS-SC2: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without NephritisA Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With Systemic Lupus Erythematosus With or Without NephritisSystemic Lupus ErythematosusDrug: Blisibimod;Drug: PlaceboAnthera PharmaceuticalsNULLWithdrawn18 YearsN/ABoth0Phase 3NULL
444NCT02609789
(ClinicalTrials.gov)
December 201518/11/2015A Single Ascending Dose Study in Healthy Participants and Multiple Dose Study of JNJ-55920839 in Participants With Mild to Moderate Systemic Lupus ErythematosusA Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study in Healthy Subjects and Multiple Dose Study of JNJ-55920839 in Subjects With Mild to Moderate Systemic Lupus ErythematosusSystemic Lupus Erythematosus;HealthyDrug: JNJ-55920839;Drug: PlaceboJanssen Research & Development, LLCNULLCompleted18 Years55 YearsAll72Phase 1United States;Belgium;Moldova, Republic of;Poland;Romania;Spain;Taiwan
445NCT02537028
(ClinicalTrials.gov)
November 30, 201528/8/2015MSC2364447C Phase 1b in Systemic Lupus ErythematosusA Phase Ib Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Biological Effect of MSC2364447C in Systemic Lupus ErythematosusLupus Erythematosus, SystemicDrug: MSC2364447C;Drug: PlaceboEMD Serono Research & Development Institute, Inc.Merck KGaACompleted18 Years65 YearsAll24Phase 1United States;Bulgaria
446EUCTR2014-004633-96-RO
(EUCTR)
26/11/201508/10/2015A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus ErythematosusA Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Anifrolumab
INN or Proposed INN: Anifrolumab
Product Name: Anifrolumab
INN or Proposed INN: Anifrolumab
AstraZeneca ABNULLNot Recruiting Female: yes
Male: yes
450 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Taiwan;Ukraine;Chile;Israel;Colombia;Italy;United Kingdom;Hungary;Argentina;Poland;Brazil;Romania;Peru;Australia;Germany;New Zealand;Korea, Republic of
447EUCTR2015-001341-86-DE
(EUCTR)
19/11/201501/09/2015Phase IIb study of IFN-K in Systemic Lupus ErythematosusA Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Neutralization of the Interferon Gene Signature and the Clinical Efficacy of IFNa-Kinoid in Adult Subjects with Systemic Lupus Erythematosus - Phase IIb study of IFN-K in Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: IFN-Kinoid
Product Code: IFN-K
INN or Proposed INN: Not yet assigned
Other descriptive name: IFN-Kinoid Drug Substance
Neovacs S.A.NULLNot RecruitingFemale: yes
Male: yes
178Phase 2Russian Federation;United States;Thailand;Korea, Republic of;Poland;Bulgaria;Chile;France;Serbia;Tunisia;Croatia;Colombia;Argentina;Philippines;Ukraine;Switzerland;Spain;Belgium;Moldova, Republic of;Taiwan;Italy;Mexico;Georgia;Peru;Germany
448EUCTR2014-004633-96-DE
(EUCTR)
12/11/201528/05/2015A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus ErythematosusA Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Anifrolumab
INN or Proposed INN: Anifrolumab
Product Name: Anifrolumab
INN or Proposed INN: Anifrolumab
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;Taiwan;Ukraine;Chile;Israel;Colombia;United Kingdom;Italy;Hungary;Argentina;Brazil;Poland;Romania;Australia;Peru;Germany;New Zealand;Korea, Republic of
449EUCTR2014-004632-19-DE
(EUCTR)
12/11/201506/08/2015A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus ErythematosusA Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Anifrolumab
INN or Proposed INN: Anifrolumab
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
360Phase 3Argentina;Russian Federation;United States;Spain;Canada;Czech Republic;Belgium;Brazil;Korea, Republic of;Mexico;South Africa;Bulgaria;France;Lithuania;Germany
450NCT02477150
(ClinicalTrials.gov)
November 201517/6/2015Safety and Immunogenicity of a Zoster Vaccine in SLEImmunogenicity and Safety of a Herpes Zoster Vaccine (Zostavax) in Patients With Systemic Lupus Erythematosus: a Randomized Controlled TrialSystemic Lupus ErythematosusBiological: Zostavax;Biological: placeboTuen Mun HospitalNULLCompleted18 YearsN/AAll90Phase 4China
451EUCTR2015-001341-86-HR
(EUCTR)
23/10/201510/11/2015Phase IIb study of IFN-K in Systemic Lupus ErythematosusA Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Neutralization of the Interferon Gene Signature and the Clinical Efficacy of IFNa-Kinoid in Adult Subjects with Systemic Lupus Erythematosus - Phase IIb study of IFN-K in Systemic Lupus Erythematosus Systemic Lupus Erythematosus;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: IFN-Kinoid
Product Code: IFN-K
INN or Proposed INN: Not yet assigned
Other descriptive name: IFN-Kinoid Drug Substance
Neovas S.A.NULLNot RecruitingFemale: yes
Male: yes
178Phase 2Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Peru;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of;Korea, Republic of;United States;Philippines;Taiwan;Spain;Thailand;Russian Federation;Chile;Colombia;Switzerland
452JPRN-JapicCTI-153077
21/10/201520/11/2015A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of lulizumab pegol of Subjects with Active Systemic Lupus ErythematosusA Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of lulizumab pegol vs. Placebo on a Background of Limited Standard of Care in the Treatment of Subjects with Active Systemic Lupus Erythematosus Systemic Lupus ErythematosusIntervention name : Lulizumab pegol
INN of the intervention : -
Dosage And administration of the intervention : Four treatments of lulizumab pegol will be administered along with placebo treatment:12.5 mg weekly, 12.5 mg every other week (EOW), 5 mg EOW and 1.25mg EOW, on a background of limited standard of care medications. The dose levels may be modified based on the interim analysis results.
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Bristol-Myers Squibb K.K.NULLcomplete1870BOTH350Phase 2Japan, Asia except Japan, North America, South America, Europe
453NCT02349061
(ClinicalTrials.gov)
October 15, 201523/1/2015A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus ErythematosusA Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study of Ustekinumab in Subjects With Active Systemic Lupus ErythematosusLupus Erythematosus, SystemicDrug: Ustekinumab IV;Drug: Placebo Infusion;Drug: Placebo SC;Drug: Ustekinumab SC;Other: Concomitant MedicationJanssen Research & Development, LLCNULLCompleted18 Years75 YearsAll102Phase 2United States;Argentina;Australia;Germany;Hungary;Mexico;Poland;Spain;Taiwan;United Kingdom
454EUCTR2014-004633-96-PL
(EUCTR)
14/10/201505/08/2015A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus ErythematosusA Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Anifrolumab
INN or Proposed INN: Anifrolumab
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;Taiwan;Ukraine;Chile;Israel;Colombia;United Kingdom;Italy;Hungary;Argentina;Poland;Brazil;Romania;Australia;Peru;Germany;New Zealand;Korea, Republic of
455EUCTR2015-000372-95-DE
(EUCTR)
08/10/201517/06/2015Study Evaluating ALX-0061 Administered Subcutaneously in Patients with Systemic Lupus ErythematosusA Phase II Multicenter, Randomized, Double-blind, Placebo controlled, Dose-range Finding Study to Evaluate the Safety and Efficacy of ALX 0061 Administered Subcutaneously in Subjects with Moderate to Severe Active Systemic Lupus Erythematosus - STEADY Moderate to Severe Active Systemic Lupus Erythematosus
MedDRA version: 19.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ALX-0061 150 mg/mL
INN or Proposed INN: vobarilizumab
Other descriptive name: IL-6R nanobody
Ablynx N.V.NULLNot RecruitingFemale: yes
Male: yes
300Phase 2Serbia;Portugal;United States;Philippines;Taiwan;Spain;Ukraine;Russian Federation;Chile;Czech Republic;Hungary;Mexico;Argentina;Poland;Peru;Germany;Korea, Republic of
456NCT02429934
(ClinicalTrials.gov)
October 201524/4/2015Abatacept for SLE Arthritis (IM101-330)Efficacy of Abatacept in Inflammatory Polyarthritis of Systemic Lupus Erythematosus (SLE)Systemic Lupus Erythematosus ArthritisBiological: abatacept also known as Orencia also known as CTLA4-Ig;Drug: PlaceboUniversity of California, Los AngelesBristol-Myers SquibbTerminated18 YearsN/AAll28Phase 1/Phase 2United States
457NCT02554019
(ClinicalTrials.gov)
September 28, 201516/9/2015Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus ErythematosusA Prospective, Double-blind, Randomized, Placebo-controlled, Repeated Dose, Multicentre Phase IIa Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusBiological: BT063;Biological: PlaceboBiotestNULLCompleted18 Years75 YearsAll36Phase 2Belarus;Georgia;Poland;Serbia
458EUCTR2015-000372-95-HU
(EUCTR)
24/09/201530/06/2015Study Evaluating ALX-0061 Administered Subcutaneously in Patients with Systemic Lupus ErythematosusA Phase II Multicenter, Randomized, Double-blind, Placebo controlled, Dose-range Finding Study to Evaluate the Safety and Efficacy of ALX 0061 Administered Subcutaneously in Subjects with Moderate to Severe Active Systemic Lupus Erythematosus - STEADY Moderate to Severe Active Systemic Lupus Erythematosus
MedDRA version: 19.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ALX-0061 150 mg/mL
INN or Proposed INN: vobarilizumab
Other descriptive name: IL-6R nanobody
Ablynx N.V.NULLNot RecruitingFemale: yes
Male: yes
300Phase 2Serbia;Portugal;United States;Philippines;Taiwan;Spain;Ukraine;Russian Federation;Chile;Hungary;Czech Republic;Mexico;Argentina;Poland;Peru;Germany;Korea, Republic of
459NCT02665364
(ClinicalTrials.gov)
September 23, 201517/11/2015Phase IIb Study of IFN-K in Systemic Lupus ErythematosusA Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Neutralization of the Interferon Gene Signature and the Clinical Efficacy of IFNa-Kinoid in Adult Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusBiological: IFNa-Kinoid;Other: Placebo;Other: ISA 51 VGNeovacsNULLTerminated18 Years65 YearsAll185Phase 2United States;Argentina;Belgium;Chile;Colombia;Croatia;France;Georgia;Germany;Italy;Korea, Republic of;Mexico;Moldova, Republic of;Peru;Philippines;Poland;Russian Federation;Switzerland;Taiwan;Thailand;Tunisia
460EUCTR2014-004632-19-CZ
(EUCTR)
23/09/201528/07/2015A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus ErythematosusA Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Anifrolumab
INN or Proposed INN: Anifrolumab
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
360Phase 3Argentina;Russian Federation;Singapore;United States;Spain;Canada;Czech Republic;Belgium;Brazil;Korea, Republic of;Mexico;South Africa;Bulgaria;France;Lithuania;Germany
461EUCTR2014-005000-19-PL
(EUCTR)
22/09/201518/08/2015A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus ErythematosusA Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
102Phase 2United States;Hungary;Taiwan;Mexico;Argentina;Spain;Poland;Australia;Germany
462EUCTR2014-004632-19-ES
(EUCTR)
21/09/201524/06/2015A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus ErythematosusA Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Anifrolumab
INN or Proposed INN: Anifrolumab
AstraZeneca ABNULLNot Recruiting Female: yes
Male: yes
360 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;South Africa;Bulgaria;Germany;Korea, Republic of
463EUCTR2015-001341-86-IT
(EUCTR)
19/09/201510/11/2020Phase IIb study of IFN-K in Systemic Lupus ErythematosusA Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study toEvaluate the Neutralization of the Interferon Gene Signature and theClinical Efficacy of IFNa-Kinoid in Adult Subjects with Systemic LupusErythematosus - IFN-K-002 Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: IFN-Kinoid
Product Code: IFN-K
NEOVACSNULLNot RecruitingFemale: yes
Male: yes
178Phase 2United States;Philippines;Taiwan;Spain;Thailand;Korea, Democratic People's Republic of;Russian Federation;Chile;Colombia;Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Peru;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of;Korea, Republic of
464EUCTR2014-004633-96-IT
(EUCTR)
16/09/201521/01/2020A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus - NA Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Anifrolumab
Product Code: NA
INN or Proposed INN: Anifrolumab
Product Name: Anifrolumab
Product Code: NA
INN or Proposed INN: Anifrolumab
ASTRAZENECA ABNULLNot Recruiting Female: yes
Male: yes
450 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Taiwan;Ukraine;Chile;Israel;Colombia;Italy;United Kingdom;Hungary;Argentina;Poland;Brazil;Romania;Peru;Australia;Germany;New Zealand;Korea, Republic of
465EUCTR2014-005526-35-PL
(EUCTR)
12/09/201510/08/2015Clinical study to evaluate the safety and tolerability of treatment with BT063 versus Placebo in Subjects with Systemic Lupus Erythematosus (BT063 in SLE)A Prospective, Double-blind, Randomized, Placebo-controlled, Repeated dose, Multicentre Phase IIa Proof-of-Concept Study with BT063 in Subjects with Systemic Lupus Erythematosus (BT063 in SLE) Systemic Lupus Erythematosus
MedDRA version: 19.1;Level: LLT;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BT063
Product Code: BT063
INN or Proposed INN: BT063
Other descriptive name: BT063
Biotest AGNULLNot RecruitingFemale: yes
Male: yes
36Phase 2Serbia;Belarus;Poland;Georgia
466EUCTR2015-000372-95-PT
(EUCTR)
11/09/201526/06/2015 Study Evaluating ALX-0061 Administered Subcutaneously in Patients with Systemic Lupus ErythematosusA Phase II Multicenter, Randomized, Double-blind, Placebo controlled, Dose-range Finding Study to Evaluate the Safety and Efficacy of ALX 0061 Administered Subcutaneously in Subjects with Moderate to Severe Active Systemic Lupus Erythematosus - STEADY Moderate to Severe Active Systemic Lupus Erythematosus
MedDRA version: 18.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ALX-0061 150 mg/mL
INN or Proposed INN: N/A
Other descriptive name: IL-6R nanobody
Ablynx N.V.NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;Portugal;United States;Philippines;Taiwan;Spain;Ukraine;Russian Federation;Chile;Czech Republic;Hungary;Mexico;Argentina;Poland;Peru;Germany;Korea, Republic of
467EUCTR2014-004632-19-BE
(EUCTR)
07/09/201523/06/2015A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus ErythematosusA Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Anifrolumab
INN or Proposed INN: Anifrolumab
AstraZeneca ABNULLNot Recruiting Female: yes
Male: yes
360 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;South Africa;Bulgaria;Germany;Korea, Republic of
468EUCTR2015-001341-86-BE
(EUCTR)
07/09/201503/09/2015Phase IIb study of IFN-K in Systemic Lupus ErythematosusA Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Neutralization of the Interferon Gene Signature and the Clinical Efficacy of IFNa-Kinoid in Adult Subjects with Systemic Lupus Erythematosus - Phase IIb study of IFN-K in Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: IFN-Kinoid
Product Code: IFN-K
INN or Proposed INN: Not yet assigned
Other descriptive name: IFN-Kinoid Drug Substance
Neovacs S.A.NULLNot RecruitingFemale: yes
Male: yes
178Phase 2Russian Federation;United States;Thailand;Korea, Republic of;Poland;Bulgaria;Chile;France;Serbia;Tunisia;Croatia;Colombia;Argentina;Philippines;Ukraine;Switzerland;Spain;Belgium;Moldova, Republic of;Taiwan;Italy;Mexico;Georgia;Peru;Germany
469EUCTR2014-004633-96-HU
(EUCTR)
02/09/201529/06/2015A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus ErythematosusA Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Anifrolumab
INN or Proposed INN: Anifrolumab
Product Name: Anifrolumab
INN or Proposed INN: Anifrolumab
AstraZeneca ABNULLNot Recruiting Female: yes
Male: yes
450 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Taiwan;Ukraine;Chile;Israel;Colombia;United Kingdom;Italy;Hungary;Argentina;Poland;Brazil;Romania;Peru;Australia;Germany;New Zealand;Korea, Republic of
470JPRN-UMIN000020859
2015/09/0105/02/2016Effects of Royal Jelly Supplementation on Regulatory T Cells and Lymphocytes Apoptosis in Children with Systemic Lupus ErythematosusEffects of Royal Jelly Supplementation on Regulatory T Cells and Lymphocytes Apoptosis in Children with Systemic Lupus Erythematosus - Royal Jelly Supplementation in SLE Systemic Lupus Erythematosus.two-month Royal Jelly (2 gm) treatmentFaculty of medicine, University of Assiut, Assiut 71516, Egypt.NULLComplete: follow-up complete8years-old17years-oldMale and Female30Not selectedAfrica
471NCT02535689
(ClinicalTrials.gov)
August 28, 201528/8/2015Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Systemic Lupus ErythematosusSafety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Systemic Lupus Erythematosus; a Phase Ib Clinical Trial and Associated Mechanistic StudiesSystemic Lupus ErythematosusDrug: Tofacitinib;Drug: PlaceboNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NULLCompleted18 Years100 YearsAll34Phase 1United States
472EUCTR2014-004632-19-LT
(EUCTR)
20/08/201519/06/2015A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus ErythematosusA Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Anifrolumab
INN or Proposed INN: Anifrolumab
AstraZeneca ABNULLNot Recruiting Female: yes
Male: yes
360 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;South Africa;Bulgaria;Germany;Korea, Republic of
473EUCTR2015-000372-95-CZ
(EUCTR)
20/08/201516/06/2015Study Evaluating ALX-0061 Administered Subcutaneously in Patients with Systemic Lupus ErythematosusA Phase II Multicenter, Randomized, Double-blind, Placebo controlled, Dose-range Finding Study to Evaluate the Safety and Efficacy of ALX 0061 Administered Subcutaneously in Subjects with Moderate to Severe Active Systemic Lupus Erythematosus - STEADY Moderate to Severe Active Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000017968;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ALX-0061 150 mg/mL
INN or Proposed INN: vobarilizumab
Other descriptive name: IL-6R nanobody
Ablynx N.V.NULLNot RecruitingFemale: yes
Male: yes
300Phase 2Serbia;Portugal;United States;Philippines;Taiwan;Spain;Ukraine;Russian Federation;Chile;Czech Republic;Hungary;Mexico;Argentina;Poland;Peru;Germany;Korea, Republic of
474EUCTR2015-000372-95-ES
(EUCTR)
07/08/201510/07/2015Study Evaluating ALX-0061 Administered Subcutaneously in Patients with Systemic Lupus ErythematosusA Phase II Multicenter, Randomized, Double-blind, Placebo controlled, Dose-range Finding Study to Evaluate the Safety and Efficacy of ALX 0061 Administered Subcutaneously in Subjects with Moderate to Severe Active Systemic Lupus Erythematosus - STEADY Moderate to Severe Active Systemic Lupus Erythematosus
MedDRA version: 18.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ALX-0061 150 mg/mL
INN or Proposed INN: N/A
Other descriptive name: IL-6R nanobody
Ablynx N.V.NULLNot RecruitingFemale: yes
Male: yes
300Phase 2Germany;Korea, Republic of;Serbia;Portugal;United States;Philippines;Taiwan;Spain;Ukraine;Russian Federation;Chile;Czech Republic;Hungary;Mexico;Argentina;Poland;Peru
475EUCTR2014-004633-96-GB
(EUCTR)
16/07/201508/05/2015A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus ErythematosusA Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Anifrolumab
INN or Proposed INN: Anifrolumab
Product Name: Anifrolumab
INN or Proposed INN: Anifrolumab
AstraZeneca ABNULLNot Recruiting Female: yes
Male: yes
450 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Taiwan;Ukraine;Chile;Israel;Colombia;United Kingdom;Italy;Hungary;Argentina;Poland;Brazil;Romania;Peru;Australia;Germany;New Zealand;Korea, Republic of
476NCT02446899
(ClinicalTrials.gov)
July 9, 201514/5/2015Efficacy and Safety of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus ErythematosusA Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus ErythematosusActive Systemic Lupus ErythematosusBiological: Anifrolumab;Drug: PlaceboAstraZenecaPRA Health SciencesCompleted18 Years70 YearsAll373Phase 3United States;Argentina;Belgium;Brazil;Bulgaria;Canada;France;Germany;Japan;Korea, Republic of;Lithuania;Mexico;Russian Federation;South Africa;Spain;Czech Republic;Czechia;Singapore
477NCT02477254
(ClinicalTrials.gov)
July 201517/6/2015Long-term Immunogenicity of a HPV Vaccine in SLELong-term Immunogenicity of a Quadrivalent Human Papillomavirus (HPV) Vaccine in Patients With Systemic Lupus Erythematosus: a Case-control StudySystemic Lupus ErythematosusBiological: VaccinationTuen Mun HospitalNULLCompleted18 Years35 YearsFemale84N/AChina
478NCT02533570
(ClinicalTrials.gov)
July 20159/7/2015Dose Ranging Study of Brentuximab Vedotin in Adults With LupusA Multi-center, Randomized, Double-blinded, Placebo-controlled, Multiple-ascending-dose Study of Brentuximab Vedotin in Adults With Active Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: Brentuximab vedotin;Drug: PlaceboSeagen Inc.NULLTerminated18 YearsN/AAll20Phase 2United States
479NCT02444728
(ClinicalTrials.gov)
July 201512/5/2015Cyclophosphamide and Hydroxychloroquine for Thrombocytopenia in SLECyclophosphamide and Hydroxychloroquine for the Treatment of Severe Thrombocytopenia in Systemic Lupus ErythematosusThrombocytopeniaDrug: Hydroxychloroquine;Drug: Cyclophosphamide;Drug: Azathioprine;Drug: MethylprednisoloneChinese SLE Treatment And Research GroupPeking Union Medical College HospitalRecruiting18 Years70 YearsAll220Phase 3China
480NCT02437890
(ClinicalTrials.gov)
July 201529/4/2015A Phase II Study to Evaluate Safety and Efficacy of ALX-0061 in Subjects With Systemic Lupus ErythematosusA Phase II Multicenter, Randomized, Double-blind, Placebo Controlled, Dose-range Finding Study to Evaluate the Safety and Efficacy of ALX-0061 Administered Subcutaneously in Subjects With Moderate to Severe Active Systemic Lupus ErythematosusLupus Erythematosus, SystemicBiological: ALX-0061;Biological: PlaceboAblynxNULLCompleted18 Years64 YearsAll312Phase 2United States;Argentina;Chile;Czechia;Germany;Hungary;Korea, Republic of;Mexico;Peru;Philippines;Poland;Portugal;Russian Federation;Serbia;Spain;Taiwan;Ukraine;Czech Republic
481EUCTR2014-005000-19-DE
(EUCTR)
17/06/201512/02/2015A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus ErythematosusA Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 18.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
134Phase 2United States;Hungary;Taiwan;Mexico;Argentina;Poland;Spain;Australia;Germany
482NCT02446912
(ClinicalTrials.gov)
June 9, 201514/5/2015Efficacy and Safety of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus ErythematosusA Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects With Active Systemic Lupus ErythematosusActive Systemic Lupus ErythematosusBiological: Anifrolumab;Drug: PlaceboAstraZenecaPRA Health SciencesCompleted18 Years70 YearsAll460Phase 3United States;Argentina;Australia;Brazil;Chile;Colombia;Germany;Hungary;Israel;Italy;Korea, Republic of;New Zealand;Peru;Poland;Romania;Taiwan;Ukraine;United Kingdom
483EUCTR2014-002984-14-BG
(EUCTR)
05/06/201511/05/2015International clinical trial to evaluate the biological activity and safety of ACT-334441 in lupusA multicenter, randomized, double-blind, placebo-controlled, dose-response study to investigate the biological activity, safety, tolerability, and pharmacokinetics of ACT-334441 in subjects with systemic lupus erythematosus. - Systemic lupus erythematosus
;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: ACT-334441
Other descriptive name: ACT-334441
ACTELION Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
64Phase 2Belarus;United States;Ukraine;Russian Federation;Georgia;Bulgaria
484NCT02472795
(ClinicalTrials.gov)
June 1, 201514/5/2015Clinical Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus ErythematosusA Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-response Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: Matching placebo;Drug: CenerimodIdorsia Pharmaceuticals Ltd.NULLCompleted18 Years65 YearsAll105Phase 1/Phase 2United States;Belarus;Bulgaria;Georgia;Russian Federation;Ukraine
485NCT02465580
(ClinicalTrials.gov)
June 20153/6/2015A Pilot-Study With Low-dose hrIL-2 for the Treatment of Systemic Lupus ErythematosusA Phase II Pilot-Study With Low-dose hrIL-2 for the Treatment of Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: hrIL-2 active;Drug: hrIL-2 placeboPeking University People's HospitalMonash University;Beijing SL Pharmaceutical Company LtdRecruiting18 Years65 YearsBoth60Phase 2China
486EUCTR2014-005000-19-ES
(EUCTR)
11/05/201503/03/2015A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus ErythematosusA Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 17.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
100Phase 2United States;Hungary;Taiwan;Mexico;Argentina;Poland;Spain;Australia;Germany
487EUCTR2014-005418-45-SE
(EUCTR)
04/05/201518/03/2015Are risk factors factors of pertaining to or involving the heart and blood vessels and markers characterized or caused by inflammation in Rheumatoid Arthritis (a chronic, systemic inflammatory disorder that primarily affects joints) and Systemic Lupus Erythematosus (systemic disease in which the body’s immune system mistakenly attacks healthy tissue)improved? New aspects of Hydroxychloroquine – an interventional study (HCQCVDRASLE)Improved cardiovascular risk factors and inflammatory markers in Rheumatoid Arthritis and Systemic Lupus Erythematosus? New aspects of Hydroxychloroquine – an interventional study (HCQCVDRASLE) - HCQCVDRASLE Rheumatoid Arthritis and Systemic Lupus Erythematosus;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Plaquenil
INN or Proposed INN: HYDROXYCHLOROQUINE
Christine BengtssonSolveig Wållberg-JonssonNot RecruitingFemale: yes
Male: yes
Phase 2Sweden
488NCT01773616
(ClinicalTrials.gov)
April 20151/11/2012Trial of Rituximab and Mycophenolate Mofetil Without Oral Steroids for Lupus NephritisPhase 3 Open Label Randomised Multicentre Controlled Trial of Rituxmab and Mycophenolate Mofetil Without Oral Steroids for the Treatment of Lupus NephritisSystemic Lupus Erythematosus, Lupus NephritisDrug: Oral prednisolone;Drug: Rituximab;Drug: Mycophenolate mofetil;Drug: Methyl prednisoloneImperial College LondonKarolinska Institutet;Ohio State University;Dutch Working Party on Systemic Lupus Erythematosus;EULAR Lupus Nephritis Trial Network Study GroupTerminated12 Years75 YearsAll24Phase 3United Kingdom
489NCT02548936
(ClinicalTrials.gov)
April 201531/8/2015Efficacy and Safety of Simvastatin-ezetimibe Combination Therapy Among Patients With SLEEfficacy and Safety of Simvastatin-ezetimibe Combination Therapy in Reduction of Progression of Atherosclerosis Among Patients With Systemic Lupus Erythematosus: A Randomized Single-Blind TrialAtherosclerosisDrug: Ezetimibe+Simvastatin Drug CombinationPeking Union Medical College HospitalNULLEnrolling by invitation18 Years65 YearsBoth30Phase 0China
490EUCTR2014-005000-19-HU
(EUCTR)
18/03/201503/02/2015A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus ErythematosusA Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 18.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Janssen-Cilag International N.V.NULLNot Recruiting Female: yes
Male: yes
134 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Taiwan;Hungary;Mexico;Argentina;Poland;Spain;Australia;Germany
491NCT02504645
(ClinicalTrials.gov)
March 201517/7/2015A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus ErythematosusA 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus ErythematosusLupus Erythematosus, SystemicDrug: IPP-201101;Drug: Placebo;Other: Standard of CareImmuPharmaNULLCompleted18 Years70 YearsAll202Phase 3United States;Czechia;France;Germany;Hungary;Mauritius;Poland;Puerto Rico;Czech Republic;Italy
492EUCTR2014-002184-14-DE
(EUCTR)
26/02/201523/12/2014Safety and Efficacy Study of a Biologic to Treat Systemic Lupus ErythomatosusA Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of lulizumab pegol vs. Placebo on a Background of Limited Standard of care in the Treatment of Subjects with Active Systemic Lupus ErythematosusPharmacogenetics Blood Sample Amendment 01 - Site Specific- dated-20-Aug-2014 Active Systemic Lupus Erythematosus
MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: lulizumab pegol
Product Code: BMS-931699
INN or Proposed INN: lulizumab pegol
Other descriptive name: Anti-CD28dAb
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
350Phase 2United States;Taiwan;Spain;Chile;Colombia;Italy;France;Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Brazil;Romania;South Africa;Netherlands;Germany;Korea, Republic of
493EUCTR2014-002184-14-IT
(EUCTR)
24/02/201509/01/2015Safety and Efficacy Study of a Biologic to Treat Systemic Lupus ErythomatosusA Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of BMS-931699 vs. Placebo on a Background of Limited Standard of care in the Treatment of Subjects with Active Systemic Lupus Erythematosus Active Systemic Lupus Erythematosus
MedDRA version: 17.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Anti-CD28dab
Product Code: BMS-931699
INN or Proposed INN: Lulizumab Pegol
Other descriptive name: Lulizumab Pegol
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
350Phase 2United States;Taiwan;Spain;Chile;Colombia;Italy;France;Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Brazil;Romania;South Africa;Netherlands;Germany;Korea, Republic of
494EUCTR2014-002184-14-HU
(EUCTR)
16/02/201529/12/2014Safety and Efficacy Study of a Biologic to Treat Systemic Lupus ErythomatosusA Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of BMS-931699 vs. Placebo on a Background of Limited Standard of care in the Treatment of Subjects with Active Systemic Lupus ErythematosusPharmacogenetics Blood Sample Amendment 1 - Site Specific - dated-20-Aug-2014 Active Systemic Lupus Erythematosus
MedDRA version: 17.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Anti-CD28dab
Product Code: BMS-931699
INN or Proposed INN: Anti-CD28dAb
Other descriptive name: Anti-CD28dAb
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
350Phase 2United States;Taiwan;Spain;Chile;Colombia;Italy;France;Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Brazil;Romania;South Africa;Netherlands;Germany;Korea, Republic of
495NCT02307643
(ClinicalTrials.gov)
February 201518/11/2014Exploratory Study of MT-1303 in Systemic Lupus Erythematosus PatientsAn Exploratory Study of MT-1303 in Subjects With Systemic Lupus Erythematosus (a Multicenter, Open-label Study)Systemic Lupus ErythematosusDrug: MT-1303 Low dose;Drug: MT-1303 High doseMitsubishi Tanabe Pharma CorporationNULLCompleted20 Years64 YearsAll17Phase 1Japan
496EUCTR2014-002184-14-ES
(EUCTR)
26/12/201422/12/2014Safety and Efficacy Study of a Biologic to Treat Systemic Lupus ErythomatosusA Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of BMS-931699 vs. Placebo on a Background of Limited Standard of care in the Treatment of Subjects with Active Systemic Lupus Erythematosus Active Systemic Lupus Erythematosus
MedDRA version: 17.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Anti-CD28dab
Product Code: BMS-931699
INN or Proposed INN: Anti-CD28dAb
Other descriptive name: Anti-CD28dAb
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
350Phase 2Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Brazil;Romania;South Africa;Netherlands;Germany;Korea, Republic of;France;United States;Taiwan;Spain;Chile;Colombia;Italy
497JPRN-jRCTs071180052
26/12/201415/03/2019Control of steroid-associated osteonecrosis of the femoral head in SLE patientsClinical trial for the control of osteonecrosis of the femoral head secondary to the initial corticosteroid treatment in patients with systemic lupus erythematosus - None systemic lupus erythematosus;D008180Objectives take three below candidate drugs for the prevention for at least 3 months after the initial corticosteroid treatment.
1. Clopidogrel Bisulfate (Plavix)
Taking a dose of 300mg once daily on the first day, and a dose of 75mg once daily on subsequent days.
2. Pitavastatin Calcium (LIVALO)
Taking a dose of 2mg once daily.
3. Tocopherol Acetate (Juvela)
Taking a dose of 100mg three times daily (total of 300mg daily).
Nakashima YasuharuNULLRecruiting>= 20age oldNot applicableBoth150Phase 2Japan
498NCT02265744
(ClinicalTrials.gov)
November 13, 201415/10/2014Safety and Efficacy Study of a Biologic to Treat Systemic Lupus ErythematosusA Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lulizumab Pegol vs. Placebo on a Background of Limited Standard of Care in the Treatment of Subjects With Active Systemic Lupus ErythematosusLupusDrug: BMS-931699;Drug: Placebo matching BMS-931699Bristol-Myers SquibbNULLCompleted18 Years70 YearsAll730Phase 2United States;Argentina;Brazil;Canada;Chile;Colombia;France;Germany;Hungary;Italy;Japan;Korea, Republic of;Lebanon;Mexico;Netherlands;Peru;Poland;Puerto Rico;Romania;Russian Federation;South Africa;Spain;Taiwan;Qatar
499NCT02306629
(ClinicalTrials.gov)
November 201429/11/2014Study to Compare Properties of Epratuzumab When Given as an Injection Under the Skin or Directly Into the BloodAn Open-label, Parallel-group, Single-dose Escalation Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Pharmacodynamics of Subcutaneous Epratuzumab in Healthy Caucasian and Japanese SubjectsSystemic Lupus ErythematosusBiological: Epratuzumab sc;Biological: Epratuzumab ivUCB Biopharma S.P.R.L.Pharmaceutical Research Associates;Richmond Pharmacology Limited;ACM Global Europe;Eurofins Pharma Bioanalysis;The Doctors LaboratoryCompleted18 Years50 YearsBoth42Phase 1United Kingdom
500NCT02321709
(ClinicalTrials.gov)
November 20145/12/2014Multiple Ascending Dose Study To Assess The Safety Profile Of SAR113244 Versus Placebo In Lupus Male And Female PatientsA Randomized, Double-blind, Placebo-controlled Study Of Safety, Tolerability, And Pharmacokinetics Of Repeated Ascending Subcutaneous Doses Of SAR113244 And Pharmacodynamics Of Single Dose Of SAR113244 In Male And Female Lupus PatientsSystemic Lupus ErythematosusDrug: SAR113244;Drug: placeboSanofiNULLCompleted18 Years75 YearsBoth21Phase 1Germany
501EUCTR2013-002758-62-IT
(EUCTR)
14/10/201431/03/2014Long-term safety and tolerability study of atacicept in patients with Systemic Lupus Erythematosus who completed protocol EMR-700461-023 (ADDRESS II)A Phase IIb, Multi-Center, Long-Term Extension Trial to Evaluate the Safety and Tolerability of Atacicept in Subjects with Systemic Lupus Erythematosus (SLE) who Completed Protocol EMR-700461-023 (ADDRESS II) Systemic Lupus Erythematosus (SLE)
MedDRA version: 16.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
213Phase 2United States;Philippines;Spain;Ukraine;Chile;Russian Federation;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Brazil;Poland;Peru;South Africa;Bulgaria;Germany;Korea, Republic of
502NCT02270970
(ClinicalTrials.gov)
October 201413/10/2014Evaluation of Belimumab Impact on a BLyS Activity Signature Test in the Absence of Confounding PolypharmacyEvaluation of Belimumab Impact on a BLyS Activity Signature Test in the Absence of Confounding PolypharmacySystemic Lupus ErythematosusBiological: belimumabOklahoma Medical Research FoundationGlaxoSmithKlineRecruiting16 Years70 YearsAll20Phase 4United States
503NCT02102594
(ClinicalTrials.gov)
October 201425/3/2014Therapy of Antibody-mediated Autoimmune Diseases by Bortezomib (TAVAB)Therapy of Antibody-mediated Autoimmune Diseases by Bortezomib (TAVAB)Myasthenia Gravis;Systemic Lupus Erythematosus;Rheumatoid ArthritisDrug: BortezomibCharite University, Berlin, GermanyProf. Dr. med. Falk Hiepe (Charité, Internal Medicine / Rheumathology);NeuroCure Clinical Research Center, Charite, BerlinTerminated18 Years75 YearsAll11Phase 2Germany
504NCT02185040
(ClinicalTrials.gov)
September 16, 20147/7/2014A Pilot Study of CC-220 to Treat Systemic Lupus Erythematosus.A Pilot, Phase 2, Randomized, Placebo-Controlled, Double-Blind, Study To Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Pharmacogenetics of CC-220 In Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: CC-220;Drug: PlaceboCelgeneNULLCompleted18 YearsN/AAll42Phase 2United States
505NCT02066311
(ClinicalTrials.gov)
September 201412/2/2014Nelfinavir in Systemic Lupus ErythematosusNelfinavir in Systemic Lupus Erythematosus: A Pilot Phase IIa Clinical TrialSystemic Lupus ErythematosusDrug: NelfinavirNorthwell HealthNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Terminated18 Years65 YearsAll15Phase 2United States
506EUCTR2013-002758-62-DE
(EUCTR)
18/08/201413/03/2014Long-term safety and tolerability study of atacicept in patients with Systemic Lupus Erythematosus who completed protocol EMR-700461-023 (ADDRESS II)A Phase IIb, Multi-Center, Long-Term Extension Trial to Evaluate the Safety and Tolerability of Atacicept in Subjects with Systemic Lupus Erythematosus (SLE) who Completed Protocol EMR-700461-023 (ADDRESS II) Systemic Lupus Erythematosus (SLE)
MedDRA version: 17.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
213Phase 2United States;Philippines;Spain;Ukraine;Russian Federation;Chile;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Poland;Brazil;Peru;South Africa;Bulgaria;Germany;Korea, Republic of
507JPRN-UMIN000008230
2014/08/0122/06/2012Clinical trial for the control of osteonecrosis of the femoral head secondary to the initial corticosteroid treatment in patients with systemic lupus erythematosusClinical trial for the control of osteonecrosis of the femoral head secondary to the initial corticosteroid treatment in patients with systemic lupus erythematosus - Control of steroid-induced osteonecrosis of the femoral head in SLE patients Systemic lupus erythematosusObjectives take three below candidate drugs for the prevention for at least 3 months after the initial corticosteroid treatment.
1. Clopidgrel Bisulfate (Plavix)
Taking a dose of 300mg once daily on the first day, and a dose of 75mg once daily on subsequent days.
2. Pitavastatin Calcium (LIVALO)
Taking a dose of 2mg once daily.
3. Tocopherol Acetate (Juvela)
Taking a dose of 100mg three times daily (total of 300mg daily).
Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kyushu UniversityNULLRecruiting20years-oldNot applicableMale and Female150Phase 2Japan
508NCT02070978
(ClinicalTrials.gov)
July 29, 201421/2/2014Long-term Safety and Tolerability of Atacicept (Long-term Follow-Up of Participant Who Participated in ADDRESS II)A Phase IIb, Multi-Center, Long-Term Extension Trial to Evaluate the Safety and Tolerability of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed Protocol EMR-700461-023 (ADDRESS II)Lupus Erythematosus, SystemicDrug: Atacicept 75 mg;Drug: Atacicept 150 mgEMD SeronoNULLTerminated18 YearsN/AAll253Phase 2United States;Argentina;Brazil;Bulgaria;Chile;Czechia;Germany;Italy;Korea, Republic of;Mexico;Peru;Philippines;Poland;Russian Federation;South Africa;Spain;United Kingdom
509EUCTR2013-002758-62-ES
(EUCTR)
16/07/201421/07/2014Long-term safety and tolerability study of atacicept in patients with Systemic Lupus Erythematosus who completed protocol EMR-700461-023 (ADDRESS II)A Phase IIb, Multi-Center, Long-Term Extension Trial to Evaluate the Safety and Tolerability of Atacicept in Subjects with Systemic Lupus Erythematosus (SLE) who Completed Protocol EMR-700461-023 (ADDRESS II) Systemic Lupus Erythematosus (SLE)
MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
213Phase 2United States;Philippines;Spain;Ukraine;Russian Federation;Chile;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Poland;Brazil;Peru;South Africa;Bulgaria;Germany;Korea, Republic of
510NCT02194400
(ClinicalTrials.gov)
July 201416/7/2014Dose Escalation Study of RSLV-132 in Subjects With Systemic Lupus ErythematosusA Double-Blind, Placebo-Controlled Dose Escalation Study of the Administration of Multiple Intravenous Doses of RSLV-132 in Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusBiological: RSLV-132Resolve TherapeuticsNULLCompleted18 Years70 YearsBoth32Phase 1United States
511EUCTR2013-002758-62-CZ
(EUCTR)
19/06/201416/04/2014Long-term safety and tolerability study of atacicept in patients with Systemic Lupus Erythematosus who completed protocol EMR-700461-023 (ADDRESS II)A Phase IIb, Multi-Center, Long-Term Extension Trial to Evaluate the Safety and Tolerability of Atacicept in Subjects with Systemic Lupus Erythematosus (SLE) who Completed Protocol EMR-700461-023 (ADDRESS II) Systemic Lupus Erythematosus (SLE)
MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
213Phase 2United States;Philippines;Spain;Ukraine;Chile;Russian Federation;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Brazil;Poland;Peru;South Africa;Bulgaria;Germany;Korea, Republic of
512EUCTR2011-005667-25-PL
(EUCTR)
22/05/201407/06/2013Belimumab Assessment of Safety in SLE (BASE)A Randomized, Double-Blind, Placebo-Controlled 52-Week Studyto Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab Lupus Erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion
Product Name: Belimumab
Product Code: L04AA26
INN or Proposed INN: BELIMUMAB
Other descriptive name: Benlysta
Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)NULLNot RecruitingFemale: yes
Male: yes
4000Phase 4United States;Serbia;Portugal;Philippines;Taiwan;Hong Kong;Estonia;Slovakia;Thailand;Spain;Ukraine;Indonesia;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Malaysia;Australia;Peru;China;Korea, Republic of;Turkey;Lithuania;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Croatia;Bulgaria;Norway;New Zealand
513NCT02119156
(ClinicalTrials.gov)
May 13, 201417/4/2014Belimumab Treatment Holiday and Treatment Re-start Study in Lupus PatientsAn Open-label, Non-randomized, 52-Week Study to Evaluate Treatment Holidays and Rebound Phenomenon After Treatment With Belimumab 10 mg/kg in Systemic Lupus Erythematosus SubjectsSystemic Lupus ErythematosusDrug: BelimumabGlaxoSmithKlineNULLCompleted18 YearsN/AAll80Phase 3United States;China;Japan;Korea, Republic of
514EUCTR2014-000488-42-NL
(EUCTR)
12/05/201409/05/2014Synergetic B-cell immunomodulation in SLE The SYNBioSe Study A proof-of-concept study involving synergetic B-cell imunnomodulation in patients with refractory systemic lupus erythematosus - SynBiose Systemic lupus erythematosus
MedDRA version: 17.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: rituximab
Product Name: Rituximab
INN or Proposed INN: RITUXIMAB
Trade Name: Benlysta
Product Name: Belimumab
INN or Proposed INN: BELIMUMAB
Leiden University Medical CenterNULLNot Recruiting Female: yes
Male: yes
15 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noNetherlands
515EUCTR2012-004619-30-BG
(EUCTR)
09/05/201407/03/2014A Study to Evaluate Long-term Safety of MEDI-546 in Adults with Systemic Lupus ErythematosusA Phase 2, Open-label Extension Study to Evaluate Long-term Safety of MEDI-546 in Adults with Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: anifrolumab
Product Code: Medi-546
INN or Proposed INN: anifrolumab
Product Name: anifrolumab
Product Code: Medi-546
INN or Proposed INN: anifrolumab
MedImmune, LLC, a wholly owned subsidiary of AstraZenecaNULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Taiwan;Ukraine;Colombia;Czech Republic;Hungary;Mexico;Brazil;Poland;Romania;Peru;Bulgaria;Korea, Republic of
516EUCTR2013-002758-62-GB
(EUCTR)
09/05/201413/05/2014Long-term safety and tolerability study of atacicept in patients with Systemic Lupus Erythematosus who completed protocol EMR-700461-023 (ADDRESS II)A Phase IIb, Multi-Center, Long-Term Extension Trial to Evaluate the Safety and Tolerability of Atacicept in Subjects with Systemic Lupus Erythematosus (SLE) who Completed Protocol EMR-700461-023 (ADDRESS II) Systemic Lupus Erythematosus (SLE)
MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Merck KGaANULLNot Recruiting Female: yes
Male: yes
213 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Philippines;Spain;Ukraine;Russian Federation;Chile;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Poland;Brazil;Peru;South Africa;Bulgaria;Germany;Korea, Republic of
517NCT01956188
(ClinicalTrials.gov)
May 201425/9/2013Omega 3 in LES and APSEfficacy of EPA and DHA Supplementation in Systemic Lupus Erythematosus and Primary Antiphospholipid SyndromeSystemic Lupus Erythematosus;Primary Antiphospholipid SyndromeDietary Supplement: EPA and DHA supplementation;Dietary Supplement: PlaceboUniversity of Sao PauloNULLActive, not recruiting20 Years45 YearsFemale22N/ABrazil
518EUCTR2013-002758-62-BG
(EUCTR)
30/04/201401/04/2014Long-term safety and tolerability study of atacicept in patients with Systemic Lupus Erythematosus who completed protocol EMR-700461-023 (ADDRESS II)A Phase IIb, Multi-Center, Long-Term Extension Trial to Evaluate the Safety and Tolerability of Atacicept in Subjects with Systemic Lupus Erythematosus (SLE) who Completed Protocol EMR-700461-023 (ADDRESS II) Systemic Lupus Erythematosus (SLE)
MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Merck KGaANULLNot Recruiting Female: yes
Male: yes
213 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Philippines;Spain;Ukraine;Russian Federation;Chile;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Poland;Brazil;Peru;Bulgaria;South Africa;Germany;Korea, Republic of
519NCT02106897
(ClinicalTrials.gov)
April 30, 20144/4/2014Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Single Doses and Multiple Doses of BIIB059 (Litifilimab) in Healthy Volunteers and Participants With Systemic Lupus ErythematosusA Single-Ascending-Dose and Multiple-Ascending-Dose Study of BIIB059 in Healthy Volunteers and Subjects With Systemic Lupus ErythematosusSystemic Lupus Erythematosus;Healthy VolunteersDrug: BIIB059 (litifilimab);Drug: PlaceboBiogenNULLCompleted18 YearsN/AAll109Phase 1United States
520JPRN-UMIN000012478
2014/04/0101/01/2014Open label trial for efficacy and safety of Hydroxychloroquine for systemic lupus erythematosusOpen label trial for efficacy and safety of Hydroxychloroquine for systemic lupus erythematosus - Hydroxychloroquine for systemic lupus erythematosus systemic lupus erythematosuscutaneous lupus erythematosusTreatment with HydroxychloroquineDepartment of Internal Medicine, Teikyo University School of MedicineNULLRecruitingNot applicableNot applicableMale and Female10Not selectedJapan
521EUCTR2010-022101-18-HR
(EUCTR)
31/03/201417/10/2014Study investigating a new medicine, LY2127399, in patients diagnosed with Systemic Lupus Erythematosus (SLE).A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-X) - ILLUMINATE-X Systemic Lupus Erythematosus (SLE)
MedDRA version: 17.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: Not available
Other descriptive name: LA294; Anti LP40 antibody, subclass IgG4; Anti BAFF (B cell activating factor)
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1276Phase 3Serbia;United States;Belarus;Philippines;Taiwan;Ecuador;Thailand;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;India;France;Macedonia, the former Yugoslav Republic of;Malaysia;Peru;Australia;South Africa;Latvia;Tunisia;Korea, Democratic People's Republic of;Guatemala;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
522JPRN-UMIN000013508
2014/03/2826/03/2014A phase II randomized trial of evaluation for boltezomib in refractory Systemic lupus erythematosus:cross over additional trialA phase II randomized trial of evaluation for boltezomib in refractory Systemic lupus erythematosus:cross over additional trial - A phase II randomized trial of evaluation for boltezomib in refractory Systemic lupus erythematosus:cross over additional trial Systemic lupus erythmatosussaline
bortezomib(1.3mg/m2)
2times/week total 8times.
Tohoku university hospitalNULLComplete: follow-up complete20years-old65years-oldMale and Female14Phase 2Japan
523EUCTR2013-002773-21-IT
(EUCTR)
25/03/201403/02/2014Efficacy and safety study of atacicept in patients with Systemic Lupus Erythematosus (ADDRESS II)A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE) - ADDRESS II Systemic Lupus Erythematosus (SLE)
MedDRA version: 16.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
279Phase 2United States;Philippines;Spain;Ukraine;Chile;Russian Federation;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Brazil;Poland;Peru;South Africa;Bulgaria;Germany;Korea, Republic of
524EUCTR2013-002773-21-GB
(EUCTR)
03/03/201415/01/2014Efficacy and safety study of atacicept in patients with Systemic Lupus Erythematosus (ADDRESS II)A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE) Systemic Lupus Erythematosus (SLE)
MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
279Phase 2United States;Philippines;Spain;Ukraine;Russian Federation;Chile;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Poland;Brazil;Peru;South Africa;Bulgaria;Germany;Korea, Republic of
525EUCTR2013-002773-21-CZ
(EUCTR)
20/02/201411/12/2013Efficacy and safety study of atacicept in patients with Systemic Lupus Erythematosus (ADDRESS II)A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE) Systemic Lupus Erythematosus (SLE)
MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
279Phase 2United States;Philippines;Spain;Ukraine;Russian Federation;Chile;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Poland;Brazil;Peru;South Africa;Bulgaria;Germany;Korea, Republic of
526EUCTR2013-002773-21-ES
(EUCTR)
20/02/201422/01/2014Efficacy and safety study of atacicept in patients with Systemic Lupus Erythematosus (ADDRESS II)A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE) Systemic Lupus Erythematosus (SLE)
MedDRA version: 16.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
279Phase 2United States;Philippines;Spain;Ukraine;Chile;Russian Federation;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Brazil;Poland;Peru;South Africa;Bulgaria;Germany;Korea, Republic of
527EUCTR2013-002773-21-DE
(EUCTR)
17/02/201407/01/2014Efficacy and safety study of atacicept in patients with Systemic Lupus Erythematosus (ADDRESS II)A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE) Systemic Lupus Erythematosus (SLE)
MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
279Phase 2United States;Philippines;Spain;Ukraine;Russian Federation;Chile;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Poland;Brazil;Peru;South Africa;Bulgaria;Germany;Korea, Republic of
528NCT01988506
(ClinicalTrials.gov)
January 6, 20147/11/2013Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory DiseasesInduction of Regulatory t Cells by Low Dose IL2 in Autoimmune and Inflammatory Diseases: a Transnosographic ApproachRheumatoid Arthritis;Ankylosing Spondylitis;Systemic Lupus Erythematosus;Psoriasis;Behcet's Disease;Wegener's Granulomatosis;Takayasu's Disease;Crohn's Disease;Ulcerative Colitis;Autoimmune Hepatitis;Sclerosing Cholangitis;Gougerot-sjögren;Idiopathic Thrombocytopenic Purpura;Systemic SclerosisDrug: Interleukin 2Assistance Publique - Hôpitaux de ParisIltoo PharmaCompleted18 YearsN/AAll81Phase 2France
529EUCTR2013-001599-40-DE
(EUCTR)
03/01/201414/11/2013Evaluation of the therapeutic potential of a low-dose therapy with the interleukin-2 analogue Aldesleukin (Proleukin®) in the treatment of systemic lupus erythematosus.Evaluation of the safety, tolerability, efficacy and immunological responses of the interleukin-2 analogue Aldesleukin (Proleukin®) in the treatment of systemic lupus erythematosus as prototypic autoimmune disease (PRO-IMMUN).A COMBINED PHASE I/IIA, PROSPECTIVE, OPEN-LABEL AND UNCONTROLLED SINGLE-CENTER STUDY TO ANALYSE SAFETY, TOLERABILITY, EFFICACY AND IMMUNOLOGICAL RESPONSES OF LOW-DOSE SUBCUTANEOUS INTERLEUKIN-2 (ALDESLEUKIN, PROLEUKIN®) IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS AND INCREASED DISEASE ACTIVITY REFRACTORY TO STANDARD THERAPIES. - PRO-IMMUN Patients with systemic lupus erythematosus (SLE) and increased disease activity refractory to standard therapies.
MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 18.0;Classification code 10067657;Term: Systemic lupus erythematosus disease activity index increased;System Organ Class: 10022891 - Investigations;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Proleukin
Product Name: Proleukin
INN or Proposed INN: Aldesleukin
Other descriptive name: ALDESLEUKIN
Charité - Universitätsmedizin BerlinNULLNot RecruitingFemale: yes
Male: yes
12Phase 1;Phase 2Germany
530NCT02041091
(ClinicalTrials.gov)
January 201417/1/2014A Study of Tabalumab (LY2127399) Using Two Different Injection Methods in Participants With LupusPharmacokinetic Evaluations of Tabalumab Following Subcutaneous Administration by Prefilled Syringe or Auto Injector in Patients With Systemic Lupus ErythematosusLupus Erythematosus, SystemicDrug: Tabalumab Auto-Injector;Drug: Tabalumab Prefilled SyringeEli Lilly and CompanyNULLTerminated18 YearsN/AAll226Phase 3United States;Korea, Republic of;Puerto Rico;Mexico
531NCT02558517
(ClinicalTrials.gov)
January 201422/9/2015Evaluation of the Discontinuation of Maintenance Corticosteroid Treatment in Quiescent Systemic LupusEvaluation of the Discontinuation of Maintenance Corticosteroid Treatment (Prednisone 5 Milligram Per Day) in Quiescent Systemic LupusSystemic Lupus ErythematosusDrug: prednisone discontinuationGroupe Hospitalier Pitie-SalpetriereNULLRecruiting18 Years75 YearsBoth136Phase 3France
532NCT02270957
(ClinicalTrials.gov)
January 201413/10/2014Clarification of Abatacept Effects in SLE With Integrated Biologic and Clinical ApproachesClarification of Abatacept Effects in SLE With Integrated Biologic and Clinical Approaches (The ABC Study)Systemic Lupus ErythematosusBiological: Abatacept;Other: PlaceboOklahoma Medical Research FoundationBristol-Myers SquibbCompleted18 Years70 YearsAll66Phase 2United States
533NCT01972568
(ClinicalTrials.gov)
December 201324/10/2013Efficacy and Safety of Atacicept in Systemic Lupus ErythematosusA Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE)Lupus Erythematosus, SystemicDrug: Atacicept 75 milligram (mg);Drug: Atacicept 150 mg;Drug: PlaceboEMD SeronoNULLCompleted18 YearsN/AAll306Phase 2United States;Argentina;Brazil;Bulgaria;Chile;Czechia;Germany;Italy;Japan;Korea, Republic of;Mexico;Peru;Philippines;Poland;Russian Federation;South Africa;Spain;United Kingdom;Czech Republic;Ukraine
534NCT01946880
(ClinicalTrials.gov)
November 20, 201313/9/2013Randomized MMF Withdrawal in Systemic Lupus Erythematosus (SLE)An Investigator-Initiated, Phase II, Randomized, Withdrawal Study of Mycophenolate Mofetil (MMF) in Patients With Stable, Quiescent Systemic Lupus Erythematosus (SLE)Systemic Lupus Erythematosus;SLEDrug: Mycophenolate Mofetil;Drug: Hydroxychloroquine or Chloroquine;Drug: PrednisoneNational Institute of Allergy and Infectious Diseases (NIAID)Autoimmunity Centers of Excellence;Rho Federal Systems Division, Inc.Terminated18 Years70 YearsAll102Phase 2United States
535JPRN-UMIN000012227
2013/11/0606/11/2013A phase II randomized trial of evaluation for boltezomib in refractory Systemic lupus erythematosusA phase II randomized trial of evaluation for boltezomib in refractory Systemic lupus erythematosus - A phase II randomized trial of evaluation for boltezomib in refractory Systemic lupus erythematosus Systemic lupus erythmatosusbortezomib(1.3mg/m2)
2times/week total 8times.
saline
Tohoku university hospitalNULLComplete: follow-up complete20years-old65years-oldMale and Female14Phase 2Japan
536NCT01894360
(ClinicalTrials.gov)
October 14, 20133/7/2013A Study to Estimate the Relative Bioavailability, Tolerability and Safety of a Single Dose of Belimumab Self-Administered Subcutaneously (SC) by Healthy SubjectsA Randomized, Parallel-Group, Open-Label Study to Estimate the Relative Bioavailability, Tolerability and Safety of a Single Dose of Belimumab Administered Subcutaneously to Healthy Subjects by Prefilled Syringe or AutoinjectorSystemic Lupus ErythematosusDrug: Belimumab 200 mg/mLGlaxoSmithKlineNULLCompleted18 Years55 YearsAll81Phase 1United States
537NCT01953835
(ClinicalTrials.gov)
October 4, 201326/9/2013A Two-part Study to Investigate the Interaction and Pharmacokinetics of GSK2586184A Two-part Healthy Volunteer Study to Investigate Both the Interaction of GSK2586184 With Rosuvastatin and Simvastatin and to Compare the Pharmacokinetics of Two Different Formulations of GSK2586184Systemic Lupus ErythematosusDrug: GSK2586184 standard formulation;Drug: Simvastatin;Drug: Rosuvastatin;Drug: GSK2586184 new formulationGlaxoSmithKlineNULLCompleted18 Years65 YearsAll37Phase 1United States
538NCT01992666
(ClinicalTrials.gov)
October 20138/11/2013GENetic & Immunologic Abnomalies in Systemic Lupus ErythematosusGENetic & Immunologic Abnomalies in Systemic Lupus ErythematosusSystemic Lupus Erythematosus (SLE)Genetic: Blood samplingHospices Civils de LyonNULLCompletedN/AN/AAll271N/AFrance
539EUCTR2012-004619-30-CZ
(EUCTR)
29/08/201319/06/2013A Study to Evaluate Long-term Safety of MEDI-546 in Adults with Systemic Lupus ErythematosusA Phase 2, Open-label Extension Study to Evaluate Long-term Safety of MEDI-546 in Adults with Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: anifrolumab
Product Code: Medi-546
INN or Proposed INN: anifrolumab
Product Name: anifrolumab
Product Code: Medi-546
INN or Proposed INN: anifrolumab
MedImmune, LLC, a wholly owned subsidiary of AstraZenecaNULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Taiwan;Ukraine;Colombia;Czech Republic;Hungary;Mexico;Brazil;Poland;Romania;Peru;Bulgaria;Korea, Republic of
540EUCTR2012-004619-30-HU
(EUCTR)
27/08/201328/06/2013A Phase 2, Open-label Extension Study to Evaluate Long-term Safety of MEDI-546 in Adults with Systemic Lupus Erythematosus A Phase 2, Open-label Extension Study to Evaluate Long-term Safety of MEDI-546 in Adults with Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: anifrolumab
Product Code: Medi-546
INN or Proposed INN: anifrolumab
Product Name: anifrolumab
Product Code: Medi-546
INN or Proposed INN: anifrolumab
MedImmune, LLC, a wholly owned subsidiary of AstraZenecaNULLNot RecruitingFemale: yes
Male: yes
240Phase 2United States;Taiwan;Ukraine;Colombia;Hungary;Czech Republic;Mexico;Brazil;Poland;Romania;Peru;Bulgaria;Korea, Republic of
541NCT02084238
(ClinicalTrials.gov)
August 20138/3/2014Low-dose IL-2( Interleukin-2) Treatment in SLESafety and Efficiency Study of Low-dose IL-2 Treatment in Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: Interleukin-2Peking University People's HospitalMonash UniversityCompleted18 Years65 YearsAll40N/AChina
542EUCTR2011-005667-25-RO
(EUCTR)
21/06/201321/07/2014Belimumab Assessment of Safety in SLE (BASE)A Randomized, Double-Blind, Placebo-Controlled 52-Week Studyto Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab Lupus Erythematosus
MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion
Product Name: Belimumab
Product Code: L04AA26
INN or Proposed INN: BELIMUMAB
Other descriptive name: Benlysta
Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)NULLNot RecruitingFemale: yes
Male: yes
5000Phase 4United States;Serbia;Portugal;Philippines;Taiwan;Hong Kong;Estonia;Slovakia;Thailand;Spain;Ukraine;Indonesia;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Malaysia;Australia;Peru;China;Korea, Republic of;Turkey;Lithuania;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Romania;Bulgaria;Norway;New Zealand
543EUCTR2011-005672-42-GB
(EUCTR)
11/06/201327/03/2013Efficacy and Safety of Belimumab in Black Race Patients With Systemic Lupus Erythematosus (SLE) (EMBRACE)A Phase 3/4, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Adult Subjects of Black Race With Systemic Lupus Erythematosus (SLE) - EMBRACE Systemic Lupus Erythematosus (SLE)
MedDRA version: 19.1;Level: LLT;Classification code 10025134;Term: Lupus erythematosus;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion
Product Name: Belimumab
Product Code: L04AA26
INN or Proposed INN: BELIMUMAB
Other descriptive name: Benlysta
Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)NULLNot RecruitingFemale: yes
Male: yes
501Phase 3;Phase 4United States;France;Martinique;Brazil;South Africa;Colombia;United Kingdom
544EUCTR2011-004296-36-BG
(EUCTR)
10/06/201314/03/2013NAA Phase 2, Randomized Study to Evaluate the Efficacy and Safety of MEDI-546 in Subjects with Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: MEDI-546
Product Code: MEDI-546
INN or Proposed INN: MEDI-546
MedImmune, LLC,NULLNot RecruitingFemale: yes
Male: yes
300Phase 2United States;Taiwan;Hong Kong;Ukraine;Colombia;India;Hungary;Czech Republic;Mexico;Poland;Brazil;Romania;Peru;Bulgaria;Korea, Republic of
545NCT01709474
(ClinicalTrials.gov)
June 201316/10/2012Vitamin D3 Treatment in Pediatric Systemic Lupus ErythematosusVitamin D3 Effects on Immune Function in Pediatric Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: Vitamin D3 6000 IU;Drug: Vitamin D3 400 IUNational Institute of Allergy and Infectious Diseases (NIAID)Autoimmunity Centers of ExcellenceTerminated5 Years20 YearsAll7Phase 2United States
546EUCTR2010-022101-18-IT
(EUCTR)
13/05/201303/09/2012Non disponibileA Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-X) - ILLUMINATE-X Systemic Lupus Erythematosus (SLE)
MedDRA version: 15.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: LY2127399
Product Code: LY2127399
ELI LILLY AND COMPANYNULLNot RecruitingFemale: yes
Male: yes
1276Phase 3United States;Belarus;Philippines;Taiwan;Ecuador;Spain;Thailand;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;Macedonia, the former Yugoslav Republic of;Malaysia;Peru;Australia;South Africa;Latvia;Tunisia;Korea, Republic of;Guatemala;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;New Zealand
547EUCTR2011-005667-25-LT
(EUCTR)
10/05/201329/11/2012Belimumab Assessment of Safety in SLE (BASE)A Randomized, Double-Blind, Placebo-Controlled 52-Week Studyto Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab Lupus Erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion
Product Name: Belimumab
Product Code: L04AA26
INN or Proposed INN: BELIMUMAB
Other descriptive name: Benlysta
GlaxoSmithKline, LLCNULLNot RecruitingFemale: yes
Male: yes
4000Phase 4Portugal;Serbia;United States;Philippines;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Thailand;Ukraine;Indonesia;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;Malaysia;Australia;Peru;China;Korea, Republic of;Czechia;Lithuania;Turkey;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Norway;New Zealand
548EUCTR2011-005667-25-BG
(EUCTR)
24/04/201331/01/2013Belimumab Assessment of Safety in SLE (BASE)A Randomized, Double-Blind, Placebo-Controlled 52-Week Studyto Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab Lupus Erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion
Product Name: Belimumab
Product Code: L04AA26
INN or Proposed INN: BELIMUMAB
Other descriptive name: Benlysta
GlaxoSmithKline, LLCNULLNot RecruitingFemale: yes
Male: yes
4000Phase 4Portugal;Serbia;United States;Philippines;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Thailand;Ukraine;Indonesia;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;Malaysia;Australia;Peru;China;Korea, Republic of;Czechia;Lithuania;Turkey;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Norway;New Zealand
549EUCTR2012-001645-41-CZ
(EUCTR)
15/04/201305/12/2012A study to assess the efficacy and safety of GSK2586184 in SLEAn adaptive Phase II study to evaluate the efficacy, pharmacodynamics, safety and tolerability of GSK2586184 in patients with active systemic lupus erythematosus. Systemic Lupus Erythematosus
MedDRA version: 16.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]
Product Name: GSK2586184
Product Code: GSK2586184
INN or Proposed INN: GSK2586184
Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide
Product Name: GSK2586184
Product Code: GSK2586184
INN or Proposed INN: GSK2586184
Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
250Phase 2Estonia;Hong Kong;Greece;Spain;Thailand;Chile;Russian Federation;India;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Peru;South Africa;Germany;Sweden;Korea, Republic of
550EUCTR2011-005667-25-PT
(EUCTR)
05/04/201317/01/2013Belimumab Assessment of Safety in SLE (BASE)A Randomized, Double-Blind, Placebo-Controlled 52-Week Studyto Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab Lupus Erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion
Product Name: Belimumab
Product Code: L04AA26
INN or Proposed INN: BELIMUMAB
Other descriptive name: Benlysta
GlaxoSmithKline, LLCNULLNot RecruitingFemale: yes
Male: yes
4000Phase 4Portugal;Serbia;United States;Philippines;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Thailand;Ukraine;Indonesia;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;Malaysia;Australia;Peru;China;Korea, Republic of;Czechia;Lithuania;Turkey;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Norway;New Zealand
551NCT01863641
(ClinicalTrials.gov)
April 201317/5/2013The Effect of Calcitriol on Progress and Activity of Lupus NephritisThe Effect of Calcitriol on Progress and Activity of Lupus NephritisSystemic Lupus ErythematosusDrug: calcitriol;Drug: placeboGuilan University of Medical SciencesNULLRecruiting18 Years65 YearsBoth50Phase 2Iran, Islamic Republic of
552NCT01753193
(ClinicalTrials.gov)
March 28, 201317/12/2012An Open-label Study to Evaluate the Long-term Safety of MEDI-546, for the Treatment of SLE, in AdultsA Phase 2, Open-label Extension Study to Evaluate Long-term Safety of MEDI-546 in Adults With Systemic Lupus ErythematosusLupus Erythematosus, SystemicBiological: AnifrolumabMedImmune LLCNULLCompleted18 Years68 YearsAll218Phase 2United States;Brazil;Bulgaria;Colombia;Czechia;Hungary;Korea, Republic of;Mexico;Peru;Poland;Romania;Taiwan;Ukraine;Czech Republic
553EUCTR2011-005667-25-SK
(EUCTR)
27/03/201305/02/2013Belimumab Assessment of Safety in SLE (BASE)A Randomized, Double-Blind, Placebo-Controlled 52-Week Studyto Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion
Product Name: Belimumab
Product Code: L04AA26
INN or Proposed INN: BELIMUMAB
Other descriptive name: Benlysta
Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)NULLNot RecruitingFemale: yes
Male: yes
4000Phase 4United States;Serbia;Portugal;Philippines;Taiwan;Hong Kong;Estonia;Slovakia;Thailand;Spain;Ukraine;Indonesia;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Malaysia;Australia;Peru;China;Korea, Republic of;Turkey;Lithuania;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Norway;New Zealand
554EUCTR2011-005667-25-IT
(EUCTR)
21/03/201314/01/2013Belimumab Assessment of Safety in SLE (BASE)A Randomized, Double-Blind, Placebo-Controlled 52-Week Study to Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab Lupus Erythematosus
MedDRA version: 15.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 15.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion
INN or Proposed INN: BELIMUMAB
HUMAN GENOME SCIENCES INCNULLNot RecruitingFemale: yes
Male: yes
5000Phase 4Portugal;United States;Philippines;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Thailand;Ukraine;Indonesia;Chile;Israel;Russian Federation;Colombia;Italy;Switzerland;India;Malaysia;Australia;Peru;China;Korea, Republic of;Korea, Democratic People's Republic of;Lithuania;Turkey;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;New Zealand
555EUCTR2010-022101-18-DE
(EUCTR)
20/03/201310/12/2012Study investigating a new medicine, LY2127399, in patients diagnosed with Systemic Lupus Erythematosus (SLE).A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-X) - ILLUMINATE-X Systemic Lupus Erythematosus (SLE)
MedDRA version: 16.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: LY2127399
Product Code: LY2127399
Other descriptive name: LA294; Anti LP40 antibody, subclass IgG4; Anti BAFF (B cell activating factor)
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1276Phase 3United States;Belarus;Serbia;Philippines;Taiwan;Ecuador;Thailand;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;India;France;Macedonia, the former Yugoslav Republic of;Malaysia;Australia;Peru;South Africa;Latvia;Tunisia;Korea, Democratic People's Republic of;Guatemala;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand
556EUCTR2012-001645-41-PL
(EUCTR)
14/03/201320/12/2012A study to assess the efficacy and safety of GSK2586184 in SLEAn adaptive Phase II study to evaluate the efficacy, pharmacodynamics, safety and tolerability of GSK2586184 in patients with active systemic lupus erythematosus. Systemic Lupus Erythematosus
MedDRA version: 16.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]
Product Name: GSK2586184
Product Code: GSK2586184
INN or Proposed INN: GSK2586184
Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide
Product Name: GSK2586184
Product Code: GSK2586184
INN or Proposed INN: GSK2586184
Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide
GlaxoSmithKline Research and Development LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 2Hong Kong;Estonia;Greece;Thailand;Spain;Chile;Russian Federation;Italy;India;France;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Romania;Peru;South Africa;Germany;Korea, Republic of;Sweden
557NCT01777256
(ClinicalTrials.gov)
March 1, 201324/1/2013An Adaptive Phase II Study to Evaluate the Efficacy, Pharmacodynamics, Safety and Tolerability of GSK2586184An Adaptive Phase II Study to Evaluate the Efficacy, Pharmacodynamics, Safety and Tolerability of GSK2586184 in Patients With Mild to Moderate Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: GSK2586184 50 mg;Drug: GSK2586184 100 mg;Drug: GSK2586184 200 mg;Drug: GSK2586184 400 mg;Drug: PlaceboGlaxoSmithKlineNULLTerminated18 Years75 YearsAll51Phase 2Argentina;Chile;Czechia;Estonia;France;Germany;Greece;Hong Kong;Hungary;Korea, Republic of;Peru;Poland;Romania;South Africa;Spain;Sweden;Brazil;Czech Republic
558NCT01729455
(ClinicalTrials.gov)
February 21, 201314/11/2012Safety and Effectiveness of BENLYSTA (Belimumab) in Systemic Lupus Erythematosus (SLE) RegistryA 5-Year Prospective Observational Registry to Assess Adverse Events of Interest and Effectiveness in Adults With Active, Autoantibody-Positive Systemic Lupus Erythematosus Treated With or Without BENLYSTA™ (Belimumab)Systemic Lupus ErythematosusBiological: BENLYSTA;Other: SLE treatmentGlaxoSmithKlineNULLActive, not recruiting18 YearsN/AAll3138United States;Argentina;Austria;Belgium;Canada;France;Germany;Israel;Italy;Portugal;Slovakia;Spain;Sweden
559EUCTR2012-001645-41-DE
(EUCTR)
19/02/201316/10/2012A study to assess the efficacy and safety of GSK2586184 in SLEAn adaptive Phase II study to evaluate the efficacy, pharmacodynamics, safety and tolerability of GSK2586184 in patients with active systemic lupus erythematosus. Systemic Lupus Erythematosus
MedDRA version: 16.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]
Product Name: GSK2586184
Product Code: GSK2586184
INN or Proposed INN: GSK2586184
Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide
Product Name: GSK2586184
Product Code: GSK2586184
INN or Proposed INN: GSK2586184
Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
250Phase 2India;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Peru;South Africa;Germany;Sweden;Korea, Republic of;Thailand;Russian Federation;Chile;Estonia;Hong Kong;Greece;Spain
560NCT01632241
(ClinicalTrials.gov)
February 19, 201328/6/2012Efficacy and Safety of Belimumab in Black Race Patients With Systemic Lupus Erythematosus (SLE)A Phase 3/4, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Adult Subjects of Black Race With Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusBiological: Placebo plus standard therapy;Biological: Belimumab 10 mg/kg plus standard therapy;Drug: Standard therapyHuman Genome Sciences Inc., a GSK CompanyGlaxoSmithKlineCompleted18 YearsN/AAll503Phase 4United States;Brazil;Colombia;France;South Africa;United Kingdom
561EUCTR2012-001645-41-SE
(EUCTR)
15/02/201329/10/2012A study to assess the efficacy and safety of GSK2586184 in SLEAn adaptive Phase II study to evaluate the efficacy, pharmacodynamics, safety and tolerability of GSK2586184 in patients with mild to moderate systemic lupus erythematosus. Systemic Lupus Erythematosus
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]
Product Name: GSK2586184
Product Code: GSK2586184
INN or Proposed INN: GSK2586184
Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide
Product Name: GSK2586184
Product Code: GSK2586184
INN or Proposed INN: GSK2586184
Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
250Phase 2Estonia;Hong Kong;Greece;Spain;Thailand;Russian Federation;Chile;India;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Peru;South Africa;Germany;Sweden;Korea, Republic of
562EUCTR2011-005667-25-ES
(EUCTR)
14/02/201321/12/2012Belimumab Assessment of Safety in SLE (BASE)A Randomized, Double-Blind, Placebo-Controlled 52-Week Studyto Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab Lupus Erythematosus
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion
Product Name: Belimumab
Product Code: L04AA26
INN or Proposed INN: BELIMUMAB
Other descriptive name: Benlysta
Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)NULLNot RecruitingFemale: yes
Male: yes
5000Phase 4United States;Serbia;Portugal;Philippines;Taiwan;Hong Kong;Estonia;Slovakia;Thailand;Spain;Ukraine;Indonesia;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Malaysia;Australia;Peru;China;Korea, Republic of;Turkey;Lithuania;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Norway;New Zealand
563EUCTR2011-000368-88-IT
(EUCTR)
04/02/201311/12/2012A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patient 5 to 17 years of age.A Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with Systemic Lupus Erythematosus (SLE). - Belimumab in pediatric patients with SLE Systemic lupus erythematosus
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Benlysta (belimumab)
INN or Proposed INN: BELIMUMAB
GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD.NULLNot RecruitingFemale: yes
Male: yes
100United States;Mexico;Canada;Argentina;Spain;Brazil;Peru;Netherlands;United Kingdom;Italy
564NCT01781611
(ClinicalTrials.gov)
February 20132/1/2013Dipyridamole Assessment for Flare Reduction in Systemic Lupus Erythematosus (SLE)Dipyridamole Assessment for Flare Reduction in SLESystemic Lupus ErythematosusDrug: extended release dipyridamole 200mg/aspirin 25mg;Drug: 81mg aspirinOklahoma Medical Research FoundationNULLTerminated18 Years70 YearsAll18N/AUnited States
565NCT01395745
(ClinicalTrials.gov)
February 201314/7/2011CHABLIS-SC1: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus ErythematosusA Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: blisibimod;Drug: PlaceboAnthera PharmaceuticalsNULLCompleted18 YearsN/AAll442Phase 3Belarus;Brazil;Colombia;Georgia;Guatemala;Hong Kong;India;Korea, Republic of;Malaysia;Mexico;Philippines;Russian Federation;Singapore;Sri Lanka;Taiwan;Thailand
566EUCTR2011-005667-25-CZ
(EUCTR)
30/01/201304/12/2012Belimumab Assessment of Safety in SLE (BASE)A Randomized, Double-Blind, Placebo-Controlled 52-Week Studyto Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab Lupus Erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion
Product Name: Belimumab
Product Code: L04AA26
INN or Proposed INN: BELIMUMAB
Other descriptive name: Benlysta
GlaxoSmithKline, LLCNULLNot RecruitingFemale: yes
Male: yes
4000Phase 4Portugal;Serbia;United States;Philippines;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Thailand;Ukraine;Indonesia;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;Malaysia;Australia;Peru;China;Korea, Republic of;Czechia;Lithuania;Turkey;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Norway;New Zealand
567EUCTR2011-005667-25-HU
(EUCTR)
22/01/201322/11/2012Belimumab Assessment of Safety in SLE (BASE)A Randomized, Double-Blind, Placebo-Controlled 52-Week Studyto Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab Lupus Erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion
Product Name: Belimumab
Product Code: L04AA26
INN or Proposed INN: BELIMUMAB
Other descriptive name: Benlysta
GlaxoSmithKline, LLCNULLNot RecruitingFemale: yes
Male: yes
4000Phase 4Portugal;Serbia;United States;Philippines;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Thailand;Ukraine;Indonesia;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;Malaysia;Australia;Peru;China;Korea, Republic of;Czechia;Lithuania;Turkey;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Norway;New Zealand
568EUCTR2011-004296-36-HU
(EUCTR)
22/01/201329/11/2012A Study to evaluate the efficacy and safety of MEDI-546 compared toplacebo in subjects with Systemic Lupus ErythematosusA Phase 2, Randomized Study to Evaluate the Efficacy and Safety of MEDI-546 in Subjects with Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: MEDI-546
Product Code: MEDI-546
INN or Proposed INN: MEDI-546
MedImmune, LLC,NULLNot RecruitingFemale: yes
Male: yes
300Phase 2United States;Taiwan;Hong Kong;Ukraine;Colombia;India;Hungary;Czech Republic;Mexico;Poland;Brazil;Romania;Peru;Bulgaria;Korea, Republic of
569EUCTR2011-005667-25-EE
(EUCTR)
08/01/201312/12/2012Belimumab Assessment of Safety in SLE (BASE)A Randomized, Double-Blind, Placebo-Controlled 52-Week Studyto Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion
Product Name: Belimumab
Product Code: L04AA26
INN or Proposed INN: BELIMUMAB
Other descriptive name: Benlysta
Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)NULLNot RecruitingFemale: yes
Male: yes
4000Phase 4United States;Serbia;Portugal;Philippines;Taiwan;Hong Kong;Estonia;Slovakia;Thailand;Spain;Ukraine;Indonesia;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Malaysia;Australia;Peru;China;Korea, Republic of;Turkey;Lithuania;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Norway;New Zealand
570NCT01764594
(ClinicalTrials.gov)
January 20132/1/2013Safety Study of CDP7657 in Patients With Systemic Lupus ErythematosusA Multicenter, Investigator- and Subject-Blind, Randomized, Placebo-Controlled, Parallel-Group, Repeat-Dose Study to Evaluate the Effect of CDP7657 in Subjects With Active Systemic Lupus ErythematosusImmune System Diseases;Autoimmune Diseases;Lupus Erythematosus, Systemic;Skin and Connective Tissue Diseases;Connective Tissue DiseaseBiological: CDP7657;Other: PlaceboUCB PharmaBiogenCompleted18 Years75 YearsBoth24Phase 1Belgium;Bulgaria;Germany;Poland;Romania;Russian Federation;Spain
571NCT01753401
(ClinicalTrials.gov)
January 201317/12/2012Acthar for the Treatment of Systemic Lupus Erythematosus (SLE) in Patients With a History of Persistently Active DiseaseA Two-part Study Exploring the Efficacy, Safety, and Pharmacodynamics of Acthar in Systemic Lupus Erythematosus Patients With a History of Persistently Active DiseaseSystemic Lupus Erythematosus (SLE)Drug: Acthar;Drug: Placebo;Drug: Steroid DrugMallinckrodtNULLCompleted18 YearsN/AAll38Phase 4United States
572NCT01741012
(ClinicalTrials.gov)
January 201314/11/2012Study to Determine if Gardasil Vaccine is Safe and Effective in Lupus PatientsPhase I, Safety and Immunogenicity of Gardasil® in Systemic Lupus Erythematosus.Systemic Lupus ErythematosusDrug: GardasilWayne State UniversityMerck Sharp & Dohme Corp.Completed18 Years50 YearsFemale37Phase 1United States
573EUCTR2012-001645-41-EE
(EUCTR)
28/12/201227/11/2012A study to assess the efficacy and safety of GSK2586184 in SLEAn adaptive Phase II study to evaluate the efficacy, pharmacodynamics, safety and tolerability of GSK2586184 in patients with active systemic lupus erythematosus. Systemic Lupus Erythematosus
MedDRA version: 16.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]
Product Name: GSK2586184
Product Code: GSK2586184
INN or Proposed INN: GSK2586184
Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide
Product Name: GSK2586184
Product Code: GSK2586184
INN or Proposed INN: GSK2586184
Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
250Phase 2Estonia;Hong Kong;Greece;Spain;Chile;Czech Republic;Hungary;Argentina;Poland;Brazil;Peru;South Africa;Germany;Korea, Republic of;Sweden
574EUCTR2010-022101-18-GB
(EUCTR)
21/12/201228/11/2012Study investigating a new medicine, LY2127399, in patients diagnosed with Systemic Lupus Erythematosus (SLE).A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-X) - ILLUMINATE-X Systemic Lupus Erythematosus (SLE)
MedDRA version: 16.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: Not available
Other descriptive name: LA294; Anti LP40 antibody, subclass IgG4; Anti BAFF (B cell activating factor)
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1276Phase 3United States;Belarus;Serbia;Philippines;Taiwan;Ecuador;Thailand;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;India;France;Macedonia, the former Yugoslav Republic of;Malaysia;Australia;Peru;South Africa;Latvia;Tunisia;Korea, Democratic People's Republic of;Guatemala;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand
575EUCTR2012-001645-41-ES
(EUCTR)
19/12/201212/11/2012A study to assess the efficacy and safety of GSK2586184 in SLEAn adaptive Phase II study to evaluate the efficacy, pharmacodynamics, safety and tolerability of GSK2586184 in patients with mild to moderate systemic lupus erythematosus. Systemic Lupus Erythematosus
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]
Product Name: GSK2586184
Product Code: GSK2586184
INN or Proposed INN: GSK2586184
Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide
Product Name: GSK2586184
Product Code: GSK2586184
INN or Proposed INN: GSK2586184
Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide
GlaxoSmithKline, S.A.NULLNot RecruitingFemale: yes
Male: yes
250Phase 2Estonia;Hong Kong;Greece;Spain;Thailand;Russian Federation;Chile;India;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Peru;South Africa;Germany;Sweden;Korea, Republic of
576EUCTR2012-001645-41-HU
(EUCTR)
13/12/201224/10/2012A study to assess the efficacy and safety of GSK2586184 in SLEAn adaptive Phase II study to evaluate the efficacy, pharmacodynamics, safety and tolerability of GSK2586184 in patients with mild to moderate systemic lupus erythematosus. Systemic Lupus Erythematosus
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]
Product Name: GSK2586184
Product Code: GSK2586184
INN or Proposed INN: GSK2586184
Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide
Product Name: GSK2586184
Product Code: GSK2586184
INN or Proposed INN: GSK2586184
Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
250Phase 2Estonia;Hong Kong;Greece;Spain;Thailand;Russian Federation;Chile;India;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Peru;South Africa;Germany;Sweden;Korea, Republic of
577EUCTR2012-001645-41-GR
(EUCTR)
11/12/201213/11/2012A study to assess the efficacy and safety of GSK2586184 in SLEAn adaptive Phase II study to evaluate the efficacy, pharmacodynamics, safety and tolerability of GSK2586184 in patients with mild to moderate systemic lupus erythematosus. Systemic Lupus Erythematosus
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]
Product Name: GSK2586184
Product Code: GSK2586184
INN or Proposed INN: GSK2586184
Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide
Product Name: GSK2586184
Product Code: GSK2586184
INN or Proposed INN: GSK2586184
Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
250Phase 2Estonia;Hong Kong;Greece;Spain;Thailand;Russian Federation;Chile;India;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Peru;South Africa;Germany;Sweden;Korea, Republic of
578EUCTR2011-000368-88-NL
(EUCTR)
03/12/201202/07/2012A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patients 5 to 17 years of ageA Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with Systemic Lupus Erythematosus (SLE) - Belimumab in pediatric patients with SLE Systemic Lupus Erythematosus
MedDRA version: 17.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: BENLYSTA™ (belimumab)
Product Name: Benlysta (belimumab)
Product Code: GSK1550188
INN or Proposed INN: belimumab
GlaxoSmithKline Research & Development LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100United States;Mexico;Canada;Argentina;Poland;Brazil;Spain;Peru;Russian Federation;Netherlands;Italy;United Kingdom
579NCT01705977
(ClinicalTrials.gov)
November 27, 201210/10/2012Belimumab Assessment of Safety in SLEA Randomized, Double-Blind, Placebo-Controlled 52-Week Study to Assess Adverse Events of Special Interest in Adults With Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving BelimumabSystemic Lupus ErythematosusBiological: Placebo plus standard therapy;Biological: Belimumab 10 mg/kg plus standard therapy;Other: Standard therapyGlaxoSmithKlineNULLCompleted18 YearsN/AAll4019Phase 4United States;Argentina;Australia;Brazil;Bulgaria;Canada;Chile;Colombia;Croatia;Czechia;Estonia;Hong Kong;Hungary;Indonesia;Italy;Korea, Republic of;Lithuania;Malaysia;Mexico;New Zealand;Peru;Philippines;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;Spain;Switzerland;Taiwan;Thailand;Ukraine;Czech Republic;Norway
580NCT01686555
(ClinicalTrials.gov)
November 201213/9/2012A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ABT-199 in Female Patients With Systemic Lupus Erythematosus (SLE)Assessment of the Safety, Tolerability, and Pharmacokinetics of ABT-199 After Single and Multiple Ascending Doses in Female Subjects With Systemic Lupus Erythematosus (SLE)Lupus ErythematosusDrug: ABT-199;Other: PlaceboAbbVie (prior sponsor, Abbott)NULLCompleted18 Years65 YearsFemale97Phase 1United States;Germany;Mexico;Puerto Rico
581EUCTR2012-002345-38-GB
(EUCTR)
30/10/201208/10/2012Comparison of rivaroxaban (Xarelto®; Bayer HealthCare), fixed-dose oral anticoagulant (blood thinner), versus warfarin in patients with antiphospholipid syndrome (called APS), with or without 'lupus' (systemic lupus erythematosus)A prospective randomised controlled phase II/III clinical trial of rivaroxaban versus warfarin in patients with thrombotic antiphospholipid syndrome, with or without SLE. - Rivaroxaban in Antiphospholipid Syndrome (RAPS) Patients with antiphospholipid syndrome (APS), with or without systemic lupus erythematosus (SLE).
MedDRA version: 14.1;Level: PT;Classification code 10002817;Term: Antiphospholipid syndrome;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Xarelto
Product Name: Rivaroxaban
INN or Proposed INN: Rivaroxaban
Other descriptive name: Trade name Xarelto
Trade Name: The generic name is warfarin and many producers will be involved
Product Name: Warfarin
INN or Proposed INN: Warfarin
University College LondonNULLNot Recruiting Female: yes
Male: yes
156 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom
582NCT01689350
(ClinicalTrials.gov)
October 201217/9/2012A Prospective Study of Cyclophosphamide in Systemic Lupus Erythematosus TreatmentProspective Study Based on Genetic Polymorphisms Related to Individual Variations of Side Effects of Cyclophosphamide in Systemic Lupus Erythematosus TreatmentSystemic Lupus ErythematosusGenetic: Genotype DetectionSun Yat-sen UniversityFirst Affiliated Hospital, Sun Yat-Sen UniversityCompleted12 Years60 YearsAll92N/AChina
583NCT01769937
(ClinicalTrials.gov)
October 201215/1/2013Open-label Trial of Acthar Gel in Subjects With Moderate to Severe Active Systemic Lupus ErythematosusA Single-site, Investigator Initiated Open-Label Trial of H.P. Acthar Gel (Repository Corticotropin Injection)an Adrenocorticotropic Hormone (ACTH) Analogue in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)Lupus Erythematosus Systemic ExacerbationDrug: H.P. Acthar GelFiechtner, Justus J., M.D., P.C.NULLCompleted18 Years75 YearsBoth10Phase 4United States
584NCT01687192
(ClinicalTrials.gov)
October 201213/9/2012Multicenter Trial Evaluating the Immunogenicity of HPV Vaccination in Girls on Immunosuppressive Therapy.Multicenter Clinical Trial Evaluating the Immunological Response of Vaccination Against Infection by Human Papillomavirus (HPV) 6, 11, 16, 18 in Girls Receiving Immunosuppressive Therapy.Transplantation;Systemic Lupus Erythematosus;Systemic Immune DiseaseBiological: HPV prophylactic vaccine GardasilUniversity Hospital, BordeauxNULLActive, not recruiting9 Years18 YearsFemale37Phase 2France
585NCT01649765
(ClinicalTrials.gov)
September 7, 201223/7/2012Pediatric Lupus Trial of Belimumab Plus Background Standard TherapyA Multi-center, Randomized, Placebo-Controlled Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: belimumab 10mg/kg;Other: placeboGlaxoSmithKlineHuman Genome Sciences Inc., a GSK CompanyActive, not recruiting5 Years17 YearsAll93Phase 2United States;Argentina;Canada;Japan;Mexico;Peru;Poland;Russian Federation;Spain;United Kingdom;Brazil;Italy;Netherlands
586ChiCTR-TRC-12002419
2012-09-012012-08-01The clinical research of metformin in achievienging the reduction in Flare of Mild/Moderate Active Lupus PatientsThe clinical research of metformin in achievienging the reduction in Flare of Mild/Moderate Active Lupus Patients systemic lupus erythematosus1:Background treatment( - hydroxychloroquine );2:Background treatment( + hydroxychloroquine );3:Background treatment + hydroxychloroquine + Metformin;Renji Hospital, Shanghai JiaoTong University School of MedicineNULLCompleted1870Both1:60;2:60;3:60;China
587NCT01689025
(ClinicalTrials.gov)
September 201214/9/2012An Investigation of Safety and Tolerability of NNC0114-0006 in Subjects With Systemic Lupus Erythematosus (SLE)A Randomised, Placebo-controlled, Double-blind, Multiple-dose, Dose-escalation Trial Investigating the Safety and Tolerability of NNC0114-0006 in Subjects With Systemic Lupus ErythematosusInflammation;Systemic Lupus ErythematosusDrug: NNC0114-0006;Drug: placeboNovo Nordisk A/SNULLTerminated18 Years64 YearsBoth10Phase 1United States;Hungary;Poland;Serbia
588EUCTR2011-004296-36-CZ
(EUCTR)
29/08/201228/06/2012A study to evaluate the efficacy and safety of MEDI-546 compared to placebo in subjects with Systemic Lupus ErythematosusA Phase 2, Randomized Study to Evaluate the Efficacy and Safety of MEDI-546 in Subjects with Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: MEDI-546
Product Code: MEDI-546
INN or Proposed INN: MEDI-546
MedImmune, LLC,NULLNot RecruitingFemale: yes
Male: yes
300Phase 2United States;Taiwan;Hong Kong;Ukraine;Israel;Colombia;India;Czech Republic;Hungary;Mexico;Poland;Brazil;Romania;Peru;Bulgaria;Korea, Republic of
589EUCTR2010-022101-18-BG
(EUCTR)
28/08/201229/08/2012Study investigating a new medicine, LY2127399, in patients diagnosed with Systemic Lupus Erythematosus (SLE).A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-X) - ILLUMINATE-X Systemic Lupus Erythematosus (SLE)
MedDRA version: 17.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: LY2127399
Product Code: LY2127399
Other descriptive name: LA294; Anti LP40 antibody, subclass IgG4; Anti BAFF (B cell activating factor)
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1276Phase 3Serbia;United States;Belarus;Philippines;Taiwan;Ecuador;Thailand;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;India;France;Macedonia, the former Yugoslav Republic of;Malaysia;Peru;Australia;South Africa;Latvia;Tunisia;Korea, Democratic People's Republic of;Guatemala;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
590EUCTR2010-024069-30-BG
(EUCTR)
21/08/201208/08/2012A study to investigate the optimum dose, the efficacy and the safety of sifalimumab in adult patients with Systemic Lupus Erythematosus, a disease of the immune systemA Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults with Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Sifalimumab
Product Code: MEDI-545
INN or Proposed INN: sifalimumab
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
400Phase 2United States;Philippines;Spain;Thailand;Chile;Italy;United Kingdom;India;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Peru;Bulgaria;South Africa;Netherlands;Germany
591EUCTR2010-022101-18-HU
(EUCTR)
17/08/201217/05/2012Study investigating a new medicine, LY2127399, in patients diagnosed with Systemic Lupus Erythematosus (SLE)A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-X) - ILLUMINATE-X Systemic Lupus Erythematosus (SLE)
MedDRA version: 16.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: LY2127399
Product Code: LY2127399
Other descriptive name: LA294; Anti LP40 antibody, subclass IgG4; Anti BAFF (B cell activating factor)
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1276Phase 3South Africa;Latvia;Tunisia;Korea, Democratic People's Republic of;Guatemala;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Romania;Bulgaria;Germany;Japan;New Zealand;Serbia;United States;Belarus;Philippines;Taiwan;Ecuador;Thailand;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;India;France;Macedonia, the former Yugoslav Republic of;Malaysia;Peru;Australia
592EUCTR2010-022101-18-LV
(EUCTR)
10/08/201228/05/2012Study investigating a new medicine, LY2127399, in patients diagnosed with Systemic Lupus Erythematosus (SLE).A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-X) - ILLUMINATE-X Systemic Lupus Erythematosus (SLE)
MedDRA version: 16.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: LY2127399
Product Code: LY2127399
Other descriptive name: LA294; Anti LP40 antibody, subclass IgG4; Anti BAFF (B cell activating factor)
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1276Phase 3Serbia;United States;Belarus;Philippines;Taiwan;Ecuador;Thailand;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;India;France;Macedonia, the former Yugoslav Republic of;Malaysia;Peru;Australia;South Africa;Latvia;Tunisia;Korea, Democratic People's Republic of;Guatemala;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Romania;Bulgaria;Germany;Japan;New Zealand
593NCT01597050
(ClinicalTrials.gov)
August 20129/5/2012Safety and Efficacy of Topical R333 in Patients With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) LesionsA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of R333 6% Ointment Administered Topically to Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) Patients With Active Cutaneous Discoid LesionsLupus Erythematosus, Discoid;Lupus Erythematosus, SystemicDrug: R932333;Drug: PlaceboRigel PharmaceuticalsNULLCompleted18 Years75 YearsAll54Phase 2United States;Canada
594EUCTR2011-000368-88-ES
(EUCTR)
27/07/201221/05/2012A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patients 5 to 17 years of age.A Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with Systemic Lupus Erythematosus (SLE). - Belimumab in pediatric patients with SLE Systemic Lupus Erythematosus
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: BENLYSTA? (belimumab)
Product Name: Benlysta (belimumab)
Product Code: GSK1550188
INN or Proposed INN: belimumab
GlaxoSmithKline, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Germany;Netherlands;Italy;Brazil;Russian Federation;United Kingdom;Canada;Peru;Argentina;Mexico;Spain;United States;Poland
595NCT01532310
(ClinicalTrials.gov)
July 16, 20122/2/2012Belimumab (BENLYSTA®) Pregnancy RegistryWEUKBRE6076: Belimumab (BENLYSTA) Pregnancy Registry ProtocolSystemic Lupus ErythematosusDrug: belimumabGlaxoSmithKlinePPDCompletedN/AN/AFemale77United States;Argentina;Austria;Belgium;Canada;France;Germany;Israel;Italy;Portugal;Spain;Sweden;Switzerland
596NCT01892748
(ClinicalTrials.gov)
July 201217/6/2013Cholecalciferol Supplementation on Disease Activity, Fatigue and Bone Mass on Juvenile Systemic Lupus Erythematosus.Effects of Cholecalciferol Supplementation on Disease Activity, Fatigue and Bone Mass on Juvenile Onset Systemic Lupus Erythematosus.Systemic Lupus ErythematosusDrug: Cholecalciferol;Drug: PlaceboROSA MARIA RODRIGUES PEREIRANULLCompleted10 Years25 YearsFemale60N/ABrazil
597EUCTR2010-020859-30-IT
(EUCTR)
23/06/201206/03/2012Open-label study of long-term Epratuzumab treatment in subjects withSystemic Lupus Erythematosus (SLE)A phase 3, multicenter, open-label, extension study to asssess the safety and tolerability of Epratuzumab treatment in systemic lupus erythematosus subjects (EMBODY 4) - EMBODY 4 Systemic lupus erythematosus
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: EPRATUZUMAB
Other descriptive name: NA
UCB Inc.NULLNot RecruitingFemale: yes
Male: yes
1400Phase 3United States;Estonia;Taiwan;Hong Kong;Spain;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;India;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Australia;Bulgaria;South Africa;Germany;Korea, Republic of
598EUCTR2011-000420-15-DE
(EUCTR)
21/06/201206/12/2011STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF 04236921 IN SUBJECTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04236921 IN SUBJECTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) - Butterfly SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)
MedDRA version: 16.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Not applicable
Product Code: PF-04236921
INN or Proposed INN: Not applicable
Pfizer Inc.235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
180United States;Taiwan;Lithuania;Chile;Israel;Colombia;India;Hungary;Mexico;Argentina;Poland;Romania;Peru;Germany;Moldova, Republic of;Korea, Republic of
599EUCTR2010-020859-30-EE
(EUCTR)
15/06/201204/06/2012Open-label study of long-term Epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)A phase 3, multicenter, open-label, extension study to assess the safety and tolerability of Epratuzumab treatment in systemic lupus erythematosus subjects (EMBODY 4) - EMBODY 4 Systemic Lupus Erythematosus
MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab
UCB Inc.NULLNot RecruitingFemale: yes
Male: yes
1250Phase 3United States;Taiwan;Estonia;Hong Kong;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Bulgaria;Germany
600EUCTR2011-000368-88-GB
(EUCTR)
13/06/201218/04/2012A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patients 5 to 17 years of ageA Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with Systemic Lupus Erythematosus (SLE) - Belimumab in pediatric patients with SLE Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: BENLYSTA™ (belimumab)
Product Name: Benlysta (belimumab)
Product Code: GSK1550188
INN or Proposed INN: belimumab
GlaxoSmithKline Research & Development LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2United States;Mexico;Canada;Argentina;Spain;Poland;Brazil;Peru;Russian Federation;Netherlands;Italy;United Kingdom
601NCT01597622
(ClinicalTrials.gov)
June 11, 201210/5/2012BEL114333, a Continuation Study of BEL113750 in Subjects With Systemic Lupus Erythematosus (SLE) in Northeast Asia, and in Japan Subjects Completing the Open-label Extension of HGS1006-C1115BEL114333, a Multicenter, Continuation Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase III Study BEL113750 in Northeast Asia or Completed the Open-label Extension of HGS1006-C1115 in JapanSystemic Lupus ErythematosusDrug: BelimumabGlaxoSmithKlineHuman Genome Sciences Inc.Completed18 YearsN/AAll142Phase 3Japan;Korea, Republic of
602EUCTR2011-003814-18-PL
(EUCTR)
06/06/201219/06/2012A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC Systemic lupus erythematosis (SLE)
MedDRA version: 18.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Belimumab
INN or Proposed INN: Belimumab
Other descriptive name: Benlysta
Human Genome Sciences, a wholly owned subsidiary of GlaxoSmithKline, PlcNULLNot RecruitingFemale: yes
Male: yes
816Phase 3United States;Portugal;Serbia;Philippines;Taiwan;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden
603JPRN-JapicCTI-121864
01/6/2012A Phase I study of rontalizumabA Phase I study of rontalizumab Systemic lupus erythematosus (SLE)Intervention name : Rontalizumab
Dosage And administration of the intervention : Single and multiple subcutaneous administration of 3 different doses of rontalizumab
Control intervention name : null
Chugai Pharmaceutical Co., Ltd.NULL2064BOTH21Phase 1NULL
604EUCTR2011-003814-18-PT
(EUCTR)
01/06/201221/02/2012A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC Systemic lupus erythematosis (SLE)
MedDRA version: 18.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Belimumab
INN or Proposed INN: Belimumab
Other descriptive name: Benlysta
Human Genome Sciences, a wholly owned subsidiary of GlaxoSmithKline, PlcNULLNot RecruitingFemale: yes
Male: yes
816Phase 3Serbia;United States;Portugal;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Denmark;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden
605NCT01683695
(ClinicalTrials.gov)
June 201214/3/2012Safety Study of AMG 557 in Subjects With Lupus ArthritisA Randomized, Double-blind, Parallel, Placebo-controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effect of AMG 557 in Systemic Lupus Erythematosus (SLE) Subjects With Active Lupus ArthritisLupus Arthritis, Systemic Lupus ErythematosusDrug: AMG 557;Drug: Matching PlaceboAmgenNULLCompleted18 Years65 YearsAll20Phase 1United States;Australia;Denmark;France;Germany;Malaysia;Taiwan;United Kingdom;Singapore
606NCT01597492
(ClinicalTrials.gov)
May 31, 20128/5/2012A Study to Evaluate the Effect of Belimumab on Vaccine Responses in Subjects With Systemic Lupus Erythematosus (SLE)A Phase 4, Multi-Center, Randomized, Open-Label Study to Evaluate the Effect of BENLYSTA™ (Belimumab; HGS1006) on Vaccine Responses in Subjects With Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusBiological: Belimumab plus Early Vaccination;Biological: Belimumab plus Late VaccinationHuman Genome Sciences Inc., a GSK CompanyGlaxoSmithKlineCompleted18 YearsN/AAll79Phase 4United States
607EUCTR2010-023396-25-PL
(EUCTR)
30/05/201223/09/2011A study to assess the safety and effectiveness of SL101 in the treatment of systemic lupus erythematosus (SLE)Phase IIa, 2:2:1 randomised, double-blind, placebo-controlled, parallel group, multi-centre clinical trial to investigate the safety, efficacy and pharmacokinetics of recombinant human soluble Fc-gamma receptor IIb (SM101) for intravenous application in the treatment of systemic lupus erythematosus (SLE) patients with or without a history of lupus nephritis - SMILE Systemic lupus erythematosus (SLE)
MedDRA version: 15.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: soluble Fc-gamma receptor IIb
Product Code: SM101
INN or Proposed INN: .
Other descriptive name: soluble Fc receptor
SuppreMol GmbHNULLNot RecruitingFemale: yes
Male: yes
50Phase 2France;Czech Republic;Belgium;Spain;Poland;Australia;Netherlands;Germany;Italy;United Kingdom
608EUCTR2011-003814-18-BE
(EUCTR)
29/05/201201/02/2012A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC Systemic lupus erythematosis (SLE)
MedDRA version: 15.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Belimumab
INN or Proposed INN: Belimumab
Other descriptive name: Benlysta
Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)NULLNot RecruitingFemale: yes
Male: yes
816Phase 3Serbia;Portugal;United States;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden
609EUCTR2010-022101-18-ES
(EUCTR)
25/05/201221/05/2012A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-X)A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-X) - ILLUMINATE-X Systemic Lupus Erythematosus (SLE)
MedDRA version: 14.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: LY2127399
Product Code: LY2127399
Other descriptive name: LA294; Anti LP40 antibody, subclass IgG4; Anti BAFF (B cell activating factor)
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1276Phase 3Serbia;United States;Belarus;Philippines;Taiwan;Ecuador;Thailand;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Macedonia, the former Yugoslav Republic of;Malaysia;Peru;Australia;South Africa;Latvia;Tunisia;Korea, Democratic People's Republic of;Guatemala;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Romania;Bulgaria;Germany;Japan;New Zealand
610EUCTR2011-005392-16-ES
(EUCTR)
23/05/201217/04/2012Stydy to evaluate the efficacy and security of anakinra for the treatment of unresponsiveness arthritis to conventional treatment in systemic lupus erythematosusStudy to evaluate the efficacy and safety of Anakinra in the treatment of articular manifestations refractory to conventional therapy in Systemic Lupus Erythematosus patients - ANAKINRA AND LUPUS ARTHRITIS Systemic lupus erythematosus
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: KINERET
Product Name: KINERET
Product Code: KINERET
INN or Proposed INN: ANAKINRA
Dr Josep Ordi RosNULLNot RecruitingFemale: yes
Male: yes
20Phase 2Spain
611EUCTR2011-003814-18-BG
(EUCTR)
22/05/201221/05/2012A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC Systemic lupus erythematosis (SLE)
MedDRA version: 17.0;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Belimumab
INN or Proposed INN: Belimumab
Other descriptive name: Benlysta
Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)NULLNot RecruitingFemale: yes
Male: yes
816Phase 3Serbia;Portugal;United States;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden
612EUCTR2011-003814-18-IT
(EUCTR)
15/05/201208/06/2012A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC Systemic lupus erythematosis (SLE)
MedDRA version: 14.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Belimumab
Product Code: NA
INN or Proposed INN: BELIMUMAB
Other descriptive name: Benlysta
HUMAN GENOME SCIENCES INCNULLNot RecruitingFemale: yes
Male: yes
816Phase 3United States;Portugal;Philippines;Taiwan;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;Italy;India;Malaysia;Denmark;Peru;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Bulgaria;Germany;Sweden
613EUCTR2010-022101-18-AT
(EUCTR)
14/05/201211/04/2012Study investigating a new medicine, LY2127399, in patients diagnosed with Systemic Lupus Erythematosus (SLE).A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-X) - ILLUMINATE-X Systemic Lupus Erythematosus (SLE)
MedDRA version: 14.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: LY2127399
Product Code: LY2127399
Other descriptive name: LA294; Anti LP40 antibody, subclass IgG4; Anti BAFF (B cell activating factor)
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1276Phase 3United States;Serbia;Belarus;Philippines;Taiwan;Ecuador;Thailand;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Macedonia, the former Yugoslav Republic of;Malaysia;Peru;Australia;South Africa;Tunisia;Latvia;Guatemala;Korea, Democratic People's Republic of;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
614EUCTR2011-003814-18-ES
(EUCTR)
03/05/201229/02/2012A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC Systemic lupus erythematosis (SLE)
MedDRA version: 14.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Belimumab
INN or Proposed INN: Belimumab
Other descriptive name: Benlysta
Human Genome Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
816Phase 3Serbia;Portugal;United States;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden
615EUCTR2011-003814-18-DE
(EUCTR)
03/05/201216/12/2011A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC Systemic lupus erythematosis (SLE)
MedDRA version: 18.0;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Belimumab
INN or Proposed INN: Belimumab
Other descriptive name: Benlysta
Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)NULLNot RecruitingFemale: yes
Male: yes
816Phase 3Serbia;Portugal;United States;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Denmark;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden
616NCT01687309
(ClinicalTrials.gov)
April 30, 201210/5/2012A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Repeat Doses of GSK2586184 and the Effect of Food and GenderA Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK2586184 Following a Single Doseof 800mg and Repeat Oral Tablet Doses of 800mg b.d and the Effect of Food and Gender on the Pharmacokinetics of oralGSK2586184 in Healthy SubjectsSystemic Lupus ErythematosusDrug: GSK2586184 800mg single and repeat dose;Drug: Placebo-to-match GSK2586184;Other: GSK2586184 single dose taken with food;Other: GSK2586184 single dose taken without foodGlaxoSmithKlineNULLCompleted18 Years65 YearsAll19Phase 1Belgium
617NCT01559090
(ClinicalTrials.gov)
April 20, 201219/3/2012Safety and Tolerability of Intravenous Dose of MEDI-546 in Japanese Subjects With Systemic Lupus Erythematosus.A Phase 2, Multicenter, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of Intravenous Dose of MEDI-546, a Human Monoclonal Antibody Directed Against Type I Interferon Receptor (IFNAR), in Japanese Subjects With Active Systemic Lupus Erythematosus (SLE).Systemic Lupus ErythematosusDrug: MEDI-546AstraZenecaMedImmune LLCCompleted18 Years65 YearsAll17Phase 2Japan
618EUCTR2011-003814-18-GB
(EUCTR)
12/04/201219/04/2012A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC Systemic lupus erythematosis (SLE)
MedDRA version: 14.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Belimumab
INN or Proposed INN: Belimumab
Other descriptive name: Benlysta
Human Genome Sciences, Inc. (a wholy owned subsidiary of GlaxoSmithKline PLC)NULLNot Recruiting Female: yes
Male: yes
816 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United States;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden
619EUCTR2010-018563-41-EE
(EUCTR)
09/04/201209/03/2012Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1) - EMBODY 1 Systemic Lupus Erythmatosus
MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab
UCB Inc.NULLNot RecruitingFemale: yes
Male: yes
780Phase 3Estonia;Taiwan;Spain;Lithuania;Israel;Russian Federation;Italy;United Kingdom;India;Czech Republic;Mexico;Brazil;Belgium;Australia;Bulgaria;Germany;Korea, Republic of
620NCT01616472
(ClinicalTrials.gov)
April 20127/6/2012WEUKBRE5716: Steroid-related Damage in Systemic Lupus Erythematosus (Hopkins)WEUKBRE5716: Quantifying the Burden of Steroid-related Damage in Systemic Lupus Erythematosus in the Hopkins Lupus CohortSystemic Lupus ErythematosusDrug: Cumulative corticosteroid exposureGlaxoSmithKlineNULLCompletedN/AN/ABoth1N/ANULL
621EUCTR2011-003814-18-SE
(EUCTR)
28/03/201231/01/2012A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC Systemic lupus erythematosis (SLE)
MedDRA version: 14.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Belimumab
INN or Proposed INN: Belimumab
Other descriptive name: Benlysta
Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)NULLNot RecruitingFemale: yes
Male: yes
816Phase 3United States;Serbia;Portugal;Philippines;Taiwan;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden
622EUCTR2011-003814-18-CZ
(EUCTR)
27/03/201225/01/2012A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC Systemic lupus erythematosis (SLE)
MedDRA version: 14.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Belimumab
INN or Proposed INN: Belimumab
Other descriptive name: Benlysta
Human Genome Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
816Phase 3Serbia;Portugal;United States;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden
623EUCTR2010-018563-41-LT
(EUCTR)
14/03/201214/02/2012Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1) - EMBODY 1 Systemic Lupus Erythmatosus
MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab
UCB Inc.NULLNot RecruitingFemale: yes
Male: yes
780Phase 3Estonia;Taiwan;Spain;Lithuania;Israel;Russian Federation;Italy;United Kingdom;India;Czech Republic;Mexico;Brazil;Belgium;Australia;Bulgaria;Germany;Korea, Republic of
624EUCTR2011-003814-18-DK
(EUCTR)
08/03/201208/03/2012A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC Systemic lupus erythematosis (SLE)
MedDRA version: 14.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Belimumab
INN or Proposed INN: Belimumab
Other descriptive name: Benlysta
Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)NULLNot RecruitingFemale: yes
Male: yes
816Phase 3United States;Portugal;Serbia;Philippines;Taiwan;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden
625EUCTR2011-003814-18-HU
(EUCTR)
08/03/201218/01/2012A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC Systemic lupus erythematosis (SLE)
MedDRA version: 18.0;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Belimumab
INN or Proposed INN: Belimumab
Other descriptive name: Benlysta
Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)NULLNot RecruitingFemale: yes
Male: yes
816Phase 3Serbia;Portugal;United States;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Denmark;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden
626NCT01551069
(ClinicalTrials.gov)
March 20128/3/2012Multicenter Study Assessing the Efficacy & Safety of Hydroxychloroquine Sulfate in Patients With Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus With Active Lupus Erythematosus Specific Skin LesionA Randomized, Double Blind, Baseline Controlled Study Using Placebo as Reference for Assessing the Efficacy and Safety of Hydroxychloroquine Sulfate in Patients With Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus in the Presence of Active Lupus Erythematosus Specific Skin LesionCutaneous Lupus Erythematosus-Systemic Lupus ErythematosusDrug: hydroxychloroquine (Z0188);Drug: PlaceboSanofiNULLCompleted18 YearsN/ABoth103Phase 3Japan
627EUCTR2010-023396-25-NL
(EUCTR)
16/02/201224/10/2011A study to assess the safety and effectiveness of SL101 in the treatment of systemic lupus erythematosus (SLE)Phase IIa, 2:2:1 randomised, double-blind, placebo-controlled, parallel group, multi-centre clinical trial to investigate the safety, efficacy and pharmacokinetics of recombinant human soluble Fc-gamma receptor IIb (SM101) for intravenous application in the treatment of systemic lupus erythematosus (SLE) patients with or without a history of lupus nephritis - SMILE Systemic lupus erythematosus (SLE)
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: soluble Fc-gamma receptor IIb
Product Code: SM101
INN or Proposed INN: .
Other descriptive name: soluble Fc receptor
SuppreMol GmbHNULLNot RecruitingFemale: yes
Male: yes
50Phase 2France;Czech Republic;Belgium;Spain;Poland;Australia;Germany;Netherlands;Italy;United Kingdom
628EUCTR2011-000420-15-HU
(EUCTR)
08/02/201215/12/2011STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF 04236921 IN SUBJECTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04236921 IN SUBJECTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) - Butterfly SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)
MedDRA version: 15.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Not applicable
Product Code: PF-04236921
INN or Proposed INN: Not applicable
Pfizer Inc.235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
180United States;Taiwan;Lithuania;Chile;Israel;Colombia;India;Hungary;Mexico;Argentina;Poland;Romania;Peru;Germany;Moldova, Republic of;Korea, Republic of
629EUCTR2011-003814-18-AT
(EUCTR)
01/02/201223/01/2012A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC Systemic lupus erythematosis (SLE)
MedDRA version: 14.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Belimumab
INN or Proposed INN: Belimumab
Other descriptive name: Benlysta
Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)NULLNot RecruitingFemale: yes
Male: yes
816Phase 3United States;Portugal;Serbia;Philippines;Taiwan;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden
630NCT01440231
(ClinicalTrials.gov)
February 201222/9/2011Atacicept Demonstrating Dose RESponSeA Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Dose-Response Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: Placebo;Drug: AtaciceptEMD SeronoNULLWithdrawn18 YearsN/ABoth0Phase 2United States
631NCT02021513
(ClinicalTrials.gov)
January 201213/12/2013Pilot Study - Effect of Omega-3 on Systemic Lupus ErythematosusPilot Study - Effect of Omega-3 on Systemic Lupus ErythematosusSystemic Lupus ErythematosusDietary Supplement: Fish Oil;Dietary Supplement: Olive OilUniversity of Texas Southwestern Medical CenterNULLCompleted18 Years64 YearsBoth50Phase 2United States
632NCT01534403
(ClinicalTrials.gov)
January 201213/2/2012Open Label Extension Study of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE) SubjectsA Phase 2, Multicenter, Open-label, Long-term, Extension Study to Assess the Safety of Epratuzumab Treatment in Japanese Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusBiological: EpratuzumabUCB PharmaNULLCompleted18 Years65 YearsBoth17Phase 2Japan
633NCT01741857
(ClinicalTrials.gov)
January 201226/11/2012Umbilical Cord Derived Mesenchymal Stem Cells Transplantation for Active and Refractory Systemic Lupus ErythematosusPhase I/II: Umbilical Cord Derived Mesenchymal Stem Cells Transplantation For Active And Refractory Systemic Lupus ErythematosusSystemic Lupus ErythematosusBiological: human umbilical cord derived MSC transplantation for SLEThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolNULLRecruiting15 Years60 YearsBoth40Phase 1/Phase 2China
634NCT01488708
(ClinicalTrials.gov)
January 20126/12/2011On Open-Label Study in Participants With Systemic Lupus ErythematosusA Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Subcutaneous LY2127399 in Participants With Systemic Lupus Erythematosus (SLE) (Illuminate-X)Systemic Lupus Erythematosus;Connective Tissue Disease;Autoimmune DiseaseDrug: LY2127399;Drug: PlaceboEli Lilly and CompanyNULLTerminated18 YearsN/AAll1518Phase 3United States
635NCT01438489
(ClinicalTrials.gov)
January 20129/9/2011A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus ErythematosusA Phase 2, Randomized Study to Evaluate the Efficacy and Safety of MEDI-546 in Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusBiological: Anifrolumab 300 mg;Biological: Anifrolumab 1000 mg;Other: PlaceboMedImmune LLCNULLCompleted18 Years65 YearsAll626Phase 2United States;Brazil;Bulgaria;Colombia;Czech Republic;Hungary;India;Korea, Republic of;Mexico;Peru;Poland;Romania;Taiwan;Ukraine;Hong Kong
636NCT01516450
(ClinicalTrials.gov)
December 26, 201121/12/2011Japanese phase1 Study of Belimumab (IV vs SC)An Open Label, Randomized, Parallel, Single Dose Study to Investigate Safety and Pharmacokinetics Following Intravenous Administration and Subcutaneous Administration of GSK1550188 in Healthy Japanese MalesSystemic Lupus ErythematosusDrug: GSK1550188 IV;Drug: GSK1550188 SCGlaxoSmithKlineNULLCompleted20 Years55 YearsMale16Phase 1Japan
637EUCTR2010-024069-30-DE
(EUCTR)
21/12/201119/05/2011A study to investigate the optimum dose, the efficacy and the safety of sifalimumab in adult patients with Systemic Lupus Erythematosus, a disease of the immune systemA Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults with Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Sifalimumab
Product Code: MEDI-545
INN or Proposed INN: sifalimumab
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
400Phase 2United States;Philippines;Spain;Thailand;Chile;Italy;United Kingdom;India;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Peru;South Africa;Bulgaria;Netherlands;Germany
638NCT01405196
(ClinicalTrials.gov)
December 201127/7/2011Subcutaneous Treatment In Randomized Subjects To Evaluate Safety And Efficacy In Generalized Lupus ErythematosusA Double-blind, Randomized, Placebo-controlled, Multicenter Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-04236921 In Subjects With Systemic Lupus Erythematosus (Sle)Lupus Erythematosus, SystemicBiological: PF-04236921PfizerNULLCompleted18 Years75 YearsAll183Phase 2United States;Argentina;Chile;Colombia;Germany;Hungary;Korea, Republic of;Moldova, Republic of;Peru;Poland;Puerto Rico;Romania;Taiwan;Mexico
639NCT01541670
(ClinicalTrials.gov)
November 28, 201120/2/2012Safety Study of Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody in Lupus NephritisA Study to Assess the Safety and Tolerability of Anti-MIF Antibody in Subjects With Lupus NephritisSystemic Lupus ErythematosusDrug: Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) AntibodyBaxalta now part of ShireNULLTerminated18 YearsN/AAll4Phase 1United States;Australia;Canada;Mexico;New Zealand
640EUCTR2010-020859-30-BG
(EUCTR)
18/11/201118/07/2011Open-label study of long-term Epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)A phase 3, multicenter, open-label, extension study to assess the safety and tolerability of Epratuzumab treatment in systemic lupus erythematosus subjects (EMBODY 4) - EMBODY 4 Systemic Lupus Erythematosus
MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab
UCB Inc.NULLNot RecruitingFemale: yes
Male: yes
1250Phase 3United States;Estonia;Taiwan;Hong Kong;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Korea, Republic of;Korea, Democratic People's Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Bulgaria;Germany
641NCT01484496
(ClinicalTrials.gov)
November 16, 201128/11/2011A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE)A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects With Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusBiological: Placebo;Biological: Belimumab 200 mg SC;Drug: Standard therapyHuman Genome Sciences Inc., a GSK CompanyGlaxoSmithKlineCompleted18 YearsN/AAll839Phase 3United States;Argentina;Austria;Belgium;Brazil;Bulgaria;Chile;Colombia;Croatia;Czechia;Denmark;France;Germany;Hungary;Italy;Japan;Malaysia;Mexico;Philippines;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Spain;Sweden;Taiwan;Thailand;Ukraine;United Kingdom;Czech Republic
642EUCTR2010-023396-25-DE
(EUCTR)
09/11/201114/06/2011A study to assess the safety and effectiveness of SL101 in the treatment of systemic lupus erythematosus (SLE)Phase IIa, 2:2:1 randomised, double-blind, placebo-controlled,parallel group, multi-centre clinical trial toinvestigate the safety, efficacy and pharmacokinetics ofrecombinant human soluble Fc-gamma receptor IIb(SM101) for intravenous application in the treatment ofsystemic lupus erythematosus (SLE) patients with orwithout a history of lupus nephritis - SMILE Systemic lupus erythematosus (SLE)
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: soluble Fc-gamma receptor IIb
Product Code: SM101
INN or Proposed INN: .
Other descriptive name: soluble Fc receptor
SuppreMol GmbHNULLNot RecruitingFemale: yes
Male: yes
50Phase 2France;Czech Republic;Belgium;Spain;Poland;Australia;Netherlands;Germany;Italy;United Kingdom
643NCT01474720
(ClinicalTrials.gov)
November 201115/11/2011Zostavax in Systemic Lupus ErythematosusImmunologic Response to Varicella Zoster Vaccination With Zostavax in Patients With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: Zostavax vaccineOklahoma Medical Research FoundationNULLCompleted50 Years75 YearsBoth20Phase 1United States
644EUCTR2010-023396-25-CZ
(EUCTR)
13/10/201101/08/2011A study to assess the safety and effectiveness of SL101 in the treatment of systemic lupus erythematosus (SLE)Phase IIa, 2:2:1 randomised, double-blind, placebo-controlled,parallel group, multi-centre clinical trial toinvestigate the safety, efficacy and pharmacokinetics ofrecombinant human soluble Fc-gamma receptor IIb(SM101) for intravenous application in the treatment ofsystemic lupus erythematosus (SLE) patients with orwithout a history of lupus nephritis - SMILE Systemic lupus erythematosus (SLE)
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: soluble Fc-gamma receptor IIb
Product Code: SM101
INN or Proposed INN: .
Other descriptive name: soluble Fc receptor
SuppreMol GmbHNULLNot RecruitingFemale: yes
Male: yes
50Phase 2France;Czech Republic;Belgium;Spain;Poland;Australia;Netherlands;Germany;Italy;United Kingdom
645EUCTR2010-020859-30-LT
(EUCTR)
10/10/201111/08/2011Open-label study of long-term Epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)A phase 3, multicenter, open-label, extension study to assess the safety and tolerability of Epratuzumab treatment in systemic lupus erythematosus subjects (EMBODY 4) - EMBODY 4 Systemic Lupus Erythematosus
MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab
UCB Inc.NULLNot RecruitingFemale: yes
Male: yes
1250Phase 3United States;Taiwan;Estonia;Hong Kong;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Korea, Democratic People's Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Bulgaria;Germany
646NCT01359826
(ClinicalTrials.gov)
October 201119/4/2011The Effect of Milnacipran on Fatigue and Quality of Life in Lupus PatientsThe Effect of Milnacipran on Fatigue and Quality of Life in a Lupus CohortSystemic Lupus Erythematosus;Widespread Pain;FibromyalgiaDrug: MilnacipranLoma Linda UniversityForest LaboratoriesWithdrawn18 YearsN/ABoth0Phase 4United States
647NCT01449071
(ClinicalTrials.gov)
October 20113/10/2011Study Evaluating the Pharmacokinetics and Safety of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE)A Phase1/2, Randomized, Parallel-group, Double-Blind, Placebo-Controlled, Multicenter Study of the Safety and Pharmacokinetics of One 12 Week Treatment Cycle of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE) Subjects With Moderate to Severe DiseaseSystemic Lupus ErythematosusBiological: Placebo;Biological: Epratuzumab 400 mg;Biological: Epratuzumab 1200 mg;Biological: Epratuzumab 100 mg;Biological: Epratuzumab 600 mgUCB PharmaNULLCompleted18 Years64 YearsBoth20Phase 1/Phase 2Japan
648EUCTR2010-023396-25-GB
(EUCTR)
22/09/201111/04/2011A study to assess the safety and effectiveness of SL101 in the treatment of systemic lupus erythematosus (SLE)Phase IIa, 2:2:1 randomised, double-blind, placebo-controlled,parallel group, multi-centre clinical trial toinvestigate the safety, efficacy and pharmacokinetics ofrecombinant human soluble Fc-gamma receptor IIb(SM101) for intravenous application in the treatment ofsystemic lupus erythematosus (SLE) patients with orwithout a history of lupus nephritis - SMILE Systemic lupus erythematosus (SLE)
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: soluble Fc-gamma receptor IIb
Product Code: SM101
INN or Proposed INN: .
Other descriptive name: soluble Fc receptor
SuppreMol GmbHNULLNot RecruitingFemale: yes
Male: yes
50Phase 2France;Czech Republic;Belgium;Spain;Poland;Australia;Netherlands;Germany;Italy;United Kingdom
649EUCTR2010-023396-25-ES
(EUCTR)
20/09/201111/11/2011A study to assess the safety and effectiveness of SL101 in the treatment of systemic lupus erythematosus (SLE)Ensayo clínico multicéntrico, de grupos paralelos, controlado por placebo, doble ciego, randomizado 2:2:1, de fase IIa, para investigar la seguridad, eficacia y farmacocinética del receptor Fc-gamma IIb recombinante, humano, soluble (SM101) para su aplicación intravenosa en el tratamiento de pacientes con lupus eritematoso sistémico (LES) con o sin un historial de nefritis lúpica - SMILE lupus eritematoso sistémico (LES)
MedDRA version: 14.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: soluble Fc-gamma receptor IIb
Product Code: SM101
Other descriptive name: soluble Fc receptor
SuppreMol GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Czech Republic;United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Poland;Australia
650EUCTR2010-018565-26-IT
(EUCTR)
15/09/201105/01/2012Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF FOUR 12-WEEK TREATMENT CYCLES (48 WEEKS TOTAL) OF EPRATUZUMAB IN SYSTEMIC LUPUS ERYTHEMATOSUS SUBJECTS WITH MODERATE TO SEVERE DISEASE (EMBODY 2) - EMBODY 2 Systemic Lupus Erythmatosus
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: EPRATUZUMAB
UCB Inc.NULLNot RecruitingFemale: yes
Male: yes
780Phase 3Hungary;Mexico;Canada;Spain;Brazil;Ukraine;South Africa;Russian Federation;Germany;United Kingdom;Italy;India
651EUCTR2010-018563-41-BG
(EUCTR)
02/09/201125/07/2011Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1) - EMBODY 1 Systemic Lupus Erythmatosus
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab
UCB Inc.NULLNot RecruitingFemale: yes
Male: yes
780Phase 3Estonia;Taiwan;Spain;Lithuania;Russian Federation;Israel;Italy;United Kingdom;India;Czech Republic;Mexico;Brazil;Belgium;Australia;Bulgaria;Germany;Korea, Republic of
652EUCTR2010-020859-30-DE
(EUCTR)
31/08/201124/01/2011Open-label study of long-term Epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)A phase 3, multicenter, open-label, extension study to assess the safety and tolerability of Epratuzumab treatment in systemic lupus erythematosus subjects (EMBODY 4) - EMBODY 4 Systemic Lupus Erythematosus
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab
UCB Inc.NULLNot RecruitingFemale: yes
Male: yes
1400Phase 3United States;Estonia;Taiwan;Hong Kong;Spain;Ukraine;Lithuania;Russian Federation;Israel;Italy;United Kingdom;India;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Australia;Bulgaria;South Africa;Germany;Korea, Republic of
653EUCTR2010-024069-30-NL
(EUCTR)
05/08/201104/05/2011A study to investigate the optimum dose, the efficacy and the safety of sifalimumab in adult patients with Systemic Lupus Erythematosus, a disease of the immune systemA Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults with Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 14.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Sifalimumab
Product Code: MEDI-545
INN or Proposed INN: sifalimumab
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
544Phase 2United States;Philippines;Thailand;Spain;Chile;United Kingdom;Italy;India;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Peru;Bulgaria;South Africa;Netherlands;Germany
654EUCTR2010-023396-25-BE
(EUCTR)
13/07/201120/04/2011A study to assess the safety and effectiveness of SL101 in the treatment of systemic lupus erythematosus (SLE)Phase IIa, 2:2:1 randomised, double-blind, placebo-controlled,parallel group, multi-centre clinical trial toinvestigate the safety, efficacy and pharmacokinetics ofrecombinant human soluble Fc-gamma receptor IIb(SM101) for intravenous application in the treatment ofsystemic lupus erythematosus (SLE) patients with orwithout a history of lupus nephritis - SMILE Systemic lupus erythematosus (SLE)
MedDRA version: 13.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: soluble Fc-gamma receptor IIb
Product Code: SM101
Other descriptive name: soluble Fc receptor
SuppreMol GmbHNULLNot RecruitingFemale: yes
Male: yes
50Phase 2France;Czech Republic;Spain;Poland;Belgium;Australia;Netherlands;Germany;Italy;United Kingdom
655EUCTR2010-024069-30-IT
(EUCTR)
05/07/201119/01/2012A study to investigate the optimum dose, the efficacy and the safety of sifalimumab in adult patients with Systemic Lupus Erythematosus, a disease of the immune systemA Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults with Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Sifalimumab
Product Code: MEDI-545
INN or Proposed INN: sifalimumab
ASTRAZENECANULLNot RecruitingFemale: yes
Male: yes
544Phase 2United States;Philippines;Spain;Thailand;Chile;United Kingdom;Italy;India;Hungary;Mexico;Canada;Argentina;Brazil;Peru;Bulgaria;South Africa;Germany;Netherlands
656EUCTR2010-022099-29-DE
(EUCTR)
04/07/201114/12/2010Study investigating a new medicine, LY2127399, in patients diagnosed with Systemic Lupus Erythematosus (SLE).A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-1) - ILLUMINATE-1 Systemic Lupus Erythematosus (SLE)
MedDRA version: 16.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: LY2127399
Product Code: LY2127399
Other descriptive name: LA294; Anti LP40 antibody, subclass IgG4
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1140Phase 3United States;Belarus;Philippines;Thailand;Ukraine;Guatemala;Turkey;Austria;Chile;Colombia;Italy;Egypt;Canada;Macedonia, the former Yugoslav Republic of;Argentina;Poland;Singapore;Croatia;Peru;Bulgaria;Germany;Japan;Korea, Republic of
657NCT01408576
(ClinicalTrials.gov)
July 20111/8/2011Open Label Extension Study of Epratuzumab in Subjects With Systemic Lupus ErythematosusA Phase 3, Multicenter, Open-label, Extension Study to Assess the Safety and Tolerability of Epratuzumab Treatment in Systemic Lupus Erythematosus SubjectsSystemic Lupus ErythematosusDrug: EpratuzumabUCB PharmaNULLCompleted18 YearsN/AAll1250Phase 3United States;Australia;Belgium;Brazil;Bulgaria;Canada;Czechia;Estonia;France;Germany;Hong Kong;Hungary;Israel;Italy;Korea, Republic of;Lithuania;Mexico;Poland;Romania;Russian Federation;South Africa;Spain;Taiwan;Ukraine;United Kingdom;Czech Republic
658EUCTR2010-018563-41-IT
(EUCTR)
23/06/201120/03/2012Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF FOUR 12-WEEK TREATMENT CYCLES (48 WEEKS TOTAL) OF EPRATUZUMAB IN SYSTEMIC LUPUS ERYTHEMATOSUS SUBJECTS WITH MODERATE TO SEVERE DISEASE (EMBODY 1) - EMBODY 1 Systemic Lupus Erythmatosus
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: EPRATUZUMAB
UCB Inc.NULLNot RecruitingFemale: yes
Male: yes
780Phase 3Estonia;Taiwan;Spain;Lithuania;Russian Federation;Israel;United Kingdom;Italy;India;Czech Republic;Mexico;Brazil;Belgium;Australia;Bulgaria;Germany;Korea, Republic of
659EUCTR2010-018563-41-DE
(EUCTR)
21/06/201121/01/2011Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1) - EMBODY 1 Systemic Lupus Erythmatosus
MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab
UCB Inc.NULLNot RecruitingFemale: yes
Male: yes
780Phase 3Estonia;Taiwan;Spain;Lithuania;Israel;Russian Federation;Italy;United Kingdom;India;Czech Republic;Mexico;Brazil;Belgium;Australia;Bulgaria;Germany;Korea, Republic of
660EUCTR2010-018565-26-DE
(EUCTR)
21/06/201121/01/2011Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 2) - EMBODY 2 Systemic Lupus Erythmatosus
MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab
UCB Inc.NULLNot RecruitingFemale: yes
Male: yes
780Phase 3Hungary;Mexico;Canada;Spain;Brazil;Ukraine;Russian Federation;South Africa;Germany;Italy;United Kingdom;India
661EUCTR2010-022099-29-BG
(EUCTR)
16/06/201124/02/2011Study investigating a new medicine, LY2127399, in patients diagnosed with Systemic Lupus Erythematosus (SLE).A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-1) - ILLUMINATE-1 Systemic Lupus Erythematosus (SLE)
MedDRA version: 17.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: LY2127399
Product Code: LY2127399
Other descriptive name: LA294; Anti LP40 antibody, subclass IgG4
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1140Phase 3United States;Belarus;Philippines;Thailand;Guatemala;Ukraine;Turkey;Austria;Chile;Colombia;Italy;Egypt;Macedonia, the former Yugoslav Republic of;Canada;Argentina;Poland;Singapore;Croatia;Peru;Bulgaria;Germany;Japan;Korea, Republic of
662EUCTR2010-022099-29-IT
(EUCTR)
01/06/201107/02/2011A Phase 3, Multicenter, Randomized, Double-Blind,Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) - NDA Phase 3, Multicenter, Randomized, Double-Blind,Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) - ND Systemic Lupus Erythematosus (SLE)
MedDRA version: 9.1;Level: PT;Classification code 10042945
Product Name: LY2127399
Product Code: LY2127399
ELI LILLYNULLNot RecruitingFemale: yes
Male: yes
1140Phase 3Austria;Bulgaria;Germany;Italy
663NCT01911169
(ClinicalTrials.gov)
June 201122/7/2013Vitamin D to Improve Endothelial Function in SLEVitamin D Repletion to Improve Endothelial Function in Lupus PatientsAtherosclerosis;Systemic Lupus ErythematosusDrug: CholecalciferolMedical University of South CarolinaNULLCompleted18 Years80 YearsAll9Phase 2United States
664EUCTR2010-018563-41-BE
(EUCTR)
25/05/201119/11/2010Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1) - EMBODY 1 Systemic Lupus Erythmatosus
MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab
UCB Inc.NULLNot RecruitingFemale: yes
Male: yes
780Phase 3Estonia;Taiwan;Spain;Lithuania;Israel;Russian Federation;Italy;United Kingdom;India;Czech Republic;Mexico;Belgium;Brazil;Australia;Bulgaria;Germany;Korea, Republic of
665EUCTR2010-020859-30-BE
(EUCTR)
25/05/201119/11/2010Open-label study of long-term Epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)A phase 3, multicenter, open-label, extension study to asssess the safety and tolerability of Epratuzumab treatment in systemic lupus erythematosus subjects (EMBODY 4) - EMBODY 4 Systemic Lupus Erythematosus
MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab
UCB Inc.NULLNot RecruitingFemale: yes
Male: yes
1250Phase 3United States;Estonia;Taiwan;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Australia;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Bulgaria;Germany
666NCT01345253
(ClinicalTrials.gov)
May 23, 201128/4/2011GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast AsiaGSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast AsiaSystemic Lupus ErythematosusDrug: Belimumab;Drug: PlaceboGlaxoSmithKlineHuman Genome Sciences Inc.Completed18 YearsN/AAll709Phase 3China;Japan;Korea, Republic of
667EUCTR2010-024069-30-ES
(EUCTR)
19/05/201119/05/2011A study to investigate the optimum dose, the efficacy and the safety of sifalimumab in adult patients with Systemic Lupus Erythematosus, a disease of the immune systemA Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults with Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 13.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Sifalimumab
Product Code: MEDI-545
INN or Proposed INN: sifalimumab
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
544Phase 2United States;Philippines;Spain;Thailand;Chile;Italy;United Kingdom;India;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Peru;Bulgaria;South Africa;Germany;Netherlands
668EUCTR2010-024069-30-GB
(EUCTR)
18/05/201113/05/2011A study to investigate the optimum dose, the efficacy and the safety of sifalimumab in adult patients with Systemic Lupus Erythematosus, a disease of the immune systemA Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults with Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Sifalimumab
Product Code: MEDI-545
INN or Proposed INN: sifalimumab
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
400Phase 2Romania;Peru;Bulgaria;South Africa;Netherlands;Germany;Brazil;United States;Philippines;Spain;Thailand;Chile;Italy;United Kingdom;India;France;Hungary;Mexico;Canada;Argentina;Poland
669EUCTR2010-020859-30-GB
(EUCTR)
17/05/201109/02/2011Open-label study of long-term Epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)A phase 3, multicenter, open-label, extension study to asssess the safety and tolerability of Epratuzumab treatment in systemic lupus erythematosus subjects (EMBODY 4) - EMBODY 4 Systemic Lupus Erythematosus
MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab
UCB Inc.NULLNot Recruiting Female: yes
Male: yes
1250 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Estonia;Taiwan;Hong Kong;Spain;Ukraine;Russian Federation;Israel;Italy;India;France;Australia;South Africa;Korea, Republic of;Korea, Democratic People's Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Bulgaria;Germany
670EUCTR2010-018565-26-GB
(EUCTR)
13/05/201109/02/2011 Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 2) - EMBODY 2 Systemic Lupus Erythmatosus
MedDRA version: 16.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab
UCB Inc.NULLNot Recruiting Female: yes
Male: yes
780 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noHungary;Mexico;Canada;Spain;Brazil;Ukraine;South Africa;Russian Federation;Germany;Italy;United Kingdom;India
671EUCTR2010-018563-41-GB
(EUCTR)
13/05/201109/02/2011 Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1) - EMBODY 1 Systemic Lupus Erythmatosus
MedDRA version: 16.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab
UCB Inc.NULLNot Recruiting Female: yes
Male: yes
780 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noEstonia;Taiwan;Spain;Lithuania;Israel;Russian Federation;Italy;United Kingdom;India;Czech Republic;Mexico;Brazil;Belgium;Australia;Bulgaria;Germany;Korea, Republic of
672EUCTR2010-019293-32-BE
(EUCTR)
10/05/201119/07/2010A clinical study to evaluate the tolerability of repeated doses of CEP-33457 administered in patients with a chronic autoimmune disease (Lupus)An Open-Label Long-Term Study of the Safety and Tolerability of Repeated administration of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 75 Patients With Systemic Lupus Erythematosus (SLE)
MedDRA version: 14.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Lupuzor
Product Code: CEP-33457
INN or Proposed INN: Forigerimod
Other descriptive name: IPP-201101, P140
Cephalon, Inc.NULLNot RecruitingFemale: yes
Male: yes
130Phase 3United States;Portugal;Hungary;Czech Republic;Spain;Poland;Belgium;Ukraine;Germany
673EUCTR2010-024131-16-DE
(EUCTR)
06/05/201104/02/2011Efficacy and Safety of oral Alitretinoin (Toctino®) in the Treatment of Patients with Cutaneous LupusErythematosus: A Multicentre, Open-Label, Prospective Pilot StudyEfficacy and Safety of oral Alitretinoin (Toctino®) in the Treatment of Patients with Cutaneous LupusErythematosus: A Multicentre, Open-Label, Prospective Pilot Study - AliCLE ?dult subjects of any ethnicity and either gender with Subacute Cutaneous Lupus Erythematosus (SCLE), Discoid Lupus Erythematosus (DLE), Lupus erythematosus tumidus (LET) or Systemic Lupus Erythematosus (SLE) with DLE or SCLE lesions and without major organ involvement to investigate the efficacy of alitretinoin (30 mg per day) in the treatment of Cutaneous Lupus Erythematosus lesions.
MedDRA version: 16.0;Level: PT;Classification code 10056509;Term: Cutaneous lupus erythematosus;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Toctino®
INN or Proposed INN: ALITRETINOIN
Universitätsklinikum MünsterNULLNot RecruitingFemale: yes
Male: yes
33Germany
674NCT01858792
(ClinicalTrials.gov)
May 201119/12/2012A Pooled Analysis of the HGS1006-C1056 (BLISS-52) and HGS1006-C1057 (BLISS-76) StudiesEfficacy and Safety of Belimumab in a Subgroup of Systemic Lupus Erythematosus (SLE) Patients With Higher Disease Activity (Anti-dsDNA Positive and Low Complement): A Pooled Analysis of the HGS1006-C1056 (BLISS-52) and HGS1006-C1057 (BLISS-76) StudiesLupus Erythematosus, DiscoidDrug: Belimumab 1 mg/kg;Drug: Belimumab 10 mg/kg;Other: PlaceboHuman Genome Sciences Inc., a GSK CompanyGlaxoSmithKlineCompleted18 YearsN/ABoth1N/ANULL
675EUCTR2010-022100-42-GB
(EUCTR)
28/04/201119/01/2011Not availableA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-2) - (ILLUMINATE-2) Systemic Lupus Erythematosus (SLE)
MedDRA version: 16.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: LY2127399
Product Code: LY2127399
Other descriptive name: LA294; Anti LP40 antibody, subclass IgG4
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1140Phase 3United States;Serbia;Taiwan;Ecuador;Spain;Russian Federation;Israel;United Kingdom;India;France;Hungary;Mexico;Canada;Brazil;Malaysia;Romania;Australia;South Africa;Tunisia;Latvia;New Zealand
676EUCTR2010-022100-42-ES
(EUCTR)
20/04/201115/02/2011Estudio de Fase 3, multicéntrico, aleatorizado, doble ciego y controlado con placebo, para evaluar la eficacia y la seguridad de LY2127399 subcutáneo en pacientes con lupus sistémico eritematoso (LSE)//A Phase 3, Multicenter, Randomized, Double-Blind,Placebo-Controlled Study to Evaluate the Efficacy andSafety of Subcutaneous LY2127399 in Patients withSystemic Lupus Erythematosus (SLE)Estudio de Fase 3, multicéntrico, aleatorizado, doble ciego y controlado con placebo, para evaluar la eficacia y la seguridad de LY2127399 subcutáneo en pacientes con lupus sistémico eritematoso (LSE)//A Phase 3, Multicenter, Randomized, Double-Blind,Placebo-Controlled Study to Evaluate the Efficacy andSafety of Subcutaneous LY2127399 in Patients withSystemic Lupus Erythematosus (SLE) Lupus Eritematoso Sistémico (LES) //Systemic Lupus Erythematosus (SLE)
MedDRA version: 12.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic
Product Name: LY2127399
Product Code: LY2127399
Other descriptive name: Anti LP40 anticuerpo, subclase IgG4
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1140Phase 3Hungary;Spain;Latvia;United Kingdom
677NCT02799173
(ClinicalTrials.gov)
April 15, 201110/6/2016Determination of the RANKL/Osteoprotegerin Ratio in Patients With Systemic Lupus Erythematosus. Role in Osteoporosis and Cardiovascular CalcificationDetermination of the RANKL/Osteoprotegerin Ratio in Patients With Systemic Lupus Erythematosus. Role in Osteoporosis and Cardiovascular CalcificationOsteoporosis;Lupus Erythematosus, SystemicBiological: RANKL/OPG ratio;Device: bone densitometry;Device: fan beam CT scan;Device: Doppler ultrasoundCentre Hospitalier Universitaire, AmiensNULLCompleted18 Years99 YearsFemale74N/AFrance
678EUCTR2010-022100-42-LV
(EUCTR)
08/04/201113/01/2011A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-2) - ILLUMINATE-2A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-2) - ILLUMINATE-2 Systemic Lupus Erythematosus (SLE)
MedDRA version: 16.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: LY2127399
Product Code: LY2127399
Other descriptive name: LA294; Anti LP40 antibody, subclass IgG4
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1140Phase 3Serbia;United States;Taiwan;Ecuador;Spain;Israel;Russian Federation;United Kingdom;India;France;Hungary;Mexico;Canada;Malaysia;Brazil;Romania;Australia;South Africa;Latvia;Tunisia;New Zealand
679NCT01305746
(ClinicalTrials.gov)
April 201125/2/2011A Trial for Subjects With Systemic Lupus Erythematosus Who Have Completed Protocol AN-SLE3321An Open-Label Long-term Safety Extension Trial for Subjects With Systemic Lupus Erythematosus Who Have Completed Protocol AN-SLE3321 (PEARL-SC)Systemic Lupus ErythematosusDrug: A-623Anthera PharmaceuticalsNULLCompleted18 YearsN/ABoth382Phase 2United States;Argentina;Brazil;Chile;Colombia;Hong Kong;India;Mexico;Peru;Philippines;Taiwan
680NCT01283139
(ClinicalTrials.gov)
March 31, 201120/1/2011A Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus ErythematosusA Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus ErythematosusSystemic Lupus ErythematosusBiological: Sifalimumab 200 mg;Biological: Sifalimumab 600 mg;Biological: Sifalimumab 1,200 mg;Other: PlaceboMedImmune LLCNULLCompleted18 Years75 YearsAll834Phase 2United States;Argentina;Brazil;Bulgaria;Canada;Chile;France;Germany;Hungary;India;Italy;Jamaica;Mexico;Netherlands;Peru;Philippines;Poland;Romania;South Africa;Spain;Thailand;United Kingdom
681EUCTR2010-023645-29-DE
(EUCTR)
15/03/201111/01/2011Efficacy and safety of fumaric acid esters in the treatment of patients with cutaneous lupus erythematosus: A monocentre, open-label, prospective pilot study - FumaCLEEfficacy and safety of fumaric acid esters in the treatment of patients with cutaneous lupus erythematosus: A monocentre, open-label, prospective pilot study - FumaCLE Adult subjects of any ethnicity and either gender with Cutaneous Lupus Erythematosus lesions of Subacute Cutaneous Lupus Erythematosus (SCLE), Discoid Lupus Erythematosus (DLE), Lupus erythematosus tumidus (LET) or Systemic Lupus Erythematosus (SLE) with DLE or SCLE lesions and without major organ involvement to investigate the efficacy of fumaric acid esters in the treatment of Cutaneous Lupus Erythematosus lesions.
MedDRA version: 12.1;Level: LLT;Classification code 10056509;Term: Cutaneous lupus erythematosus
MedDRA version: 12.1;Level: PT;Term: Cutaneous lupus erythematosus
Trade Name: Fumaderm® initial
Product Name: -
Product Code: -
INN or Proposed INN: Dimethylfumarat
INN or Proposed INN: Ethylhydrogenfumarat, Calciumsalz
INN or Proposed INN: Ethylhydrogenfumarat, Magnesiumsalz
INN or Proposed INN: Ethylhydrogenfumarat, Zinksalz
Trade Name: Fumaderm®
Product Name: -
Product Code: -
INN or Proposed INN: Dimethylfumarat
INN or Proposed INN: Ethylhydrogenfumarat, Calciumsalz
INN or Proposed INN: Ethylhydrogenfumarat, Magnesiumsalz
INN or Proposed INN: Ethylhydrogenfumarat, Zinksalz
Universitätsklinikum MünsterNULLNot RecruitingFemale: yes
Male: yes
11Germany
682NCT03979976
(ClinicalTrials.gov)
March 201118/9/2013Ramipril, Endothelial Function and Endothelial Progenitor Cells in Patients With Systemic Lupus ErythematosusRamipril Improves Endothelial Function and Endothelial Progenitor Cells in Patients With Systemic Lupus Erythematosus: a Randomized and Controlled Study.Systemic Lupus ErythematosusDrug: RamiprilFederal University of São PauloFundação de Amparo à Pesquisa do Estado de São PauloCompleted18 YearsN/AFemale37Phase 2/Phase 3Brazil
683EUCTR2010-018563-41-CZ
(EUCTR)
25/02/201126/01/2011Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1) - EMBODY 1 Systemic Lupus Erythmatosus
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab
UCB Inc.NULLNot RecruitingFemale: yes
Male: yes
780Phase 3Estonia;Taiwan;Spain;Lithuania;Israel;Russian Federation;Italy;United Kingdom;India;Czech Republic;Mexico;Brazil;Belgium;Australia;Bulgaria;Germany;Korea, Republic of
684EUCTR2010-020859-30-CZ
(EUCTR)
25/02/201126/01/2011Open-label study of long-term Epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)A phase 3, multicenter, open-label, extension study to assess the safety and tolerability of Epratuzumab treatment in systemic lupus erythematosus subjects (EMBODY 4) - EMBODY 4 Systemic Lupus Erythematosus
MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab
UCB Inc.NULLNot RecruitingFemale: yes
Male: yes
1400Phase 3United States;Estonia;Taiwan;Hong Kong;Spain;Ukraine;Lithuania;Russian Federation;Israel;Italy;United Kingdom;India;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Australia;Bulgaria;South Africa;Germany;Korea, Republic of
685EUCTR2010-022100-42-HU
(EUCTR)
23/02/201113/01/2011A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-2) - ILLUMINATE-2A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-2) - ILLUMINATE-2 Systemic Lupus Erythematosus (SLE)
MedDRA version: 14.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: LY2127399
Product Code: LY2127399
Other descriptive name: LA294; Anti LP40 antibody, subclass IgG4
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1140Phase 3Serbia;United States;Taiwan;Ecuador;Spain;Israel;Russian Federation;United Kingdom;India;France;Hungary;Mexico;Canada;Malaysia;Brazil;Romania;Australia;South Africa;Latvia;Tunisia;New Zealand
686EUCTR2010-020859-30-ES
(EUCTR)
22/02/201122/12/2010ESTUDIO EN FASE 3, MULTICÉNTRICO, ABIERTO Y DEEXTENSIÓN, PARA EVALUAR LA EFICACIA Y LATOLERABILIDAD DEL TRATAMIENTO CONEPRATUZUMAB EN PACIENTES CON LUPUSERITEMATOSO SISTÉMICO (EMBODY 4) - EMBODY 4ESTUDIO EN FASE 3, MULTICÉNTRICO, ABIERTO Y DEEXTENSIÓN, PARA EVALUAR LA EFICACIA Y LATOLERABILIDAD DEL TRATAMIENTO CONEPRATUZUMAB EN PACIENTES CON LUPUSERITEMATOSO SISTÉMICO (EMBODY 4) - EMBODY 4 Lupus eritematoso sistémico
MedDRA version: 12.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab
UCB Inc.NULLNot RecruitingFemale: yes
Male: yes
1250Estonia;Hungary;Czech Republic;Belgium;Spain;Lithuania;Bulgaria;Germany;Italy;United Kingdom
687EUCTR2010-018565-26-ES
(EUCTR)
22/02/201123/12/2010Estudio en fase III, aleatorizado, doble ciego, controlado con placebo y multicéntrico sobre la eficacia y la seguridad de cuatro ciclos de tratamiento de 12 semanas (48 semanas) con epratuzumab en pacientes con lupus eritematoso sistémico moderado a intenso (EMBODY2). - EMBODY 2Estudio en fase III, aleatorizado, doble ciego, controlado con placebo y multicéntrico sobre la eficacia y la seguridad de cuatro ciclos de tratamiento de 12 semanas (48 semanas) con epratuzumab en pacientes con lupus eritematoso sistémico moderado a intenso (EMBODY2). - EMBODY 2 Lupus Sistémico Eritematoso
MedDRA version: 12.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab
UCB Inc.NULLNot RecruitingFemale: yes
Male: yes
780Hungary;Spain;Germany;Italy;United Kingdom
688EUCTR2010-018563-41-ES
(EUCTR)
21/02/201122/12/2010Estudio en fase 3, aleatorizado, doble ciego, controlado con placebo y multicéntrico sobre la eficacia y la seguridad de cuatro ciclos de tratamiento de 12 semanas (48 semanas) con epratuzumab en pacientes con lupus eritematoso sistémico moderado a intenso (EMBODY 1). //A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1). - EMBODY 1Estudio en fase 3, aleatorizado, doble ciego, controlado con placebo y multicéntrico sobre la eficacia y la seguridad de cuatro ciclos de tratamiento de 12 semanas (48 semanas) con epratuzumab en pacientes con lupus eritematoso sistémico moderado a intenso (EMBODY 1). //A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1). - EMBODY 1 Lupus eritematoso sistémico
MedDRA version: 12.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab
UCB Inc.NULLNot RecruitingFemale: yes
Male: yes
780Phase 3Estonia;Czech Republic;Belgium;Spain;Lithuania;Bulgaria;Germany;Italy;United Kingdom
689EUCTR2010-019293-32-DE
(EUCTR)
10/02/201116/07/2010A clinical study to evaluate the tolerability of repeated doses of CEP-33457 administered in patients with a chronic autoimmune disease (Lupus)An Open-Label Long-Term Study of the Safety and Tolerability of Repeated administration of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 75 Patients With Systemic Lupus Erythematosus (SLE)
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Lupuzor
Product Code: CEP-33457
INN or Proposed INN: Forigerimod
Other descriptive name: IPP-201101, P140
Cephalon, Inc.NULLNot RecruitingFemale: yes
Male: yes
130United States;Portugal;Hungary;Czech Republic;Spain;Poland;Belgium;Ukraine;Germany
690EUCTR2010-020859-30-HU
(EUCTR)
08/02/201110/02/2011Open-label study of long-term Epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)A phase 3, multicenter, open-label, extension study to assess the safety and tolerability of Epratuzumab treatment in systemic lupus erythematosus subjects (EMBODY 4) - EMBODY 4 Systemic Lupus Erythematosus
MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab
UCB Inc.NULLNot RecruitingFemale: yes
Male: yes
1250Phase 3United States;Estonia;Taiwan;Hong Kong;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Australia;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Bulgaria;Germany
691EUCTR2010-022099-29-AT
(EUCTR)
27/01/201128/12/2010Study investigating a new medicine, LY2127399, in patients diagnosedwith Systemic Lupus Erythematosus (SLE).A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-1) - ILLUMINATE-1 Systemic Lupus Erythematosus (SLE)
MedDRA version: 17.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: LY2127399
Product Code: LY2127399
Other descriptive name: LA294; Anti LP40 antibody, subclass IgG4
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1140Phase 3United States;Belarus;Philippines;Thailand;Ukraine;Guatemala;Turkey;Austria;Chile;Colombia;Italy;Egypt;Macedonia, the former Yugoslav Republic of;Canada;Argentina;Poland;Singapore;Croatia;Peru;Bulgaria;Germany;Japan;Korea, Republic of
692EUCTR2010-018565-26-HU
(EUCTR)
16/01/201122/11/2010Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 2) - EMBODY 2 Systemic Lupus Erythmatosus
MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab
UCB Inc.NULLNot RecruitingFemale: yes
Male: yes
780Phase 3Hungary;Mexico;Canada;Spain;Brazil;Ukraine;Russian Federation;South Africa;Germany;Italy;United Kingdom;India
693NCT01276782
(ClinicalTrials.gov)
January 201112/1/2011Levothyroxine in Pregnant SLE PatientsPilot Double-Blind Placebo Controlled Trial of Levothyroxine in Pregnant Systemic Lupus Erythematosus (SLE) Patients With Autoimmune Thyroid DiseaseSystemic Lupus ErythematosusDrug: LevothyroxineJohns Hopkins UniversityNew York University School of Medicine;Duke University;University of Chicago;Stanford UniversityWithdrawn18 Years45 YearsFemale0Phase 4United States
694NCT01205438
(ClinicalTrials.gov)
January 201117/9/2010A Study of LY2127399 in Participants With Systemic Lupus ErythematosusA Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients With Systemic Lupus Erythematosus (SLE)Systemic Lupus Erythematosus;Connective Tissue Disease;Autoimmune DiseaseDrug: LY2127399;Drug: Placebo every 2 weeks;Drug: Placebo every 4 weeksEli Lilly and CompanyNULLCompleted18 YearsN/AAll1124Phase 3United States;Australia;Brazil;Canada;Ecuador;France;Hungary;India;Israel;Latvia;Malaysia;Mexico;New Zealand;Romania;Russian Federation;Serbia;South Africa;Spain;Taiwan;Tunisia;United Kingdom
695NCT01217320
(ClinicalTrials.gov)
January 20116/10/2010Creatine Supplementation in Pediatric RheumatologyEfficacy and Safety of Creatine Supplementation in Patients With Juvenile Systemic Lupus Erythematosus and Juvenile DermatomyositisJuvenile Systemic Lupus Erythematosus;Juvenile DermatomyositisDietary Supplement: creatine;Dietary Supplement: placebo (dextrose)University of Sao PauloNULLRecruiting6 Years18 YearsBoth40N/ABrazil
696NCT01240694
(ClinicalTrials.gov)
December 9, 201015/10/2010A Long-Term Study of the Safety and Tolerability of Repeated Administration of CEP-33457 in Participants With Systemic Lupus ErythematosusAn Open-Label Long-Term Study of the Safety and Tolerability of Repeated Administration of CEP-33457 in Patients With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: CEP-33457Cephalon, Inc.NULLTerminated18 Years70 YearsAll136Phase 3United States;Belgium;Czechia;France;Germany;Hungary;Poland;Portugal;Spain;Ukraine;United Kingdom;Czech Republic
697NCT01262365
(ClinicalTrials.gov)
December 201014/12/2010Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus ErythematosusA Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Four 12-week Treatment Cycles (48 Weeks Total) of Epratuzumab in Systemic Lupus Erythematosus Subjects With Moderate to Severe DiseaseSystemic Lupus ErythematosusDrug: Epratuzumab;Drug: PlaceboUCB PharmaNULLCompleted18 YearsN/AAll793Phase 3United States;Australia;Belgium;Brazil;Bulgaria;Czechia;Estonia;France;Germany;India;Israel;Italy;Korea, Republic of;Lithuania;Mexico;Puerto Rico;Romania;Russian Federation;Spain;Taiwan;United Kingdom;Czech Republic
698NCT01196091
(ClinicalTrials.gov)
December 20103/9/2010A Study of LY2127399 in Participants With Systemic Lupus ErythematosusA Phase 3, Multicenter, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Participants With Systemic Lupus Erythematosus (SLE)Systemic Lupus Erythematosus;Connective Tissue Disease;Autoimmune DiseaseDrug: LY2127399;Drug: Placebo every 2 weeks;Drug: Placebo every 4 weeks;Drug: Standard of CareEli Lilly and CompanyNULLCompleted18 YearsN/AAll1164Phase 3United States;Argentina;Austria;Belarus;Bulgaria;Canada;Chile;Colombia;Croatia;Egypt;Germany;Guatemala;Italy;Japan;Korea, Republic of;Macedonia, The Former Yugoslav Republic of;Peru;Philippines;Poland;Puerto Rico;Singapore;Thailand;Ukraine;Turkey
699NCT01261793
(ClinicalTrials.gov)
December 201014/12/2010Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus (SLE)A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Four 12-week Treatment Cycles (48 Weeks Total) of Epratuzumab in Systemic Lupus Erythematosus Subjects With Moderate to Severe DiseaseSystemic Lupus ErythematosusDrug: Placebo;Drug: EpratuzumabUCB PharmaNULLCompleted18 YearsN/AAll791Phase 3United States;Brazil;Canada;France;Germany;Hungary;India;Italy;Mexico;Poland;Romania;Russian Federation;South Africa;Spain;Ukraine;United Kingdom;Netherlands
700NCT01269866
(ClinicalTrials.gov)
December 20103/1/2011Study of Duloxetine in the Reduction of Pain in Patient With Systemic Lupus ErythematosusDuloxetine (Cymbalta) in the Reduction of Pain Severity in Patient With Systemic Lupus Erythematosus: A Pilot StudySystemic Lupus ErythematosusDrug: CymbaltaDr. Jesus Gutierrez StoneNULLCompleted18 Years65 YearsBoth26N/AUnited States
701EUCTR2010-018383-16-BE
(EUCTR)
10/11/201019/07/2010A clinical study to evaluate the effectiveness and tolerability of a 200mcg dose of CEP-33457 in patients with a chronic autoimmune disease (Lupus).A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47 Patients With Systemic Lupus Erythematosus (SLE)
MedDRA version: 14.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Lupuzor
Product Code: CEP-33457
INN or Proposed INN: Forigerimod
Other descriptive name: IPP-201101, P140
Cephalon, Inc.NULLNot RecruitingFemale: yes
Male: yes
220Phase 2France;United States;Portugal;Hungary;Czech Republic;Spain;Poland;Belgium;Ukraine;Germany
702EUCTR2009-017273-38-ES
(EUCTR)
26/10/201027/07/2010Estudio fase III, multicéntrico, aleatorizado, abierto de grupos paralelos para comparar la eficacia y seguridad de la pauta Prednisona-Ac Micofenólico-Ciclosporina a Prednisona-Ac Micofenólico en el tratamiento de las nefropatias lúpicas tipo III-IV-VEstudio fase III, multicéntrico, aleatorizado, abierto de grupos paralelos para comparar la eficacia y seguridad de la pauta Prednisona-Ac Micofenólico-Ciclosporina a Prednisona-Ac Micofenólico en el tratamiento de las nefropatias lúpicas tipo III-IV-V Nefritis lúpico tipo III,IV y V.
MedDRA version: 9;Level: LLT;Classification code 10029142;Term: Nephritis systemic lupus erythematosus
Product Name: Ciclosporina
Product Code: Csa
INN or Proposed INN: CICLOSPORINA
Other descriptive name: CICLOSPORIN
INN or Proposed INN: PREDNISONA
Other descriptive name: PREDNISONE
Product Name: Acido Micofenolico
Product Code: ACM
INN or Proposed INN: MICOFENOLICO ACIDO
Other descriptive name: MYCOPHENOLIC ACID
Manuel Praga TerenteNULLNot RecruitingFemale: yes
Male: yes
38Spain
703NCT01085084
(ClinicalTrials.gov)
October 4, 20109/3/2010A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus ArthritisA Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Clinical Effect of Laquinimod in Systemic Lupus Erythematosus Patients With Active Lupus ArthritisLupus ArthritisDrug: Laquinimod;Drug: PlaceboTeva Branded Pharmaceutical Products R&D, Inc.NULLCompleted18 Years75 YearsAll82Phase 2United States;Canada
704EUCTR2010-018383-16-PT
(EUCTR)
01/10/201023/07/2010A clinical study to evaluate the effectiveness and tolerability of a 200mcg dose of CEP-33457 in patients with a chronic autoimmune disease (Lupus).A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47 Patients With Systemic Lupus Erythematosus (SLE)
MedDRA version: 13.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Lupuzor
Product Code: CEP-33457
INN or Proposed INN: Forigerimod
Other descriptive name: IPP-201101, P140
Cephalon, Inc.NULLNot RecruitingFemale: yes
Male: yes
220France;United States;Portugal;Hungary;Czech Republic;Belgium;Spain;Poland;Ukraine;Germany
705EUCTR2010-019293-32-PT
(EUCTR)
01/10/201026/07/2010A clinical study to evaluate the tolerability of repeated doses of CEP-33457 administered in patients with a chronic autoimmune disease (Lupus)An Open-Label Long-Term Study of the Safety and Tolerability of Repeated administration of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 75 Patients With Systemic Lupus Erythematosus (SLE)
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Lupuzor
Product Code: CEP-33457
INN or Proposed INN: Forigerimod
Other descriptive name: IPP-201101, P140
Cephalon, Inc.NULLNot RecruitingFemale: yes
Male: yes
130United States;Portugal;Hungary;Czech Republic;Belgium;Spain;Poland;Ukraine;Germany
706JPRN-UMIN000004182
2010/10/0130/09/2010efficacy and safety of tacrolimus for mild/modelate flare in patients with systemic lupus erythematosusefficacy and safety of tacrolimus for mild/modelate flare in patients with systemic lupus erythematosus - FK for SLE Flare systemic lupus erythematosusAdministration of TacrolimusDepartment of Medicine and Clinical Science, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical SciencesNULLRecruiting20years-old80years-oldMale and Female30Not applicableJapan
707EUCTR2010-019293-32-ES
(EUCTR)
28/09/201021/07/2010Estudio abierto a largo plazo de la seguridad y la tolerabilidad de la administración repetida de CEP-33457 en pacientes con lupus eritematoso sistémico.An Open-Label Long-Term Study of the Safety and Tolerability of Repeated administration of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 75Estudio abierto a largo plazo de la seguridad y la tolerabilidad de la administración repetida de CEP-33457 en pacientes con lupus eritematoso sistémico.An Open-Label Long-Term Study of the Safety and Tolerability of Repeated administration of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 75 Pacientes con lupus eritematoso sístemico (LES). Patients With Systemic Lupus Erythematosus (SLE)
MedDRA version: 12.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: Lupuzor
Product Code: CEP-33457
INN or Proposed INN: rigerimod
Other descriptive name: IPP-201101, P140
Cephalon, Inc.NULLNot RecruitingFemale: yes
Male: yes
130Phase 3Portugal;Czech Republic;Hungary;Belgium;Spain;Germany
708EUCTR2010-018383-16-DE
(EUCTR)
17/09/201016/07/2010A clinical study to evaluate the effectiveness and tolerability of a 200mcg dose of CEP-33457 in patients with a chronic autoimmune disease (Lupus).A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47 Patients With Systemic Lupus Erythematosus (SLE)
MedDRA version: 14.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Lupuzor
Product Code: CEP-33457
INN or Proposed INN: Forigerimod
Other descriptive name: IPP-201101, P140
Cephalon, Inc.NULLNot RecruitingFemale: yes
Male: yes
220United States;Portugal;France;Hungary;Czech Republic;Spain;Poland;Belgium;Ukraine;Germany
709NCT01085097
(ClinicalTrials.gov)
September 1, 20104/3/2010A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus NephritisA Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Clinical Effect of Laquinimod in Active Lupus Nephritis Patients, in Combination With Standard of Care (Mycophenolate Mofetil and Steroids)Lupus NephritisDrug: Laquinimod;Drug: Mycophenolate Mofetil;Drug: Prednisolone/Prednisone;Drug: Placebo;Drug: MethylprednisoloneTeva Branded Pharmaceutical Products R&D, Inc.NULLCompleted18 Years75 YearsAll46Phase 2United States;Canada;France;Russian Federation;United Kingdom
710EUCTR2010-019293-32-CZ
(EUCTR)
19/08/201022/07/2010A clinical study to evaluate the tolerability of repeated doses of CEP-33457 administered in patients with a chronic autoimmune disease (Lupus)An Open-Label Long-Term Study of the Safety and Tolerability of Repeated administration of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 75 Patients With Systemic Lupus Erythematosus (SLE)
MedDRA version: 14.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Lupuzor
Product Code: CEP-33457
INN or Proposed INN: Forigerimod
Other descriptive name: IPP-201101, P140
Cephalon, Inc.NULLNot RecruitingFemale: yes
Male: yes
130Poland;United States;Portugal;Hungary;Czech Republic;Belgium;Spain;Ukraine;Germany
711EUCTR2010-018383-16-HU
(EUCTR)
16/08/201020/07/2010A clinical study to evaluate the effectiveness and tolerability of a 200mcg dose of CEP-33457 in patients with a chronic autoimmune disease (Lupus).A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47 Patients With Systemic Lupus Erythematosus (SLE)
MedDRA version: 14.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Lupuzor
Product Code: CEP-33457
INN or Proposed INN: Forigerimod
Other descriptive name: IPP-201101, P140
Cephalon, Inc.NULLNot RecruitingFemale: yes
Male: yes
220Portugal;Hungary;Germany;Czech Republic;Ukraine;Belgium;France;Spain;United States;Poland
712EUCTR2010-019293-32-HU
(EUCTR)
16/08/201021/07/2010An Open-Label Long-Term Study of the Safety and Tolerability of Repeated administration of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 75 Patients With Systemic Lupus Erythematosus (SLE)
MedDRA version: 12.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: Lupuzor
Product Code: CEP-33457
INN or Proposed INN: rigerimod
Other descriptive name: IPP-201101, P140
Cephalon, Inc.NULLNot RecruitingFemale: yes
Male: yes
130Portugal;Hungary;Czech Republic;Spain
713EUCTR2010-018383-16-CZ
(EUCTR)
13/08/201022/07/2010A clinical study to evaluate the effectiveness and tolerability of a 200mcg dose of CEP-33457 in patients with a chronic autoimmune disease (Lupus).A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47 Patients With Systemic Lupus Erythematosus (SLE)
MedDRA version: 14.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Lupuzor
Product Code: CEP-33457
INN or Proposed INN: Forigerimod
Other descriptive name: IPP-201101, P140
Cephalon, Inc.NULLNot RecruitingFemale: yes
Male: yes
220France;United States;Portugal;Hungary;Czech Republic;Belgium;Spain;Poland;Ukraine;Germany
714EUCTR2009-012059-47-DE
(EUCTR)
12/08/201021/01/2010A phase I-II, randomized, double-blind, placebo-controlled, dose escalation study of Neovacs’ IFNa-Kinoid in adult subjects with Systemic Lupus Erythematosus. - IFN-Kinoid in Systemic Lupus ErythematosusA phase I-II, randomized, double-blind, placebo-controlled, dose escalation study of Neovacs’ IFNa-Kinoid in adult subjects with Systemic Lupus Erythematosus. - IFN-Kinoid in Systemic Lupus Erythematosus Systemic Lupus Erythematosus (SLE)
MedDRA version: 12.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: IFN-a2b Kinoid
Product Code: IFN-K
INN or Proposed INN: Not assigned yet
Other descriptive name: IFN-a 2b Kinoid Drug Substance
Neovacs SANULLNot RecruitingFemale: yes
Male: yes
28Phase 1;Phase 2France;Belgium;Bulgaria;Germany
715EUCTR2010-018383-16-ES
(EUCTR)
10/08/201020/07/2010Estudio aleatorizado, doble ciego, con grupos paralelos y controlado con placebo para evaluar la eficacia y la seguridad de una dosis de 200 µg de CEP-33457 en pacientes con lupus eritematoso sistémico.A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47Estudio aleatorizado, doble ciego, con grupos paralelos y controlado con placebo para evaluar la eficacia y la seguridad de una dosis de 200 µg de CEP-33457 en pacientes con lupus eritematoso sistémico.A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47 Pacientes con lupus eritematoso sistémico (LES). Patients With Systemic Lupus Erythematosus (SLE)
MedDRA version: 13;Level: LLT;Classification code 10042945;Term: Lupus eritematoso sistémico
Product Name: Lupuzor
Product Code: CEP-33457
INN or Proposed INN: rigerimod
Other descriptive name: IPP-201101, P140
Cephalon, Inc.NULLNot RecruitingFemale: yes
Male: yes
220Phase 2France;Portugal;Czech Republic;Hungary;Belgium;Spain;Germany
716EUCTR2010-018383-16-FR
(EUCTR)
05/08/201029/07/2010A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47 Patients With Systemic Lupus Erythematosus (SLE)
MedDRA version: 12.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: Lupuzor
Product Code: CEP-33457
INN or Proposed INN: rigerimod
Other descriptive name: IPP-201101, P140
Cephalon, Inc.NULLNot RecruitingFemale: yes
Male: yes
220Phase 2Portugal;France;Czech Republic;Hungary;Spain;Belgium;Germany
717NCT01164917
(ClinicalTrials.gov)
August 201015/7/2010Safety Study of AMG 811 in Subjects With Discoid Lupus ErythematosusA Randomized, Double-blind, Placebo-controlled, Single Dose, Two-period, Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Efficacy of AMG 811 in Subjects With Discoid Lupus ErythematosusCutaneous Lupus;Discoid Lupus;Lupus;Systemic Lupus ErythematosusDrug: AMG811;Drug: AMG811 PlaceboAmgenNULLTerminated18 Years70 YearsBoth16Phase 1United States
718NCT00979654
(ClinicalTrials.gov)
August 201017/9/2009A Study to Evaluate the Long-Term Safety of MEDI-545 in Adult Participants With Systemic Lupus Erythematosus or MyositisA Phase 2 Open-label Study to Evaluate the Long-term Safety of Sifalimumab in Adult Subjects With Systemic Lupus Erythematosus or MyositisSystemic Lupus ErythematosusDrug: SifalimumabMedImmune LLCPPDCompleted18 Years99 YearsAll118Phase 2United States;Brazil;Canada;Chile
719NCT01381536
(ClinicalTrials.gov)
July 20, 201021/4/2011Phase I Study of GSK1550188 in Japanese Subjects With Systemic Lupus Erythematosus (SLE)GSK1550188, A Randomised, Single-blind, Placebo Controlled, Dose Ascending, Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic of GSK1550188 in Japanese Subjects With Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: GSK1550188 1mg/kg or 10mg/kgGlaxoSmithKlineNULLCompleted20 YearsN/AAll12Phase 1Japan
720NCT01170585
(ClinicalTrials.gov)
July 201026/7/2010A Trial of Rosuvastatin in Systemic Lupus ErythematosusA Randomised Placebo Controlled Trial of Rosuvastatin in Systemic Lupus ErythematosusAtherosclerosis;Systemic Lupus ErythematosusDrug: Rosuvastatin;Drug: PlaceboImperial College LondonNULLCompleted18 Years80 YearsBoth33Phase 2United Kingdom
721NCT01162681
(ClinicalTrials.gov)
July 201013/7/2010PEARL-SC Trial: A Study of the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus ErythematosusA Randomized, Double-Blind Phase 2b Study to Evaluate the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: A-623;Other: Placebo ComparatorAnthera PharmaceuticalsNULLCompleted18 YearsN/ABoth547Phase 2United States;Argentina;Brazil;Chile;Colombia;Hong Kong;India;Mexico;Peru;Philippines;Taiwan
722NCT01135459
(ClinicalTrials.gov)
June 20101/6/2010A Study to Evaluate the Efficacy and Safety of CEP-33457 in Patients With Systemic Lupus ErythematosusA Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: Lupuzor;Drug: PlaceboCephalonNULLCompleted18 Years70 YearsBoth183Phase 2United States;Belgium;Czech Republic;France;Germany;Hungary;Poland;Portugal;Spain;Ukraine;United Kingdom
723EUCTR2009-012059-47-FR
(EUCTR)
07/05/201002/02/2010A phase I-II, randomized, observer-blind, placebo-controlled, dose escalation study to evaluate the safety and immune responses of various doses of Neovacs’ IFNa-Kinoid in adult patients with Systemic Lupus Erythematosus. - IFN-Kinoid in Systemic Lupus ErythematosusA phase I-II, randomized, observer-blind, placebo-controlled, dose escalation study to evaluate the safety and immune responses of various doses of Neovacs’ IFNa-Kinoid in adult patients with Systemic Lupus Erythematosus. - IFN-Kinoid in Systemic Lupus Erythematosus Systemic Lupus Erythematosus (SLE)
MedDRA version: 12.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: IFN-a2b Kinoid
Product Code: IFN-K
INN or Proposed INN: Not assigned yet
Other descriptive name: IFN-a 2b Kinoid Drug Substance
Neovacs SANULLNot Recruiting Female: yes
Male: yes
28 Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Belgium;Bulgaria;Germany
724NCT01127321
(ClinicalTrials.gov)
May 201014/4/2010A Safety and Tolerability Study of MEDI-570 in Systemic Lupus ErythematosusA Phase 1, Double-blind, Randomized, Single Ascending Dose Study of the Safety and Tolerability of MEDI-570 in SLELupus Erythematosus, SystemicOther: Placebo;Biological: MEDI-570 0.03 MG;Biological: MEDI-570 0.1 MG;Biological: MEDI-570 0.3 MG;Biological: MEDI-570 1 MGMedImmune LLCAstraZenecaTerminated18 YearsN/AAll44Phase 1United States;Canada;Mexico;Peru;South Africa
725NCT01060410
(ClinicalTrials.gov)
May 20101/2/2010Exploration of Genotype Based Personalized Prescription of Cyclophosphamide in Systemic Lupus Erythematosus TreatmentExploration of Genetic Polymorphisms Related to Individual Variations of Side Effects of Cyclophosphamide in Systemic Lupus Erythematosus TreatmentLupus Erythematosus, Systemic;Adverse EffectsGenetic: Polymorphism Analysis;Drug: Cyclophosphamide;Other: Pharmacokinetic analysisSun Yat-sen UniversityFirst Affiliated Hospital, Sun Yat-Sen UniversityCompleted12 Years80 YearsBoth222N/AChina
726EUCTR2009-012059-47-BG
(EUCTR)
23/04/201015/04/2010A phase I-II, randomized, double-blind, placebo-controlled, dose escalation study of Neovacs’ IFNa-Kinoid in adult subjects with Systemic Lupus Erythematosus.A phase I-II, randomized, double-blind, placebo-controlled, dose escalation study of Neovacs’ IFNa-Kinoid in adult subjects with Systemic Lupus Erythematosus. - IFN-Kinoid in Systemic Lupus Erythematosus Systemic Lupus Erythematosus (SLE)
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Product Name: IFN-a2b Kinoid
Product Code: IFN-K
INN or Proposed INN: Not assigned yet
Other descriptive name: IFN-a 2b Kinoid Drug Substance
Neovacs SANULLNot RecruitingFemale: yes
Male: yes
28Phase 1;Phase 2France;Belgium;Bulgaria;Germany
727NCT01425775
(ClinicalTrials.gov)
April 201018/8/2011The Effect of Vitamin D Supplementation on Disease Activity Markers in Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: vitamin D 25(OH)D;Other: PlaceboFaculty of Medicine, University of AlexandriaNULLCompleted18 Years60 YearsBoth248N/AEgypt
728NCT01151644
(ClinicalTrials.gov)
April 201025/6/2010Safety and Efficacy of Anti-Pandemic H1N1 Vaccination in Rheumatic DiseasesSafety and Efficacy of Anti-Pandemic H1N1 Vaccination in Rheumatic DiseasesRheumatoid Arthritis;Spondyloarthritis;Systemic Lupus Erythematosus (SLE);Dermatomyositis (DM);DMixed Connective Tissue Disease;Systemic Vasculitis;Systemic Sclerosis (SSc);Sjögren's Syndrome;Antiphospholipid Syndrome;Juvenile Idiopathic Arthritis;Juvenile SLE;Juvenile DMBiological: Anti-pandemic H1N1 influenza vaccineUniversity of Sao PauloFundação de Amparo à Pesquisa do Estado de São PauloActive, not recruitingN/AN/ABoth5000Phase 4Brazil
729NCT01058343
(ClinicalTrials.gov)
March 201027/1/2010Safety of IFNa Kinoid in Systemic Lupus ErythematosusA Phase I-II, Randomized, Double-blind, Placebo-controlled, Dose Escalation Study of Neovacs' IFNa-Kinoid in Adult Subjects With Systemic Lupus Erythematosus.Systemic Lupus ErythematosusBiological: IFN-KNeovacsNULLCompleted18 Years50 YearsAll28Phase 1/Phase 2Belgium;Bulgaria;Croatia;France;Germany;Switzerland;Romania;Spain
730NCT01093911
(ClinicalTrials.gov)
March 201012/3/2010Safety Study of CDP7657 in Healthy Volunteers and Patients With Systemic Lupus Erythematosus (SLE)A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalating Study to Evaluate Safety, Tolerability, Pharmacokinetics, Immunogenicity and to Explore the Pharmacodynamics of CDP7657 Administered in Healthy Subjects and in SLE Patients.Immune System Diseases;Autoimmune Diseases;Lupus Erythematosus, Systemic;Skin and Connective Tissue Diseases;Connective Tissue DiseaseBiological: CDP7657;Other: PlaceboUCB PharmaNULLCompleted18 Years60 YearsBoth44Phase 1Belgium;Bulgaria;Germany
731EUCTR2006-006214-16-GB
(EUCTR)
23/02/201029/02/2008A randomised placebo controlled trial of rosuvastatin in systemic lupus erythematosus. - RCT of statin in SLEA randomised placebo controlled trial of rosuvastatin in systemic lupus erythematosus. - RCT of statin in SLE Systemic lupus erythematosus.
MedDRA version: 13.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: Crestor
Product Name: Crestor
INN or Proposed INN: ROSUVASTATIN CALCIUM
Other descriptive name: rosuvastatin
Trade Name: Crestor
Product Name: Crestor
INN or Proposed INN: ROSUVASTATIN CALCIUM
Other descriptive name: rosuvastatin
Imperial CollegeNULLNot Recruiting Female: yes
Male: yes
64 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom
732EUCTR2009-012059-47-BE
(EUCTR)
28/01/201005/01/2010A phase I-II, randomized, double-blind, placebo-controlled, dose escalation study of Neovacs’ IFNa-Kinoid in adult subjects with Systemic Lupus Erythematosus. - IFN-Kinoid in Systemic Lupus ErythematosusA phase I-II, randomized, double-blind, placebo-controlled, dose escalation study of Neovacs’ IFNa-Kinoid in adult subjects with Systemic Lupus Erythematosus. - IFN-Kinoid in Systemic Lupus Erythematosus Systemic Lupus Erythematosus (SLE)
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Product Name: IFN-a2b Kinoid
Product Code: IFN-K
INN or Proposed INN: Not assigned yet
Other descriptive name: IFN-a 2b Kinoid Drug Substance
Neovacs SANULLNot RecruitingFemale: yes
Male: yes
28Phase 1;Phase 2France;Belgium;Bulgaria;Germany
733EUCTR2007-007648-85-AT
(EUCTR)
21/01/201009/12/2008A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057 - NA Systemic lupus erythematosus (SLE)
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Belimumab
Product Code: HGS1006
INN or Proposed INN: Belimumab
Other descriptive name: LymphoStat-B
Human Genome Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
1620Phase 3United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Austria;Chile;Israel;Colombia;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Belgium;Brazil;Peru;Netherlands;Germany;Sweden;Korea, Republic of
734NCT01413230
(ClinicalTrials.gov)
January 201024/6/2011Vitamin D Supplementation in Systemic Lupus ErythematosusEvaluation of Immunologic Response After Vitamin D Supplementation in Patients With Systemic Lupus ErythematosusVitamin D DeficiencyDrug: cholecalciferolAssistance Publique - Hôpitaux de ParisNULLCompleted18 YearsN/ABoth20N/AFrance
735NCT01112215
(ClinicalTrials.gov)
December 200926/4/2010Enteric-coated Mycophenolate Sodium Versus Azathioprine for the Extra-renal Lupus ManifestationsRandomized Controlled Trial to Evaluate the Efficacy of Enteric-coated Mycophenolate Sodium Versus Azathioprine for the Induction and Maintenance of Remission of the Extra-renal Lupus ManifestationsSystemic Lupus ErythematosusDrug: Azathioprine;Drug: Enteric-Coated Mycophenolate SodiumHospital Universitari Vall d'Hebron Research InstituteNULLCompleted18 Years65 YearsBoth240Phase 4Spain
736NCT01031836
(ClinicalTrials.gov)
November 25, 200911/12/2009A Study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545 in Patients With Systemic Lupus Erythematosus.A Phase II, Multicenter, Open-Label, Dose-Escalation Study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545, a Fully Human Monoclonal Antibody Directed Against Interferon Alpha Subtypes, in Japanese Patients Who Have Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: MEDI-545;Drug: MEDI-545 600AstraZenecaMedImmune LLCCompleted20 Years130 YearsAll30Phase 2Japan
737NCT01006681
(ClinicalTrials.gov)
November 200931/10/2009Vaccination Against Influenza H1N1 in Rheumatic DiseasesEfficacy and Safety of Vaccination Against Influenza H1N1 in Patients With Rheumatoid Arthritis, Systemic Lupus Erythematosus, Psoriatic Arthritis and Ankylosing Spondylitis Treated With Immunomodulatory DrugsInfluenza;Rheumatic DiseasesBiological: Focetria (Monovalent MF59-Adjuvanted vaccine)Tel-Aviv Sourasky Medical CenterNULLNot yet recruiting18 Years65 YearsBoth400Phase 2NULL
738NCT01018238
(ClinicalTrials.gov)
November 200916/11/2009An Investigation of NNC 0151-0000-0000 in Subjects With Systemic Lupus Erythematosus (SLE)A Multiple Dose, Randomised, Double-blind, Placebo-controlled, Multiple Site Study of Anti-C5a Receptor Antibody (NNC 0151-0000-0000) in Subjects With Systemic Lupus Erythematosus (SLE)Inflammation;Systemic Lupus ErythematosusDrug: NNC 0151-0000-0000;Drug: placeboNovo Nordisk A/SNULLWithdrawn18 Years65 YearsBoth0Phase 1United States
739NCT00911521
(ClinicalTrials.gov)
October 200928/5/2009Immunogenicity and Safety of a Quadrivalent Human Papillomavirus (HPV) Vaccine in Patients With SLE: a Controlled StudyImmunogenicity and Safety of a Quadrivalent Human Papillomavirus (HPV) Vaccine in Patients With Systemic Lupus Erythematosus (SLE): a Controlled StudySystemic Lupus ErythematosusDrug: human papillomavirus vaccination (Gardasil)Tuen Mun HospitalNULLCompletedN/A35 YearsFemale100Phase 4China
740EUCTR2007-007648-85-FR
(EUCTR)
08/09/200917/07/2009A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057 Systemic lupus erythematosus (SLE)
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: Belimumab
Product Code: HGS1006
INN or Proposed INN: Belimumab
Other descriptive name: LymphoStat-B
Human Genome Sciences, Inc.NULLNot Recruiting Female: yes
Male: yes
1620 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4):France;Czech Republic;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
741NCT00962832
(ClinicalTrials.gov)
September 200919/8/2009A Study to Evaluate the Efficacy and Safety of Rontalizumab in Patients With Moderately to Severely Active Systemic Lupus ErythematosusA Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rontalizumab (rhuMAb IFNalpha) in Patients With Moderately to Severely Active Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: Placebo;Drug: RontalizumabGenentech, Inc.NULLCompleted18 Years65 YearsBoth238Phase 2United States;Argentina;Colombia;Mexico;Poland;Russian Federation;United Kingdom
742NCT01072734
(ClinicalTrials.gov)
September 200919/2/2010Auto-immunity in Lupus Patients After Influenza VaccineRole of CXCR4/CXCL12 Axis on the Control of Humoral Immunity and Auto-immunity in Lupus Patients After Influenza Vaccine ChallengeSystemic Lupus Erythematosus (SLE)Drug: VaccineAssistance Publique - Hôpitaux de ParisInstitut National de la Santé Et de la Recherche Médicale, FranceCompleted18 YearsN/ABoth28Phase 2France
743EUCTR2007-007648-85-SE
(EUCTR)
26/08/200903/06/2009A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057 - NA Systemic lupus erythematosus (SLE)
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Belimumab
Product Code: HGS1006
INN or Proposed INN: Belimumab
Other descriptive name: LymphoStat-B
Human Genome Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
1620Phase 1;Phase 3United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Austria;Chile;Israel;Colombia;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Belgium;Brazil;Peru;Netherlands;Germany;Sweden;Korea, Republic of
744NCT00997100
(ClinicalTrials.gov)
August 200916/10/2009Exploratory Study of Changes in Disease Activity and Biomarkers With ABR-215757 in Patients With Mild Active Systemic Lupus Erythematosus (SLE)An Exploratory Study to Evaluate Changes in Disease Activity and Biomarkers During Treatment With ABR-215757 in Patients With Mild Active Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: paquinimod (ABR-215757)Active Biotech ABNULLCompleted18 YearsN/ABoth13Phase 2Denmark;Sweden
745EUCTR2007-007648-85-SK
(EUCTR)
28/07/200924/06/2009A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057 Systemic lupus erythematosus (SLE)
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term:
Product Name: Belimumab
Product Code: HGS1006
INN or Proposed INN: BELIMUMAB
Other descriptive name: LymphoStat-B
Human Genome Sciences, IncNULLNot RecruitingFemale: yes
Male: yes
1620Phase 3France;Czech Republic;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
746EUCTR2007-007648-85-BE
(EUCTR)
01/07/200905/01/2009A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057 - NA Systemic lupus erythematosus (SLE)
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Belimumab
Product Code: HGS1006
INN or Proposed INN: Belimumab
Other descriptive name: LymphoStat-B
Human Genome Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
1620Phase 3United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Austria;Chile;Israel;Colombia;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Belgium;Brazil;Peru;Netherlands;Germany;Sweden;Korea, Republic of
747NCT05063513
(ClinicalTrials.gov)
July 20096/5/2009Autologous Stem Cell Transplantation: International Lupus TrialRemission Induction Therapy for Refractory Systemic Lupus Erythematosus With Autologous Hematopoietic Stem Cell Transplantation (AHSCT) Versus Rituximab (antiCD20) Followed by Maintenance Therapy With Mycophenolate Mofetil (MMF)REFRACTORY SYSTEMIC LUPUS ERYTHEMATOSUSBiological: Autologous Hematopoietic Stem Cell Transplantation;Drug: RituximabEuropean Society for Blood and Marrow TransplantationEULARWithdrawn16 Years60 YearsAll0Phase 2/Phase 3France
748NCT01914770
(ClinicalTrials.gov)
July 20093/4/2012Effectiveness of Belimumab Treatment in a Subpopulation of Systemic Lupus Erythematosus (SLE) Patients: a Pooled Analysis of BLISS-52 and BLISS-76Effectiveness of Belimumab Treatment in a Subpopulation of Systemic Lupus Erythematosus (SLE) Patients: a Pooled Analysis of BLISS-52 and BLISS-76Systemic Lupus ErythematosusDrug: Belimumab 1 mg/kg;Drug: Belimumab 10 mg/kg;Drug: PlaceboGlaxoSmithKlineHuman Genome Sciences Inc.Completed18 YearsN/ABoth1016N/ANULL
749NCT00960362
(ClinicalTrials.gov)
July 200914/8/2009An Investigation of AGS-009 in Patients With Systemic Lupus Erythematosus (SLE)A Randomised, Double-blind, Placebo-controlled, and Single Dose-escalation Trial of AGS-009 Administered in Subjects With Systemic Lupus ErythematosusInflammation;Systemic Lupus Erythematosus (SLE)Drug: AGS-009;Drug: placeboArgos TherapeuticsNULLCompleted18 Years65 YearsBoth13Phase 1United States;Sweden
750EUCTR2009-011245-55-DK
(EUCTR)
08/06/200927/04/2009An Exploratory Study to Evaluate Changes in Disease Activity and Biomarkers During Treatment With ABR-215757 in Patients With Mild Active Systemic Lupus Erythematosus (SLE). Final Protocol dated 2009-03-16. Protocol Amendment 1 dated 2009-10-13. Protocol Amendment 2 dated 2009-12-02An Exploratory Study to Evaluate Changes in Disease Activity and Biomarkers During Treatment With ABR-215757 in Patients With Mild Active Systemic Lupus Erythematosus (SLE). Final Protocol dated 2009-03-16. Protocol Amendment 1 dated 2009-10-13. Protocol Amendment 2 dated 2009-12-02 Systemic Lupus Erythematosus (SLE)
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: ABR-215757
Product Code: ABR-215757
INN or Proposed INN: paquinimod
Active Biotech Research ABNULLNot RecruitingFemale: yes
Male: yes
20Denmark;Sweden
751EUCTR2007-007648-85-IT
(EUCTR)
03/06/200920/04/2009A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057 - ND A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057 - ND Systemic lupus erythematosus (SLE)
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: Belimumab
Product Code: HGS1006
Product Name: Belimumab
Product Code: HGS1006
HUMAN GENOME SCIENCES INCNULLNot RecruitingFemale: yes
Male: yes
1620Phase 3France;Czech Republic;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden
752EUCTR2009-011245-55-SE
(EUCTR)
06/05/200918/03/2009An Exploratory Study to Evaluate Changes in Disease Activity and Biomarkers During Treatment With ABR-215757 in Patients With Mild Active Systemic Lupus Erythematosus (SLE). Final Protocol dated 2009-03-16, Protocol Amendment 1 dated 2009-10-13, Protocol Amendment 2 dated 2009-12-02An Exploratory Study to Evaluate Changes in Disease Activity and Biomarkers During Treatment With ABR-215757 in Patients With Mild Active Systemic Lupus Erythematosus (SLE). Final Protocol dated 2009-03-16, Protocol Amendment 1 dated 2009-10-13, Protocol Amendment 2 dated 2009-12-02 Systemic Lupus Erythematosus (SLE)Product Name: ABR-215757
Product Code: ABR-215757
INN or Proposed INN: paquinimod
Active Biotech Research ABNULLNot RecruitingFemale: yes
Male: yes
20Denmark;Sweden
753NCT00976729
(ClinicalTrials.gov)
May 200911/9/2009NOX-E36 First-in-Human (FIH) StudyNOX-E36 - A Phase I, Double-Blind, Placebo Controlled, Single Intravenous and Subcutaneous Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy SubjectsChronic Inflammatory Diseases;Type 2 Diabetes Mellitus;Systemic Lupus ErythematosusDrug: NOX-E36;Drug: PlaceboNOXXON Pharma AGNULLCompleted18 Years60 YearsBoth72Phase 1United Kingdom
754EUCTR2007-007648-85-ES
(EUCTR)
27/04/200925/02/2009A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B?), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057Estudio de continuación multicéntrico de belimumab (HGS1006, LymphoStat-B?), un anticuerpo monoclonal totalmente humano anti-BLyS, en pacientes con lupus eritematoso sistémico (LES) que completaron el protocolo de fase III HGS1006-C1056 o HGS1006-C1057A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B?), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057Estudio de continuación multicéntrico de belimumab (HGS1006, LymphoStat-B?), un anticuerpo monoclonal totalmente humano anti-BLyS, en pacientes con lupus eritematoso sistémico (LES) que completaron el protocolo de fase III HGS1006-C1056 o HGS1006-C1057 Systemic lupus erythematosus (SLE)Lupus Eritematoso Sistémico (LES)
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: Belimumab
Product Code: HGS1006
INN or Proposed INN: Belimumab
Other descriptive name: LymphoStat-B
Human Genome Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
1620Phase 3France;Czech Republic;Slovakia;Belgium;Spain;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
755EUCTR2007-007648-85-NL
(EUCTR)
07/04/200919/12/2008A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057 - NA Systemic lupus erythematosus (SLE)
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Trade Name: Benlysta 400 mg powder for concentrate for solution for infusions
Product Name: Belimumab
Product Code: HGS1006
INN or Proposed INN: Belimumab
Other descriptive name: LymphoStat-B; Benlysta
Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)NULLNot RecruitingFemale: yes
Male: yes
1620Phase 3United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Austria;Chile;Israel;Colombia;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Belgium;Brazil;Peru;Germany;Netherlands;Sweden;Korea, Republic of
756EUCTR2007-007648-85-CZ
(EUCTR)
01/04/200926/01/2009A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057 - NA Systemic lupus erythematosus (SLE)
MedDRA version: 16.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Trade Name: Benlysta®
Product Name: Belimumab
Product Code: HGS1006
INN or Proposed INN: Belimumab
Other descriptive name: LymphoStat-B
Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)NULLNot RecruitingFemale: yes
Male: yes
1620Phase 3United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Austria;Chile;Israel;Colombia;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Belgium;Brazil;Peru;Netherlands;Germany;Sweden;Korea, Republic of
757EUCTR2007-003621-24-AT
(EUCTR)
30/03/200923/04/2008Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD).
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
Product Name: Aviptadil
Product Code: VIP
INN or Proposed INN: Aviptadil
Other descriptive name: VIP
MondoGEN AGNULLNot RecruitingFemale: yes
Male: yes
48Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria
758EUCTR2007-007648-85-GB
(EUCTR)
13/03/200919/01/2009A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057 - NA Systemic lupus erythematosus (SLE)
MedDRA version: 14.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Belimumab
Product Code: HGS1006
INN or Proposed INN: Belimumab
Other descriptive name: LymphoStat-B
Human Genome Sciences, Inc.NULLNot Recruiting Female: yes
Male: yes
1620 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Austria;Chile;Israel;Colombia;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Belgium;Brazil;Peru;Netherlands;Germany;Sweden;Korea, Republic of
759NCT00714116
(ClinicalTrials.gov)
March 20098/7/2008Study Evaluating The SBI-087 In Subjects With Systemic Lupus ErythematosusAn Ascending Single Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Sbi-087 Administered To Subjects With Systemic Lupus Erythematosus.Lupus Erythematosus, SystemicDrug: SBI-087PfizerEmergent Product Development Seattle LLCCompleted18 Years70 YearsAll30Phase 1United States;Canada
760NCT02524795
(ClinicalTrials.gov)
March 20098/7/2015Omega 3 Fatty Acids and Systemic Lupus ErythematosusOmega 3 Fatty Acids, Inflammatory Status and Biochemical Markers of Patients With Systemic Lupus Erythematosus: a Pilot StudySystemic Lupus ErythematosusDietary Supplement: Hiomega-3 supplement of Naturalis® company -Federal University of Minas GeraisNULLCompleted18 Years60 YearsFemale49N/ANULL
761NCT00818948
(ClinicalTrials.gov)
March 200918/12/2008Safety Study of AMG 811 in Subjects With Systemic Lupus Erythematosus With and Without GlomerulonephritisA Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 811 in Subjects With Systemic Lupus Erythematosus With and Without GlomerulonephritisNephritis;Systemic Lupus ErythematosusDrug: AMG 811AmgenNULLCompleted18 Years70 YearsBoth56Phase 1United States;France;Hong Kong;Malaysia;Mexico;Singapore
762EUCTR2008-008169-36-NL
(EUCTR)
17/02/200929/12/2008Immune response after Human Papillomavirus vaccination in patients with auto-immune disease - HPV studyImmune response after Human Papillomavirus vaccination in patients with auto-immune disease - HPV study Juvenile Idiopathic ArthritisSystemic lupus erythematosus childhood dermatomyositis
MedDRA version: 9.1;Level: LLT;Classification code 10042947;Term: Systemic lupus erythematosus synd
MedDRA version: 9.1;Classification code 10059176;Term: Juvenile idiopathic arthritis
MedDRA version: 9.1;Classification code 10008521;Term: Childhood dermatomyositis
Trade Name: Cervarix suspensie voor injectie
Product Name: not applicable
Product Code: not applicable
University Medical Center UtrechtNULLNot RecruitingFemale: yes
Male: no
Netherlands
763EUCTR2008-004852-62-IT
(EUCTR)
09/02/200927/01/2009Safety and clinical efficacy of abetimus sodium (LJP-394) in prevention of renal flares in patients with systemic lupus erythematosus and a history of renal disease. - ABETIMUS FOR LUPUS NEPHRITISSafety and clinical efficacy of abetimus sodium (LJP-394) in prevention of renal flares in patients with systemic lupus erythematosus and a history of renal disease. - ABETIMUS FOR LUPUS NEPHRITIS
MedDRA version: 9.1;Level: SOC;Classification code 10028395
MedDRA version: 9.1;Level: LLT;Classification code 10040970
Product Name: ABETIMUS SODIUM
Product Code: LJP394
INN or Proposed INN: RIQUENT
AZIENDA OSPEDALIERA UNIVERSITARIA DELLA SECONDA UNIVERSITA` DEGLI STUDI DI NAPOLINULLNot RecruitingFemale: yes
Male: yes
Italy
764EUCTR2007-007648-85-DE
(EUCTR)
06/02/200903/12/2008A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057 - NA Systemic lupus erythematosus (SLE)
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Belimumab
Product Code: HGS1006
INN or Proposed INN: Belimumab
Other descriptive name: LymphoStat-B
Human Genome Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
1620Phase 3Philippines;Taiwan;Hong Kong;Slovakia;Spain;Austria;Chile;Israel;Colombia;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Belgium;Brazil;Peru;Netherlands;Germany;Sweden;Korea, Republic of
765EUCTR2008-003833-25-DE
(EUCTR)
05/02/200916/10/2008Efficacy ans safety of subcutaneous Efalizumab in the treatment of patients with cutaneous lupus erythematosus: A mono-centre, open-label, prospective pilot study - EFALUPUSEfficacy ans safety of subcutaneous Efalizumab in the treatment of patients with cutaneous lupus erythematosus: A mono-centre, open-label, prospective pilot study - EFALUPUS Cutaneous lupus erythematosus (discoid LE or subacute cutaneous LE) or systemic lupus erythematosus with cutaneous DLE or SCLE lesions without major organ involvment.
MedDRA version: 9.1;Level: LLT;Classification code 10013071;Term: Discoid lupus erythematosis
MedDRA version: 9.1;Classification code 10057903;Term: Subacute cutaneous lupus erythematosus
MedDRA version: 9.1;Classification code 10056509;Term: Cutaneous lupus erythematosus
Trade Name: RaptivaUniversitätskrankenhaus Schleswig-HolsteinNULLNot RecruitingFemale: yes
Male: yes
17Germany
766NCT00828178
(ClinicalTrials.gov)
February 200922/1/2009Efficacy of Fish Oil in Lupus PatientsA Randomized, Double-blind, Placebo-controlled, Clinical Trial of Omega-3-polyunsaturated Fatty Acids in Subjects With SLE.Systemic Lupus ErythematosusDrug: Omega-3;Device: flow-mediated dilation of the brachial artery;Other: corn starchMichelle Petri M.D.,MPHNULLCompleted18 YearsN/AAll106Phase 4United States
767EUCTR2007-003621-24-GB
(EUCTR)
02/12/200814/07/2008Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD).
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
Product Name: Aviptadil
Product Code: VIP
INN or Proposed INN: Aviptadil
Other descriptive name: VIP
MondoGEN AGNULLNot Recruiting Female: yes
Male: yes
48 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Spain;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom
768NCT00774943
(ClinicalTrials.gov)
December 200816/10/2008A Study of AMG 557 in Adults With Systemic Lupus ErythematosusA Randomized, Double-blind, Placebo-controlled, Ascending, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: AMG 557AmgenNULLCompleted18 Years70 YearsBoth58Phase 1United States;Canada
769NCT00710021
(ClinicalTrials.gov)
November 20081/7/2008Vitamin D3 in Systemic Lupus ErythematosusEffect of Vitamin D3 on the IFN Alpha Signature in Patients With Systemic Lupus Erythematosus (ALE02)Systemic Lupus Erythematosus;SLE;LupusDrug: Vitamin D3;Drug: Vitamin D3 placeboNational Institute of Allergy and Infectious Diseases (NIAID)Autoimmunity Centers of ExcellenceCompleted18 YearsN/AAll57Phase 2United States
770NCT00752999
(ClinicalTrials.gov)
November 200815/9/2008Efficacy and Safety Study of R935788 Tablets to Treat Systemic Lupus ErythematosusA Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of R935788 in Systemic Lupus Erythematosus Patients With Active DiseaseSystemic Lupus ErythematosusDrug: Fostamatinib Disodium (R935788);Drug: PlaceboRigel PharmaceuticalsNULLWithdrawn18 YearsN/ABoth0Phase 2NULL
771NCT00786409
(ClinicalTrials.gov)
November 20085/11/2008Immunogenicity and Safety of HPV Vaccine Gardasil in Young WomenImmunogenicity and Safety of the Quadrivalent HPV Vaccine Gardasil in Female Systemic Lupus Erythematosus Patients Aged 9-26Systemic Lupus ErythematosusBiological: GardasilUniversity of ChicagoMerck Sharp & Dohme Corp.Completed9 Years26 YearsFemale27N/AUnited States
772NCT00732940
(ClinicalTrials.gov)
October 20088/8/2008Phase 2 Study of Belimumab Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus (SLE)A Phase 2, Multi-Center, Randomized, Open Label, Trial to Evaluate the Safety, Tolerability, and Biological Activity of 2 Dosing Schedules of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: Belimumab 100 mg SCHuman Genome Sciences Inc.GlaxoSmithKlineTerminated18 YearsN/AAll56Phase 2United States;Mexico
773NCT00779194
(ClinicalTrials.gov)
October 200823/10/2008Prospective Study of Rapamycin for the Treatment of SLEProspective Study of Rapamycin for the Treatment of SLESystemic Lupus Erythematosus (SLE)Drug: RapamycinState University of New York - Upstate Medical UniversityPfizer;PfizerCompleted18 YearsN/ABoth40Phase 2United States
774EUCTR2007-003698-13-BG
(EUCTR)
29/09/200807/08/2008A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/IIIA randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III Systemic Lupus Erythematosus (SLE)
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: Atacicept
Product Code: TACI-Fc5
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5
Product Name: Atacicept
Product Code: TACI-Fc5
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5
Merck Serono InternationalNULLNot RecruitingFemale: yes
Male: yes
510Phase 2/3France;Czech Republic;Greece;Spain;Lithuania;Austria;Bulgaria;Latvia;Germany;Netherlands;United Kingdom
775EUCTR2007-003698-13-LV
(EUCTR)
15/09/200819/06/2008A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/IIIA randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III Systemic Lupus Erythematosus
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: Atacicept
Product Code: TACI-Fc5
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5
Merck Serono S.A. Geneva. An affiliate of Merck KGaA, Darmstadt, GermanyNULLNot RecruitingFemale: yes
Male: yes
510Phase 2/3Germany;Czech Republic;United Kingdom;Netherlands;Bulgaria;France;Spain;Greece;Latvia;Austria;Lithuania
776EUCTR2007-003698-13-GR
(EUCTR)
09/09/200829/10/2009A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/IIIA randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III Systemic Lupus Erythematosus
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: Atacicept
Product Code: TACI-Fc5
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5
Merck Serono S.A. Geneva. An affiliate of Merck KGaA, Darmstadt, GermanyNULLNot RecruitingFemale: yes
Male: yes
510Phase 2/3France;Czech Republic;Greece;Spain;Lithuania;Austria;Bulgaria;Latvia;Germany;Netherlands;United Kingdom
777EUCTR2006-000674-73-BG
(EUCTR)
14/08/200814/08/2008A Randomized, Double-Blind, Placebo-Controlled, Four-Arm, Parallel-Group, Multicenter, Multinational Safety and Efficacy Trial 300 mg and 900 mg of Abetimus Sodium in Systemic Lupus Erythematosus (SLE) Patients with a History of Renal DiseaseA Randomized, Double-Blind, Placebo-Controlled, Four-Arm, Parallel-Group, Multicenter, Multinational Safety and Efficacy Trial 300 mg and 900 mg of Abetimus Sodium in Systemic Lupus Erythematosus (SLE) Patients with a History of Renal Disease Systemic lupus erythematosus patients with a history of renal disease
MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: Abetimus Sodium
Product Code: LJP 394
INN or Proposed INN: Abetimus Sodium
Other descriptive name: RIQUENT
La Jolla Pharmaceutical CompanyNULLNot RecruitingFemale: yes
Male: yes
730Portugal;Hungary;Czech Republic;Germany;Bulgaria;Spain;Italy
778NCT00724867
(ClinicalTrials.gov)
August 200828/7/2008A Continuation Trial for Subjects With Lupus Who Completed Protocol HGS1006-C1056 in the United StatesA Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase 3 Protocol HGS1006-C1056 in the United StatesSystemic Lupus ErythematosusBiological: Belimumab 1 mg/kg;Biological: Belimumab 10 mg/kgHuman Genome Sciences Inc., a GSK CompanyGlaxoSmithKlineCompleted18 YearsN/AAll268Phase 3United States;Canada
779EUCTR2007-003621-24-NL
(EUCTR)
23/07/200813/03/2008Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD).
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
Product Name: Aviptadil
Product Code: VIP
INN or Proposed INN: Aviptadil
Other descriptive name: VIP
MondoGEN AGNULLNot RecruitingFemale: yes
Male: yes
48Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria
780EUCTR2007-002589-37-GB
(EUCTR)
17/07/200804/01/2008A Phase IIb, Multi-center, Open-label, Follow-up Study to Assess the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease Who Participated in Study SL0007. - SL0008A Phase IIb, Multi-center, Open-label, Follow-up Study to Assess the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease Who Participated in Study SL0007. - SL0008 systemic lupus erythematosus
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: epratuzumab
Product Code: CDP3194
INN or Proposed INN: epratuzumab
UCB IncNULLNot Recruiting Female: yes
Male: yes
175 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noHungary;Spain;Belgium;Lithuania;United Kingdom
781EUCTR2007-003621-24-IT
(EUCTR)
15/07/200817/11/2008Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension - NDDouble-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension - ND Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD).
MedDRA version: 9.1;Level: LLT;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
Product Name: Aviptadil
Product Code: VIP
INN or Proposed INN: Aviptadil
Product Name: Aviptadil
Product Code: VIP
INN or Proposed INN: Aviptadil
Product Name: Aviptadil
Product Code: VIP
INN or Proposed INN: Aviptadil
MONDOGEN AGNULLNot RecruitingFemale: yes
Male: yes
48Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria
782NCT00657189
(ClinicalTrials.gov)
July 20089/4/2008A Study to Evaluate Safety and Tolerability of Subcutaneous Doses of MEDI-545 in Subjects With LupusA Phase 2A , Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Dose Study to Evaluate the Safety and Tolerability of Multiple Subcutaneous Doses of MEDI-545, A Fully Human Anti-Interferon-Alpha Monoclonal Antibody, In Subjects With Systemic Lupus ErythematosusLupus Erythematosus, Systemic;LupusDrug: MEDI-545;Drug: PlaceboMedImmune LLCNULLCompleted18 YearsN/ABoth87Phase 2United States
783EUCTR2007-003621-24-BE
(EUCTR)
20/06/200808/01/2008Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD).
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
Product Name: Aviptadil
Product Code: VIP
INN or Proposed INN: Aviptadil
Other descriptive name: VIP
MondoGEN AGNULLNot RecruitingFemale: yes
Male: yes
48France;Spain;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom
784EUCTR2006-005357-29-BG
(EUCTR)
18/06/200817/04/2008Clinical trial to study a drug in people with kidney disease related to lupusA Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus - BELONG Patients with ISN/RPS or WHO class III or IV Active Lupus Nephritis
MedDRA version: 15.1;Level: PT;Classification code 10025140;Term: Lupus nephritis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
369Portugal;France;Hungary;Spain;Bulgaria;Netherlands;Germany;United Kingdom;Sweden
785EUCTR2007-002566-35-HU
(EUCTR)
09/06/200828/01/2008A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007 systemic lupus erythematosus
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: epratuzumab
Product Code: CDP3194
INN or Proposed INN: epratuzumab
Other descriptive name: hLL2
UCB IncNULLNot RecruitingFemale: yes
Male: yes
210Phase 2Hungary;United Kingdom;Belgium;Spain;Lithuania
786EUCTR2007-002589-37-HU
(EUCTR)
09/06/200829/01/2008A Phase IIb, Multi-center, Open-label, Follow-up Study to Assess the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease Who Participated in Study SL0007. - SL0008A Phase IIb, Multi-center, Open-label, Follow-up Study to Assess the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease Who Participated in Study SL0007. - SL0008 systemic lupus erythematosus
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: epratuzumab
Product Code: CDP3194
INN or Proposed INN: epratuzumab
UCB IncNULLNot RecruitingFemale: yes
Male: yes
175Phase 2Hungary;United Kingdom;Belgium;Spain;Lithuania
787NCT02151409
(ClinicalTrials.gov)
June 200828/5/2014Dose-escalation Trial of Anti-C5aR Antibody in Healthy SubjectsA Randomised, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Trial of Anti-C5aR Antibody (NNC 0151-0000-0000) Administered by i.v. Infusion or s.c. Injection in Healthy Subjects.Inflammation;Systemic Lupus Erythematosus;Rheumatoid Arthritis;HealthyDrug: NNC 0151-0000-0000;Drug: placeboNovo Nordisk A/SNULLCompleted18 Years55 YearsMale60Phase 1Netherlands
788NCT00712933
(ClinicalTrials.gov)
May 30, 20088/7/2008A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™)a Fully Human Monoclonal Anti-BLyS Antibody in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057Systemic Lupus ErythematosusDrug: belimumabHuman Genome Sciences Inc., a GSK CompanyGlaxoSmithKlineCompleted18 YearsN/AAll738Phase 3Argentina;Austria;Belgium;Brazil;Canada;Chile;Colombia;Czechia;France;Germany;Hong Kong;India;Israel;Italy;Korea, Republic of;Mexico;Netherlands;Peru;Philippines;Poland;Puerto Rico;Romania;Russian Federation;Slovakia;Spain;Sweden;Taiwan;United Kingdom;Australia;China;Costa Rica;Czech Republic
789EUCTR2007-003621-24-FR
(EUCTR)
29/05/200827/12/2007Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD).
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
Product Name: Aviptadil
Product Code: VIP
INN or Proposed INN: Aviptadil
Other descriptive name: VIP
MondoGEN AGNULLNot RecruitingFemale: yes
Male: yes
48Phase 2France;Spain;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom
790EUCTR2007-003698-13-LT
(EUCTR)
14/05/200813/03/2008Atacicept Phase II/III in Generalized Systemic Lupus Erythematosus (APRIL SLE)A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III Systemic Lupus Erythematosus
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Atacicept
Product Code: TACI-Fc5
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5
Merck Serono S.A. Geneva. An affiliate of Merck KGaA, Darmstadt, GermanyNULLNot RecruitingFemale: yes
Male: yes
510Phase 2/3Serbia;United States;Philippines;Taiwan;Greece;Spain;Lebanon;Israel;Chile;Switzerland;India;France;Malaysia;Peru;Australia;Latvia;Netherlands;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Mexico;Argentina;Brazil;Croatia;Bulgaria;Germany
791EUCTR2006-000674-73-IT
(EUCTR)
12/05/200820/03/2008A randomized, double-blind, placebo-controlled, three-arm, parallel-group, multicenter, multinational, safety and efficacy trial of 300 mg and 900 mg of Abetimus sodium in Systemic Lupus Erythematosus (SLE) patients with a history of renal disease - NDA randomized, double-blind, placebo-controlled, three-arm, parallel-group, multicenter, multinational, safety and efficacy trial of 300 mg and 900 mg of Abetimus sodium in Systemic Lupus Erythematosus (SLE) patients with a history of renal disease - ND Systemic lupus erithematosus (SLE) patients with a history of renal disease.
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: Abetimus sodium
Product Code: LJP 394
INN or Proposed INN: Abetimus
LA JOLLA PHARMACEUTICAL COMPANYNULLNot RecruitingFemale: yes
Male: yes
730Portugal;Hungary;Czech Republic;Germany;Bulgaria;Spain;Italy
792EUCTR2007-003698-13-ES
(EUCTR)
09/05/200812/02/2008Estudio randomizado, doble ciego, controlado frente a placebo, prospectivo, multicéntrico, de búsqueda de dosis, en fase II/III, con atacicept subcutáneo en sujetos que recientemente han experimentado un brote de Lupus eritematoso sistémico.A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/IIIEstudio randomizado, doble ciego, controlado frente a placebo, prospectivo, multicéntrico, de búsqueda de dosis, en fase II/III, con atacicept subcutáneo en sujetos que recientemente han experimentado un brote de Lupus eritematoso sistémico.A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III Lupus Eritematoso Sistémico Systemic Lupus Erythematosus
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: Atacicept
Product Code: TACI-Fc5
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5
Merck Serono International SA, An affiliate of Merck KGaA, Darmstadt, GermanyNULLNot RecruitingFemale: yes
Male: yes
510Phase 2;Phase 3France;Czech Republic;Greece;Spain;Lithuania;Austria;Bulgaria;Latvia;Germany;Netherlands;United Kingdom
793EUCTR2006-005355-16-GB
(EUCTR)
07/05/200816/08/2007A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus ErythematosusA Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus (SLE)Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
423Portugal;Hungary;Germany;United Kingdom;Netherlands;France;Spain;Poland;Sweden
794EUCTR2006-005357-29-GB
(EUCTR)
07/05/200816/08/2007A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus ErythematosusA Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus Lupus NephritisProduct Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
369 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;France;Hungary;Poland;Spain;Bulgaria;Netherlands;Germany;United Kingdom;Sweden
795NCT00660881
(ClinicalTrials.gov)
May 200815/4/2008Open-label Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients With Active DiseaseA Phase IIb Multi-Center, Open-label, Follow-up Study to Assess Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients With Active Disease Who Participated in Study SL0007Systemic Lupus ErythematosusBiological: EpratuzumabUCB PharmaNULLCompleted18 YearsN/ABoth210Phase 2United States;Belgium;Brazil;Hong Kong;Hungary;India;Lithuania;Poland;Spain;Ukraine;United Kingdom
796NCT00611663
(ClinicalTrials.gov)
May 200828/1/2008Safety Study of Two Vaccine Strategies in Patients With Systemic Lupus ErythematosusVACCILUP A Multicenter, Randomized Double-blind Trial Comparing Two Pneumococcal Vaccination Strategies in Patients With Systemic Lupus ErythematosusLupus Erythematosus, SystemicBiological: Prevenar® and Pneumo23®;Biological: Placebo, Pneumo23®Assistance Publique - Hôpitaux de ParisNULLCompleted18 Years65 YearsBoth47Phase 2/Phase 3France
797NCT00508898
(ClinicalTrials.gov)
May 200827/7/2007The Efficacy and Safety of Calcitriol for the Treatment of Lupus Nephritis and Persistent ProteinuriaThe Efficacy and Safety of Calcitriol for the Treatment of Lupus Nephritis and Persistent ProteinuriaSystemic Lupus Erythematosus;Nephritis;ProteinuriaDrug: Calcitriol;Drug: MultivitaminChinese University of Hong KongNULLWithdrawn18 Years65 YearsBoth0Phase 4Hong Kong
798EUCTR2007-003698-13-AT
(EUCTR)
30/04/200810/03/2008A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/IIIA randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III Systemic Lupus Erythematosus
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: Atacicept
Product Code: TACI-Fc5
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5
Merck Serono SA - GenevaNULLNot RecruitingFemale: yes
Male: yes
510Phase 2/3France;Czech Republic;Greece;Spain;Lithuania;Austria;Bulgaria;Latvia;Germany;Netherlands;United Kingdom
799EUCTR2007-004892-21-BG
(EUCTR)
16/04/200815/04/2008A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety, Tolerability and Efficacy of Two Doses of Subcutaneous IPP-201101 Plus Standard of Care, Versus Placebo Plus Standard of Care in Subjects with Systemic Lupus Erythematosus (SLE)A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety, Tolerability and Efficacy of Two Doses of Subcutaneous IPP-201101 Plus Standard of Care, Versus Placebo Plus Standard of Care in Subjects with Systemic Lupus Erythematosus (SLE) Systemic Lupus Erythematosus (SLE)
MedDRA version: 9.1;Level: HLT;Classification code 10025135;Term: Lupus erythematosus (incl subtypes)
Product Code: IPP-201101
INN or Proposed INN: IPP - 201101
Other descriptive name: P 140
IMMUPHARMA SANULLNot RecruitingFemale: yes
Male: yes
296Phase 2Bulgaria;Spain
800EUCTR2007-002589-37-BE
(EUCTR)
10/04/200830/01/2008Open-label Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients With Active DiseaseA Phase IIb, Multi-center, Open-label, Follow-up Study to Assess the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease Who Participated inStudy SL0007. Systemic Lupus Erythematosus
MedDRA version: 14.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab
UCB IncNULLNot RecruitingFemale: yes
Male: yes
203Phase 2Hungary;Hong Kong;Brazil;Spain;Poland;Belgium;Ukraine;Lithuania;United Kingdom;India
801EUCTR2006-005355-16-SE
(EUCTR)
10/04/200821/12/2007A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus ErythematosusA Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus (SLE)Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
423Portugal;Hungary;Germany;United Kingdom;Netherlands;France;Spain;Poland;Sweden
802EUCTR2007-003698-13-CZ
(EUCTR)
09/04/200806/02/2008Atacicept phase II/III in Generalized Systemic Lupus Erythematosus (APRIL SLE)A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III Systemic Lupus Erythematosus
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Product Name: Atacicept
Product Code: TACI-Fc5
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5
Merck Serono S.A. Geneva. An affiliate of Merck KGaA, Darmstadt, GermanyNULLNot RecruitingFemale: yes
Male: yes
510Phase 2/3United States;Philippines;Taiwan;Greece;Spain;Lebanon;Israel;Chile;India;France;Malaysia;Australia;Peru;Netherlands;Latvia;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Mexico;Argentina;Brazil;Croatia;Bulgaria;Germany
803EUCTR2006-005355-16-PL
(EUCTR)
04/04/200803/01/2008A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus (SLE)Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
423Phase 3United Kingdom;Sweden;Portugal;France;Hungary;Spain;Poland;Netherlands;Germany
804EUCTR2007-002589-37-LT
(EUCTR)
02/04/200808/01/2008Open-label Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients With Active DiseaseA Phase IIb, Multi-center, Open-label, Follow-up Study to Assess the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease Who Participated in Study SL0007. - SL0008 Systemic Lupus Erythematosus
MedDRA version: 14.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: epratuzumab
Product Code: CDP3194
INN or Proposed INN: epratuzumab
UCB IncNULLNot RecruitingFemale: yes
Male: yes
175Phase 2India;Hungary;United Kingdom;Ukraine;Belgium;Spain;Hong Kong;Poland;Brazil;Lithuania
805EUCTR2007-003698-13-NL
(EUCTR)
01/04/200808/01/2008Atacicept Phase II/III in Generalized Systemic Lupus Erythematosus (APRIL SLE)A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III Systemic Lupus Erythematosus
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Atacicept
Product Code: TACI-Fc5
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5
Merck Serono S.A. Geneva. An affiliate of Merck KGaA, Darmstadt, GermanyNULLNot RecruitingFemale: yes
Male: yes
510Phase 2/3Serbia;United States;Philippines;Taiwan;Greece;Spain;Lebanon;Israel;Chile;Switzerland;India;France;Malaysia;Peru;Australia;Latvia;Netherlands;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Mexico;Argentina;Brazil;Croatia;Bulgaria;Germany
806NCT00866229
(ClinicalTrials.gov)
April 200819/3/2009Efficacy and Adverse Effect of Simvastatin Compare to Rosuvastatin in Systemic Lupus Erythematosus (SLE) Patients With Corticosteroid Therapy and High Low-Density Lipoprotein (LDL) Cholesterol LevelEfficacy and Adverse Effect of Simvastatin Compare to Rosuvastatin in SLE Patients With Corticosteroid Therapy and High LDL Cholesterol LevelSystemic Lupus Erythematosus;High LDL Cholesterol LevelDrug: Rosuvastatin;Drug: SimvastatinRamathibodi HospitalAstraZenecaRecruiting18 Years60 YearsBoth140Phase 4Thailand
807EUCTR2007-002589-37-ES
(EUCTR)
26/03/200807/02/2008Estudio en fase IIb de seguimiento abierto, multicéntrico para evaluar la seguridad y la eficacia del epratuzumab en pacientes con lupus eritematoso sistémico activo con serología positiva que participaron en el estudio SL0007A Phase IIb, Multi-center, Open-label, Follow-up Study to Assess the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease Who Participated in Study SL0007. - SL0008Estudio en fase IIb de seguimiento abierto, multicéntrico para evaluar la seguridad y la eficacia del epratuzumab en pacientes con lupus eritematoso sistémico activo con serología positiva que participaron en el estudio SL0007A Phase IIb, Multi-center, Open-label, Follow-up Study to Assess the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease Who Participated in Study SL0007. - SL0008 Lupus eritematoso sistémicosystemic lupus erythematosus
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: epratuzumab
Product Code: CDP3194
INN or Proposed INN: epratuzumab
UCB IncNULLNot RecruitingFemale: yes
Male: yes
175Phase 2Hungary;Belgium;Spain;Lithuania;United Kingdom
808EUCTR2006-005355-16-DE
(EUCTR)
25/03/200801/10/2007A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus ErythematosusA Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus (SLE)Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
423Portugal;Hungary;United Kingdom;Germany;Netherlands;France;Spain;Poland;Sweden
809EUCTR2007-003621-24-DE
(EUCTR)
20/03/200813/02/2009Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD).
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
Product Name: Aviptadil
Product Code: VIP
INN or Proposed INN: Aviptadil
Other descriptive name: VIP
MondoGEN AGNULLNot RecruitingFemale: yes
Male: yes
48United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria
810EUCTR2007-002566-35-GB
(EUCTR)
19/03/200829/11/2007A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007 systemic lupus erythematosus
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: epratuzumab
Product Code: CDP3194
INN or Proposed INN: epratuzumab
Other descriptive name: hLL2
UCB IncNULLNot RecruitingFemale: yes
Male: yes
210Phase 2Hungary;United Kingdom;Belgium;Spain;Lithuania
811EUCTR2005-004575-37-GB
(EUCTR)
14/03/200808/10/2008A Phase II/III Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects with Active Proliferative Glomerulonephritis Due to Systemic Lupus Erythematosus (SLE). Revised Protocol 03, incorporating Protocol Amendment 05 (V2.0, dated 08-Feb-2008), Administrative Letter 01 (dated 13-Jun-2007), Protocol Amendment 07 (V1.0, dated 17-Apr-2008), and Protocol Amendment 11 (V1.0, dated 11-Dec-2008). + Pharmacogenetics Blood Sample Amendment Number 1 - Site Specific (V2.0, Date 19-Jan-07). And Protocol Amendment 02 - Site specific (v1.0, date 09-Mar-2007).A Phase II/III Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects with Active Proliferative Glomerulonephritis Due to Systemic Lupus Erythematosus (SLE). Revised Protocol 03, incorporating Protocol Amendment 05 (V2.0, dated 08-Feb-2008), Administrative Letter 01 (dated 13-Jun-2007), Protocol Amendment 07 (V1.0, dated 17-Apr-2008), and Protocol Amendment 11 (V1.0, dated 11-Dec-2008). + Pharmacogenetics Blood Sample Amendment Number 1 - Site Specific (V2.0, Date 19-Jan-07). And Protocol Amendment 02 - Site specific (v1.0, date 09-Mar-2007). IMMUNOSUPPRESSION FOR DISEASE, NOS
MedDRA version: 9.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic
Trade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Trade Name: CellCept
Product Name: mycophenolate mofetil
INN or Proposed INN: mycophenolate mofetil
Other descriptive name: CellCept
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
460Phase 2;Phase 3France;Belgium;United Kingdom
812EUCTR2006-005355-16-PT
(EUCTR)
07/03/200823/11/2007A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus ErythematosusA Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus (SLE)Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
423Hungary;Portugal;Germany;United Kingdom;Netherlands;France;Spain;Poland;Sweden
813EUCTR2006-005357-29-PT
(EUCTR)
07/03/200823/11/2007A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus ErythematosusA Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus Lupus NephritisProduct Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
369Hungary;Portugal;Germany;United Kingdom;Netherlands;Bulgaria;France;Spain;Sweden
814EUCTR2007-003698-13-GB
(EUCTR)
06/03/200813/12/2007Atacicept Phase II/III in Generalized Systemic Lupus Erythematosus (APRIL SLE)A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III Systemic Lupus Erythematosus
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Atacicept
Product Code: TACI-Fc5
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5
Merck Serono S.A. Geneva. An affiliate of Merck KGaA, Darmstadt, GermanyNULLNot Recruiting Female: yes
Male: yes
510 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Serbia;Philippines;Taiwan;Greece;Spain;Lebanon;Chile;Israel;Switzerland;India;France;Malaysia;Australia;Peru;Latvia;Netherlands;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Mexico;Argentina;Brazil;Croatia;Bulgaria;Germany
815EUCTR2007-003698-13-FR
(EUCTR)
04/03/200828/01/2008A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/IIIA randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III Systemic Lupus Erythematosus
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: Atacicept
Product Code: TACI-Fc5
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5
Merck Serono International SA, An affiliate of Merck KGaA, Darmstadt, GermanyNULLNot RecruitingFemale: yes
Male: yes
510Phase 2;Phase 3France;Czech Republic;Greece;Spain;Lithuania;Austria;Bulgaria;Latvia;Germany;Netherlands;United Kingdom
816EUCTR2007-002566-35-BE
(EUCTR)
25/02/200803/12/2007A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007 systemic lupus erythematosus
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: epratuzumab
Product Code: CDP3194
INN or Proposed INN: epratuzumab
Other descriptive name: hLL2
UCB IncNULLNot RecruitingFemale: yes
Male: yes
210Phase 2Hungary;United Kingdom;Belgium;Spain;Lithuania
817EUCTR2006-005355-16-NL
(EUCTR)
22/02/200822/11/2007A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus ErythematosusA Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus (SLE)Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
423Portugal;Hungary;Germany;United Kingdom;Netherlands;France;Spain;Poland;Sweden
818EUCTR2006-005357-29-NL
(EUCTR)
22/02/200822/11/2007A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus ErythematosusA Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus Lupus NephritisProduct Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
369Phase 3Portugal;France;Hungary;Poland;Spain;Bulgaria;Germany;Netherlands;United Kingdom;Sweden
819EUCTR2006-000674-73-ES
(EUCTR)
21/02/200803/12/2007ESTUDIO ALEATORIZADO, A DOBLE CIEGO, CONTROLADO CON PLACEBO, DE TRES BRAZOS, GRUPOS PARALELOS, MULTICÉNTRICO Y MULTINACIONAL SOBRE LA SEGURIDAD Y EFICACIA DE 300 MG Y 900 MG DE ABETIMUS SÓDICO EN PACIENTES CON LUPUS ERITEMATOSO SISTÉMICO (LES) CON ANTECEDENTES DE NEFROPATÍAESTUDIO ALEATORIZADO, A DOBLE CIEGO, CONTROLADO CON PLACEBO, DE TRES BRAZOS, GRUPOS PARALELOS, MULTICÉNTRICO Y MULTINACIONAL SOBRE LA SEGURIDAD Y EFICACIA DE 300 MG Y 900 MG DE ABETIMUS SÓDICO EN PACIENTES CON LUPUS ERITEMATOSO SISTÉMICO (LES) CON ANTECEDENTES DE NEFROPATÍA Systemic lupus erythematosus patients with a history of renal disease
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: Abetimus sodium
Product Code: LJP 394
INN or Proposed INN: Abetimus Sodium
La Jolla Pharmaceutical CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
730Portugal;Hungary;Czech Republic;Germany;Bulgaria;Spain;Italy
820EUCTR2007-002566-35-ES
(EUCTR)
14/02/200820/12/2007Estudio en fase IIb aleatorizado, doble ciego, controlado con placebo, de búsqueda de dosis y pauta posológica, para evaluar la seguridad y eficacia de epratuzumab en pacientes con lupus eritematoso sistémico con serología positiva y enfermedad activa.A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007Estudio en fase IIb aleatorizado, doble ciego, controlado con placebo, de búsqueda de dosis y pauta posológica, para evaluar la seguridad y eficacia de epratuzumab en pacientes con lupus eritematoso sistémico con serología positiva y enfermedad activa.A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007 Lupus eritematoso sistémicosystemic lupus erythematosus
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: epratuzumab
Product Code: CDP3194
INN or Proposed INN: epratuzumab
Other descriptive name: hLL2
UCB IncNULLNot RecruitingFemale: yes
Male: yes
210Phase 2Hungary;Belgium;Spain;Lithuania;United Kingdom
821EUCTR2007-002566-35-LT
(EUCTR)
11/02/200804/12/2007A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007 systemic lupus erythematosus
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: epratuzumab
Product Code: CDP3194
INN or Proposed INN: epratuzumab
Other descriptive name: hLL2
UCB IncNULLNot RecruitingFemale: yes
Male: yes
210Phase 2Hungary;United Kingdom;Belgium;Spain;Lithuania
822NCT00626197
(ClinicalTrials.gov)
February 200820/2/2008A Study to Evaluate Ocrelizumab in Patients With Nephritis Due to Systemic Lupus Erythematosus (BELONG)A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Two Doses of Ocrelizumab in Patients With WHO or ISN Class III or IV Nephritis Due to Systemic Lupus ErythematosusLupus Nephritis;Systemic Lupus ErythematosusDrug: corticosteroids;Drug: cyclophosphamide;Drug: mycophenolate mofetil;Drug: ocrelizumab;Drug: placeboGenentech, Inc.Roche Pharma AGCompleted16 YearsN/AAll381Phase 3United States
823EUCTR2006-005357-29-DE
(EUCTR)
31/01/200801/10/2007A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus - BELONGA Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus - BELONG Lupus NephritisProduct Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
369Portugal;Hungary;United Kingdom;Germany;Netherlands;Bulgaria;France;Spain;Sweden
824EUCTR2006-005357-29-SE
(EUCTR)
30/01/200821/12/2007A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus ErythematosusA Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus Lupus NephritisProduct Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
369Portugal;France;Hungary;Spain;Bulgaria;Netherlands;Germany;United Kingdom;Sweden
825EUCTR2006-000674-73-DE
(EUCTR)
23/01/200816/10/2007A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, THREE-ARM,PARALLEL-GROUP, MULTICENTER, MULTINATIONAL SAFETY ANDEFFICACY TRIAL OF 300 MG AND 900 MG OF ABETIMUS SODIUM INSYSTEMIC LUPUS ERYTHEMATOSUS (SLE) PATIENTS WITH A HISTORY OFRENAL DISEASEA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, THREE-ARM,PARALLEL-GROUP, MULTICENTER, MULTINATIONAL SAFETY ANDEFFICACY TRIAL OF 300 MG AND 900 MG OF ABETIMUS SODIUM INSYSTEMIC LUPUS ERYTHEMATOSUS (SLE) PATIENTS WITH A HISTORY OFRENAL DISEASE Systemic lupus erythematosus patients with a history of renal disease
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: Abetimus sodium
Product Code: LJP 394
INN or Proposed INN: Abetimus Sodium
La Jolla Pharmaceutical CompanyNULLNot RecruitingFemale: yes
Male: yes
850Portugal;Hungary;Czech Republic;Germany;Bulgaria;Spain;Italy
826ChiCTR-TRC-12001935
2008-01-122012-02-12Effect of Detoxification, Removing Stasis and Nourishing Kidney Method on Promoting the Reduction of Prednisone in Treating SLEEffect of Detoxification, Removing Stasis and Nourishing Kidney Method on Promoting the Reduction of Prednisone in Treating SLE mild-to-moderate systemic lupus erythematosusTreatment Group:treated with prednisone and Jieduquyuzishen recipe;control group:treated with prednisone;Zhejinag University of Chinese MedicineNULLCompleted1860BothTreatment Group:161;control group:161;3 (Phase 3 study)China
827EUCTR2006-000674-73-PT
(EUCTR)
11/01/200817/09/2007A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, THREE-ARM,PARALLEL-GROUP, MULTICENTER, MULTINATIONAL SAFETY ANDEFFICACY TRIAL OF 300 MG AND 900 MG OF ABETIMUS SODIUM INSYSTEMIC LUPUS ERYTHEMATOSUS (SLE) PATIENTS WITH A HISTORY OFRENAL DISEASEA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, THREE-ARM,PARALLEL-GROUP, MULTICENTER, MULTINATIONAL SAFETY ANDEFFICACY TRIAL OF 300 MG AND 900 MG OF ABETIMUS SODIUM INSYSTEMIC LUPUS ERYTHEMATOSUS (SLE) PATIENTS WITH A HISTORY OFRENAL DISEASE Systemic lupus erythematosus patients with a history of renal disease
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: Abetimus sodium
Product Code: LJP 394
INN or Proposed INN: Abetimus Sodium
La Jolla Pharmaceutical CompanyNULLNot RecruitingFemale: yes
Male: yes
730Portugal;Czech Republic;Hungary;Spain;Bulgaria;Germany;Italy
828EUCTR2006-000674-73-CZ
(EUCTR)
07/01/200825/10/2007A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, THREE-ARM,PARALLEL-GROUP, MULTICENTER, MULTINATIONAL SAFETY ANDEFFICACY TRIAL OF 300 MG AND 900 MG OF ABETIMUS SODIUM INSYSTEMIC LUPUS ERYTHEMATOSUS (SLE) PATIENTS WITH A HISTORY OFRENAL DISEASEA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, THREE-ARM,PARALLEL-GROUP, MULTICENTER, MULTINATIONAL SAFETY ANDEFFICACY TRIAL OF 300 MG AND 900 MG OF ABETIMUS SODIUM INSYSTEMIC LUPUS ERYTHEMATOSUS (SLE) PATIENTS WITH A HISTORY OFRENAL DISEASE Systemic lupus erythematosus patients with a history of renal disease
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: Abetimus sodium
Product Code: LJP 394
INN or Proposed INN: Abetimus Sodium
La Jolla Pharmaceutical CompanyNULLNot RecruitingFemale: yes
Male: yes
730Portugal;Hungary;Germany;Czech Republic;Bulgaria;Spain;Italy
829NCT00624338
(ClinicalTrials.gov)
January 200815/2/2008Atacicept Phase 2/3 in Generalized Systemic Lupus Erythematosus (APRIL-SLE)A Randomised, Double-blind, Placebo Controlled, Multicentre Prospective Dose-finding Phase II/III Study With Atacicept Given Subcutaneously to Subjects Having Recently Experienced a Flare of Systemic Lupus Erythematosus (SLE)Lupus Erythematosus, SystemicDrug: Atacicept 75 mg;Drug: Atacicept 150 mg;Other: Placebo ComparatorEMD SeronoMerck KGaACompleted16 YearsN/AAll461Phase 2/Phase 3United States;Argentina;Australia;Austria;Bulgaria;Croatia;Czech Republic;France;Germany;Greece;India;Israel;Korea, Republic of;Latvia;Lebanon;Lithuania;Malaysia;Mexico;Netherlands;Philippines;Poland;Russian Federation;Serbia;South Africa;Spain;Switzerland;Taiwan;Ukraine;United Kingdom
830NCT00624351
(ClinicalTrials.gov)
January 200815/2/2008Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus (SLE) Patients With Active DiseaseA Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus (SLE) Patients With Active DiseaseSystemic Lupus ErythematosusBiological: Epratuzumab;Other: PlaceboUCB PharmaNULLCompleted18 YearsN/ABoth227Phase 2United States;Belgium;Brazil;Hong Kong;Hungary;India;Lithuania;Poland;Spain;Ukraine;United Kingdom
831NCT00539838
(ClinicalTrials.gov)
December 19, 20073/10/2007A Study to Evaluate Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus (BEGIN)A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: Prednisone;Drug: Immunosuppressive regime (azathioprine, mycophenolate mofetil or methotrexate);Drug: Methylprednisolone;Drug: Ocrelizumab;Drug: PlaceboGenentech, Inc.Roche Pharma AGTerminated16 YearsN/AAll33Phase 3United States
832EUCTR2006-005177-21-AT
(EUCTR)
06/12/200726/02/2007A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 Systemic Lupus Erythematosus (SLE)
MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: belimumab
Product Code: HGS1006
INN or Proposed INN: belimumab
Other descriptive name: LymphoStat-B TM
Human Genome Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
810Phase 3Czech Republic;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
833NCT02291588
(ClinicalTrials.gov)
December 20073/11/2014A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 811 in Subjects With Systemic Lupus ErythematosusA Phase 1, Randomized, Double-blind, Placebo-controlled, Single Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 811 in Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: AMG 811;Drug: PlaceboAmgenNULLCompleted18 Years65 YearsBoth26Phase 1NULL
834EUCTR2006-005357-29-HU
(EUCTR)
21/11/200718/10/2007A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus Lupus NephritisProduct Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
369Phase 3Portugal;France;Hungary;Poland;Spain;Bulgaria;Netherlands;Germany;United Kingdom;Sweden
835EUCTR2005-004575-37-BE
(EUCTR)
21/11/200715/06/2007A Phase II/III Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects with Active Proliferative Glomerulonephritis Due to Systemic Lupus Erythematosus (SLE).Revised Protocol 05, incorporating Protocol Amendment 05 (V2.0, dated 08-Feb-2008), Administrative Letter 01 (dated 13-Jun-2007), Amendment 07 (V1.0, dated 17-Apr-2008), Amendment 11 (V1.0, dated 11-Dec-2008), Amendment 13 (V1.0, dated 30-Apr-2010), Amendment 14 (V1.0, dated 12-Oc t-2010), Administrative Letter 04 (V1.0, dated 15-Oct-2009), Administrative Letter 05 (V1.0, dated 02-Dec-2009), and Administrative Letter 06 (V1.0, dated 12-May-2010) + Pharmacogenetics Blood Sample Amendment Number 1 - Site Specific (V2.0, Date 19-Jan-07). And Protocol Amendment 02 - Site specific (v1.0, date 09-Mar-2007).A Phase II/III Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects with Active Proliferative Glomerulonephritis Due to Systemic Lupus Erythematosus (SLE).Revised Protocol 05, incorporating Protocol Amendment 05 (V2.0, dated 08-Feb-2008), Administrative Letter 01 (dated 13-Jun-2007), Amendment 07 (V1.0, dated 17-Apr-2008), Amendment 11 (V1.0, dated 11-Dec-2008), Amendment 13 (V1.0, dated 30-Apr-2010), Amendment 14 (V1.0, dated 12-Oc t-2010), Administrative Letter 04 (V1.0, dated 15-Oct-2009), Administrative Letter 05 (V1.0, dated 02-Dec-2009), and Administrative Letter 06 (V1.0, dated 12-May-2010) + Pharmacogenetics Blood Sample Amendment Number 1 - Site Specific (V2.0, Date 19-Jan-07). And Protocol Amendment 02 - Site specific (v1.0, date 09-Mar-2007). IMMUNOSUPPRESSION FOR DISEASE, NOS
MedDRA version: 9.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic
Trade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Trade Name: CellCept
Product Name: mycophenolate mofetil
INN or Proposed INN: mycophenolate mofetil
Other descriptive name: CellCept
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
460Phase 2;Phase 3France;Belgium;United Kingdom
836EUCTR2006-005355-16-HU
(EUCTR)
21/11/200718/10/2007A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus ErythematosusA Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus (SLE)Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
423Portugal;Hungary;Germany;United Kingdom;Netherlands;France;Spain;Poland;Sweden
837EUCTR2006-005355-16-FR
(EUCTR)
15/11/200728/08/2007A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus ErythematosusA Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus (SLE)
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
423Phase 3Portugal;France;Hungary;Poland;Spain;Netherlands;Germany;United Kingdom;Sweden
838EUCTR2007-004635-29-DK
(EUCTR)
09/11/200702/10/2007Randomised, placebo controlled, international multi-centre, double blind, dose confirmation study testing the safety and efficacy of ASF-1096 cream 0.25%, 0.5% and 1% and placebo applied twice daily in the treatment of cutaneous lupus erythematosus lesions - ASF-1096-301Randomised, placebo controlled, international multi-centre, double blind, dose confirmation study testing the safety and efficacy of ASF-1096 cream 0.25%, 0.5% and 1% and placebo applied twice daily in the treatment of cutaneous lupus erythematosus lesions - ASF-1096-301 Patients with Discoid Lupus Erythematosus (DLE) or Subacute Cutaneous Lupus Erythematosus (SCLE) symptoms of the skin can be included in this study. Those patients who have a diagnosis of Systemic Lupus Erythematosus (SLE) with DLE or SCLE lesions of the skin can also be included in the study.Product Name: ASF-1096 Cream 0.25%
INN or Proposed INN: R-salbutamol sulphate
Product Name: ASF-1096 Cream 0.5%
INN or Proposed INN: R-salbutamol sulphate
Product Name: ASF-1096 Cream 1.0%
INN or Proposed INN: R-salbutamol sulphate
Astion Pharma A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Denmark;Spain;Sweden
839EUCTR2006-005357-29-FR
(EUCTR)
09/11/200724/08/2007A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus ErythematosusA Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus Patients with ISN/RPS or WHO class III or IV Active Lupus Nephritis
MedDRA version: 9.1;Level: LLT;Classification code 10025140;Term: Lupus nephritis
Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
369Phase 3Portugal;France;Hungary;Poland;Spain;Bulgaria;Netherlands;Germany;United Kingdom;Sweden
840EUCTR2007-004635-29-SE
(EUCTR)
07/11/200712/09/2007Randomised, placebo controlled, international multi-centre, double blind, dose confirmation study testing the safety and efficacy of ASF-1096 cream 0.25%, 0.5% and 1% and placebo applied twice daily in the treatment of cutaneous lupus erythematosus lesions - ASF-1096-301Randomised, placebo controlled, international multi-centre, double blind, dose confirmation study testing the safety and efficacy of ASF-1096 cream 0.25%, 0.5% and 1% and placebo applied twice daily in the treatment of cutaneous lupus erythematosus lesions - ASF-1096-301 Patients with Discoid Lupus Erythematosus (DLE) or Subacute Cutaneous Lupus Erythematosus (SCLE) symptoms of the skin can be included in this study. Those patients who have a diagnosis of Systemic Lupus Erythematosus (SLE) with DLE or SCLE lesions of the skin can also be included in the study.Product Name: ASF-1096 Cream 0.25%
INN or Proposed INN: R-salbutamol sulphate
Product Name: ASF-1096 Cream 0.5%
INN or Proposed INN: R-salbutamol sulphate
Product Name: ASF-1096 Cream 1.0%
INN or Proposed INN: R-salbutamol sulphate
Astion Pharma A/SNULLNot RecruitingFemale: yes
Male: yes
140Denmark;Spain;Sweden
841NCT00611611
(ClinicalTrials.gov)
October 200728/1/2008BLYS and IFN in SLEBLyS and IFN Responses to Antigen Challenge in Human SLESystemic Lupus ErythematosusBiological: fluzone;Biological: pneumovaxUniversity of Alabama at BirminghamHospital for Special Surgery, New YorkCompleted19 Years65 YearsBoth39N/AUnited States
842EUCTR2006-005177-21-IT
(EUCTR)
20/09/200713/07/2007A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 76-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B?), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - HGS1006-C1056A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 76-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B?), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - HGS1006-C1056 Systemic Lupus Erythematosus
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: Belimumab
Product Code: HGS1006
HUMAN GENOME SCIENCES INCNULLNot RecruitingFemale: yes
Male: yes
810Phase 3Czech Republic;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
843NCT00739050
(ClinicalTrials.gov)
September 19, 200719/8/2008Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus (0733-271)(TERMINATED)Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: simvastatin;Drug: Comparator: PlaceboMerck Sharp & Dohme Corp.NULLTerminated18 YearsN/AFemale4Phase 4NULL
844EUCTR2006-005177-21-FR
(EUCTR)
11/09/200723/07/2007A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 Systemic Lupus Erythematosus (SLE)
MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: belimumab
Product Code: HGS1006
INN or Proposed INN: belimumab
Other descriptive name: LymphoStat-B TM
Human Genome Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
810Phase 3France;Czech Republic;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
845NCT00519363
(ClinicalTrials.gov)
September 200720/8/2007Statins and Lupus: Effects of Statins on Clinical Lupus Parameters, Serological Markers and Toll-like ReceptorsStatins and Lupus: Effects of Statins on Clinical Lupus Parameters, Serological Markers and Toll-like Receptors.Systemic Lupus ErythematosusDrug: atorvastatinThe Center for Rheumatic Disease, Allergy, & ImmunologySaint Luke's Health SystemCompleted18 Years60 YearsFemale15Phase 1/Phase 2United States
846EUCTR2007-004579-21-NL
(EUCTR)
27/08/200729/08/2007Does booster influenza vaccination improve vaccination efficacy in patients with quiescent systemic lupus erythematosus?Does booster influenza vaccination improve vaccination efficacy in patients with quiescent systemic lupus erythematosus? systemic lupus erythematosus (SLE)SLE is a systemic autoimmune disease.
MedDRA version: 9.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic
Trade Name: Influvac
INN or Proposed INN: Influenz virus surface antigens
Other descriptive name: INFLUENZA VACCINE (SURFACE ANTIGEN, INACTIVATED)
University Medical Center GroningenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
847EUCTR2006-005177-21-NL
(EUCTR)
03/08/200704/06/2007A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 Systemic Lupus Erythematosus (SLE)
MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: belimumab
Product Code: HGS1006
INN or Proposed INN: belimumab
Other descriptive name: LymphoStat-B TM
Human Genome Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
810Phase 3Czech Republic;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
848NCT00479622
(ClinicalTrials.gov)
August 200725/5/2007Study of TRU-015 in Subjects With Membranous Nephropathy Secondary to Systemic Lupus ErythematosusA Randomized, Two-Arm, Parallel Group Study of the Safety, Pharmacokinetics, and Pharmacodynamics of TRU-015 Added to Standard Therapy in Subjects With Membranous Nephropathy Secondary to Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: TRU-015Wyeth is now a wholly owned subsidiary of PfizerEmergent Product Development Seattle LLCTerminated18 Years70 YearsBoth20Phase 1United States
849NCT00684255
(ClinicalTrials.gov)
August 200722/5/2008Reduced Intensity Transplant in Medically Refractory Systemic Lupus Erythematosus (SLE) and Systemic Sclerosis (SSc)Reduced Intensity Conditioning And Allogeneic Stem Cell Transplantation in Patients With Medically Refractory Systemic Lupus Erythematosus and Medically Refractory Systemic Sclerosis (SSc)Systemic Lupus Erythematosus;Systemic SclerosisProcedure: Reduced Intensity Allogeneic Transplant;Drug: Fludarabine;Drug: Busulfan;Drug: CampathNew York Medical CollegeNULLTerminated7 Years50 YearsAll1Phase 1United States
850NCT00504244
(ClinicalTrials.gov)
July 200718/7/2007Myfortic Versus Azathioprine in Systemic Lupus ErythematosusA Randomized, Multicenter Study to Assess the Efficacy on Diseases Activity of Enteric-coated Mycophenolate Sodium Versus Continuation of Azathioprine in Patients With Systemic Lupus Erythematosus on Azathioprine Maintenance Therapy.Systemic Lupus ErythematosusDrug: switch to Myfortic;Drug: continuation of azathioprineErasmus Medical CenterNovartis PharmaceuticalsTerminated18 YearsN/ABoth12Phase 3Netherlands
851EUCTR2006-005177-21-SE
(EUCTR)
08/06/200707/05/2007A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 Systemic Lupus Erythematosus (SLE)
MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: belimumab
Product Code: HGS1006
INN or Proposed INN: belimumab
Other descriptive name: LymphoStat-B TM
Human Genome Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
810Phase 3Czech Republic;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
852NCT00430677
(ClinicalTrials.gov)
June 20071/2/2007Efficacy and Safety Study of Abatacept to Treat Lupus NephritisA Phase II/III Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects With Active Proliferative Glomerulonephritis Due to Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: Corticosteroids (prednisone or prednisolone);Drug: Abatacept;Drug: Mycophenolate mofetil (MMF)Bristol-Myers SquibbNULLTerminated18 YearsN/AAll423Phase 2/Phase 3United States;Argentina;Australia;Belgium;Brazil;Canada;China;France;Hong Kong;India;Korea, Republic of;Mexico;Poland;Russian Federation;South Africa;Taiwan;Turkey;United Kingdom;Japan;Philippines;Puerto Rico
853NCT00482989
(ClinicalTrials.gov)
June 20074/6/2007A Study to Evaluate the Safety and Tolerability of Multiple Intravenous Doses of MEDI 545 in Patients With Systemic Lupus ErythematosusA Phase 1b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety and Tolerability of Multiple Intravenous Doses of MEDI-545, a Fully Human Anti-Interferon-Alpha Monoclonal Antibody, in Patients With Systemic Lupus ErythematosusLupusBiological: MEDI 545;Other: PlaceboMedImmune LLCNULLCompleted18 YearsN/ABoth183Phase 1United States;Argentina;Brazil;Chile;Canada
854NCT00413361
(ClinicalTrials.gov)
June 200718/12/2006The Reduction of Systemic Lupus Erythematosus Flares :Study PLUSStudy of the Reduction of Systemic Lupus Erythematosus Flares Through Adaptation of the Dosage of Hydroxychloroquine to Its Whole-blood Concentration. National Multicenter Randomized Prospective StudySystemic Lupus ErythematosusDrug: versus hydroxychloroquineAssistance Publique - Hôpitaux de ParisSanofi-SynthelaboCompleted18 YearsN/ABoth543Phase 4France
855EUCTR2006-005177-21-GB
(EUCTR)
29/05/200702/01/2007A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 Systemic Lupus Erythematosus (SLE)
MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: belimumab
Product Code: HGS1006
INN or Proposed INN: belimumab
Other descriptive name: LymphoStat-B TM
Human Genome Sciences, Inc.NULLNot Recruiting Female: yes
Male: yes
810 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Czech Republic;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
856EUCTR2006-005177-21-SK
(EUCTR)
17/05/200720/03/2007A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 Systemic Lupus Erythematosus (SLE)
MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: belimumab
Product Code: HGS1006
INN or Proposed INN: belimumab
Other descriptive name: LymphoStat-B TM
Human Genome Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
810Phase 3France;Czech Republic;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
857EUCTR2006-005177-21-ES
(EUCTR)
09/05/200709/03/2007A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE)Un estudio de fase III, multicéntrico, aleatorizado, doble ciego, controlado con placebo y de 76 semanas para evaluar la eficacia y la seguridad de belimumab (HGS1006, LymphoStat-BTM), un anticuerpo monoclonal totalmente humano anti-BLyS, en pacientes con lupus eritematoso sistémico (LES) - BLISS-76A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE)Un estudio de fase III, multicéntrico, aleatorizado, doble ciego, controlado con placebo y de 76 semanas para evaluar la eficacia y la seguridad de belimumab (HGS1006, LymphoStat-BTM), un anticuerpo monoclonal totalmente humano anti-BLyS, en pacientes con lupus eritematoso sistémico (LES) - BLISS-76 Systemic Lupus Erythematosus (SLE)Lupus Eritematoso Sistémico
MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: belimumab
Product Code: HGS1006
INN or Proposed INN: belimumab
Other descriptive name: LymphoStat-B TM
Human Genome Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
810Phase 3France;Czech Republic;Slovakia;Belgium;Spain;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
858EUCTR2006-005177-21-BE
(EUCTR)
07/05/200729/01/2007A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 Systemic Lupus Erythematosus (SLE)
MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: belimumab
Product Code: HGS1006
INN or Proposed INN: belimumab
Other descriptive name: LymphoStat-B TM
Human Genome Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
810Phase 3Czech Republic;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
859EUCTR2006-005177-21-DE
(EUCTR)
03/05/200720/02/2007A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 Systemic Lupus Erythematosus (SLE)
MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: belimumab
Product Code: HGS1006
INN or Proposed INN: belimumab
Other descriptive name: LymphoStat-B TM
Human Genome Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
810Phase 3Czech Republic;United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
860JPRN-UMIN000000763
2007/05/0105/07/2007Phase II study of rituximab in patients with severe systemic lupus erythematosusPhase II study of rituximab in patients with severe systemic lupus erythematosus - Rituximab clinical investigation in severe systemic lupus erythematosus Systemic lupus erythematosus1000 mg of rituximab on days 1, 15, 169 and 183Zenyaku Kogyo Co., Ltd.NULLComplete: follow-up complete16years-old75years-oldMale and Female30Phase 2Japan
861NCT00424476
(ClinicalTrials.gov)
May 200717/1/2007A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Wk Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: Placebo;Drug: Belimumab 1 mg/kg;Drug: Belimumab 10 mg/kgHuman Genome Sciences Inc.GlaxoSmithKlineCompleted18 YearsN/AAll865Phase 3Argentina;Australia;Brazil;Chile;Colombia;Hong Kong;India;Korea, Republic of;Peru;Philippines;Romania;Russian Federation;Taiwan;Bulgaria;China
862EUCTR2005-004575-37-FR
(EUCTR)
27/04/200726/03/2007A Sequential Adaptive Phase II/III Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects with Active Proliferative Glomerulonephritis Due to Systemic Lupus Erythematosus (SLE).And Pharmacogenetics Blood Sample Amendment Number 1 - Site Specific (Version 2.0, Date 19-Jan-07).A Sequential Adaptive Phase II/III Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects with Active Proliferative Glomerulonephritis Due to Systemic Lupus Erythematosus (SLE).And Pharmacogenetics Blood Sample Amendment Number 1 - Site Specific (Version 2.0, Date 19-Jan-07). IMMUNOSUPPRESSION FOR DISEASE, NOS
MedDRA version: 9.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Trade Name: CellCept
Product Name: mycophenolate mofetil
INN or Proposed INN: mycophenolate mofetil
Other descriptive name: CellCept
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
460Phase 2;Phase 3France;Belgium;United Kingdom
863EUCTR2006-005177-21-CZ
(EUCTR)
23/04/200728/02/2007A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 Systemic Lupus Erythematosus (SLE)
MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: belimumab
Product Code: HGS1006
INN or Proposed INN: belimumab
Other descriptive name: LymphoStat-B TM
Human Genome Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
810Phase 3Germany;United Kingdom;Czech Republic;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
864NCT00668330
(ClinicalTrials.gov)
April 200725/4/2008Steroid Induced Osteoporosis in Patients With Systemic Lupus ErythematosusSteroid Induced Osteoporosis in Patients With Systemic Lupus Erythematosus-Prevalence,Risk Factors and TreatmentSystemic Lupus ErythematosusDrug: Ibandronate+alfacalcidol+calcium;Drug: placebo ibandronate+alfacalcidol+calciumChinese University of Hong KongNULLCompleted18 Years80 YearsFemale40Phase 4China
865EUCTR2006-004892-36-SE
(EUCTR)
15/03/200709/02/2007An open randomized and comparative study on the efficacy and safety of additional treatment of subcutaneous immunoglobulin (Subcuvia) during cessation of Prednisolon in patients with active systemic lupus erythematosus (SLE)An open randomized and comparative study on the efficacy and safety of additional treatment of subcutaneous immunoglobulin (Subcuvia) during cessation of Prednisolon in patients with active systemic lupus erythematosus (SLE) Systemic Lupus Erythematosus (SLE)
MedDRA version: 9.1;Level: LLT;Classification code 10040967;Term: SLE
Trade Name: SubcuviaDepartment of Rheumatology,University hospital,LundNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Sweden
866EUCTR2006-001062-17-SE
(EUCTR)
07/03/200712/01/2007Efficacy and safety of ASF-1096 Cream 0.5% in the treatment of patients with newly developed discoid lupus erythematosus (DLE) lesions. A multi centre clinical phase 2, placebo controlled and double blind proof of concept study. - Lupus studyEfficacy and safety of ASF-1096 Cream 0.5% in the treatment of patients with newly developed discoid lupus erythematosus (DLE) lesions. A multi centre clinical phase 2, placebo controlled and double blind proof of concept study. - Lupus study Male or female patients with a clinical diagnosis of either Discoid Lupus Erythematosus or Systemic Lupus Erythematosus and at least one newly developed, sharply demarcated DLE lesion.
MedDRA version: 8.1;Level: LLT;Classification code 10025138;Term:
Product Name: ASF-1096 Cream 0.5%Astion Danmark A/SNULLNot RecruitingFemale: yes
Male: yes
52Phase 2United Kingdom;Sweden
867JPRN-UMIN000000639
2007/03/0116/03/2007A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II/III study of Rituximab in Patients with Systemic Lupus ErythematosusA Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II/III study of Rituximab in Patients with Systemic Lupus Erythematosus - Rituximab clinical Investigation in Systemic lupus Erythematosus (RISE study) Systemic lupus erythematosusIDEC-C2B8 plus oral prednisolone(tapering)
1000 mg of IDEC-C2B8 on days 1 and 15.Repeated at an interval of 6 months (Days 169 and 183).
Placebo plus oral prednisolone(tapering)
1000 mg of placebo day 1 and 15.Repeated at an interval of 6 months (Days 169 and 183).
Zenyaku Kogyo Co., Ltd.NULLComplete: follow-up complete16years-old75years-oldMale and Female150Phase 2/3Japan
868NCT01702740
(ClinicalTrials.gov)
March 20076/7/2012A Study of the Safety and Pharmacokinetics of CNTO 136 in Patients With Cutaneous Lupus Erythematosus and Systemic Lupus ErythematosusA Phase 1, Double-blind, Placebo-controlled, Multiple Intravenous, Ascending-Dose Study of CNTO 136 to Evaluate Safety and Pharmacokinetics in Subjects With Cutaneous Lupus Erythematosus and to Evaluate Safety and Pharmacokinetics in a Cohort of Subjects With Systemic Lupus ErythematosusLupus Erythematosus, Cutaneous;Lupus Erythematosus, SystemicDrug: 1 mg/kg CNTO 136;Drug: 4 mg/kg CNTO 136;Drug: 10 mg/kg CNTO 136;Drug: PlaceboCentocor Research & Development, Inc.NULLCompleted18 Years70 YearsBoth49Phase 1NULL
869NCT00698191
(ClinicalTrials.gov)
March 200713/6/2008Mesenchymal Stem Cells Transplantation for Refractory Systemic Lupus Erythematosus (SLE)Phase I/IIa: Allogeneic Bone Marrow Derived Mesenchymal Stem Cells Transplantation For Refractory Systemic Lupus ErythematosusRefractory Systemic Lupus ErythematosusBiological: Allogeneic MSC (AlloMSC)Nanjing Medical UniversityNational Natural Science Foundation of ChinaRecruiting15 Years70 YearsBoth20Phase 1/Phase 2China
870NCT00432354
(ClinicalTrials.gov)
March 20076/2/2007An Open Labeled Pilot Study of Atorvastatin in Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: atorvastatinBuddhist Tzu Chi General HospitalPfizerRecruiting16 Years80 YearsBoth40Phase 2/Phase 3Taiwan
871NCT01322308
(ClinicalTrials.gov)
March 200723/3/2011Effect of Pioglitazone on Endothelial Function in Premenopausal Women With Uncomplicated Systemic Lupus ErythematosusEffect of Pioglitazone on Endothelial Function in Premenopausal Women With Uncomplicated Systemic Lupus Erythematosus, a Randomized, Double-blind, Placebo-controlled Clinical TrialSystemic Lupus ErythematosusDrug: pioglitazone;Drug: placeboNational Heart Institute, MexicoNational Council of Science and Technology, Mexico;Universidad Nacional Autonoma de MexicoCompleted18 Years55 YearsFemale30Phase 4NULL
872NCT00541749
(ClinicalTrials.gov)
February 20077/10/2007A Study of rhuMAb IFNalpha in Adults With Systemic Lupus ErythematosusA Phase I, Randomized, Double-Blind, Placebo-Controlled, Escalating Single- and Multiple-Dose Study of the Safety, Tolerability, and Pharmacokinetics of rhuMAb IFNalpha in Adults With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: rhuMAb IFNalphaGenentech, Inc.NULLCompleted18 Years65 YearsBoth60Phase 1United States
873NCT01845740
(ClinicalTrials.gov)
January 200717/4/2013Phase Ib Study of SC Milatuzumab in SLEA Phase Ib Study of Milatuzumab Administered Subcutaneously in Patients With Active Systemic Lupus Erythematosus (SLE)Lupus Erythematosus, Cutaneous;Lupus Erythematosus, Discoid;Lupus Erythematosus, Systemic;Lupus Vasculitis, Central Nervous System;Lupus NephritisDrug: milatuzumab;Drug: PlaceboGilead SciencesUnited States Department of DefenseCompleted18 YearsN/AAll22Phase 1United States
874NCT00382837
(ClinicalTrials.gov)
January 200729/9/2006Study of Epratuzumab in Systemic Lupus ErythematosusA Phase III Multi-Center, OpenLabel, Follow-Up Study to Assess the Safety & Efficacy of Epratuzumab in Patients With Acute Severe SLE Flares Excluding the Renal or Neurologic SystemsSystemic Lupus ErythematosusDrug: EpratuzumabUCB PharmaNULLWithdrawn18 YearsN/ABoth0Phase 3United States;Belgium;Brazil;Canada;Czech Republic;France;Germany;Hungary;Italy;Netherlands;Slovakia;Spain;United Kingdom
875EUCTR2005-003957-28-DK
(EUCTR)
21/12/200620/11/2006FIVE-YEAR SINGLE-BLIND, PHASE III EFFECTIVENESS RANDOMISEDACTIVELY CONTROLLED CLINICAL TRIAL IN NEW ONSET JUVENILESYSTEMIC LUPUS ERYTHEMATOSUS NEPHRITIS: ORALCYCLOPHOSPHAMIDE VERSUS HIGH DOSE INTRAVENOUSCYCLOPHOSPHAMIDE VERSUS INTERMEDIATE DOSE INTRAVENOUSCYCLOPHOSPHAMIDEFIVE-YEAR SINGLE-BLIND, PHASE III EFFECTIVENESS RANDOMISEDACTIVELY CONTROLLED CLINICAL TRIAL IN NEW ONSET JUVENILESYSTEMIC LUPUS ERYTHEMATOSUS NEPHRITIS: ORALCYCLOPHOSPHAMIDE VERSUS HIGH DOSE INTRAVENOUSCYCLOPHOSPHAMIDE VERSUS INTERMEDIATE DOSE INTRAVENOUSCYCLOPHOSPHAMIDE SYSTEMIC LUPUS ERYTHEMATOSUS NEPHRITIS
MedDRA version: 8.1;Level: LLT;Classification code 10029142;Term: Nephritis systemic lupus erythematosus
Product Name: Cyclophosphamide
Product Name: Cyclophosphamide
Istituto Giannina GasliniNULLNot RecruitingFemale: yes
Male: yes
141Phase 3Denmark;Italy
876NCT00410384
(ClinicalTrials.gov)
December 20068/12/2006A Study of Belimumab in Subjects With Systemic Lupus ErythematosusA Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 76-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: Placebo;Drug: Belimumab 1 mg/kg;Drug: Belimumab 10 mg/kgHuman Genome Sciences Inc.GlaxoSmithKlineCompleted18 YearsN/AAll819Phase 3United States;Austria;Belgium;Canada;Costa Rica;Czech Republic;France;Germany;Israel;Italy;Mexico;Netherlands;Poland;Puerto Rico;Romania;Slovakia;Spain;Sweden;United Kingdom
877NCT00418587
(ClinicalTrials.gov)
December 20064/1/2007Vitamin D Therapy in Patients With Systemic Lupus Erythematosus (SLE)Phase 1 Study of Vitamin D Therapy in Patients With Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: CholecalciferolMedical University of South CarolinaAmerican College of Rheumatology Research and Education Foundation;National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Completed18 Years85 YearsAll18Phase 1United States
878EUCTR2006-002107-13-IT
(EUCTR)
24/11/200609/03/2007A randomized, multicenter, open-label, 6-month study to explore the efficacy and safety of enteric-coated mycophenolate sodium myfortic in combination with two corticosteroid regimens for the treatment of lupus nephritis flare - NDA randomized, multicenter, open-label, 6-month study to explore the efficacy and safety of enteric-coated mycophenolate sodium myfortic in combination with two corticosteroid regimens for the treatment of lupus nephritis flare - ND Systemic lupus erythematosis
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Trade Name: MYFORTIC*50CPR RIV 360MG
INN or Proposed INN: Mycophenolic acid
Trade Name: DELTACORTENE*20CPR 5MG
INN or Proposed INN: Prednisone
Trade Name: MYFORTIC*50CPR RIV 360MG
INN or Proposed INN: Mycophenolic acid
Trade Name: DELTACORTENE*20CPR 5MG
INN or Proposed INN: Prednisone
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
80Hungary;Germany;United Kingdom;France;Spain;Italy;Greece
879NCT02391259
(ClinicalTrials.gov)
November 20066/1/2015A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus ErythematosusRandomized, Multicenter, Double-Blind, Placebo-Controlled, Rising Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: AMG 557;Drug: PlaceboAmgenNULLCompleted18 Years70 YearsBoth57Phase 1United States;United Kingdom
880NCT00594932
(ClinicalTrials.gov)
November 20064/1/2008Biomarker-Linked Outcomes of Cellcept in Lupus ArthritisBiomarker-Linked Outcomes of Cellcept in Lupus ArthritisSystemic Lupus Erythematosus;ArthritisDrug: mycophenolate mofetil;Other: placeboOklahoma Medical Research FoundationNYU Langone HealthCompleted14 Years70 YearsAll27Phase 1/Phase 2United States
881EUCTR2006-000674-73-SK
(EUCTR)
09/10/200609/08/2006A Randomized, Double-Blind, Placebo-Controlled, Four-Arm, Parallel-Group, Multicenter, Multinational Safety and Efficacy Trial of 100 mg, 300 mg, and 900 mg of Abetimus Sodium in Systemic Lupus Erythematosus (SLE) Patients with a History of Renal DiseaseA Randomized, Double-Blind, Placebo-Controlled, Four-Arm, Parallel-Group, Multicenter, Multinational Safety and Efficacy Trial of 100 mg, 300 mg, and 900 mg of Abetimus Sodium in Systemic Lupus Erythematosus (SLE) Patients with a History of Renal Disease Systemic lupus erythematosus patients with a history of renal disease
MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: Abetimus
Product Code: LJP 394
INN or Proposed INN: Abetimus Sodium
La Jolla Pharmaceutical CompanyNULLNot RecruitingFemale: yes
Male: yes
588Phase 3Portugal;Czech Republic;Hungary;Slovakia;Spain;Bulgaria;Germany;Italy
882EUCTR2005-004067-30-DE
(EUCTR)
05/10/200611/05/2006A Double Blind, Randomized, Placebo Controlled, Multi-Center Trial of Anti-TNFafa Chimeric Monoclonal Antibody (Infliximab, Remicade®) and Azathioprine in Patients Suffering from Systemic Lupus Erythematosus (SLE) with WHO Class V GlomerulonephritisA Double Blind, Randomized, Placebo Controlled, Multi-Center Trial of Anti-TNFafa Chimeric Monoclonal Antibody (Infliximab, Remicade®) and Azathioprine in Patients Suffering from Systemic Lupus Erythematosus (SLE) with WHO Class V Glomerulonephritis Systemic Lupus Erythematosus (SLE) with WHO Class V GlomerulonephritisTrade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Trade Name: Azathioprine
Other descriptive name: Azathioprine
Department of Rheumatology, Internal Medicine III, Medical University of ViennaNULLNot RecruitingFemale: yes
Male: yes
44Germany;Netherlands;Austria
883NCT00390091
(ClinicalTrials.gov)
September 200617/10/2006Study of LJP 394 (Abetimus Sodium) in Lupus PatientsA Randomized, Double-Blind Study to Evaluate the Safety, Pharmacokinetic and Pharmacodynamic Effects of Abetimus Sodium in Patients With Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: abetimus sodium (LJP 394)La Jolla Pharmaceutical CompanyNULLWithdrawn12 Years70 YearsBoth0Phase 2United States
884NCT00588393
(ClinicalTrials.gov)
September 200622/12/2007FolateScan in Autoimmune DiseaseStudy of the Efficacy and Safety of FolateScan (Technetium TC99m EC20) in Patients With Rheumatoid Arthritis and Other Inflammatory DiseasesRheumatoid Arthritis;Osteoarthritis;Multiple Sclerosis;Crohn's Disease;Systemic Lupus ErythematosusDrug: FolateScan (Technetium Tc 99mEC20)Mayo ClinicEndocyteCompleted18 YearsN/ABoth75Phase 2United States
885NCT00368264
(ClinicalTrials.gov)
September 200623/8/2006TNF Blockade With Remicade in Active Lupus Nephritis WHO Class V (TRIAL )A Double Blind, Randomized, Placebo Controlled, Multi-Center Trial of Anti-TNF-alpha Chimeric Monoclonal Antibody (Infliximab) and Azathioprine in Patients Suffering From Systemic Lupus Erythematosus (SLE) With WHO Class V GlomerulonephritisLupus Erythematosus, Systemic;Lupus NephritisDrug: infliximab;Drug: placeboMedical University of ViennaHospital Hietzing;Medical University of Graz;Charite University, Berlin, Germany;University of Erlangen-Nürnberg;Heinrich-Heine University, Duesseldorf;University Medical Centre Groningen;Leiden University Medical Center;Radboud UniversityTerminated18 YearsN/ABoth1Phase 2/Phase 3Austria;Germany;Netherlands
886EUCTR2006-000674-73-HU
(EUCTR)
11/08/200615/06/2006A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, THREE-ARM,PARALLEL-GROUP, MULTICENTER, MULTINATIONAL SAFETY ANDEFFICACY TRIAL OF 300 MG AND 900 MG OF ABETIMUS SODIUM INSYSTEMIC LUPUS ERYTHEMATOSUS (SLE) PATIENTS WITH A HISTORY OFRENAL DISEASEA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, THREE-ARM,PARALLEL-GROUP, MULTICENTER, MULTINATIONAL SAFETY ANDEFFICACY TRIAL OF 300 MG AND 900 MG OF ABETIMUS SODIUM INSYSTEMIC LUPUS ERYTHEMATOSUS (SLE) PATIENTS WITH A HISTORY OFRENAL DISEASE Systemic lupus erythematosus patients with a history of renal disease
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: Abetimus sodium
Product Code: LJP 394
INN or Proposed INN: Abetimus Sodium
La Jolla Pharmaceutical CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
730Portugal;Hungary;Czech Republic;Germany;Bulgaria;Spain;Italy
887EUCTR2005-004067-30-NL
(EUCTR)
08/08/200620/04/2006A Double Blind, Randomized, Placebo Controlled, Multi-Center Trial of Anti-TNFafa Chimeric Monoclonal Antibody (Infliximab, Remicade®) and Azathioprine in Patients Suffering from Systemic Lupus Erythematosus (SLE) with WHO Class V GlomerulonephritisA Double Blind, Randomized, Placebo Controlled, Multi-Center Trial of Anti-TNFafa Chimeric Monoclonal Antibody (Infliximab, Remicade®) and Azathioprine in Patients Suffering from Systemic Lupus Erythematosus (SLE) with WHO Class V Glomerulonephritis Systemic Lupus Erythematosus (SLE) with WHO Class V GlomerulonephritisTrade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Trade Name: Azathioprine
Other descriptive name: Azathioprine
Department of Rheumatology, Internal Medicine III, Medical University of ViennaNULLNot RecruitingFemale: yes
Male: yes
44Germany;Netherlands;Austria
888NCT00381810
(ClinicalTrials.gov)
June 22, 200626/9/2006A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus ErythematosusAn Open-label, Single-arm, Multicenter Phase II/III Extension Study to Evaluate the Safety of Rituximab Re-treatment in Subjects With Moderate to Severe Systemic Lupus Erythematosus Previously Enrolled in Protocol U2971gLupus Erythematosus, SystemicDrug: Rituximab;Drug: Methylprednisolone;Drug: Acetaminophen;Drug: DiphenhydramineGenentech, Inc.NULLTerminated16 Years75 YearsAll31Phase 3United States
889NCT00336414
(ClinicalTrials.gov)
June 200612/6/2006Five-Year Actively Controlled Clinical Trial in New Onset Juvenile Systemic Lupus Erythematosus NephritisFive-Year Single-Blind, Phase III Effectiveness Randomised Actively Controlled Clinical Trial in New Onset Juvenile Systemic Lupus Erythematosus Nephritis: Oral Cyclophosphamide Versus High Dose Intravenous Cyclophosphamide Versus Intermediate Dose Intravenous CyclophosphamideSystemic Lupus Erythematosus NephritisDrug: cyclophosphamide-prednisone-azathioprineIstituto Giannina GasliniNULLWithdrawn1 Year18 YearsAll0Phase 3Italy
890NCT00371501
(ClinicalTrials.gov)
June 20061/9/2006Aspirin and Statins for Prevention of Atherosclerosis and Arterial Thromboembolism in Systemic Lupus ErythematosusLow Dose Aspirin and Statins for Primary Prevention of Atherosclerosis and Arterial Thromboembolism in Systemic Lupus Erythematosus: A Randomized Double-blind Placebo-controlled TrialAtherosclerosis;Thromboembolism;Systemic Lupus ErythematosusDrug: Rosuvastatin;Drug: placebo;Drug: aspirinTuen Mun HospitalAstraZenecaCompleted18 YearsN/ABoth72Phase 4Hong Kong
891NCT00383513
(ClinicalTrials.gov)
June 200629/9/2006Study of Epratuzumab in Systemic Lupus ErythematosusAn Open-Label Re-treatment Trial for Patients Previously Randomized Into the SL0003 and SL0004, Randomized, Double-blind, Placebo-controlled, Multi-center Studies of Epratuzumab in Patients With Systemic Lupus ErythematosusSystemic Lupus ErythematosusBiological: EpratuzumabUCB PharmaNULLCompleted18 YearsN/ABoth29Phase 2United States;Belgium;Brazil;Canada;Czech Republic;France;Germany;Italy;Netherlands;Spain;United Kingdom
892NCT00556192
(ClinicalTrials.gov)
June 20068/11/2007Can Targeted Elimination of B-cell Depletion Therapy and/or Combination Therapy on Systemic Lupus ErythematosusCan Targeted Elimination of B-cell Depletion Therapy and/or Combination Therapy Restore Peripheral B Cell Abnormalities in Systemic Lupus Erythematosus(SLE)?Systemic Lupus ErythematosusDrug: rituximabChinese University of Hong KongNULLCompleted18 Years70 YearsBoth20Phase 2China
893EUCTR2004-004051-19-IT
(EUCTR)
26/05/200630/08/2006Phase IIb, multi 8722;center, randomized, double 8722;blind, placebo 8722;controlled study to evaluate the efficacy and safety of abatacept vs placebo on a background of oral glucocorticosteroids in the tratment of subjects with systemic lupus erythematosus and the prevention of subsequent lupus flares - NDPhase IIb, multi 8722;center, randomized, double 8722;blind, placebo 8722;controlled study to evaluate the efficacy and safety of abatacept vs placebo on a background of oral glucocorticosteroids in the tratment of subjects with systemic lupus erythematosus and the prevention of subsequent lupus flares - ND Systemic Lupus Erythematosus
MedDRA version: 6.1;Level: HLT;Classification code 10025136
Product Name: abataceptBristol Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
250Phase 2United Kingdom;Germany;Italy;Sweden
894EUCTR2005-004067-30-AT
(EUCTR)
08/05/200631/03/2006A Double Blind, Randomized, Placebo Controlled, Multi-Center Trial of Anti-TNFafa Chimeric Monoclonal Antibody (Infliximab, Remicade®) and Azathioprine in Patients Suffering from Systemic Lupus Erythematosus (SLE) with WHO Class V GlomerulonephritisA Double Blind, Randomized, Placebo Controlled, Multi-Center Trial of Anti-TNFafa Chimeric Monoclonal Antibody (Infliximab, Remicade®) and Azathioprine in Patients Suffering from Systemic Lupus Erythematosus (SLE) with WHO Class V Glomerulonephritis Systemic Lupus Erythematosus (SLE) with WHO Class V GlomerulonephritisTrade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Trade Name: Azathioprine
Other descriptive name: Azathioprine
Department of Rheumatology, Internal Medicine III, Medical University of ViennaNULLNot RecruitingFemale: yes
Male: yes
44Germany;Netherlands;Austria
895EUCTR2005-003957-28-IT
(EUCTR)
02/05/200609/05/2006FIVE-YEAR SINGLE-BLIND, PHASE II EFFECTIVENESS RANDOMISED ACTIVELY CONTROLLED CLINICAL TRIAL IN NEW ONSET JUVENILE SYSTEMIC LUPUS ERYTHEMATOSUS NEPHTRITIS ORAL CYCLOPHOSPHAMIDE VERSUS HIGH DOSE INTRAVENOUS CYCLOPHOSPHAMIDE VERSUS INTERMEDIATE DOSE INTRAVENOUS CYCLOPHOSPHAMIDE. - NDFIVE-YEAR SINGLE-BLIND, PHASE II EFFECTIVENESS RANDOMISED ACTIVELY CONTROLLED CLINICAL TRIAL IN NEW ONSET JUVENILE SYSTEMIC LUPUS ERYTHEMATOSUS NEPHTRITIS ORAL CYCLOPHOSPHAMIDE VERSUS HIGH DOSE INTRAVENOUS CYCLOPHOSPHAMIDE VERSUS INTERMEDIATE DOSE INTRAVENOUS CYCLOPHOSPHAMIDE. - ND New onset juvenile sistemic lupus erythematosus nephritis
MedDRA version: 6.1;Level: PT;Classification code 10025140
INN or Proposed INN: Azathioprine
INN or Proposed INN: Methylprednisolone
INN or Proposed INN: Prednisone
INN or Proposed INN: Cyclophosphamide
INN or Proposed INN: Cyclophosphamide
ISTITUTO GIANNINA GASLININULLNot RecruitingFemale: yes
Male: yes
141Phase 3Belgium;Denmark;Italy
896EUCTR2005-003070-19-HU
(EUCTR)
25/04/200603/02/2006A randomized, multicenter, parallel-group, open-label study to assess the efficacy and safety of enteric-coated mycophenolate sodium (EC-MPS, myfortic®) versus continuation of previous therapy in patients with proliferative lupus nephritis on standard maintenance therapy - MylupusA randomized, multicenter, parallel-group, open-label study to assess the efficacy and safety of enteric-coated mycophenolate sodium (EC-MPS, myfortic®) versus continuation of previous therapy in patients with proliferative lupus nephritis on standard maintenance therapy - Mylupus lupus nephritis ( as part of the disease Systemic Lupus Erythematosus)Trade Name: Myfortic
Product Name: Myfortic
Product Code: ERL080A
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
140Phase 2Hungary
897EUCTR2005-000705-59-DE
(EUCTR)
11/04/200607/06/2005A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial of Epratuzumab in Patients with Acute Severe SLE Flares Excluding the Renal or Neurological Systems - Phase III Study of Epratuzumab in Severe Acute SLE FlaresA Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial of Epratuzumab in Patients with Acute Severe SLE Flares Excluding the Renal or Neurological Systems - Phase III Study of Epratuzumab in Severe Acute SLE Flares Systemic Lupus Erythematosus
Classification code 10042945
Product Name: Epratuzumab
Product Code: IMMU-103
Other descriptive name: hLL2 (trivial name or chemical description)
UCB Pharma, IncNULLNot RecruitingFemale: yes
Male: yes
510Phase 3Hungary;United Kingdom;Germany;Spain;Italy
898JPRN-C000000159
2006/03/0101/04/2006Mizolibin for systemic lupus erythematosus in children(JSRDC10)Mizolibin for systemic lupus erythematosus in children(JSRDC10) - Mizolibin for systemic lupus erythematosus in children(JSRDC10) systematic lupus erythematosusMethylprednisolone+mizoribine+prednisoloneJapanese Study Group of Renal Disease in Children(JSRDC)NULLComplete: follow-up complete2years-old18years-oldMale and Female30Not selectedJapan
899NCT00181298
(ClinicalTrials.gov)
March 200613/9/2005Memantine in Systemic Lupus ErythematosusMemantine in Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: Memantine;Drug: PlaceboJohns Hopkins UniversityForest LaboratoriesCompleted18 YearsN/ABoth61N/AUnited States
900NCT01101802
(ClinicalTrials.gov)
March 20069/4/2010Mycophenolate Mofetil in Systemic Lupus Erythematosus (MISSILE)A Prospective, Randomised, Double-blind, Placebo-controlled Trial Evaluating the Effects of Mycophenolate Mofetil on 'Surrogate Markers' for Atherosclerosis in Female Patients With SLE.Systemic Lupus Erythematosus;AtherosclerosisDrug: Mycophenolate mofetil;Drug: sugar pillGuy's and St Thomas' NHS Foundation TrustInstitute of Child Health, University College London, London, UK.Completed18 Years60 YearsFemale71Phase 4United Kingdom
901NCT00299819
(ClinicalTrials.gov)
March 20066/3/2006Safety and Tolerability of MEDI-545 in Patients Who Have Systemic Lupus Erythematosus (SLE)A Phase I, Randomized, Double-Blind, Placebo Controlled, Dose-Escalation Study to Evaluate Safety and Tolerability of a Single IV Dose of MEDI-545, a Fully Human Monoclonal Antibody Directed Against Interferon Alpha Subtypes, in Patients With Systemic Lupus Erythematosus (SLE)LupusBiological: MEDI-545;Biological: MEDI 545MedImmune LLCNULLCompleted18 Years80 YearsBoth45Phase 1United States;Canada
902NCT00297284
(ClinicalTrials.gov)
February 200624/2/2006Memory and Attention Problems in Lupus: New Treatment Trial With ModafinilPilot and Feasibility Study of Modafinil Treatment to Improve Cognitive Efficiency in SLE PatientsSystemic Lupus ErythematosusDrug: ModafinilHospital for Special Surgery, New YorkNULLTerminated18 Years60 YearsBoth20N/AUnited States
903EUCTR2005-000705-59-HU
(EUCTR)
09/01/200612/10/2005A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial of Epratuzumab in Patients with Acute Severe SLE Flares Excluding the Renal or Neurological Systems. - Phase III Study of Epratuzumab in Severe Acute SLE Flares A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial of Epratuzumab in Patients with Acute Severe SLE Flares Excluding the Renal or Neurological Systems. - Phase III Study of Epratuzumab in Severe Acute SLE Flares Systemic Lupus Erythematosus
Classification code 10042945
Product Name: Epratuzumab
Product Code: IMMU-103
Other descriptive name: hLL2 (trivial name or chemical description)
Immunomedics, Inc.NULLNot RecruitingFemale: yes
Male: yes
510Phase 3Hungary;Slovakia;Spain;Germany;Italy;United Kingdom
904EUCTR2005-000706-31-DE
(EUCTR)
05/01/200628/06/2005A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Studyof Epratuzumab in Patients with Active Systemic Lupus Erythematosus - Phase III Study of Epratuzumab in Active SLEA Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Studyof Epratuzumab in Patients with Active Systemic Lupus Erythematosus - Phase III Study of Epratuzumab in Active SLE Systemic Lupus Erythematosus
Classification code 10042945
Product Name: Epratuzumab
Product Code: IMMU-103
Other descriptive name: hLL2 (trivial name or chemical description)
UCB Pharma Inc.NULLNot RecruitingFemale: yes
Male: yes
300Phase 3United Kingdom;Germany;Spain;Italy
905EUCTR2005-000705-59-SK
(EUCTR)
14/10/200529/07/2005A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial of Epratuzumab in Patients with Acute Severe SLE Flares Excluding the Renal or Neurological Systems. - Phase III Study of Epratuzumab in Severe Acute SLE FlaresA Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial of Epratuzumab in Patients with Acute Severe SLE Flares Excluding the Renal or Neurological Systems. - Phase III Study of Epratuzumab in Severe Acute SLE Flares Systemic Lupus Erythematosus
Classification code 10042945
Product Name: Epratuzumab
Product Code: IMMU-103
Other descriptive name: hLL2 (trivial name or chemical description)
Immunomedics, Inc.NULLNot RecruitingFemale: yes
Male: yes
510Phase 3Hungary;Slovakia;Spain;Germany;Italy;United Kingdom
906EUCTR2005-001391-12-GB
(EUCTR)
12/10/200515/06/2005A multi-national, multi-centre, randomized, double-blind, placebo-controlled, multiple-dose, parallel-group study to assess the efficacy, tolerability and safety of three doses of edratide (TV-4710) for injection administered subcutaneously to systemic lupus erythematosus (SLE) patients - PRELUDEA multi-national, multi-centre, randomized, double-blind, placebo-controlled, multiple-dose, parallel-group study to assess the efficacy, tolerability and safety of three doses of edratide (TV-4710) for injection administered subcutaneously to systemic lupus erythematosus (SLE) patients - PRELUDE Systemic lupus erythematosus (SLE)
MedDRA version: 7.1;Level: PT;Classification code 10042945
Product Name: edratide
Product Code: TV-4710
INN or Proposed INN: edratide
TEVA Pharmaceutical Industries, Ltd.NULLNot Recruiting Female: yes
Male: yes
260 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noHungary;Spain;Germany;Italy;United Kingdom
907EUCTR2005-002207-16-GB
(EUCTR)
30/09/200516/08/2005A randomised controlled trial of Myfortic versus Mycophenolate Mofetil in the treatment of multi-system autoimmune disease. - MYFMADA randomised controlled trial of Myfortic versus Mycophenolate Mofetil in the treatment of multi-system autoimmune disease. - MYFMAD Multi-system autoimmune diseases including vasculitis and systemic lupus erythematosus (SLE)Trade Name: Myfortic
Trade Name: Cellcept
Cambridge University Hospitals NHS Foundation TrustNULLNot Recruiting Female: yes
Male: yes
40 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom
908NCT00278538
(ClinicalTrials.gov)
September 23, 200515/1/2006Cyclophosphamide and Rabbit Antithymocyte Globulin (rATG)/Rituximab in Patients With Systemic Lupus ErythematosusCyclophosphamide and rATG/Rituximab in Patients With Systemic Lupus Erythematosus: Phase II TrialSystemic Lupus ErythematosusBiological: Hematopoietic stem cell transplantationNorthwestern UniversityNULLCompleted15 Years60 YearsAll32Phase 2United States
909EUCTR2005-001391-12-DE
(EUCTR)
23/09/200515/07/2005A multi-national, multi-centre, randomized, double-blind, placebo-controlled, multiple-dose, parallel-group study to assess the efficacy, tolerability and safety of three doses of edratide (TV-4710) for injection administered subcutaneously to systemic lupus erythematosus (SLE) patients - PRELUDEA multi-national, multi-centre, randomized, double-blind, placebo-controlled, multiple-dose, parallel-group study to assess the efficacy, tolerability and safety of three doses of edratide (TV-4710) for injection administered subcutaneously to systemic lupus erythematosus (SLE) patients - PRELUDE Systemic lupus erythematosus (SLE)
MedDRA version: 7.1;Level: PT;Classification code 10042945
Product Name: edratide
Product Code: TV-4710
INN or Proposed INN: edratide
TEVA Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
260Hungary;United Kingdom;Germany;Spain;Italy
910EUCTR2005-001688-74-GB
(EUCTR)
22/09/200516/08/2005A prospective, randomized, double-blind, placebo controlled trial evaluating the effects of Mycophenolate Mofetil (MMF) on 'surrogate markers' for atherosclerosis in female patients with systemic lupus erythematosus (SLE) - MMF in SLE (Missile)A prospective, randomized, double-blind, placebo controlled trial evaluating the effects of Mycophenolate Mofetil (MMF) on 'surrogate markers' for atherosclerosis in female patients with systemic lupus erythematosus (SLE) - MMF in SLE (Missile) Atherosclerosis in patients with Systemic Lupus ErythematosisTrade Name: CellCept
Product Name: Mycophenolate mofetil
Product Code: Ro 106-1443
INN or Proposed INN: Mycophenolate motetil
Guy's & St Thomas' NHS Foundation TrustNULLNot Recruiting Female: yes
Male: no
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom
911EUCTR2005-000706-31-IT
(EUCTR)
15/09/200530/09/2005A Phase III, Randomized, Double-Blind, Placebo Controlled, Multi-Center Study of Epratuzumab in Patients with Active Systemic LupusErythematosusA Phase III, Randomized, Double-Blind, Placebo Controlled, Multi-Center Study of Epratuzumab in Patients with Active Systemic LupusErythematosus improvement of signs and symptoms of Active Systemic Lupus Erythematosus
MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: Epatuzumab
Product Code: hLL2,IMMU-103
IMMUNOMEDICSNULLNot RecruitingFemale: yes
Male: yes
Phase 3Germany;United Kingdom;Spain;Italy
912EUCTR2005-001391-12-ES
(EUCTR)
01/09/200507/07/2005A multi-national, multi-centre, randomized, double-blind, placebo-controlled, multiple-dose, parallel-group study to assess the efficacy, tolerability and safety of three doses of edratide (TV-4710) for injection administered subcutaneously to systemic lupus erythematosus (SLE) patients - PRELUDEA multi-national, multi-centre, randomized, double-blind, placebo-controlled, multiple-dose, parallel-group study to assess the efficacy, tolerability and safety of three doses of edratide (TV-4710) for injection administered subcutaneously to systemic lupus erythematosus (SLE) patients - PRELUDE Systemic lupus erythematosus (SLE)
MedDRA version: 7.1;Level: PT;Classification code 10042945
Product Name: edratide
Product Code: TV-4710
INN or Proposed INN: edratide
Product Name: edratide
Product Code: TV-4710
INN or Proposed INN: edratide
Product Name: edratide
Product Code: TV-4710
INN or Proposed INN: edratide
TEVA Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
260Phase 2Hungary;Spain;Germany;Italy;United Kingdom
913NCT00119678
(ClinicalTrials.gov)
September 200530/6/2005Abatacept in the Treatment and Prevention of Active Systemic Lupus Erythematosus (SLE) Flares in Combination With PrednisoneA Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept vs Placebo on a Background of Oral Glucocorticosteroids in the Treatment of Subjects With Systemic Lupus Erythematosus and the Prevention of Subsequent Lupus FlaresSystemic Lupus ErythematosusDrug: Abatacept;Drug: Placebo;Drug: PrednisoneBristol-Myers SquibbNULLCompleted18 YearsN/AAll183Phase 2United States;Australia;Austria;Belgium;Brazil;Canada;France;Germany;Italy;Korea, Republic of;Mexico;Puerto Rico;South Africa;Taiwan;United Kingdom;Sweden
914EUCTR2004-004051-19-AT
(EUCTR)
30/08/200526/07/2005A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study toEvaluate the Efficacy and Safety of Abatacept vs. Placebo on a Background of OralGlucocorticosteroids in the Treatment of Subjects with Systemic Lupus Erythematosusand the Prevention of Subsequent Lupus Flares.Revised Protocol 1.0 (incorporating Amendment 2) dated 03-June-2005 + Amendment 1 dated 08-Feb-2005A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study toEvaluate the Efficacy and Safety of Abatacept vs. Placebo on a Background of OralGlucocorticosteroids in the Treatment of Subjects with Systemic Lupus Erythematosusand the Prevention of Subsequent Lupus Flares.Revised Protocol 1.0 (incorporating Amendment 2) dated 03-June-2005 + Amendment 1 dated 08-Feb-2005 SYSTEMIC LUPUS ERYTHEMATOSUS, NOSProduct Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
250Phase 2Austria;Germany;Italy;United Kingdom;Sweden
915EUCTR2004-004051-19-BE
(EUCTR)
29/08/200529/06/2005A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy with Glucocorticosteroids vs. Placebo plus Glucocorticosteroids in the Treatment of Active Systemic Lupus Erythematosus and the Prevention of Subsequent Lupus Flares. Revised Protocol 03: Incorporates Amendments 2, 3 & 5 (v1.0, Date 22-Jun-2007). Protocol Amendment 1 - Site Specific. And Protocol Amendment 04: Long Term Extension (v 3.0, dated 30-Aug-2006).A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy with Glucocorticosteroids vs. Placebo plus Glucocorticosteroids in the Treatment of Active Systemic Lupus Erythematosus and the Prevention of Subsequent Lupus Flares. Revised Protocol 03: Incorporates Amendments 2, 3 & 5 (v1.0, Date 22-Jun-2007). Protocol Amendment 1 - Site Specific. And Protocol Amendment 04: Long Term Extension (v 3.0, dated 30-Aug-2006). SYSTEMIC LUPUS ERYTHEMATOSUS, NOSProduct Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
250Phase 2Belgium;Austria;Germany;Italy;United Kingdom;Sweden
916EUCTR2005-001391-12-IT
(EUCTR)
28/07/200523/03/2006A Multi-National, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Parallel Group Study to Assess the Efficacy, Tolerability and Safety of Three Doses of Edratide TV-4710 for Injection Administered Subcutaneously to Systemic Lupus Erythematosus SLE patientsA Multi-National, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Parallel Group Study to Assess the Efficacy, Tolerability and Safety of Three Doses of Edratide TV-4710 for Injection Administered Subcutaneously to Systemic Lupus Erythematosus SLE patients Treatment of active SLE patients who are concurrently undergoing a regimented program of decreased steroid use.
MedDRA version: 6.1;Level: PT;Classification code 10042945
Product Name: Edratide Acetate
Product Code: TV-4710
Product Name: Edratide Acetate
Product Code: TV-4710
Product Name: Edratide Acetate
Product Code: TV-4710
TEVANULLNot RecruitingFemale: yes
Male: yes
260Hungary;Germany;United Kingdom;Spain;Italy
917EUCTR2005-001391-12-HU
(EUCTR)
27/07/200515/06/2005A multi-national, multi-centre, randomized, double-blind, placebo-controlled, multiple-dose, parallel-group study to assess the efficacy, tolerability and safety of three doses of edratide (TV-4710) for injection administered subcutaneously to systemic lupus erythematosus (SLE) patients - PRELUDEA multi-national, multi-centre, randomized, double-blind, placebo-controlled, multiple-dose, parallel-group study to assess the efficacy, tolerability and safety of three doses of edratide (TV-4710) for injection administered subcutaneously to systemic lupus erythematosus (SLE) patients - PRELUDE Systemic lupus erythematosus (SLE)
MedDRA version: 7.1;Level: PT;Classification code 10042945
Product Name: edratide
Product Code: TV-4710
INN or Proposed INN: edratide
TEVA Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
260Hungary;Germany;United Kingdom;Spain;Italy
918EUCTR2005-000706-31-ES
(EUCTR)
25/07/200523/05/2006A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Studyof Epratuzumab in Patients with Active Systemic Lupus Erythematosus - Phase III Study of Epratuzumab in Active SLEA Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Studyof Epratuzumab in Patients with Active Systemic Lupus Erythematosus - Phase III Study of Epratuzumab in Active SLE Systemic Lupus Erythematosus
Classification code 10042945
Product Name: Epratuzumab
Product Code: IMMU-103
INN or Proposed INN: Epratuzumab
Other descriptive name: hLL2 (trivial name or chemical description)
Immunomedics, Inc.NULLNot RecruitingFemale: yes
Male: yes
300Phase 3Belgium;Spain;Germany;Italy;United Kingdom
919NCT00203151
(ClinicalTrials.gov)
July 200513/9/2005A Study to Evaluate the Tolerability, Safety and Effectiveness of Edratide in the Treatment of LupusA Multi-National, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Parallel Group Study to Assess the Efficacy, Tolerability and Safety of Edratide for Subcutaneous Injection in Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: edratideTeva Pharmaceutical IndustriesNULLTerminated18 Years65 YearsBoth340Phase 2United States
920EUCTR2005-000706-31-BE
(EUCTR)
29/06/200526/07/2005A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Studyof Epratuzumab in Patients with Active Systemic Lupus Erythematosus - Phase III Study of Epratuzumab in Active SLEA Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Studyof Epratuzumab in Patients with Active Systemic Lupus Erythematosus - Phase III Study of Epratuzumab in Active SLE Systemic Lupus Erythematosus
Classification code 10042945
Product Name: Epratuzumab
Product Code: IMMU-103
Other descriptive name: hLL2 (trivial name or chemical description)
UCB Pharma Inc.NULLNot RecruitingFemale: yes
Male: yes
300Phase 3Spain;Belgium;Germany;Italy;United Kingdom
921EUCTR2005-000705-59-GB
(EUCTR)
07/06/200519/04/2005A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial of Epratuzumab in Patients with Acute Severe SLE Flares Excluding the Renal or Neurological Systems - Phase III Study of Epratuzumab in Severe Acute SLE FlaresA Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial of Epratuzumab in Patients with Acute Severe SLE Flares Excluding the Renal or Neurological Systems - Phase III Study of Epratuzumab in Severe Acute SLE Flares Systemic Lupus Erythematosus
Classification code 10042945
Product Name: Epratuzumab
Product Code: IMMU-103
Other descriptive name: hLL2 (trivial name or chemical description)
Immunomedics, Inc.NULLNot RecruitingFemale: yes
Male: yes
510Phase 3Hungary;Germany;United Kingdom;Spain;Italy
922EUCTR2004-004051-19-SE
(EUCTR)
01/06/200529/03/2005A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study toEvaluate the Efficacy and Safety of Abatacept vs. Placebo on a Background of OralGlucocorticosteroids in the Treatment of Subjects with Systemic Lupus Erythematosusand the Prevention of Subsequent Lupus Flares.Revised Protocol Number 02: Incorporates Amendments 2 & 3 - Protocol Amendment 1 - Site Specific.A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study toEvaluate the Efficacy and Safety of Abatacept vs. Placebo on a Background of OralGlucocorticosteroids in the Treatment of Subjects with Systemic Lupus Erythematosusand the Prevention of Subsequent Lupus Flares.Revised Protocol Number 02: Incorporates Amendments 2 & 3 - Protocol Amendment 1 - Site Specific. SYSTEMIC LUPUS ERYTHEMATOSUS, NOSProduct Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
250Phase 2United Kingdom;Germany;Italy;Sweden
923NCT00111306
(ClinicalTrials.gov)
June 200519/5/2005Study of Epratuzumab in Systemic Lupus ErythematosusA Phase III, Randomized, Double-Blind. Placebo-Controlled, Multi-Center Study of Systemic Lupus Erythematosus With Acute Severe SLE Flares Excluding Renal or Neurological SystemsSystemic Lupus ErythematosusDrug: epratuzumabUCB PharmaNULLTerminated18 YearsN/ABoth510Phase 3United States;Belgium;Hungary;Netherlands;Spain;United Kingdom
924EUCTR2005-000706-31-GB
(EUCTR)
13/05/200519/04/2005A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Studyof Epratuzumab in Patients with Active Systemic Lupus Erythematosus - Phase III Study of Epratuzumab in Active SLEA Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Studyof Epratuzumab in Patients with Active Systemic Lupus Erythematosus - Phase III Study of Epratuzumab in Active SLE Systemic Lupus Erythematosus
Classification code 10042945
Product Name: Epratuzumab
Product Code: IMMU-103
Other descriptive name: hLL2 (trivial name or chemical description)
Immunomedics, Inc.NULLNot RecruitingFemale: yes
Male: yes
300Phase 3Germany;United Kingdom;Spain;Italy
925EUCTR2004-004051-19-DE
(EUCTR)
13/05/200522/03/2005A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy with Glucocorticosteroids vs. Placebo plus Glucocorticosteroids in the Treatment of Active Systemic Lupus Erythematosus and the Prevention of Subsequent Lupus Flares. Revised Protocol 03: Incorporates Amendments 2, 3 & 5 (v1.0, Date 22-Jun-2007). Protocol Amendment 1 - Site Specific. And Protocol Amendment 04: Long Term Extension (v 3.0, dated 30-Aug-2006).A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy with Glucocorticosteroids vs. Placebo plus Glucocorticosteroids in the Treatment of Active Systemic Lupus Erythematosus and the Prevention of Subsequent Lupus Flares. Revised Protocol 03: Incorporates Amendments 2, 3 & 5 (v1.0, Date 22-Jun-2007). Protocol Amendment 1 - Site Specific. And Protocol Amendment 04: Long Term Extension (v 3.0, dated 30-Aug-2006). SYSTEMIC LUPUS ERYTHEMATOSUS, NOSProduct Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
250Phase 2United Kingdom;Germany;Italy;Sweden
926NCT00137969
(ClinicalTrials.gov)
May 10, 200526/8/2005A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus ErythematosusRandomized, Double-blind, Placebo-controlled, Multicenter, Phase II/III Study to Evaluate the Efficacy and Safety of Rituximab in Subjects With Moderate to Severe Systemic Lupus ErythematosusLupus Erythematosus, SystemicDrug: Rituximab;Drug: Placebo;Drug: Prednisone;Drug: Acetaminophen;Drug: DiphenhydramineGenentech, Inc.NULLCompleted16 Years75 YearsAll262Phase 2/Phase 3United States;Canada
927NCT00583362
(ClinicalTrials.gov)
May 4, 200520/12/2007A Continuation Trial for Subjects With Systemic Lupus Erythematosus That Have Completed Protocol LBSL02A Multi-Center, Open-Label, Continuation Trial LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase 2 Protocol LBSL02Systemic Lupus ErythematosusBiological: BelimumabHuman Genome Sciences Inc., a GSK CompanyGlaxoSmithKlineCompleted18 YearsN/AAll298Phase 2United States;Canada
928NCT02411136
(ClinicalTrials.gov)
May 20053/4/2015A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of AMG 623 in Subjects With Systemic Lupus ErythematosusA Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 623 Following Multi-dose Administration in Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: AMG 623;Drug: PlaceboAmgenNULLCompleted18 Years65 YearsBoth64Phase 1NULL
929NCT00383214
(ClinicalTrials.gov)
May 200529/9/2006Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)A Phase III, Randomized, Double Blind, Placebo Controlled, Multi-Center Study of Epratuzumab in Patients With Active Systemic Lupus Erythematosus.Systemic Lupus ErythematosusDrug: Epratuzumab;Other: PlaceboUCB PharmaNULLTerminated18 YearsN/ABoth54Phase 3United States;Belgium;Brazil;Canada;Czech Republic;France;Germany;Italy;Netherlands;Spain;United Kingdom
930EUCTR2004-004051-19-GB
(EUCTR)
18/04/200524/03/2005A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study toEvaluate the Efficacy and Safety of Abatacept vs. Placebo on a Background of OralGlucocorticosteroids in the Treatment of Subjects with Systemic Lupus Erythematosusand the Prevention of Subsequent Lupus Flares.Revised Protocol 1.0 dated 03-June-2005 + Amendment 1 dated 08-Feb-2005A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study toEvaluate the Efficacy and Safety of Abatacept vs. Placebo on a Background of OralGlucocorticosteroids in the Treatment of Subjects with Systemic Lupus Erythematosusand the Prevention of Subsequent Lupus Flares.Revised Protocol 1.0 dated 03-June-2005 + Amendment 1 dated 08-Feb-2005 SYSTEMIC LUPUS ERYTHEMATOSUS, NOSProduct Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
250Phase 2Germany;United Kingdom;Italy;Sweden
931NCT00113971
(ClinicalTrials.gov)
April 200510/6/2005Pharmacokinetics Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)A Randomized Phase II Pharmacokinetics/Pharmacodynamics Study of Epratuzumab in Patients With Systemic Lupus ErythematosusLupus Erythematosus, SystemicDrug: epratuzumabUCB PharmaNULLTerminated18 YearsN/ABoth20Phase 2United States
932NCT00731302
(ClinicalTrials.gov)
April 20055/8/2008Aspirin Resistance in Systemic Lupus Erythematosus (SLE)Vascular Damage in Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: aspirin and meloxicamVanderbilt UniversityNational Heart, Lung, and Blood Institute (NHLBI)Completed18 YearsN/AAll70Phase 1United States
933EUCTR2004-004404-21-GB
(EUCTR)
10/12/200417/02/2005Omega-3-Polyunsaturated Fatty Acids and Atherosclerosis in Systemic Lupus Erythematosus: Cellular Mechanisms and Functional Consequences - Fish oils in LupusOmega-3-Polyunsaturated Fatty Acids and Atherosclerosis in Systemic Lupus Erythematosus: Cellular Mechanisms and Functional Consequences - Fish oils in Lupus Systemic Lupus ErythematosusTrade Name: Omacor
Product Name: Omacor
INN or Proposed INN: Eicosapentaenoic acid
INN or Proposed INN: Docosahexaenoic acid
INN or Proposed INN: alpha-tocopherol
GreenPark Healthcare TrustQueens University BelfastNot RecruitingFemale: yes
Male: yes
60Phase 4United Kingdom
934NCT02443506
(ClinicalTrials.gov)
October 200411/5/2015A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of Single Dose of AMG 623 in Subjects With Systemic Lupus ErythematosusA Randomized Double-blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 623 Following Single Dose Administration in Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: AMG 623;Drug: PlaceboAmgenNULLCompleted18 Years55 YearsBoth56Phase 1NULL
935NCT00089804
(ClinicalTrials.gov)
October 200413/8/2004Study of LJP 394 in Lupus Patients With History of Renal DiseaseA Randomized, Double-Blind, Placebo-Controlled, Three-Arm, Parallel-Group, Multicenter, Multinational Safety and Efficacy Trial of 300 mg and 900 mg of Abetimus Sodium in Systemic Lupus Erythematosus (SLE) Patients With a History of Renal DiseaseLupus Erythematosus, Systemic;Lupus NephritisDrug: abetimus sodium (LJP 394) and/or placebo solution;Drug: abetimus sodium (LJP 394);Drug: Phosphate-buffered salineLa Jolla Pharmaceutical CompanyNULLTerminated12 Years70 YearsBoth943Phase 3United States;Argentina;Australia;Belarus;Brazil;Bulgaria;Czech Republic;Georgia;Germany;Hong Kong;Hungary;India;Indonesia;Italy;Korea, Republic of;Lebanon;Malaysia;Mexico;Philippines;Poland;Portugal;Puerto Rico;Romania;Serbia;Slovakia;Spain;Sri Lanka;Taiwan;Thailand;Ukraine;Former Serbia and Montenegro
936NCT00417430
(ClinicalTrials.gov)
September 200428/12/2006Efficacy of Faslodex in Treatment of SLE Clinical, Serologic, and Molecular StudiesPhase II Study of Efficacy of ICI 182,780 (Faslodex) in the Treatment of Systemic Lupus Erythematosus: Clinical, Serologic, MolecularSystemic Lupus ErythematosusDrug: ICI 182,780 (Faslodex)The Center for Rheumatic Disease, Allergy, & ImmunologyAstraZenecaCompleted16 Years50 YearsFemale20Phase 2United States
937NCT00094380
(ClinicalTrials.gov)
September 200416/10/2004Treating Systemic Lupus Erythematosus (SLE) Patients With CTLA4-IgG4m (RG2077)Treatment of Systemic Lupus Erythematosus With CTLA4-IgG4m Plus Cyclophosphamide: A Phase I/IIA StudyLupus Erythematosus, Systemic;Lupus NephritisDrug: CTLA4-IgG4m (RG2077);Drug: CyclophosphamideNational Institute of Allergy and Infectious Diseases (NIAID)Immune Tolerance Network (ITN)Completed18 YearsN/AAll6Phase 1/Phase 2United States
938NCT00278590
(ClinicalTrials.gov)
July 200416/1/2006Allogeneic Stem Cell Transplantation in Systemic Lupus ErythematosusAllogeneic Stem Cell Transplantation in Patients With Systemic Lupus ErythematosusSystemic Lupus ErythematosusBiological: Allogeneic Stem Cell TransplantationNorthwestern UniversityNULLWithdrawn18 Years50 YearsAll0Phase 1United States
939NCT00076752
(ClinicalTrials.gov)
January 30, 20042/2/2004Lymphocyte Depletion and Stem Cell Transplantation to Treat Severe Systemic Lupus ErythematosusA Pilot Study of Intensified Lymphodepletion Followed by Autologous Hematopoietic Stem Cell Transplantation in Patients With Severe Systemic Lupus ErythematosusLupus Erythematosus, SystemicDrug: fludarabine phosphate;Drug: cyclophosphamide;Biological: Rituxan (rituximab);Biological: filgrastim;Drug: methylprednisolone;Other: immunologic technique;Other: laboratory biomarker analysis;Procedure: autologous hematopoietic stem cell transplantation;Drug: Diphenhydramine;Drug: MesnaNational Cancer Institute (NCI)NULLCompleted15 Years40 YearsAll9Phase 2United States
940NCT00125307
(ClinicalTrials.gov)
January 200429/7/2005Tacrolimus for the Treatment of Systemic Lupus Erythematosus With Membranous NephritisTacrolimus for the Treatment of Systemic Lupus Erythematosus With Membranous NephritisLupus Nephritis;Lupus Erythematosus, SystemicDrug: tacrolimusChinese University of Hong KongNULLCompleted18 YearsN/ABoth20Phase 4Hong Kong;China
941NCT00071487
(ClinicalTrials.gov)
October 200324/10/2003Safety and Efficacy Study of LymphoStat-B (Belimumab) in Subjects With Systemic Lupus Erythematosus (SLE)A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Tolerability, and Efficacy of LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Systemic Lupus Erythematosus (SLE)Lupus Erythematosus, SystemicDrug: Placebo;Drug: Belimumab 1 mg/kg;Drug: Belimumab 4 mg/kg;Drug: Belimumab 10 mg/kgHuman Genome Sciences Inc.NULLCompleted18 Years65 YearsAll449Phase 2United States;Canada
942NCT00189124
(ClinicalTrials.gov)
September 200313/9/2005Dehydroepiandrosterone (DHEA) in Systemic Lupus Erythematosus (SLE) for Coronary Artery Disease (CAD) PreventionDoes DHEA Improve Endothelial Dysfunction and Other Cardiovascular Risk Factors in Premenopausal Women With Systemic Lupus?Systemic Lupus ErythematosusDrug: Dehydroepiandrosterone (DHEA)University of MichiganArthritis FoundationCompleted18 YearsN/AFemale13Phase 2/Phase 3United States
943NCT00082511
(ClinicalTrials.gov)
July 200311/5/2004GL701 (Prestara™) in Women With Systemic Lupus Erythematosus Receiving Treatment With GlucocorticoidsA Multi-Center, Open-Label Study to Assess the Durability and Safety of the Prevention of Bone Loss by Treatment With GL701 (Prestara™) in Women With Systemic Lupus Erythematosus Receiving Treatment With GlucocorticoidsSystemic Lupus ErythematosusDrug: Prasterone (GL701)Genelabs TechnologiesNULLCompleted18 YearsN/AFemale114Phase 3United States;Mexico
944NCT00124514
(ClinicalTrials.gov)
June 200326/7/2005Triptorelin for Ovary Protection in Childhood Onset LupusSystemic Lupus ErythematosusDrug: Triptorelin pamoateChildren's Hospital Medical Center, CincinnatiWatson PharmaceuticalsCompleted9 Years21 YearsFemale30Phase 2United States;Brazil
945NCT00054938
(ClinicalTrials.gov)
March 200313/2/2003Prevention of Atherosclerosis and Heart Disease in Patients With Systemic Lupus Erythematosis (SLE)A Randomized Controlled Trial of Strategies for the Prevention of Accelerated Atherosclerosis in Systemic Lupus Erythematosus - A Pilot StudySystemic Lupus Erythematosus;LupusDrug: pravastatin;Drug: aspirin;Drug: ramipril;Drug: Vitamins: B6, B12, and folate;Behavioral: heart health educational programBrigham and Women's HospitalNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Completed18 YearsN/ABoth150Phase 2United States
946NCT00637819
(ClinicalTrials.gov)
January 200311/3/2008Leflunomide in Systemic Lupus ErythematosusA Randomized, Double-Blind, Placebo Controlled Clinical Trial of Leflunomide in Systemic Lupus Erythematosus (SLE)Systemic Lupus Eythematosus (SLE)Drug: LeflunomideSanofiNULLCompleted18 YearsN/ABoth27Phase 2Hong Kong
947NCT00053560
(ClinicalTrials.gov)
December 200230/1/2003To Assess Prevention of Bone Loss in Women With Lupus Receiving Treatment With GlucocorticoidsA Randomized, Double-Blind, Multi-Center, Placebo- Controlled Study to Assess Prevention of Bone Loss by Treatment With GL701 (Prestara) in Women With Systemic Lupus Erythematosus Receiving Treatment With GlucocorticoidsLupusDrug: Prasterone (GL701)Genelabs TechnologiesNULLActive, not recruiting18 YearsN/AFemale155Phase 3United States;Mexico
948NCT00412841
(ClinicalTrials.gov)
November 200218/12/2006Atorvastatin to Prevent Avascular Necrosis of Bone in Steroid Treated Exacerbated Systemic Lupus ErythematosusAVN Prevention With Lipitor in Lupus Erythematosus APLLE TrialAvascular NecrosisDrug: Atorvastatin;Procedure: MRI, Venipuncture;Drug: PlaceboNYU Langone HealthNULLTerminated18 Years75 YearsFemale43Phase 2United States
949NCT00046774
(ClinicalTrials.gov)
September 2, 20022/10/2002Monoclonal Antibody Treatment for Systemic Lupus ErythematosusA Phase I, Open-Labeled, Dose-Ascending Clinical Trial of Immunotherapy of MRA, A Humanized Anti-IL 6 Receptor Monoclonal Antibody, In Patients With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: MRA 003 USNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NULLCompleted18 YearsN/AAll23Phase 1United States
950NCT00271934
(ClinicalTrials.gov)
September 20022/1/2006Immune Ablation and Hematopoietic Stem Cell Support in Patients With Systemic Lupus Erythematosus: A Phase II StudyImmune Ablation and Hematopoietic Stem Cell Support in Patients With Poor Prognostic Indicators and Systemic Lupus Erythematosus:A Phase II StudySystemic Lupus ErythematosusBiological: Immune ablation and hematopoietic stem cell support.Richard Burt, MDNULLCompletedN/A60 YearsBoth52Phase 2United States
951NCT00120887
(ClinicalTrials.gov)
April 200212/7/2005Lupus Atherosclerosis Prevention StudyLupus Atherosclerosis Prevention StudySystemic Lupus ErythematosusDrug: AtorvastatinJohns Hopkins UniversityAlliance for Lupus ResearchCompleted18 YearsN/ABoth200Phase 4United States
952NCT00188188
(ClinicalTrials.gov)
March 20029/9/2005Study of Endothelial Dysfunction in Systemic Lupus and Its Role in Heart DiseaseEndothelial Dysfunction in Systemic Lupus Erythematosus: Its Contribution to Abnormalities in Coronary Perfusion.Systemic Lupus ErythematosusDrug: quiniprilUniversity Health Network, TorontoHeart and Stroke Foundation of CanadaRecruiting20 YearsN/ABoth50Phase 4Canada
953NCT00293072
(ClinicalTrials.gov)
March 200216/2/2006Pilot Study of Rituximab Therapy for Systemic Lupus Erythematosus (SLE) and VasculitisPilot Study of Rituximab Therapy for Systemic Lupus Erythematosus (SLE) and Vasculitis Resistant to Conventional TherapySystemic Lupus Erythematosus;ANCA Associated VasculitisDrug: RituximabCambridge University Hospitals NHS Foundation TrustRoche Pharma AGCompleted18 Years70 YearsBoth20Phase 2United Kingdom
954NCT00657007
(ClinicalTrials.gov)
February 20028/4/2008Phase 1 Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)A Phase 1, Multi-Center, Double-Blind, Single and Double Dose-Escalation Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of LymphoStat-B™ (Monoclonal Anti-BLyS Antibody) in Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusBiological: belimumab;Biological: PlaceboHuman Genome Sciences Inc.NULLCompleted18 YearsN/ABoth70Phase 1United States
955NCT00029926
(ClinicalTrials.gov)
January 200226/1/2002Positron Emission Tomography (PET) to Locate Areas of White Blood Cell ActivityA Pilot Study of F-18FDG Positron Emission Tomography (PET) to Assess the Distribution of Activated Lymphocytes in Systemic Lupus Erythematosus (SLE)Lupus Erythematosus;SystemicDrug: 2-deoxy-2 [F-18] fluoro-2-d-glucoseNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NULLCompletedN/AN/ABoth20N/AUnited States
956NCT00976300
(ClinicalTrials.gov)
January 200211/9/2009Cyclosporine A or Intravenous Cyclophosphamide for Lupus Nephritis: The Cyclofa-Lune StudyCyclosporine A or Intravenous Cyclophosphamide for Lupus Nephritis: The Cyclofa-Lune StudySystemic Lupus Erythematosus;Lupus NephritisDrug: Cyclosporine A;Drug: CyclophosphamideInstitute of Rheumatology, PragueMinistry of Health, Czech Republic;Charles University, Czech Republic;Palacky University;Department of Rheumatology, Hospital, Ceske Budejovice, Czech Republic;National Institute of Rheumatology, Piestany, Slovakia;Faculty Hospital St. Anna, BrnoCompleted18 Years70 YearsBoth40Phase 2Czech Republic
957NCT00035308
(ClinicalTrials.gov)
November 20012/5/2002Safety and Efficacy Study of LJP 394 (Abetimus Sodium) to Treat Lupus Kidney DiseaseA Randomized, Double-Blind, Placebo-Controlled, Multicenter Safety and Efficacy Trial of LJP 394 in Systemic Lupus Erythematosus (SLE) Patients With a History of Renal DiseaseImmunologic Diseases;Autoimmune Diseases;Systemic Lupus Erythematosus;Lupus Nephritis;Lupus GlomerulonephritisDrug: Abetimus sodium (LJP 394)La Jolla Pharmaceutical CompanyNULLCompleted12 Years70 YearsBoth330Phase 3United States;Austria;Canada;France;Germany;Italy;Mexico;Spain;Sweden;United Kingdom
958NCT00017641
(ClinicalTrials.gov)
April 20016/6/2001Phase I Study of Immune Ablation and CD34+ Peripheral Blood Stem Cell Support in Patients With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: anti-thymocyte globulin;Drug: cyclophosphamide;Drug: filgrastim;Procedure: CD34+ Peripheral Blood Stem Cell ReinfusionNorthwestern Memorial HospitalNULLActive, not recruitingN/A59 YearsBoth10Phase 1United States
959NCT00011908
(ClinicalTrials.gov)
February 20013/3/2001Humanized LL2IGG to Treat Systemic Lupus ErythematosusA Phase I Clinical Trial of Immunotherapy With Humanized LL2 IgG (Epratuzumab) in Patients With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: hLL2 (Epratuzumab)National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NULLCompletedN/AN/ABoth20Phase 1United States
960NCT00036491
(ClinicalTrials.gov)
January 200110/5/2002Anti-CD20 in Systemic Lupus ErythematosusAn Open-Label Safety and Efficacy Study of an Anti-CD20 Antibody (Rituximab, Rituxan®) for Anti-B Cell Therapy in the Treatment of Systemic Lupus ErythematosusLupus Erythematosus, SystemicDrug: RituximabNational Institute of Allergy and Infectious Diseases (NIAID)Autoimmunity Centers of ExcellenceCompleted18 Years70 YearsAll24Phase 1/Phase 2United States
961NCT00006133
(ClinicalTrials.gov)
June 20003/8/2000Randomized Study of Oral Contraceptives or Hormone Replacement Therapy in Women With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: estradiol;Drug: ethinyl estradiol;Drug: medroxyprogesterone;Drug: norethindroneNational Center for Research Resources (NCRR)University of Alabama at BirminghamCompletedN/AN/AFemale970N/AUnited States
962NCT00391924
(ClinicalTrials.gov)
May 200024/10/2006Dehydroepiandrosterone Administration in Women With Systemic Lupus Erythematosus or Primary Sjögren's SyndromeFatigue and General Well-Being in Patients With Systemic Lupus Erythematosus or Primary Sjögren's Syndrome: Effects of Dehydroepiandrosterone AdministrationLupus Erythematosus, Systemic;Sjogren's SyndromeDrug: DehydroepiandrosteroneUMC UtrechtUniversity Medical Centre Groningen;Dutch Arthritis AssociationCompleted18 YearsN/AFemale120Phase 2Netherlands
963NCT00006055
(ClinicalTrials.gov)
March 20005/7/2000Autologous Peripheral Blood Stem Cell Transplantation in Patients With Life Threatening Autoimmune DiseasesPurpura, Schoenlein-Henoch;Graft Versus Host Disease;Anemia, Hemolytic, Autoimmune;Rheumatoid Arthritis;Churg-Strauss Syndrome;Hypersensitivity Vasculitis;Wegener's Granulomatosis;Systemic Lupus Erythematosus;Giant Cell Arteritis;Pure Red Cell Aplasia;Juvenile Rheumatoid Arthritis;Polyarteritis Nodosa;Autoimmune Thrombocytopenic Purpura;Takayasu ArteritisDrug: anti-thymocyte globulin;Drug: cyclophosphamide;Drug: cyclosporine;Drug: filgrastim;Drug: methylprednisolone;Drug: prednisone;Procedure: Autologous Peripheral Blood Stem Cell TransplantationFairview University Medical CenterNULLActive, not recruiting1 Year55 YearsBoth10N/AUnited States
964NCT00037128
(ClinicalTrials.gov)
March 199816/5/2002Study of GL701 in Men With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: GL701Genelabs TechnologiesNULLActive, not recruiting18 YearsN/AMale40Phase 3United States
965NCT00001676
(ClinicalTrials.gov)
January 19983/11/1999Cyclophosphamide and Fludarabine to Treat Lupus NephritisCombination of Cyclophosphamide and Fludarabine for Lupus Nephritis: Tolerance, Toxicity, Efficacy and Effects on B and T Lymphocyte RegenerationGlomerulonephritis;Lupus Nephritis;Systemic Lupus ErythematosusDrug: SQ FludarabineNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NULLCompletedN/AN/ABoth15Phase 1United States
966NCT00392093
(ClinicalTrials.gov)
November 199723/10/2006Effect of Hormone Replacement Therapy on Lupus ActivityEffect Of Hormone Replacement Therapy On Disease Activity, Menopausal Symptoms And Bone Mineral Density In Peri/Postmenopausal Women With Systemic Lupus Erythematosus.Randomized Clinical TrialSystemic Lupus ErythematosusDrug: Conjugated equine estrogens 0.625 mg/d + MPA 5 mg/d/10dInstituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranNULLCompleted18 Years65 YearsFemale108Phase 4Mexico
967NCT00000421
(ClinicalTrials.gov)
September 19973/11/1999Serologically Active, Clinically Stable Systemic Lupus ErythematosusSerologically Active, Clinically Stable Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: Prednisone;Drug: PlaceboNew York University School of MedicineNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Completed13 Years65 YearsFemale154Phase 2United States
968NCT00000420
(ClinicalTrials.gov)
June 19973/11/1999Safety of Estrogens in Lupus: Birth Control PillsSafety of Estrogens in Lupus Erythematosus - National Assessment (SELENA): Oral ContraceptivesSystemic Lupus ErythematosusDrug: Ortho-Novum 777New York University School of MedicineNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);Office of Research on Women's Health (ORWH)Completed18 Years39 YearsFemale350Phase 3United States
969NCT00010400
(ClinicalTrials.gov)
April 19972/2/2001Pilot Study of Cyclophosphamide in Patients With Life-Threatening Systemic Lupus Erythematosus or Antiphospholipid Antibody SyndromeSystemic Lupus Erythematosus;Antiphospholipid Antibody SyndromeDrug: Cyclophosphamide;Drug: filgrastimJohns Hopkins UniversityNULLCompleted18 Years70 YearsBoth35N/AUnited States
970NCT00000419
(ClinicalTrials.gov)
April 19963/11/1999Safety of Estrogens in Lupus: Hormone Replacement TherapySafety of Estrogens in Lupus Erythematosus - National Assessment (SELENA): Hormone Replacement TherapySystemic Lupus ErythematosusDrug: Premarin and ProveraNew York University School of MedicineNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);Office of Research on Women's Health (ORWH)Terminated18 Years85 YearsFemale350Phase 3United States
971NCT00004662
(ClinicalTrials.gov)
March 199624/2/2000Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women With Active Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: dehydroepiandrosteroneNational Center for Research Resources (NCRR)Northwestern UniversityCompleted18 YearsN/AFemale300Phase 3NULL
972NCT00004665
(ClinicalTrials.gov)
June 199524/2/2000Phase II Study of Long-Term Dehydroepiandrosterone for Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: dehydroepiandrosteroneNational Center for Research Resources (NCRR)Northwestern UniversityCompleted18 YearsN/AFemale20Phase 2NULL
973NCT00470522
(ClinicalTrials.gov)
June 19952/5/2007Study of Methotrexate in Lupus ErythematosusA Canadian Multicenter, Randomized, Double-Blind Placebo-Controlled Study of Methotrexate and Folic Acid in Systemic Lupus Erythematosus: A Phase III Trial.Systemic Lupus ErythematosusDrug: Methotrexate and folic acidUniversity Health Network, TorontoMcGill University Health CenterCompleted18 YearsN/ABoth86Phase 3Canada
974JPRN-C000000378
1995/03/0101/04/2006A combination of methylprednisoloneand prednisolone and a combination of Methylprednisolone, prednisolone and mizoribine for systemic lupus erythematosus in children: A randomized controlled trial of efficacy and safety izolibin for (JSRDC04)A combination of methylprednisoloneand prednisolone and a combination of Methylprednisolone, prednisolone and mizoribine for systemic lupus erythematosus in children: A randomized controlled trial of efficacy and safety izolibin for (JSRDC04) - A combination of methylprednisolone and prednisolone and a combination of methylprednisolone, prednisolone and mizoribine: A randomized controlled trial (JSRDC04) systematic lupus erythematosusMethylprednisolone+prednisolone
Methylprednisolone+prednisolone+mizoribine
Japanese Study Group of Renal Disease in Children(JSRDC)NULLComplete: follow-up complete2years-old18years-oldMale and Female60Not selectedJapan
975NCT00004643
(ClinicalTrials.gov)
February 199524/2/2000Phase II Pilot Study of Cytarabine for Refractory Systemic Lupus ErythematosusLupus Erythematosus, SystemicDrug: cytarabineNational Center for Research Resources (NCRR)University of MichiganCompleted18 Years64 YearsBoth10Phase 2NULL
976NCT00004795
(ClinicalTrials.gov)
August 199424/2/2000Phase II/III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women With Mild to Moderate Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: dehydroepiandrosteroneNational Center for Research Resources (NCRR)Northwestern UniversityCompleted18 YearsN/AFemale190Phase 2/Phase 3NULL
977NCT00001212
(ClinicalTrials.gov)
November 19863/11/1999Drug Therapy in Lupus NephropathyImmunosuppressive Drug Therapy in Membranous Lupus NephropathyNephrotic Syndrome;Systemic Lupus ErythematosusDrug: prednisone;Drug: cyclophosphamide;Drug: cyclosporin ANational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NULLCompletedN/AN/ABoth45Phase 2United States
978EUCTR2017-002050-36-FR
(EUCTR)
03/11/2017Personalised approach to the tapering of corticosteroid treatment in systemic lupus patientsPersonalised pharmacological approach to the tapering of corticosteroid doses in systemic lupus patients treated with prednisone - DECOR Systemic lupus erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Prednisone
Product Name: Prednisone
INN or Proposed INN: Prednisone
Other descriptive name: Prednisone
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLNAFemale: yes
Male: yes
120Phase 4France
979EUCTR2005-003957-28-BE
(EUCTR)
24/10/2006Five year single-blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile systemic lupus erythematosus nephritis: oral cyclophosphamide versus high dose intravenous cyclophosphamide versus intermediate dose intravenous cyclophosphamide - PRINTO JSLE TrialFive year single-blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile systemic lupus erythematosus nephritis: oral cyclophosphamide versus high dose intravenous cyclophosphamide versus intermediate dose intravenous cyclophosphamide - PRINTO JSLE Trial Systemic lupus erythematosus nephritisProduct Name: Azathioprine
INN or Proposed INN: Azathioprine
Product Name: Methylprednisolone
INN or Proposed INN: Methylprednisolone sodium succinate
Product Name: Prednisolone
INN or Proposed INN: Methylprednisolone
Product Name: Cyclophosphamide
INN or Proposed INN: Cyclophosphamide
Product Name: Cyclophosphamide
INN or Proposed INN: Cyclophosphamide
University Hospital GentNULLNAFemale: yes
Male: yes
216Phase 3Belgium;Denmark;Italy
980EUCTR2020-004047-86-FR
(EUCTR)
04/06/2021A Study of ALPN-101 in Active LupusA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ALPN-101 IN SYSTEMIC LUPUS ERYTHEMATOSUS Systemic lupus erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042946;Term: Systemic lupus erythematosus rash;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 21.1;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.1;Level: LLT;Classification code 10042948;Term: Systemic lupus erythematosus syndrome aggravated;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Classification code 10029142;Term: Nephritis systemic lupus erythematosus;System Organ Class: 100000004857
MedDRA version: 20.1;Classification code 10067657;Term: Systemic lupus erythematosus disease activity index increased;System Organ Class: 10022891 - Investigations
MedDRA version: 20.0;Classification code 10067658;Term: Systemic lupus erythematosus disease activity index decreased;System Organ Class: 10022891 - Investigations
MedDRA version: 20.1;Classification code 10067659;Term: Systemic lupus erythematosus disease activity index abnormal;System Organ Class: 10022891 - Investigations
MedDRA version: 21.0;Classification code 10080670;Term: Systemic lupus erythematosus reactivation;Classification code 10073694;Term: Lupus pleurisy;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 21.1;Classification code 10040968;Term: SLE arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: ALPN-101
INN or Proposed INN: Acazicolcept
Other descriptive name: ALPN-101
Alpine Immune Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 2United States;France;Spain;Poland;Russian Federation;Germany;Korea, Republic of
981EUCTR2019-003406-27-FR
(EUCTR)
22/12/2020A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosusA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS GO Systemic lupus erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Dapirolizumab pegol
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657
UCB Biopharma SRLNULLNAFemale: yes
Male: yes
450Phase 3United States;Serbia;Portugal;Philippines;Taiwan;Greece;Spain;Chile;Colombia;Italy;France;Peru;Australia;Denmark;Korea, Republic of;Czechia;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany
982EUCTR2019-003409-83-PL
(EUCTR)
27/05/2021A Study to evaluate the safety and tolerability of dapirolizumab pegol in study participants with systemic lupus erythematosusA Multicenter, Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of Dapirolizumab Pegol Treatment in Study Participants With Systemic Lupus Erythematosus Systemic lupus erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Dapirolizumab pegol
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657
UCB Biopharma SRLNULLNAFemale: yes
Male: yes
760Phase 3Serbia;Portugal;United States;Philippines;Taiwan;Hong Kong;Greece;Spain;Chile;Colombia;Italy;France;Peru;Australia;Denmark;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan
983EUCTR2019-003406-27-PL
(EUCTR)
14/04/2020A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosusA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS GO Systemic lupus erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Dapirolizumab pegol
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657
UCB Biopharma SRLNULLNAFemale: yes
Male: yes
450Phase 3Portugal;United States;Serbia;Philippines;Taiwan;Estonia;Slovakia;Greece;Spain;Chile;Colombia;Switzerland;Italy;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Bulgaria;Germany;Norway;Sweden
984EUCTR2011-000368-88-Outside-EU/EEA
(EUCTR)
17/02/2014A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patients 5 to 17 years of ageA Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with Systemic Lupus Erythematosus (SLE) - Belimumab in pediatric patients with SLE Systemic Lupus Erythematosus
MedDRA version: 16.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: BENLYSTA™ (belimumab)
Product Name: Benlysta (belimumab)
Product Code: GSK1550188
INN or Proposed INN: belimumab
GlaxoSmithKline Research & Development LtdNULLNAFemale: yes
Male: yes
100Argentina;Brazil;Netherlands;Mexico;Peru;Poland;Russian Federation;Germany;Canada;Italy;Spain;United Kingdom;United States
985JPRN-JapicCTI-184095
03/09/2018A Randomized, Double Blind, Placebo Controlled, Parallel Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus (I4V-MC-JAIA)A Randomized, Double Blind, Placebo Controlled, Parallel Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus (I4V-MC-JAIA) Systemic Lupus ErythematosusIntervention name : LY3009104
INN of the intervention : Baricitinib
Dosage And administration of the intervention : High Dose or Low Dose. Baricitinib administered orally. Placebo administered orally to maintain the blind.
Control intervention name : Placebo
Dosage And administration of the control intervention : Placebo administered orally.
Eli Lilly Japan K.K.NULLrecruiting18BOTHPhase 3NULL
986EUCTR2019-003406-27-BE
(EUCTR)
28/02/2020A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosusA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS GO Systemic lupus erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Dapirolizumab pegol
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657
UCB Biopharma SRLNULLNAFemale: yes
Male: yes
450Phase 3United States;Serbia;Portugal;Philippines;Taiwan;Greece;Spain;Chile;Colombia;Italy;France;Peru;Australia;Denmark;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany
987EUCTR2019-003407-35-BE
(EUCTR)
24/01/2022A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosusA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS FLY Systemic lupus erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Dapirolizumab pegol
Product Code: CDP7657
INN or Proposed INN: dapirolizumab pegol
Other descriptive name: DZP
UCB Biopharma SRLNULLNAFemale: yes
Male: yes
450Phase 3Hong Kong;United States;Czechia;Japan;United Kingdom;Portugal;Spain;Greece;Canada;Austria;Belgium;China;Taiwan;Poland;Denmark;Italy;France;Bulgaria;Serbia;Germany
988EUCTR2006-005357-29-PL
(EUCTR)
10/01/2008A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus ErythematosusA Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus Lupus NephritisProduct Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
369Phase 3Portugal;France;Hungary;Spain;Poland;Bulgaria;Netherlands;Germany;United Kingdom;Sweden
989EUCTR2007-003698-13-DE
(EUCTR)
09/05/2008Atacicept Phase II/III in Generalized Systemic Lupus Erythematosus (APRIL SLE)A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III Systemic Lupus Erythematosus
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Atacicept
Product Code: TACI-Fc5
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5
Merck Serono S.A. Geneva. An affiliate of Merck KGaA, Darmstadt, GermanyNULLNot RecruitingFemale: yes
Male: yes
510Phase 2/3United States;Serbia;Philippines;Taiwan;Greece;Spain;Lebanon;Chile;Israel;Switzerland;India;France;Malaysia;Australia;Peru;Latvia;Netherlands;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Mexico;Argentina;Brazil;Croatia;Bulgaria;Germany
990EUCTR2019-003409-83-CZ
(EUCTR)
15/03/2022A Study to evaluate the safety and tolerability of dapirolizumab pegol in study participants with systemic lupus erythematosusA Multicenter, Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of Dapirolizumab Pegol Treatment in Study Participants With Systemic Lupus Erythematosus Systemic lupus erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Dapirolizumab pegol
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657
UCB Biopharma SRLNULLNAFemale: yes
Male: yes
760Phase 3Portugal;Serbia;United States;Philippines;Hong Kong;Taiwan;Greece;Spain;Chile;Colombia;Italy;France;Peru;Australia;Denmark;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan
991EUCTR2019-003407-35-AT
(EUCTR)
23/03/2022A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosusA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS FLY Systemic lupus erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Dapirolizumab pegol
Product Code: CDP7657
INN or Proposed INN: dapirolizumab pegol
Other descriptive name: DZP
UCB Biopharma SRLNULLNAFemale: yes
Male: yes
450Phase 3Portugal;Serbia;United States;Czechia;Hong Kong;Taiwan;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Poland;Belgium;Denmark;Bulgaria;Germany;China;Japan
992EUCTR2010-024069-30-HU
(EUCTR)
17/05/2011A study to investigate the optimum dose, the efficacy and the safety of sifalimumab in adult patients with Systemic Lupus Erythematosus, a disease of the immune systemA Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults with Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Sifalimumab
Product Code: MEDI-545
INN or Proposed INN: sifalimumab
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
400Phase 2United States;Philippines;Spain;Thailand;Chile;Italy;United Kingdom;India;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Peru;South Africa;Bulgaria;Netherlands;Germany
993EUCTR2011-000368-88-PL
(EUCTR)
04/06/2012A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patients 5 to 17 years of ageA Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with SLE - Belimumab in pediatric patients with SLE Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: BENLYSTA™ (belimumab)
Product Name: Benlysta (belimumab)
Product Code: GSK1550188
INN or Proposed INN: belimumab
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
100Phase 2United States;Mexico;Canada;Argentina;Brazil;Spain;Poland;Peru;Russian Federation;Netherlands;Italy;United Kingdom