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
10NCT05559671
(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
11EUCTR2022-002691-36-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
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
32NCT05352919
(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
33NCT05433857
(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
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
47NCT05236491
(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
48EUCTR2019-003406-27-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
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
73EUCTR2020-005776-35-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
74EUCTR2020-005775-12-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
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
81EUCTR2020-003509-72-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
82NCT04908865
(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
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
86NCT04895696
(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
87EUCTR2021-001567-25-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
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
98NCT04736953
(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
99ChiCTR2100050041
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
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
105EUCTR2020-005569-14-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
106NCT05000216
(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
107EUCTR2018-004175-12-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
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
111NCT04976322
(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
112EUCTR2020-003509-72-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
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
115ITMCTR2100005063
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
116EUCTR2019-003409-83-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
117ChiCTR2100048796
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
162EUCTR2019-002205-22-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
163ChiCTR2000038519
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
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
195ITMCTR2000003055
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
196ChiCTR2000030247
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
212EUCTR2017-005026-37-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
213EUCTR2017-005028-11-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
214NCT04275193
(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
215EUCTR2019-000638-20-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
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
231NCT03843125
(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
232EUCTR2019-000638-20-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
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
242EUCTR2018-001735-49-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
243NCT04184258
(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
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
265EUCTR2018-001808-11-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
266EUCTR2018-000305-23-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
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
270EUCTR2018-001808-11-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
271EUCTR2018-000305-23-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
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
306NCT03616964
(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
307NCT03616912
(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
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
319EUCTR2017-002564-40-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
320NCT03451422
(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
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
332EUCTR2016-003050-32-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
333NCT03407482
(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
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
347NCT03252587
(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
348NCT03054259
(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
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-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
364ChiCTR-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
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
366EUCTR2016-002950-19-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
367NCT03171194
(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
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
373EUCTR2016-001039-11-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
374NCT03159936
(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
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
407NCT02080195
(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
408EUCTR2015-004457-40-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
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-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
426EUCTR2015-004404-35-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
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
436NCT02677688
(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
437NCT02483624
(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
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
440ChiCTR-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
441JPRN-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)
442NCT02074020
(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
443NCT02885610
(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
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
448EUCTR2014-004632-19-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
449EUCTR2014-004633-96-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
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
459EUCTR2014-004632-19-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
460NCT02665364
(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
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;Phi