49. 全身性エリテマトーデス [臨床試験数:827,薬物数:638(DrugBank:168),標的遺伝子数:108,標的パスウェイ数:191

Searched query = "Systemic lupus erythematosus", "SLE"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04486118February 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 AllianceNot yet recruiting18 Years55 YearsAll36Phase 2NULL
2NCT04570306December 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
3NCT04647708December 2, 202023/11/2020Study of M5049 in Cutaneous Lupus Erythematosus (CLE) and Systemic Lupus Erythematosus (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 Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus Participants Treated With Standard of CareSystemic Lupus Erythematosus;Cutaneous Lupus ErythematosusDrug: M5049;Drug: PlaceboMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyNULLNot yet recruiting18 Years65 YearsAll40Phase 1Bulgaria;Germany;Moldova, Republic of;Ukraine
4NCT04643067December 1, 202012/11/2020A Study to Assess the Safety and Tolerability, PK and Efficacy of KPG-818 in Mild to Moderate SLE PatientsA Phase 1b/2a Multicenter, Randomized, Double-Blind, Placebo- Controlled Study to Assess the Safety and Tolerability, Pharmacokinetics and Preliminary Efficacy of KPG-818 in Patients With Mild to Moderate Systemic Lupus ErythematosusSLE; DrugDrug: 0.15mg KPG-818 dose;Drug: 0.6mg KPG-818 dose;Drug: 2mg KPG-818 dose;Drug: PlaceboKangpu Biopharmaceuticals, Ltd.NULLNot yet recruiting18 YearsN/AAll64Phase 1/Phase 2NULL
5EUCTR2019-000638-20-BG09/11/202014/08/2020A 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: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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;Czech Republic;Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Romania;Australia;Bulgaria;Netherlands;Germany;New Zealand;China;Japan;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2019-003323-38-GB06/11/202013/10/2020A 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: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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
7EUCTR2019-003323-38-HU04/11/202010/09/2020A 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: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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
8NCT04515719November 1, 202013/8/2020Efficacy 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 HospitalNULLNot yet recruiting18 Years70 YearsAll334Phase 4NULL
9NCT04582136November 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
10NCT04440566October 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT04516408October 1, 202013/8/2020Recombinant 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 HospitalNULLNot yet recruiting50 YearsN/AAll464N/ANULL
12EUCTR2019-002205-22-FR01/10/202013/01/2020Clinical 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: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
13ChiCTR20000385192020-10-012020-09-23A 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
14NCT00775476October 202017/10/2008Treatment 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 UniversityNULLNot yet recruiting18 YearsN/AAll290Phase 2United States
15EUCTR2020-001690-72-HU28/09/202010/09/2020A 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: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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;Germany;Netherlands;China;Japan;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2017-005028-11-NL23/09/202002/07/2020A 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: 21.1Level: LLTClassification code 10025139Term: Lupus erythematosus systemicSystem 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;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
17EUCTR2019-003406-27-DE17/09/202015/04/2020A 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: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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;Estonia;Taiwan;Slovakia;Greece;Spain;Chile;Colombia;Switzerland;Italy;France;Denmark;Australia;Peru;Netherlands;Korea, Republic of;Czechia;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Norway;Sweden
18EUCTR2019-003406-27-AT11/09/202029/05/2020A 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 Systemic lupus erythematosus (SLE)
MedDRA version: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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
19EUCTR2019-003406-27-GB09/09/202015/07/2020A 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: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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
20NCT03684564September 202013/8/2018RIvaroxaban 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, LondonArthritis Research UK;King's College London;University College London Hospitals;Hammersmith Hospitals NHS Trust;Guy's and St Thomas' NHS Foundation Trust;Barts & The London NHS Trust;King's College Hospital NHS Trust;Manchester University NHS Foundation Trust;Barking, Havering and Redbridge University Hospitals NHS Trust;St George's University Hospitals NHS Foundation TrustNot yet recruiting18 YearsN/AAll140Phase 2/Phase 3NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT04447053September 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
22NCT04127747August 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
23NCT04397107August 15, 20206/5/2020The Therapeutic Value and Mechanism of Recombinant Human Interleukin-2 on Children With Rheumatic DiseasesThe Therapeutic Value and Mechanism of Recombinant Human Interleukin-2 on Children With Rheumatic Diseases (Systemic Lupus Erythematosus, Primary Sjögren Syndrome, Juvenile Idiopathic Arthritis)Systemic Lupus ErythematosusDrug: IL-2First Hospital of Jilin UniversityNULLRecruitingN/A17 YearsAll46N/AChina
24EUCTR2019-002205-22-DE12/08/202007/07/2020Clinical 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: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 23.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
25NCT04294667August 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;Bulgaria;Canada;Chile;Hungary;Poland;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT04433585August 7, 202015/6/2020A Study of LY3471851 in Adults With Systemic Lupus Erythematosus (SLE)A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of LY3471851 (NKTR-358) in Adults With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: LY3471851;Drug: PlaceboEli Lilly and CompanyNektar TherapeuticsRecruiting18 Years65 YearsAll280Phase 2United States;Argentina;Australia;Canada;Czechia;Germany;Hungary;India;Israel;Japan;Korea, Republic of;Mexico;Poland;Puerto Rico;Romania;Russian Federation;Spain;Taiwan;Ukraine;United Kingdom
27EUCTR2019-003406-27-GR30/07/202002/06/2020A 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 Systemic lupus erythematosus (SLE)
MedDRA version: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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 3Netherlands;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;United States;Serbia;Portugal;Philippines;Taiwan;Estonia;Slovakia;Greece;Spain;Chile;Colombia;Switzerland;Italy;France;Australia;Peru;Canada;Argentina;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Norway;Sweden
28EUCTR2018-001808-11-GR29/07/202016/07/2020A 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: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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
500Phase 2United States;Philippines;Taiwan;Greece;Spain;Thailand;Ukraine;Turkey;Russian Federation;Israel;Chile;Colombia;Italy;United Kingdom;France;Hungary;Czech Republic;Mexico;Poland;Romania;Georgia;Bulgaria;Germany;China
29EUCTR2019-003406-27-HU28/07/202020/05/2020A 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: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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 3Serbia;Portugal;United States;Philippines;Taiwan;Estonia;Slovakia;Greece;Spain;Chile;Colombia;Switzerland;Italy;France;Peru;Australia;Netherlands;Korea, Republic of;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Sweden
30NCT04451772July 17, 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 UpadacitinibAbbVieNULLEnrolling by invitation18 Years65 YearsAll260Phase 2United States;Argentina;Bulgaria;China;Germany;Hungary;Japan;Mexico;Netherlands;Poland;Puerto Rico;Spain;Taiwan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31NCT04060888July 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
32NCT04305197June 29, 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.NULLRecruiting18 Years75 YearsAll60Phase 1/Phase 2China
33EUCTR2019-003406-27-BG09/06/202021/04/2020A 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 Systemic lupus erythematosus (SLE)
MedDRA version: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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
34EUCTR2017-005028-11-HR05/06/202023/11/2020A 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: 21.1Level: LLTClassification code 10025139Term: Lupus erythematosus systemicSystem 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;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
35EUCTR2019-003406-27-ES02/06/202028/05/2020A 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: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2017-005028-11-GR20/05/202026/11/2019A 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: 21.1Level: LLTClassification code 10025139Term: Lupus erythematosus systemicSystem 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;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
37EUCTR2018-003471-35-ES06/05/202010/05/2020Long-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: 21.1Level: LLTClassification code 10042947Term: Systemic lupus erythematosus syndSystem 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
38EUCTR2019-002205-22-GB01/05/202007/01/2020Clinical 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: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
39EUCTR2019-002205-22-ES06/04/202023/01/2020Clinical 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: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
40ChiCTR20000303422020-04-012020-02-29Treatment 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2019-002205-22-PL29/03/202007/02/2020Clinical 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: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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;Belgium;Poland;Netherlands;Germany;United Kingdom
42JPRN-jRCTs01119001113/03/202013/03/2020Steroid-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 applicableBoth48Japan
43NCT04233164March 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)NULLRecruiting18 Years80 YearsAll100Early Phase 1United States
44EUCTR2019-000328-16-PT02/03/202009/08/2019A 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 (SLE)
MedDRA version: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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
300Phase 2United States;Portugal;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Poland;Australia;Bulgaria;Germany;Japan;Korea, Republic of
45ChiCTR20000302472020-03-012020-02-26Clinical 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46NCT04276701March 202012/2/2020Immune Mediators and Metabolites to Stratify Systemic Lupus Erythematosus Patients at High Risk of Cardio Vascular DiseasesImmune Mediators and Metabolites to Stratify Systemic Lupus Erythematosus Patients at High Risk of Cardio Vascular DiseasesSystemic Lupus ErythematosusBiological: blood sample;Other: Ultrasonography assessment;Behavioral: questionnairesUniversity Hospital, BordeauxFoundation for Research in Rheumatology (FOREUM)Not yet recruiting18 YearsN/AAll500N/AFrance;Germany;Spain
47NCT04058028February 19, 202030/7/2019Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE)A 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) TherapySystemic Lupus Erythematosus (SLE)Drug: AMG 570;Drug: Placebo for AMG 570AmgenNULLRecruiting18 Years75 YearsAll300Phase 2United States;Argentina;Australia;Bulgaria;Canada;Czechia;France;Germany;Hungary;Italy;Japan;Korea, Republic of;Mexico;Poland;Portugal;Russian Federation
48EUCTR2019-000638-20-NL07/02/202009/12/2019A 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: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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;Taiwan;Spain;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Romania;Australia;Netherlands;Germany;New Zealand;China;Japan;Korea, Republic of
49EUCTR2018-004645-16-NL29/01/202029/10/2019A 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: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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
50EUCTR2019-000638-20-DE22/01/202009/09/2019A 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: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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;Puerto Rico;Canada;Argentina;Poland;Australia;Bulgaria;Germany;Netherlands;New Zealand;China;Japan;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51NCT04186871January 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 SquibbNULLRecruiting18 Years65 YearsAll185Phase 2United States;Argentina;Australia;Belgium;France;Germany;Mexico;Netherlands;Poland;Spain;United Kingdom
52EUCTR2018-004175-12-GB30/12/201923/07/2019A 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: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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
53EUCTR2018-004645-16-DE27/12/201918/09/2019A 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: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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
54EUCTR2019-000328-16-FR20/12/201916/07/2019A 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]
Amgen IncNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c 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
55EUCTR2018-004645-16-ES16/12/201911/11/2019A 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]
GlaxoSmithKline, S.A.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
24 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;Mexico;Argentina;Spain;Netherlands;Germany;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56NCT04179032November 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: BelimumabGlaxoSmithKlineNULLRecruiting5 Years17 YearsAll30Phase 2United States;Argentina;Germany;Japan;Mexico;Netherlands;Spain
57EUCTR2018-004175-12-PT25/11/201930/07/2019A 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]
Pfizer Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
448 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c 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
58EUCTR2018-004175-12-ES12/11/201911/11/2019A 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]
Pfizer Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
448 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c 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
59NCT04136145October 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
60EUCTR2017-005026-37-HR24/10/201920/01/2020A 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: 21.1Level: LLTClassification code 10025139Term: Lupus erythematosus systemicSystem 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;Switzerland;United Kingdom;Hungary;Czech Republic;Mexico;Belgium;Brazil;Croatia;Australia;Netherlands;Germany;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61EUCTR2017-005028-11-GB24/10/201918/03/2019A 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: 21.1Level: LLTClassification code 10025139Term: Lupus erythematosus systemicSystem 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
62NCT04275193October 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
63EUCTR2018-004175-12-BG11/10/201930/07/2019A 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: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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 2Portugal;Serbia;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Colombia;France;Australia;Netherlands;China;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan
64NCT04082416October 10, 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 therapyRemeGenNULLRecruiting18 Years65 YearsAll318Phase 3China
65EUCTR2018-001808-11-DE04/10/201918/10/2018A 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: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66NCT04128579October 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 YearsAll60Phase 1United States
67EUCTR2018-004175-12-HU23/09/201923/07/2019A 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: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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
68EUCTR2019-000328-16-HU23/09/201916/07/2019A 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]
Amgen IncNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c 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
69EUCTR2019-000638-20-HU18/09/201902/10/2019A 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: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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;Czech Republic;Mexico;Puerto Rico;Canada;Argentina;Poland;Romania;Australia;Netherlands;Germany;New Zealand;China;Japan;Korea, Republic of
70EUCTR2019-000328-16-DE17/09/201911/07/2019A 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]
Amgen IncNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71NCT04077684September 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
72EUCTR2019-000638-20-ES09/09/201927/09/2019A 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]
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
325 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c 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
73NCT03843125September 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 CorporationRecruiting18 YearsN/AAll1100Phase 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
74EUCTR2018-004175-12-PL03/09/201906/08/2019A 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: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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 2Portugal;Serbia;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Colombia;France;Australia;Netherlands;China;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan
75NCT03953261September 1, 201914/5/2019Effect of Curcumin on Systemic Lupus ErythematosusEffect of Curcumin on Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: Curcumin supplementLoma Linda UniversityNULLRecruiting18 YearsN/AAll68Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76ChiCTR19000253762019-09-012019-08-25Lenalidomide 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;China
77EUCTR2018-004175-12-CZ21/08/201925/07/2019A 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: 20.0Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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 2Portugal;Serbia;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Colombia;France;Australia;Netherlands;China;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan
78EUCTR2017-005026-37-NL06/08/201913/05/2019A 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: 21.1Level: LLTClassification code 10025139Term: Lupus erythematosus systemicSystem 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;Czechia;Taiwan;Greece;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;Brazil;Belgium;Croatia;Australia;Germany;Netherlands;China
79EUCTR2017-005026-37-GR26/07/201903/05/2019A 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: 21.1Level: LLTClassification code 10025139Term: Lupus erythematosus systemicSystem 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;Israel;Russian Federation;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;Belgium;Brazil;Croatia;Australia;Germany;Netherlands;China
80NCT03978520July 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 upadacitinibAbbVieNULLRecruiting18 Years65 YearsAll310Phase 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81NCT03951259July 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
82EUCTR2017-005028-11-PL05/07/201923/04/2019A 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: 21.1Level: LLTClassification code 10025139Term: Lupus erythematosus systemicSystem 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 3Serbia;United States;Philippines;Taiwan;Spain;Russian Federation;Chile;Colombia;Switzerland;Italy;India;France;Australia;South Africa;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Germany;Japan
83NCT04184258July 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 UniversityRecruiting18 Years75 YearsAll10Phase 1/Phase 2Belarus
84EUCTR2018-001735-49-GB01/07/201922/01/2019RIvaroxaban 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: 20.0Level: PTClassification code 10002817Term: Antiphospholipid syndromeSystem 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
85NCT03656627June 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 SquibbRecruiting18 YearsN/AAll72Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86ChiCTR19000229342019-06-202019-05-04Study 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;China
87EUCTR2017-001203-79-ES11/06/201930/04/2019A 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]
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
360 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c 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
88EUCTR2017-005028-11-AT02/06/201928/03/2019A 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: 20.0 Level: LLT Classification code 10025139 Term: Lupus erythematosus systemic System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1100 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noSerbia;United States;Philippines;Taiwan;Spain;Russian Federation;Chile;Colombia;Switzerland;Italy;India;France;Australia;South Africa;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Germany;Japan
89NCT03804723June 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
90EUCTR2017-005028-11-ES30/05/201931/05/2019A 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]
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1100 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noSerbia;United States;Philippines;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Switzerland;Italy;India;France;Australia;South Africa;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Romania;Germany;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91EUCTR2018-003471-35-HU29/05/201902/04/2019Long-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: 20.0 Level: LLT Classification code 10042947 Term: Systemic lupus erythematosus synd System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
360 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;Taiwan;Spain;Russian Federation;Israel;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Australia;Germany;Korea, Republic of
92NCT03933943May 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 CompanyNULLRecruiting18 Years70 YearsAll24Phase 1United States
93EUCTR2017-005028-11-HU20/05/201902/04/2019A 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]
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1100 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noSerbia;United States;Philippines;Taiwan;Spain;Russian Federation;Chile;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
94EUCTR2018-001808-11-PL17/05/201915/05/2019A 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: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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;Philippines;Taiwan;Greece;Thailand;Spain;Ukraine;Turkey;Russian Federation;Chile;Israel;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Poland;Romania;Bulgaria;Georgia;Germany;China
95EUCTR2018-003471-35-PL04/05/201903/04/2019Long-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: 21.1Level: LLTClassification code 10042947Term: Systemic lupus erythematosus syndSystem 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;Colombia;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Australia;Germany;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96NCT03949426May 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
97NCT03845517April 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 mgPfizerNULLRecruiting18 Years75 YearsAll448Phase 2United States;Australia;Belgium;Bulgaria;Canada;China;Colombia;Czechia;France;Germany;Greece;Hungary;Japan;Korea, Republic of;Mexico;Poland;Portugal;Romania;Serbia;Spain;Taiwan;Ukraine;United Kingdom
98EUCTR2017-005028-11-CZ08/04/201928/03/2019A 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: 21.1Level: LLTClassification code 10025139Term: Lupus erythematosus systemicSystem 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;Italy;Switzerland;India;France;Australia;South Africa;China;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Germany;Japan
99NCT03816345April 4, 201924/1/2019Nivolumab in Treating Patients With Autoimmune Disorders or Advanced, Metastatic, or Unresectable CancerA Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)Advanced Malignant Neoplasm;Autoimmune Disease;Crohn Disease;Dermatomyositis;Inflammatory Bowel Disease;Metastatic Malignant Neoplasm;Multiple Sclerosis;Rheumatoid Arthritis;Sjogren Syndrome;Systemic Lupus Erythematosus;Systemic Scleroderma;Ulcerative Colitis;Unresectable Malignant NeoplasmBiological: NivolumabNational Cancer Institute (NCI)NULLRecruiting18 YearsN/AAll264Phase 1United States
100NCT03917797April 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
101EUCTR2017-005026-37-GB27/03/201919/09/2018A 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: 21.1Level: LLTClassification code 10025139Term: Lupus erythematosus systemicSystem 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
102NCT03920267March 26, 201927/3/2019Long-Term Safety and Efficacy Study of BMS-986165 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 SquibbNULLRecruiting18 Years75 YearsAll360Phase 2United States;Argentina;Australia;Brazil;Canada;Colombia;Germany;Hungary;Israel;Japan;Korea, Republic of;Mexico;Poland;Romania;Russian Federation;Spain;Taiwan
103EUCTR2018-001808-11-BG20/03/201906/12/2018A 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]
Idorsia Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
500 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;Taiwan;Spain;Thailand;Ukraine;Turkey;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Mexico;Poland;Romania;Bulgaria;Georgia;Germany;China
104EUCTR2018-000305-23-BG20/03/201912/11/2018A 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: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 2United States;Philippines;Hungary;Mexico;Argentina;Poland;Ukraine;Romania;Peru;Georgia;Bulgaria;Colombia
105NCT03771885March 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
106ChiCTR19000208032019-03-012019-01-19Efficacy 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;China
107EUCTR2018-001808-11-HU08/02/201922/11/2018A 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: 20.0Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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
108EUCTR2018-000305-23-HU07/02/201928/11/2018NoA 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]
Boston Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
156 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;Philippines;Hungary;Mexico;Argentina;Poland;Ukraine;Romania;Peru;Georgia;Bulgaria;Colombia
109EUCTR2018-001508-12-FR05/02/201913/11/2018Study 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]
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
120 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noTaiwan;Spain;Thailand;Russian Federation;Israel;France;Czech Republic;Hungary;Argentina;Poland;Australia;Germany;China;Japan;Korea, Republic of
110EUCTR2017-001489-53-PT04/02/201908/11/2018Study 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: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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;Ecuador;Thailand;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Canada;Argentina;Poland;South Africa;Bulgaria;Germany;China;Japan;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
111ChiCTR18000202862019-02-012018-12-22Clinical 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;1 (Phase 1 study)China
112EUCTR2018-001808-11-ES24/01/201916/11/2018A 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]
Idorsia Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
500 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c 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
113EUCTR2018-001808-11-FR14/01/201931/08/2018A 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: 20.0Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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
114NCT03742037December 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.NULLRecruiting18 Years75 YearsAll500Phase 2United States;Bulgaria;Czechia;France;Georgia;Germany;Greece;Hungary;Israel;Italy;Mexico;Philippines;Poland;Romania;Russian Federation;Spain;Taiwan;Thailand;Turkey;Ukraine;United Kingdom;Lithuania
115NCT03656562December 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 PharmaceuticalsNULLRecruiting18 Years75 YearsAll120Phase 2Argentina;Australia;China;Czechia;France;Germany;Hungary;Israel;Japan;Korea, Republic of;Poland;Russian Federation;Spain;Taiwan;Thailand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
116NCT03618056December 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
117EUCTR2017-005026-37-AT18/12/201825/09/2018A 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: 21.1Level: LLTClassification code 10025139Term: Lupus erythematosus systemicSystem 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;Czechia;Taiwan;Greece;Ukraine;Austria;Russian Federation;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;Belgium;Brazil;Croatia;Australia;Netherlands;Germany;China
118EUCTR2018-001808-11-GB17/12/201817/09/2018A 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: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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
119EUCTR2017-005026-37-BE17/12/201825/09/2018A 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]
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
750 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Taiwan;Greece;Ukraine;Austria;Russian Federation;Switzerland;United Kingdom;Czech Republic;Hungary;Mexico;Belgium;Brazil;Australia;Netherlands;Germany;China
120NCT03817424December 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
121EUCTR2018-001508-12-ES12/12/201809/10/2018Study 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]
Novartis Farmacéutica, S.A.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
120 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noTaiwan;Spain;Thailand;Russian Federation;Israel;France;Czech Republic;Hungary;Argentina;Poland;Australia;Germany;China;Japan;Korea, Republic of
122EUCTR2018-001508-12-DE05/12/201828/08/2018Study 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: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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 2Taiwan;Thailand;Spain;Israel;Russian Federation;France;Czech Republic;Hungary;Argentina;Poland;Australia;Germany;China;Japan;Korea, Republic of
123NCT02525835December 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
124NCT03878303November 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
125NCT03724916November 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.NULLRecruiting18 Years75 YearsAll24Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
126EUCTR2017-005026-37-HU19/11/201825/09/2018A 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: 21.1Level: LLTClassification code 10025139Term: Lupus erythematosus systemicSystem 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;Hungary;Czech Republic;Mexico;Belgium;Brazil;Croatia;Australia;Netherlands;Germany;China
127ChiCTR18000193082018-11-122018-11-04Efficacy 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
128EUCTR2017-005026-37-CZ12/11/201826/10/2018A 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: 21.1Level: LLTClassification code 10025139Term: Lupus erythematosus systemicSystem 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
129EUCTR2018-001508-12-CZ02/11/201828/08/2018Study the efficacy and safety of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE) A placebo-controlled, patient and investigator blinded, randomized 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: 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]
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
135 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noTaiwan;Spain;Thailand;Russian Federation;Israel;France;Czech Republic;Hungary;Argentina;Poland;Australia;Germany;China;Japan;Korea, Republic of
130NCT02633163October 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
131NCT03626311October 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, LLCRecruiting18 YearsN/AAll76N/AUnited States;Canada
132NCT03747159October 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/AAll30Phase 2Netherlands
133EUCTR2018-001392-21-NL25/09/201825/09/2018Synergetic 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: 21.1Level: LLTClassification code 10042947Term: Systemic lupus erythematosus syndSystem Organ Class: 100000004859
MedDRA version: 20.0Level: LLTClassification code 10029142Term: Nephritis systemic lupus erythematosusSystem Organ Class: 100000004857
MedDRA version: 21.1Level: LLTClassification code 10042948Term: Systemic lupus erythematosus syndrome aggravatedSystem 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
134EUCTR2017-001489-53-PL24/09/201823/07/2018Study 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: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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
135EUCTR2017-005027-25-ES21/09/201824/09/2018A 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: 20.0Level: LLTClassification code 10025139Term: Lupus erythematosus systemicSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
136NCT03575156September 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, BordeauxNULLActive, not recruiting18 YearsN/AAll208N/AFrance
137NCT03527472August 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 FoundationActive, not recruiting18 Years60 YearsAll46Phase 2United States
138JPRN-JapicCTI-18397316/8/201829/05/2018A 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.NULLcomplete1675BOTH500Japan, Asia except Japan, North America, South America, Europe, Africa
139NCT03312335August 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
140NCT03616912August 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 CorporationRecruiting18 YearsN/AAll809Phase 3United States;Australia;Austria;Belgium;Brazil;China;Croatia;Czechia;Germany;Greece;Hungary;Israel;Mexico;Netherlands;Russian Federation;Switzerland;Taiwan;United Kingdom;Ukraine
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
141NCT03616964August 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 CorporationActive, not recruiting18 YearsN/AAll750Phase 3United States;Argentina;Chile;Colombia;France;India;Italy;Japan;Korea, Republic of;Philippines;Poland;Romania;Serbia;South Africa;Spain
142ChiCTR18000175402018-08-012018-08-03A 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:prednisone;2:Mycophenolate Mofetil;Ruijin HospitalNULLRecruiting1865Both1:50;2:50;China
143NCT03562065July 1, 201822/5/2018Treatment 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 ParisNULLNot yet recruiting18 Years70 YearsAll10Phase 1/Phase 2France
144EUCTR2017-001489-53-BG27/06/201828/03/2018Study 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: 20.0Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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
145EUCTR2017-001489-53-HU14/06/201803/04/2018Study 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: 20.0Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
146EUCTR2017-001489-53-ES12/06/201814/03/2018Study 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: 20.0Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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
147NCT03541564May 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
148EUCTR2016-000488-17-FR16/05/201819/03/2019A 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: 20.0Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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
149EUCTR2017-001764-37-PT14/05/201812/10/2017An 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 Erythematosus A 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]
Genentech, Inc.NULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noPortugal;United States;Taiwan;Spain;Chile;Colombia;United Kingdom;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of
150EUCTR2017-001489-53-DE08/05/201823/03/2018Study 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: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
151EUCTR2017-001489-53-LT07/05/201819/03/2018Study 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: 20.0Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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
152NCT03556007May 1, 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
153NCT03517722April 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, LLCNULLActive, not recruiting16 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
154NCT03492255April 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 PauloRecruiting18 YearsN/AAll232N/ABrazil
155NCT03451422April 10, 20181/2/2018Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of AMG 592 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 AMG 592 in Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: AMG 592;Drug: PlaceboAmgenNULLRecruiting18 Years70 YearsAll29Phase 1United States;France;Germany;Poland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
156EUCTR2017-002564-40-DE10/04/201804/12/2017Safety 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: 21.1Level: LLTClassification code 10025139Term: Lupus erythematosus systemicSystem 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
157EUCTR2017-001400-29-FR16/03/201831/07/2018Treatment 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: 20.0Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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
158EUCTR2017-004060-35-HU12/03/201810/01/2018An 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]
ImmuPharmaNULLNot Recruiting Female: yes
Male: yes
75 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Hungary;Mauritius
159NCT03393013March 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.NULLRecruiting18 Years75 YearsAll68Phase 1/Phase 2United States;Australia;Colombia;Mexico;Poland;Russian Federation;Ukraine
160NCT03312907March 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 TaperGlaxoSmithKlineNULLActive, not recruiting18 YearsN/AAll292Phase 3United States;Argentina;Brazil;Canada;France;Germany;Korea, Republic of;Mexico;Netherlands;Russian Federation;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
161ChiCTR18000150302018-03-012018-03-01A 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
162NCT03480529March 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
163NCT03396393March 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
164NCT03427151February 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
165EUCTR2016-003050-32-NL16/02/201824/10/2017 A Phase 3 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 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]
GlaxoSmithKline Research & Development LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
280 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Mexico;Canada;Argentina;Spain;Brazil;Russian Federation;Germany;Netherlands;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
166NCT03371251February 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
167NCT03370263January 15, 20186/12/2017BENLYSTA® Special Drug Use InvestigationBENLYSTA for Intravenous Injection / Subcutaneous Injection Special Drug Use InvestigationSystemic Lupus ErythematosusDrug: BenlystaGlaxoSmithKlineNULLRecruitingN/AN/AAll600Japan
168EUCTR2016-003050-32-DE09/01/201821/06/2017 A Phase 3 Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination with Rituximab to Adult Subjects with Systemic Lupus Erythematosus (SLE) – BLISS-BELIEVE A 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]
GlaxoSmithKline Research & Development LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
280 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Mexico;Canada;Argentina;Spain;Brazil;Russian Federation;Netherlands;Germany;Korea, Republic of
169NCT03407482January 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
170EUCTR2017-001203-79-PL05/01/201803/11/2017A 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: 21.1Level: LLTClassification code 10042947Term: Systemic lupus erythematosus syndSystem 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 finishedFemale: yes
Male: yes
360Phase 2Taiwan;Russian Federation;Israel;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Australia;Germany;Japan;Spain;Colombia;Korea, Republic of;United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
171NCT03030118December 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)Recruiting15 Years49 YearsAll240Phase 2United States
172NCT03093402December 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 Erythematosus (ALE09)Systemic Lupus Erythematosus;SLE;LupusDrug: JBT-101;Drug: PlaceboNational Institute of Allergy and Infectious Diseases (NIAID)Corbus Pharmaceuticals Inc.;Autoimmunity Centers of ExcellenceRecruiting18 Years70 YearsAll100Phase 2United States
173EUCTR2017-001764-37-BG15/12/201716/10/2017An 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: 20.0Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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
174EUCTR2016-003050-32-ES05/12/201701/12/2017A 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: 20.0Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3United States;Mexico;Canada;Argentina;Brazil;Spain;Russian Federation;South Africa;Netherlands;Korea, Republic of
175EUCTR2017-001203-79-HU04/12/201704/10/2017A 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: 20.0Level: LLTClassification code 10042947Term: Systemic lupus erythematosus syndSystem 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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 2United States;Taiwan;Ukraine;Russian Federation;Israel;Colombia;France;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Peru;Bulgaria;Germany;Japan;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
176EUCTR2016-004574-17-FR30/11/201728/11/2018A 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]
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
280 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noSerbia;United States;Spain;Russian Federation;Colombia;Italy;France;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Germany
177NCT03334851November 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: PlaceboPfizerNULLRecruiting18 Years70 YearsAll112Phase 1United States;Puerto Rico
178EUCTR2017-001764-37-GB14/11/201715/08/2017An 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: 20.0Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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
179EUCTR2016-004574-17-BE14/11/201707/06/2017A 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: 20.0Level: LLTClassification code 10025134Term: Lupus erythematosusSystem 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
180EUCTR2017-001764-37-ES07/11/201718/09/2017An 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]
Roche Farma, S.A por delegación de Genentech, Inc.NULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;Portugal;Taiwan;Spain;Chile;Colombia;United Kingdom;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
181EUCTR2016-004574-17-DE27/09/201721/04/2017A 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: 20.0Level: LLTClassification code 10025134Term: Lupus erythematosusSystem 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;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Germany
182ChiCTR-IOR-170128022017-09-262017-09-26Synergy 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
183NCT03054259September 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
184NCT03254784September 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
185NCT03098823September 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
186NCT03262727September 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
187NCT03260166August 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 ChinaRecruiting18 Years65 YearsAll40Phase 2China
188NCT03288324August 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, CincinnatiPfizerRecruiting18 Years45 YearsAll20Phase 1/Phase 2United States
189NCT03219801August 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
190NCT03161483July 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
191NCT03189017July 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
192NCT03296995July 1, 201725/9/2017Accuracy, Feasibility and Acceptance of CGM LupusAccuracy, Feasibility and Acceptance of Continuous Glucose Monitoring in Critically Systemic Lupus ErythematosusSystemic Lupus Erythematosus;Critical Illness;Diabetic Blood Glucose MonitoringDevice: Flash glucose monitoring systemRenJi HospitalNULLRecruiting18 YearsN/AAll30N/AChina
193NCT02920424June 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
194EUCTR2016-002950-19-DE19/06/201712/04/2017A 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]
Merck KGaANULLNot Recruiting Female: yes
Male: yes
468 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c 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
195EUCTR2016-004574-17-HU19/06/201713/04/2017A 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: 19.1Level: LLTClassification code 10025134Term: Lupus erythematosusSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
196NCT03252587June 13, 201715/8/2017An Investigational Study to Evaluate BMS-986165 in Patients 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 SquibbNULLRecruiting18 Years75 YearsAll360Phase 2United States;Argentina;Australia;Brazil;Bulgaria;Canada;Colombia;France;Germany;Hungary;Israel;Japan;Korea, Republic of;Mexico;Peru;Poland;Romania;Russian Federation;Spain;Taiwan;Ukraine
197EUCTR2015-004359-32-PL10/06/201724/04/2017Study 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: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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
198EUCTR2016-004574-17-ES08/06/201707/04/2017A 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: 19.1Level: LLTClassification code 10025134Term: Lupus erythematosusSystem 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
199NCT03122431June 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: Hydroxychloroquine highUniversity of Sao Paulo General HospitalFundação de Amparo à Pesquisa do Estado de São PauloRecruiting5 Years64 YearsAll296Phase 4Brazil
200ChiCTR-INC-170114972017-05-252017-05-26The 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
201ChiCTR-INR-170114952017-05-252017-05-26The efficacy and safety of metformin hydrochloride combined with atorvastatin in the treatment of primary mild to moderate systemic systemic lupus erythematosusThe 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
202EUCTR2016-000625-39-BG17/05/201708/03/2017A 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: 20.0Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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
203NCT03171194April 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
204EUCTR2016-002950-19-BG27/04/201727/03/2017A 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: 20.0Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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;Bulgaria;South Africa;Germany;Japan;Korea, Republic of
205JPRN-JapicCTI-17354426/4/201723/03/2017TULIP 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
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Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
206EUCTR2016-002950-19-PL25/04/201728/03/2017A 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: 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]
Merck KGaANULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
468 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;Philippines;Taiwan;Russian Federation;Chile;Colombia;Italy;Mexico;Mauritius;Argentina;Malaysia;Poland;Brazil;Romania;Peru;South Africa;Bulgaria;Germany;Japan;Korea, Republic of
207NCT03355482April 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
208EUCTR2015-001341-86-BG10/04/201716/02/2017Phase 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: 19.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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
209NCT03125486April 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
210NCT03159936April 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
211EUCTR2016-001039-11-DE03/04/201722/12/2016A 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]
Genentech, Inc.NULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;Portugal;Taiwan;Spain;Chile;Colombia;United Kingdom;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of
212EUCTR2016-000488-17-BG27/03/201713/02/2017A 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: 20.0Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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
213EUCTR2016-000488-17-IT02/03/201710/05/2019A 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: 20.0Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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
214EUCTR2015-001341-86-ES01/03/201727/12/2016Phase 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: 19.0Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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
215NCT03042260March 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
216NCT03030976March 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
217EUCTR2016-001039-11-BG20/02/201708/11/2016A 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: 20.0Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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
218NCT02962960February 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
219EUCTR2016-001039-11-ES07/02/201726/10/2016A 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]
Genentech, Inc.NULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noPortugal;United States;Taiwan;Spain;Chile;Colombia;United Kingdom;France;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of
220EUCTR2015-004359-32-BG01/02/201703/11/2016Study 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: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
221EUCTR2016-001039-11-PT30/01/201723/09/2016A 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]
Genentech, Inc.NULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noPortugal;United States;Taiwan;Spain;Chile;Colombia;United Kingdom;France;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of
222EUCTR2016-003246-93-PL26/01/201713/12/2016The 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
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 ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
32Phase 2United States;Hungary;Poland;Korea, Republic of
223NCT02880852January 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
224JPRN-JapicCTI-18395720/1/201714/05/2018A 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
225NCT02908100January 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
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Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
226NCT02955615January 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
227NCT02975336January 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
228NCT02953821December 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
229EUCTR2016-000625-39-DE13/12/201605/07/2016A 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: 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]
AstraZeneca ABNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
575 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited 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
230EUCTR2016-003246-93-HU06/12/201619/10/2016 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]Astrazeneca ABNULLNot Recruiting Female: yes
Male: yes
32 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;Hungary;Poland;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
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size
PhaseCountries
231EUCTR2016-000488-17-ES21/11/201618/11/2016A 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]
ILTOO PHARMANULLNot Recruiting Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noFrance;Portugal;Mexico;Spain;Austria;Bulgaria;Italy
232EUCTR2016-001039-11-GB16/11/201624/08/2016A 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]
Genentech, Inc.NULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;Portugal;Taiwan;Spain;Chile;Colombia;United Kingdom;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of
233EUCTR2015-004457-40-PL04/11/201602/09/2016A 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: 20.0Level: LLTClassification code 10040967Term: SLESystem 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
234EUCTR2016-000625-39-LT03/11/201617/08/2016A 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: 20.0Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan
235ChiCTR-IPR-160094512016-11-012016-10-16The 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
236EUCTR2016-000488-17-PT24/10/201628/07/2016A 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]
ILTOO PHARMANULLNot Recruiting Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noFrance;Portugal;Mexico;Mauritius;Spain;Romania;Austria;Bulgaria;Germany;Italy
237NCT02847598October 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
238EUCTR2015-003341-25-GB17/10/201622/09/2016A 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]
ImmuPharma SANULLNot Recruiting Female: yes
Male: yes
200 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noFrance;United States;Hungary;Germany;United Kingdom
239EUCTR2015-004457-40-ES10/10/201605/08/2016A 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: 19.0Level: LLTClassification code 10040967Term: SLESystem 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
240NCT02842814October 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 HospitalRecruiting18 Years60 YearsAll350N/AChina
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
241NCT02779153October 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
242EUCTR2015-004457-40-HU20/09/201613/07/2016 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]
UCB Biopharma SPRLNULLNot Recruiting Female: yes
Male: yes
160 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Germany
243EUCTR2015-004457-40-DE19/09/201622/06/2016 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]
UCB Biopharma SPRLNULLNot Recruiting Female: yes
Male: yes
160 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Germany
244EUCTR2015-004457-40-BG13/09/201603/08/2016 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]
UCB Biopharma SPRLNULLNot Recruiting Female: yes
Male: yes
160 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Germany
245NCT02080195September 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
246EUCTR2016-000625-39-ES24/08/201615/07/2016A 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: 19.0Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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
247EUCTR2016-000625-39-HU18/08/201623/06/2016A 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: 20.0Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Germany;Japan;New Zealand
248EUCTR2016-000488-17-AT08/08/201621/07/2016A 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]
ILTOO PHARMANULLNot Recruiting Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noPortugal;France;Mexico;Mauritius;Spain;Romania;Austria;Bulgaria;Germany;Italy
249EUCTR2015-003341-25-DE29/07/201617/03/2016A 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]
ImmuPharma SANULLNot Recruiting Female: yes
Male: yes
200 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noFrance;United States;Hungary;Germany;United Kingdom
250EUCTR2015-005543-14-GB19/07/201619/11/2018Safety 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: 20.0Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
251NCT02794285June 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 SciencesActive, not recruiting18 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
252NCT03155477June 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
253NCT02804763June 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
254NCT02514967June 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
255NCT02741960May 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
256NCT02932137May 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
257EUCTR2015-003341-25-HU02/05/201607/03/2016A 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: 18.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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
258EUCTR2015-004404-35-ES29/04/201604/04/2016A 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: 18.1Level: LLTClassification code 10025139Term: Lupus erythematosus systemicSystem 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
259EUCTR2015-004404-35-PL12/04/201631/03/2016A 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: 19.0Level: LLTClassification code 10025139Term: Lupus erythematosus systemicSystem 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
260EUCTR2015-004404-35-FR12/04/201604/05/2016A 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: 19.0Level: LLTClassification code 10025139Term: Lupus erythematosus systemicSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
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agemin
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gender
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size
PhaseCountries
261EUCTR2015-004404-35-AT06/04/201624/03/2016A 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: 18.1Level: LLTClassification code 10025139Term: Lupus erythematosus systemicSystem 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
262NCT02331810April 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
263NCT02618967March 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
264NCT02708095March 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
265JPRN-JapicCTI-16335901/3/2016A 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.NULL18BOTHNULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
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gender
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PhaseCountries
266NCT02711813March 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
267EUCTR2015-003341-25-FR24/02/201620/04/2016A 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: 19.0Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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
268NCT02725515February 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
269NCT02925351January 25, 20168/9/2016Fluorine F 18 Clofarabine PET/CT in Imaging Patients With Autoimmune or Inflammatory DiseasesThe Biodistribution of 18F-Clofarabine in Patients With Autoimmune and Inflammatory DiseasesAutoimmune Disease;Crohn Disease;Inflammatory Disorder;Rheumatoid Arthritis;Systemic Lupus Erythematosus;Takayasu ArteritisProcedure: Computed Tomography;Radiation: Fluorine F 18 Clofarabine;Procedure: Positron Emission TomographyJonsson Comprehensive Cancer CenterNULLCompleted18 YearsN/AAll8Early Phase 1United States
270NCT02660944January 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
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gender
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size
PhaseCountries
271NCT02677688January 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 HospitalNULLActive, not recruiting18 YearsN/AAll9Phase 1/Phase 2France
272NCT02483624January 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
273EUCTR2014-002184-14-NL22/12/201503/09/2015Safety 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: 18.0Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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
274EUCTR2014-004632-19-BG11/12/201527/10/2015A 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: 20.0Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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 3United States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;South Africa;Bulgaria;Germany;Korea, Republic of
275ChiCTR-ONC-150075472015-12-052015-12-04Clinical 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
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Status
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agemin
Inclusion_
agemax
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gender
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size
PhaseCountries
276JPRN-UMIN0000253282015/12/0525/12/2016A 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)
277NCT02609789December 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
278NCT02074020December 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
279NCT02885610December 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
280NCT02537028November 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
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agemin
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agemax
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gender
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size
PhaseCountries
281EUCTR2014-004633-96-RO26/11/201508/10/2015A 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]
AstraZeneca ABNULLNot Recruiting Female: yes
Male: yes
450 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c 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
282EUCTR2015-001341-86-DE19/11/201501/09/2015Phase 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]
Neovacs S.A.NULLNot Recruiting Female: yes
Male: yes
178 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited 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
283EUCTR2014-004633-96-DE12/11/201528/05/2015A 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: 19.0Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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
284EUCTR2014-004632-19-DE12/11/201506/08/2015A 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: 20.0Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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 3United States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Bulgaria;South Africa;Germany;Korea, Republic of
285NCT02477150November 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
286EUCTR2015-001341-86-HR23/10/201510/11/2015Phase 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
287JPRN-JapicCTI-15307721/10/201520/11/2015A 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
288NCT02349061October 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
289EUCTR2014-004633-96-PL14/10/201505/08/2015A 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: 20.0Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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
290EUCTR2015-000372-95-DE08/10/201517/06/2015Study 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: 19.0Level: LLTClassification code 10025139Term: Lupus erythematosus systemicSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
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agemin
Inclusion_
agemax
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PhaseCountries
291NCT02429934October 201524/4/2015Abatacept for SLE Arthritis (IM101-330)Efficacy of Abatacept in Inflammatory Polyarthritis of Systemic Lupus Erythematosus (SLE)Systemic Lupus Erythematosus ArthritisDrug: abatacept;Drug: PlaceboUniversity of California, Los AngelesBristol-Myers SquibbTerminated18 YearsN/AAll28Phase 1/Phase 2United States
292NCT02554019September 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
293EUCTR2015-000372-95-HU24/09/201530/06/2015Study 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: 19.0Level: LLTClassification code 10025139Term: Lupus erythematosus systemicSystem 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
294NCT02665364September 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
295EUCTR2014-004632-19-CZ23/09/201528/07/2015A 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: 18.0Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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 3United States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;South Africa;Bulgaria;Germany;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
296EUCTR2014-005000-19-PL22/09/201518/08/2015A 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: 20.0Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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
297EUCTR2014-004632-19-ES21/09/201524/06/2015A 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]
AstraZeneca ABNULLNot Recruiting Female: yes
Male: yes
360 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c 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
298EUCTR2015-001341-86-IT19/09/201510/11/2020Phase 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: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: IFN-Kinoid
Product Code: IFN-K
NEOVACSNULLNot RecruitingFemale: yes
Male: yes
178Phase 2United States;Philippines;Taiwan;Spain;Thailand;Korea, Democratic People's Republic of;Russian Federation;Chile;Colombia;Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Peru;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of;Korea, Republic of
299EUCTR2014-004633-96-IT16/09/201521/01/2020A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus - NA Systemic Lupus Erythematosus
MedDRA version: 21.1 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
ASTRAZENECA ABNULLNot Recruiting Female: yes
Male: yes
450 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c 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
300EUCTR2014-005526-35-PL12/09/201510/08/2015Clinical study to evaluate the safety and tolerability of treatment with BT063 versus Placebo in Subjects with Systemic Lupus Erythematosus (BT063 in SLE)A Prospective, Double-blind, Randomized, Placebo-controlled, Repeated dose, Multicentre Phase IIa Proof-of-Concept Study with BT063 in Subjects with Systemic Lupus Erythematosus (BT063 in SLE) Systemic Lupus Erythematosus
MedDRA version: 19.1Level: LLTClassification code 10042947Term: Systemic lupus erythematosus syndSystem Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BT063
Product Code: BT063
INN or Proposed INN: BT063
Other descriptive name: BT063
Biotest AGNULLNot RecruitingFemale: yes
Male: yes
36Phase 2Serbia;Belarus;Poland;Georgia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
301EUCTR2015-000372-95-PT11/09/201526/06/2015 Study Evaluating ALX-0061 Administered Subcutaneously in Patients with Systemic Lupus ErythematosusA Phase II Multicenter, Randomized, Double-blind, Placebo controlled, Dose-range Finding Study to Evaluate the Safety and Efficacy of ALX 0061 Administered Subcutaneously in Subjects with Moderate to Severe Active Systemic Lupus Erythematosus - STEADY Moderate to Severe Active Systemic Lupus Erythematosus
MedDRA version: 18.0 Level: LLT Classification code 10025139 Term: Lupus erythematosus systemic System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Ablynx N.V.NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noSerbia;Portugal;United States;Philippines;Taiwan;Spain;Ukraine;Russian Federation;Chile;Czech Republic;Hungary;Mexico;Argentina;Poland;Peru;Germany;Korea, Republic of
302EUCTR2015-001341-86-BE07/09/201503/09/2015Phase IIb study of IFN-K in Systemic Lupus ErythematosusA Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Neutralization of the Interferon Gene Signature and the Clinical Efficacy of IFNa-Kinoid in Adult Subjects with Systemic Lupus Erythematosus - Phase IIb study of IFN-K in Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 20.0Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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 2Serbia;United States;Philippines;Taiwan;Spain;Thailand;Ukraine;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Peru;Tunisia;Moldova, Republic of;Korea, Republic of;Mexico;Argentina;Belgium;Poland;Croatia;Georgia;Bulgaria;Germany
303EUCTR2014-004632-19-BE07/09/201523/06/2015A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus ErythematosusA Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 20.0 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
AstraZeneca ABNULLNot Recruiting Female: yes
Male: yes
360 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c 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
304EUCTR2014-004633-96-HU02/09/201529/06/2015A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus ErythematosusA Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 20.0 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
AstraZeneca ABNULLNot Recruiting Female: yes
Male: yes
450 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Taiwan;Ukraine;Chile;Israel;Colombia;United Kingdom;Italy;Hungary;Argentina;Poland;Brazil;Romania;Peru;Australia;Germany;New Zealand;Korea, Republic of
305JPRN-UMIN0000208592015/09/0105/02/2016Effects of Royal Jelly Supplementation on Regulatory T Cells and Lymphocytes Apoptosis in Children with Systemic Lupus Erythematosus Systemic Lupus Erythematosus.two-month Royal Jelly (2 gm) treatmentFaculty of medicine, University of Assiut, Assiut 71516, Egypt.NULLComplete: follow-up complete8years-old17years-oldMale and Female30Not selectedAfrica
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
306NCT02535689August 28, 201528/8/2015Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Systemic Lupus ErythematosusSafety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Systemic Lupus Erythematosus; a Phase Ib Clinical Trial and Associated Mechanistic StudiesSystemic Lupus ErythematosusDrug: Tofacitinib;Drug: PlaceboNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NULLCompleted18 Years100 YearsAll34Phase 1United States
307EUCTR2014-004632-19-LT20/08/201519/06/2015A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus ErythematosusA Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 20.0 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
AstraZeneca ABNULLNot Recruiting Female: yes
Male: yes
360 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c 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
308EUCTR2015-000372-95-CZ20/08/201516/06/2015Study Evaluating ALX-0061 Administered Subcutaneously in Patients with Systemic Lupus ErythematosusA Phase II Multicenter, Randomized, Double-blind, Placebo controlled, Dose-range Finding Study to Evaluate the Safety and Efficacy of ALX 0061 Administered Subcutaneously in Subjects with Moderate to Severe Active Systemic Lupus Erythematosus - STEADY Moderate to Severe Active Systemic Lupus Erythematosus
MedDRA version: 20.0Level: LLTClassification code 10025139Term: Lupus erythematosus systemicSystem Organ Class: 100000017968;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ALX-0061 150 mg/mL
INN or Proposed INN: vobarilizumab
Other descriptive name: IL-6R nanobody
Ablynx N.V.NULLNot RecruitingFemale: yes
Male: yes
300Phase 2Serbia;Portugal;United States;Philippines;Taiwan;Spain;Ukraine;Russian Federation;Chile;Czech Republic;Hungary;Mexico;Argentina;Poland;Peru;Germany;Korea, Republic of
309EUCTR2015-000372-95-ES07/08/201510/07/2015Study Evaluating ALX-0061 Administered Subcutaneously in Patients with Systemic Lupus ErythematosusA Phase II Multicenter, Randomized, Double-blind, Placebo controlled, Dose-range Finding Study to Evaluate the Safety and Efficacy of ALX 0061 Administered Subcutaneously in Subjects with Moderate to Severe Active Systemic Lupus Erythematosus - STEADY Moderate to Severe Active Systemic Lupus Erythematosus
MedDRA version: 18.0Level: LLTClassification code 10025139Term: Lupus erythematosus systemicSystem Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ALX-0061 150 mg/mL
INN or Proposed INN: N/A
Other descriptive name: IL-6R nanobody
Ablynx N.V.NULLNot RecruitingFemale: yes
Male: yes
300Phase 2Germany;Korea, Republic of;Serbia;Portugal;United States;Philippines;Taiwan;Spain;Ukraine;Russian Federation;Chile;Czech Republic;Hungary;Mexico;Argentina;Poland;Peru
310EUCTR2014-004633-96-GB16/07/201508/05/2015A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus ErythematosusA Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 20.0 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
AstraZeneca ABNULLNot Recruiting Female: yes
Male: yes
450 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Taiwan;Ukraine;Chile;Israel;Colombia;United Kingdom;Italy;Hungary;Argentina;Poland;Brazil;Romania;Peru;Australia;Germany;New Zealand;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
311NCT02446899July 9, 201514/5/2015Efficacy and Safety of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus ErythematosusA Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus ErythematosusActive Systemic Lupus ErythematosusBiological: Anifrolumab;Drug: PlaceboAstraZenecaPRA Health SciencesCompleted18 Years70 YearsAll373Phase 3United States;Argentina;Belgium;Brazil;Bulgaria;Canada;France;Germany;Japan;Korea, Republic of;Lithuania;Mexico;Russian Federation;South Africa;Spain;Czech Republic;Czechia;Singapore
312NCT02533570July 20159/7/2015Dose Ranging Study of Brentuximab Vedotin in Adults With LupusA Multi-center, Randomized, Double-blinded, Placebo-controlled, Multiple-ascending-dose Study of Brentuximab Vedotin in Adults With Active Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: Brentuximab vedotin;Drug: PlaceboSeagen Inc.NULLTerminated18 YearsN/AAll20Phase 2United States
313NCT02477254July 201517/6/2015Long-term Immunogenicity of a HPV Vaccine in SLELong-term Immunogenicity of a Quadrivalent Human Papillomavirus (HPV) Vaccine in Patients With Systemic Lupus Erythematosus: a Case-control StudySystemic Lupus ErythematosusBiological: VaccinationTuen Mun HospitalNULLCompleted18 Years35 YearsFemale84N/AChina
314NCT02444728July 201512/5/2015Cyclophosphamide and Hydroxychloroquine for Thrombocytopenia in SLECyclophosphamide and Hydroxychloroquine for the Treatment of Severe Thrombocytopenia in Systemic Lupus ErythematosusThrombocytopeniaDrug: Hydroxychloroquine;Drug: Cyclophosphamide;Drug: Azathioprine;Drug: MethylprednisoloneChinese SLE Treatment And Research GroupPeking Union Medical College HospitalRecruiting18 Years70 YearsAll220Phase 3China
315NCT02437890July 201529/4/2015A Phase II Study to Evaluate Safety and Efficacy of ALX-0061 in Subjects With Systemic Lupus ErythematosusA Phase II Multicenter, Randomized, Double-blind, Placebo Controlled, Dose-range Finding Study to Evaluate the Safety and Efficacy of ALX-0061 Administered Subcutaneously in Subjects With Moderate to Severe Active Systemic Lupus ErythematosusLupus Erythematosus, SystemicBiological: ALX-0061;Biological: PlaceboAblynxNULLCompleted18 Years64 YearsAll312Phase 2United States;Argentina;Chile;Czechia;Germany;Hungary;Korea, Republic of;Mexico;Peru;Philippines;Poland;Portugal;Russian Federation;Serbia;Spain;Taiwan;Ukraine;Czech Republic
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
316EUCTR2014-005000-19-DE17/06/201512/02/2015A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus ErythematosusA Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 18.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
134Phase 2United States;Hungary;Taiwan;Mexico;Argentina;Poland;Spain;Australia;Germany
317NCT02446912June 9, 201514/5/2015Efficacy and Safety of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus ErythematosusA Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects With Active Systemic Lupus ErythematosusActive Systemic Lupus ErythematosusBiological: Anifrolumab;Drug: PlaceboAstraZenecaPRA Health SciencesCompleted18 Years70 YearsAll460Phase 3United States;Argentina;Australia;Brazil;Chile;Colombia;Germany;Hungary;Israel;Italy;Korea, Republic of;New Zealand;Peru;Poland;Romania;Taiwan;Ukraine;United Kingdom
318EUCTR2014-002984-14-BG05/06/201511/05/2015International clinical trial to evaluate the biological activity and safety of ACT-334441 in lupusA multicenter, randomized, double-blind, placebo-controlled, dose-response study to investigate the biological activity, safety, tolerability, and pharmacokinetics of ACT-334441 in subjects with systemic lupus erythematosus. - Systemic lupus erythematosus
;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: ACT-334441
Other descriptive name: ACT-334441
ACTELION Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
64Phase 2Belarus;United States;Ukraine;Russian Federation;Georgia;Bulgaria
319NCT02472795June 1, 201514/5/2015Clinical Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus ErythematosusA Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-response Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: Matching placebo;Drug: CenerimodIdorsia Pharmaceuticals Ltd.NULLCompleted18 Years65 YearsAll105Phase 1/Phase 2United States;Belarus;Bulgaria;Georgia;Russian Federation;Ukraine
320NCT02465580June 20153/6/2015A Pilot-Study With Low-dose hrIL-2 for the Treatment of Systemic Lupus ErythematosusA Phase II Pilot-Study With Low-dose hrIL-2 for the Treatment of Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: hrIL-2 active;Drug: hrIL-2 placeboPeking University People's HospitalMonash University;Beijing SL Pharmaceutical Company LtdRecruiting18 Years65 YearsBoth60Phase 2China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
321EUCTR2014-005000-19-ES11/05/201503/03/2015A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus ErythematosusA Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 17.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
100Phase 2United States;Hungary;Taiwan;Mexico;Argentina;Poland;Spain;Australia;Germany
322EUCTR2014-005418-45-SE04/05/201518/03/2015Are risk factors factors of pertaining to or involving the heart and blood vessels and markers characterized or caused by inflammation in Rheumatoid Arthritis (a chronic, systemic inflammatory disorder that primarily affects joints) and Systemic Lupus Erythematosus (systemic disease in which the body’s immune system mistakenly attacks healthy tissue)improved? New aspects of Hydroxychloroquine – an interventional study (HCQCVDRASLE)Improved cardiovascular risk factors and inflammatory markers in Rheumatoid Arthritis and Systemic Lupus Erythematosus? New aspects of Hydroxychloroquine – an interventional study (HCQCVDRASLE) - HCQCVDRASLE Rheumatoid Arthritis and Systemic Lupus Erythematosus;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Plaquenil
INN or Proposed INN: HYDROXYCHLOROQUINE
Christine BengtssonSolveig Wållberg-JonssonNot RecruitingFemale: yes
Male: yes
Phase 2Sweden
323NCT01773616April 20151/11/2012Trial of Rituximab and Mycophenolate Mofetil Without Oral Steroids for Lupus NephritisPhase 3 Open Label Randomised Multicentre Controlled Trial of Rituxmab and Mycophenolate Mofetil Without Oral Steroids for the Treatment of Lupus NephritisSystemic Lupus Erythematosus, Lupus NephritisDrug: Oral prednisolone;Drug: Rituximab;Drug: Mycophenolate mofetil;Drug: Methyl prednisoloneImperial College LondonKarolinska Institutet;Ohio State University;Dutch Working Party on Systemic Lupus Erythematosus;EULAR Lupus Nephritis Trial Network Study GroupTerminated12 Years75 YearsAll24Phase 3United Kingdom
324NCT02548936April 201531/8/2015Efficacy and Safety of Simvastatin-ezetimibe Combination Therapy Among Patients With SLEEfficacy and Safety of Simvastatin-ezetimibe Combination Therapy in Reduction of Progression of Atherosclerosis Among Patients With Systemic Lupus Erythematosus: A Randomized Single-Blind TrialAtherosclerosisDrug: Ezetimibe+Simvastatin Drug CombinationPeking Union Medical College HospitalNULLEnrolling by invitation18 Years65 YearsBoth30Phase 0China
325EUCTR2014-005000-19-HU18/03/201503/02/2015A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus ErythematosusA Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 18.1 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Janssen-Cilag International N.V.NULLNot Recruiting Female: yes
Male: yes
134 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;Taiwan;Hungary;Mexico;Argentina;Poland;Spain;Australia;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
326NCT02504645March 201517/7/2015A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus ErythematosusA 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus ErythematosusLupus Erythematosus, SystemicDrug: IPP-201101;Drug: Placebo;Other: Standard of CareImmuPharmaNULLCompleted18 Years70 YearsAll202Phase 3United States;Czechia;France;Germany;Hungary;Mauritius;Poland;Puerto Rico;Czech Republic;Italy
327EUCTR2014-002184-14-DE26/02/201523/12/2014Safety and Efficacy Study of a Biologic to Treat Systemic Lupus ErythomatosusA Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of lulizumab pegol vs. Placebo on a Background of Limited Standard of care in the Treatment of Subjects with Active Systemic Lupus ErythematosusPharmacogenetics Blood Sample Amendment 01 - Site Specific- dated-20-Aug-2014 Active Systemic Lupus Erythematosus
MedDRA version: 19.0Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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
328EUCTR2014-002184-14-IT24/02/201509/01/2015Safety and Efficacy Study of a Biologic to Treat Systemic Lupus ErythomatosusA Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of BMS-931699 vs. Placebo on a Background of Limited Standard of care in the Treatment of Subjects with Active Systemic Lupus Erythematosus Active Systemic Lupus Erythematosus
MedDRA version: 17.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Anti-CD28dab
Product Code: BMS-931699
INN or Proposed INN: Lulizumab Pegol
Other descriptive name: Lulizumab Pegol
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
350Phase 2United States;Taiwan;Spain;Chile;Colombia;Italy;France;Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Brazil;Romania;South Africa;Netherlands;Germany;Korea, Republic of
329EUCTR2014-002184-14-HU16/02/201529/12/2014Safety and Efficacy Study of a Biologic to Treat Systemic Lupus ErythomatosusA Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of BMS-931699 vs. Placebo on a Background of Limited Standard of care in the Treatment of Subjects with Active Systemic Lupus ErythematosusPharmacogenetics Blood Sample Amendment 1 - Site Specific - dated-20-Aug-2014 Active Systemic Lupus Erythematosus
MedDRA version: 17.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Anti-CD28dab
Product Code: BMS-931699
INN or Proposed INN: Anti-CD28dAb
Other descriptive name: Anti-CD28dAb
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
350Phase 2United States;Taiwan;Spain;Chile;Colombia;Italy;France;Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Brazil;Romania;South Africa;Netherlands;Germany;Korea, Republic of
330NCT02307643February 201518/11/2014Exploratory Study of MT-1303 in Systemic Lupus Erythematosus PatientsAn Exploratory Study of MT-1303 in Subjects With Systemic Lupus Erythematosus (a Multicenter, Open-label Study)Systemic Lupus ErythematosusDrug: MT-1303 Low dose;Drug: MT-1303 High doseMitsubishi Tanabe Pharma CorporationNULLCompleted20 Years64 YearsAll17Phase 1Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
331NCT01845740January 201517/4/2013Phase Ib Study of SC Milatuzumab in SLEA Phase Ib Study of Milatuzumab Administered Subcutaneously in Patients With Active Systemic Lupus Erythematosus (SLE)Lupus Erythematosus, Cutaneous;Lupus Erythematosus, Discoid;Lupus Erythematosus, Systemic;Lupus Vasculitis, Central Nervous System;Lupus NephritisDrug: milatuzumab;Drug: PlaceboImmunomedics, Inc.Department of DefenseRecruiting18 YearsN/ABoth30Phase 1/Phase 2United States
332EUCTR2014-002184-14-ES26/12/201422/12/2014Safety and Efficacy Study of a Biologic to Treat Systemic Lupus ErythomatosusA Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of BMS-931699 vs. Placebo on a Background of Limited Standard of care in the Treatment of Subjects with Active Systemic Lupus Erythematosus Active Systemic Lupus Erythematosus
MedDRA version: 17.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Anti-CD28dab
Product Code: BMS-931699
INN or Proposed INN: Anti-CD28dAb
Other descriptive name: Anti-CD28dAb
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
350Phase 2Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Brazil;Romania;South Africa;Netherlands;Germany;Korea, Republic of;France;United States;Taiwan;Spain;Chile;Colombia;Italy
333JPRN-jRCTs07118005226/12/201415/03/2019Control of steroid-associated osteonecrosis of the femoral head in SLE patientsClinical trial for the control of osteonecrosis of the femoral head secondary to the initial corticosteroid treatment in patients with systemic lupus erythematosus - None systemic lupus erythematosus;D008180Objectives take three below candidate drugs for the prevention for at least 3 months after the initial corticosteroid treatment.
1. Clopidogrel Bisulfate (Plavix)
Taking a dose of 300mg once daily on the first day, and a dose of 75mg once daily on subsequent days.
2. Pitavastatin Calcium (LIVALO)
Taking a dose of 2mg once daily.
3. Tocopherol Acetate (Juvela)
Taking a dose of 100mg three times daily (total of 300mg daily).
Nakashima YasuharuNULLRecruiting>= 20age oldNot applicableBoth150Japan
334NCT02265744November 13, 201415/10/2014Safety and Efficacy Study of a Biologic to Treat Systemic Lupus ErythematosusA Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lulizumab Pegol vs. Placebo on a Background of Limited Standard of Care in the Treatment of Subjects With Active Systemic Lupus ErythematosusLupusDrug: BMS-931699;Drug: Placebo matching BMS-931699Bristol-Myers SquibbNULLCompleted18 Years70 YearsAll730Phase 2United States;Argentina;Brazil;Canada;Chile;Colombia;France;Germany;Hungary;Italy;Japan;Korea, Republic of;Lebanon;Mexico;Netherlands;Peru;Poland;Puerto Rico;Romania;Russian Federation;South Africa;Spain;Taiwan;Qatar
335NCT02306629November 201429/11/2014Study to Compare Properties of Epratuzumab When Given as an Injection Under the Skin or Directly Into the BloodAn Open-label, Parallel-group, Single-dose Escalation Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Pharmacodynamics of Subcutaneous Epratuzumab in Healthy Caucasian and Japanese SubjectsSystemic Lupus ErythematosusBiological: Epratuzumab sc;Biological: Epratuzumab ivUCB Biopharma S.P.R.L.Pharmaceutical Research Associates;Richmond Pharmacology Limited;ACM Global Europe;Eurofins Pharma Bioanalysis;The Doctors LaboratoryCompleted18 Years50 YearsBoth42Phase 1United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
336NCT02321709November 20145/12/2014Multiple Ascending Dose Study To Assess The Safety Profile Of SAR113244 Versus Placebo In Lupus Male And Female PatientsA Randomized, Double-blind, Placebo-controlled Study Of Safety, Tolerability, And Pharmacokinetics Of Repeated Ascending Subcutaneous Doses Of SAR113244 And Pharmacodynamics Of Single Dose Of SAR113244 In Male And Female Lupus PatientsSystemic Lupus ErythematosusDrug: SAR113244;Drug: placeboSanofiNULLCompleted18 Years75 YearsBoth21Phase 1Germany
337EUCTR2013-002758-62-IT14/10/201431/03/2014Long-term safety and tolerability study of atacicept in patients with Systemic Lupus Erythematosus who completed protocol EMR-700461-023 (ADDRESS II)A Phase IIb, Multi-Center, Long-Term Extension Trial to Evaluate the Safety and Tolerability of Atacicept in Subjects with Systemic Lupus Erythematosus (SLE) who Completed Protocol EMR-700461-023 (ADDRESS II) Systemic Lupus Erythematosus (SLE)
MedDRA version: 16.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
213Phase 2United States;Philippines;Spain;Ukraine;Chile;Russian Federation;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Brazil;Poland;Peru;South Africa;Bulgaria;Germany;Korea, Republic of
338NCT02270970October 201413/10/2014Evaluation of Belimumab Impact on a BLyS Activity Signature Test in the Absence of Confounding PolypharmacyEvaluation of Belimumab Impact on a BLyS Activity Signature Test in the Absence of Confounding PolypharmacySystemic Lupus ErythematosusBiological: belimumabOklahoma Medical Research FoundationGlaxoSmithKlineRecruiting16 Years70 YearsAll20Phase 4United States
339NCT02102594October 201425/3/2014Therapy of Antibody-mediated Autoimmune Diseases by Bortezomib (TAVAB)Therapy of Antibody-mediated Autoimmune Diseases by Bortezomib (TAVAB)Myasthenia Gravis;Systemic Lupus Erythematosus;Rheumatoid ArthritisDrug: BortezomibCharite University, Berlin, GermanyProf. Dr. med. Falk Hiepe (Charité, Internal Medicine / Rheumathology);NeuroCure Clinical Research Center, Charite, BerlinTerminated18 Years75 YearsAll11Phase 2Germany
340NCT02281513October 201422/10/2014Activity and Nutrition Trial in Lupus to Energize and RenewActivity and Nutrition Trial in Lupus to Energize and RenewSystemic Lupus Erythematosus;Physical Activity;SleepOther: Smartphone Application;Other: Fitbit Activity Monitor;Other: Coaching SessionsNorthwestern UniversityNULLActive, not recruiting18 YearsN/AAll12N/AUnited States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
341NCT02185040September 16, 20147/7/2014A Pilot Study of CC-220 to Treat Systemic Lupus Erythematosus.A Pilot, Phase 2, Randomized, Placebo-Controlled, Double-Blind, Study To Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Pharmacogenetics of CC-220 In Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: CC-220;Drug: PlaceboCelgeneNULLCompleted18 YearsN/AAll42Phase 2United States
342NCT02066311September 201412/2/2014Nelfinavir in Systemic Lupus ErythematosusNelfinavir in Systemic Lupus Erythematosus: A Pilot Phase IIa Clinical TrialSystemic Lupus ErythematosusDrug: NelfinavirNorthwell HealthNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Terminated18 Years65 YearsAll15Phase 2United States
343EUCTR2013-002758-62-DE18/08/201413/03/2014Long-term safety and tolerability study of atacicept in patients with Systemic Lupus Erythematosus who completed protocol EMR-700461-023 (ADDRESS II)A Phase IIb, Multi-Center, Long-Term Extension Trial to Evaluate the Safety and Tolerability of Atacicept in Subjects with Systemic Lupus Erythematosus (SLE) who Completed Protocol EMR-700461-023 (ADDRESS II) Systemic Lupus Erythematosus (SLE)
MedDRA version: 17.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
213Phase 2United States;Philippines;Spain;Ukraine;Russian Federation;Chile;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Poland;Brazil;Peru;South Africa;Bulgaria;Germany;Korea, Republic of
344JPRN-UMIN0000082302014/08/0122/06/2012Clinical trial for the control of osteonecrosis of the femoral head secondary to the initial corticosteroid treatment in patients with systemic lupus erythematosus Systemic lupus erythematosusObjectives take three below candidate drugs for the prevention for at least 3 months after the initial corticosteroid treatment.
1. Clopidgrel Bisulfate (Plavix)
Taking a dose of 300mg once daily on the first day, and a dose of 75mg once daily on subsequent days.
2. Pitavastatin Calcium (LIVALO)
Taking a dose of 2mg once daily.
3. Tocopherol Acetate (Juvela)
Taking a dose of 100mg three times daily (total of 300mg daily).
Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kyushu UniversityNULLRecruiting20years-oldNot applicableMale and Female150Phase 2Japan
345NCT02070978July 29, 201421/2/2014Long-term Safety and Tolerability of Atacicept (Long-term Follow-Up of Participant Who Participated in ADDRESS II)A Phase IIb, Multi-Center, Long-Term Extension Trial to Evaluate the Safety and Tolerability of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed Protocol EMR-700461-023 (ADDRESS II)Lupus Erythematosus, SystemicDrug: Atacicept 75 mg;Drug: Atacicept 150 mgEMD SeronoNULLTerminated18 YearsN/AAll253Phase 2United States;Argentina;Brazil;Bulgaria;Chile;Czechia;Germany;Italy;Korea, Republic of;Mexico;Peru;Philippines;Poland;Russian Federation;South Africa;Spain;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
346EUCTR2013-005362-19-DE17/07/201418/12/2013Therapy of antibody-mediated autoimmune diseases by Bortezomib (TAVAB)Therapy of antibody-mediated autoimmune diseases by Bortezomib (TAVAB) - TAVAB Myasthenia Gravis Systemic Lupus Erythematosus Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Charité - Universitätsmedizin BerlinNULLNot Recruiting Female: yes
Male: yes
18 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noGermany
347EUCTR2013-002758-62-ES16/07/201421/07/2014Long-term safety and tolerability study of atacicept in patients with Systemic Lupus Erythematosus who completed protocol EMR-700461-023 (ADDRESS II)A Phase IIb, Multi-Center, Long-Term Extension Trial to Evaluate the Safety and Tolerability of Atacicept in Subjects with Systemic Lupus Erythematosus (SLE) who Completed Protocol EMR-700461-023 (ADDRESS II) Systemic Lupus Erythematosus (SLE)
MedDRA version: 17.0Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
213Phase 2United States;Philippines;Spain;Ukraine;Russian Federation;Chile;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Poland;Brazil;Peru;South Africa;Bulgaria;Germany;Korea, Republic of
348NCT02194400July 201416/7/2014Dose Escalation Study of RSLV-132 in Subjects With Systemic Lupus ErythematosusA Double-Blind, Placebo-Controlled Dose Escalation Study of the Administration of Multiple Intravenous Doses of RSLV-132 in Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusBiological: RSLV-132Resolve TherapeuticsNULLCompleted18 Years70 YearsBoth32Phase 1United States
349EUCTR2013-002758-62-CZ19/06/201416/04/2014Long-term safety and tolerability study of atacicept in patients with Systemic Lupus Erythematosus who completed protocol EMR-700461-023 (ADDRESS II)A Phase IIb, Multi-Center, Long-Term Extension Trial to Evaluate the Safety and Tolerability of Atacicept in Subjects with Systemic Lupus Erythematosus (SLE) who Completed Protocol EMR-700461-023 (ADDRESS II) Systemic Lupus Erythematosus (SLE)
MedDRA version: 19.0Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Merck KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
213Phase 2United States;Philippines;Spain;Ukraine;Russian Federation;Chile;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Poland;Brazil;Peru;South Africa;Bulgaria;Germany;Korea, Republic of
350EUCTR2011-005667-25-PL22/05/201407/06/2013Belimumab Assessment of Safety in SLE (BASE) A Randomized, Double-Blind, Placebo-Controlled 52-Week Study to Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab Lupus Erythematosus
MedDRA version: 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]
Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
4000 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): yesSerbia;Portugal;United States;Philippines;Taiwan;Estonia;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Indonesia;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;Malaysia;Peru;Australia;China;Korea, Republic of;Lithuania;Turkey;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Croatia;Bulgaria;Norway;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
351NCT02124798May 20, 201424/4/2014A Phase 2B Open-Label, Single-Arm, Repeat-Dose Study to Evaluate the Reliability of an AutoinjectorAn Open-Label Single-Arm Study to Evaluate the Reliability of an Autoinjector That Administers Belimumab Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDevice: Belimumab autoinjectorGlaxoSmithKlineNULLCompleted18 YearsN/AAll95Phase 2United States
352NCT02119156May 13, 201417/4/2014Belimumab Treatment Holiday and Treatment Re-start Study in Lupus PatientsAn Open-label, Non-randomized, 52-Week Study to Evaluate Treatment Holidays and Rebound Phenomenon After Treatment With Belimumab 10 mg/kg in Systemic Lupus Erythematosus SubjectsSystemic Lupus ErythematosusDrug: BelimumabGlaxoSmithKlineNULLCompleted18 YearsN/AAll80Phase 3United States;China;Japan;Korea, Republic of
353EUCTR2014-000488-42-NL12/05/201409/05/2014Synergetic B-cell immunomodulation in SLE The SYNBioSe Study A proof-of-concept study involving synergetic B-cell imunnomodulation in patients with refractory systemic lupus erythematosus - SynBiose Systemic lupus erythematosus
MedDRA version: 17.0 Level: LLT Classification code 10025139 Term: Lupus erythematosus systemic System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Leiden University Medical CenterNULLNot Recruiting Female: yes
Male: yes
15 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noNetherlands
354EUCTR2012-004619-30-BG09/05/201407/03/2014A Study to Evaluate Long-term Safety of MEDI-546 in Adults with Systemic Lupus ErythematosusA Phase 2, Open-label Extension Study to Evaluate Long-term Safety of MEDI-546 in Adults with Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 18.0 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
MedImmune, LLC, a wholly owned subsidiary of AstraZenecaNULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;Taiwan;Ukraine;Colombia;Czech Republic;Hungary;Mexico;Brazil;Poland;Romania;Peru;Bulgaria;Korea, Republic of
355EUCTR2013-002758-62-GB09/05/201413/05/2014Long-term safety and tolerability study of atacicept in patients with Systemic Lupus Erythematosus who completed protocol EMR-700461-023 (ADDRESS II)A Phase IIb, Multi-Center, Long-Term Extension Trial to Evaluate the Safety and Tolerability of Atacicept in Subjects with Systemic Lupus Erythematosus (SLE) who Completed Protocol EMR-700461-023 (ADDRESS II) Systemic Lupus Erythematosus (SLE)
MedDRA version: 17.0 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Merck KGaANULLNot Recruiting Female: yes
Male: yes
213 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;Philippines;Spain;Ukraine;Russian Federation;Chile;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Poland;Brazil;Peru;South Africa;Bulgaria;Germany;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
356NCT01956188May 201425/9/2013Omega 3 in LES and APSEfficacy of EPA and DHA Supplementation in Systemic Lupus Erythematosus and Primary Antiphospholipid SyndromeSystemic Lupus Erythematosus;Primary Antiphospholipid SyndromeDietary Supplement: EPA and DHA supplementation;Dietary Supplement: PlaceboUniversity of Sao PauloNULLActive, not recruiting20 Years45 YearsFemale22N/ABrazil
357NCT02106897April 30, 20144/4/2014Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Single Doses and Multiple Doses of BIIB059 in Healthy Volunteers and Participants With Systemic Lupus ErythematosusA Single-Ascending-Dose and Multiple-Ascending-Dose Study of BIIB059 in Healthy Volunteers and Subjects With Systemic Lupus ErythematosusSystemic Lupus Erythematosus;Healthy VolunteersDrug: BIIB059;Drug: PlaceboBiogenNULLCompleted18 YearsN/AAll109Phase 1United States
358EUCTR2013-002758-62-BG30/04/201401/04/2014Long-term safety and tolerability study of atacicept in patients with Systemic Lupus Erythematosus who completed protocol EMR-700461-023 (ADDRESS II)A Phase IIb, Multi-Center, Long-Term Extension Trial to Evaluate the Safety and Tolerability of Atacicept in Subjects with Systemic Lupus Erythematosus (SLE) who Completed Protocol EMR-700461-023 (ADDRESS II) Systemic Lupus Erythematosus (SLE)
MedDRA version: 18.0 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Merck KGaANULLNot Recruiting Female: yes
Male: yes
213 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;Philippines;Spain;Ukraine;Russian Federation;Chile;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Poland;Brazil;Peru;Bulgaria;South Africa;Germany;Korea, Republic of
359JPRN-UMIN0000124782014/04/0101/01/2014Open label trial for efficacy and safety of Hydroxychloroquine for systemic lupus erythematosusOpen label trial for efficacy and safety of Hydroxychloroquine for systemic lupus erythematosus - Hydroxychloroquine for systemic lupus erythematosus systemic lupus erythematosuscutaneous lupus erythematosusTreatment with HydroxychloroquineDepartment of Internal Medicine, Teikyo University School of MedicineNULLRecruitingNot applicableNot applicableMale and Female10Not selectedJapan
360EUCTR2010-022101-18-HR31/03/201417/10/2014Study investigating a new medicine, LY2127399, in patients diagnosed with Systemic Lupus Erythematosus (SLE).A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-X) - ILLUMINATE-X Systemic Lupus Erythematosus (SLE)
MedDRA version: 17.0Level: LLTClassification code 10025139Term: Lupus erythematosus systemicSystem Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: Not available
Other descriptive name: LA294; Anti LP40 antibody, subclass IgG4; Anti BAFF (B cell activating factor)
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1276Phase 3Serbia;United States;Belarus;Philippines;Taiwan;Ecuador;Thailand;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;India;France;Macedonia, the former Yugoslav Republic of;Malaysia;Peru;Australia;South Africa;Latvia;Tunisia;Korea, Democratic People's Republic of;Guatemala;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
361JPRN-UMIN0000135082014/03/2826/03/2014A phase II randomized trial of evaluation for boltezomib in refractory Systemic lupus erythematosus:cross over additional trial Systemic lupus erythmatosussaline
bortezomib(1.3mg/m2)
2times/week total 8times.
Tohoku university hospitalNULLComplete: follow-up complete20years-old65years-oldMale and Female14Phase 2Japan
362EUCTR2013-002773-21-IT25/03/201403/02/2014Efficacy and safety study of atacicept in patients with Systemic Lupus Erythematosus (ADDRESS II)A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE) - ADDRESS II Systemic Lupus Erythematosus (SLE)
MedDRA version: 16.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
279Phase 2United States;Philippines;Spain;Ukraine;Chile;Russian Federation;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Brazil;Poland;Peru;South Africa;Bulgaria;Germany;Korea, Republic of
363EUCTR2013-002773-21-GB03/03/201415/01/2014Efficacy and safety study of atacicept in patients with Systemic Lupus Erythematosus (ADDRESS II)A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE) Systemic Lupus Erythematosus (SLE)
MedDRA version: 17.0Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
279Phase 2United States;Philippines;Spain;Ukraine;Russian Federation;Chile;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Poland;Brazil;Peru;South Africa;Bulgaria;Germany;Korea, Republic of
364EUCTR2013-002773-21-CZ20/02/201411/12/2013Efficacy and safety study of atacicept in patients with Systemic Lupus Erythematosus (ADDRESS II)A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE) Systemic Lupus Erythematosus (SLE)
MedDRA version: 18.0Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
279Phase 2United States;Philippines;Spain;Ukraine;Russian Federation;Chile;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Poland;Brazil;Peru;South Africa;Bulgaria;Germany;Korea, Republic of
365EUCTR2013-002773-21-ES20/02/201422/01/2014Efficacy and safety study of atacicept in patients with Systemic Lupus Erythematosus (ADDRESS II)A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE) Systemic Lupus Erythematosus (SLE)
MedDRA version: 16.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
279Phase 2United States;Philippines;Spain;Ukraine;Chile;Russian Federation;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Brazil;Poland;Peru;South Africa;Bulgaria;Germany;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
366EUCTR2013-002773-21-DE17/02/201407/01/2014Efficacy and safety study of atacicept in patients with Systemic Lupus Erythematosus (ADDRESS II)A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE) Systemic Lupus Erythematosus (SLE)
MedDRA version: 17.0Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
279Phase 2United States;Philippines;Spain;Ukraine;Russian Federation;Chile;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Poland;Brazil;Peru;South Africa;Bulgaria;Germany;Korea, Republic of
367NCT01988506January 6, 20147/11/2013Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory DiseasesInduction of Regulatory t Cells by Low Dose IL2 in Autoimmune and Inflammatory Diseases: a Transnosographic ApproachRheumatoid Arthritis;Ankylosing Spondylitis;Systemic Lupus Erythematosus;Psoriasis;Behcet's Disease;Wegener's Granulomatosis;Takayasu's Disease;Crohn's Disease;Ulcerative Colitis;Autoimmune Hepatitis;Sclerosing Cholangitis;Gougerot-sjögren;Idiopathic Thrombocytopenic Purpura;Systemic SclerosisDrug: Interleukin 2Assistance Publique - Hôpitaux de ParisIltoo PharmaActive, not recruiting18 YearsN/AAll81Phase 2France
368EUCTR2013-001599-40-DE03/01/201414/11/2013Evaluation of the therapeutic potential of a low-dose therapy with the interleukin-2 analogue Aldesleukin (Proleukin®) in the treatment of systemic lupus erythematosus. Evaluation of the safety, tolerability, efficacy and immunological responses of the interleukin-2 analogue Aldesleukin (Proleukin®) in the treatment of systemic lupus erythematosus as prototypic autoimmune disease (PRO-IMMUN). A COMBINED PHASE I/IIA, PROSPECTIVE, OPEN-LABEL AND UNCONTROLLED SINGLE-CENTER STUDY TO ANALYSE SAFETY, TOLERABILITY, EFFICACY AND IMMUNOLOGICAL RESPONSES OF LOW-DOSE SUBCUTANEOUS INTERLEUKIN-2 (ALDESLEUKIN, PROLEUKIN®) IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS AND INCREASED DISEASE ACTIVITY REFRACTORY TO STANDARD THERAPIES. - PRO-IMMUN Patients with systemic lupus erythematosus (SLE) and increased disease activity refractory to standard therapies.
MedDRA version: 18.0 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 18.0 Level: PT Classification code 10067657 Term: Systemic lupus erythematosus disease activity index increased System Organ Class: 10022891 - Investigations ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Charité - Universitätsmedizin BerlinNULLNot Recruiting Female: yes
Male: yes
12 Human pharmacology (Phase 1): yes Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noGermany
369NCT02558517January 201422/9/2015Evaluation of the Discontinuation of Maintenance Corticosteroid Treatment in Quiescent Systemic LupusEvaluation of the Discontinuation of Maintenance Corticosteroid Treatment (Prednisone 5 Milligram Per Day) in Quiescent Systemic LupusSystemic Lupus ErythematosusDrug: prednisone discontinuationGroupe Hospitalier Pitie-SalpetriereNULLRecruiting18 Years75 YearsBoth136Phase 3France
370NCT02041091January 201417/1/2014A Study of Tabalumab (LY2127399) Using Two Different Injection Methods in Participants With LupusPharmacokinetic Evaluations of Tabalumab Following Subcutaneous Administration by Prefilled Syringe or Auto Injector in Patients With Systemic Lupus ErythematosusLupus Erythematosus, SystemicDrug: Tabalumab Auto-Injector;Drug: Tabalumab Prefilled SyringeEli Lilly and CompanyNULLTerminated18 YearsN/AAll226Phase 3United States;Korea, Republic of;Puerto Rico;Mexico
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
371NCT02270957January 201413/10/2014Clarification of Abatacept Effects in SLE With Integrated Biologic and Clinical ApproachesClarification of Abatacept Effects in SLE With Integrated Biologic and Clinical Approaches (The ABC Study)Systemic Lupus ErythematosusBiological: Abatacept;Other: PlaceboOklahoma Medical Research FoundationBristol-Myers SquibbActive, not recruiting18 Years70 YearsAll66Phase 2United States
372NCT01972568December 201324/10/2013Efficacy and Safety of Atacicept in Systemic Lupus ErythematosusA Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE)Lupus Erythematosus, SystemicDrug: Atacicept 75 milligram (mg);Drug: Atacicept 150 mg;Drug: PlaceboEMD SeronoNULLCompleted18 YearsN/AAll306Phase 2United States;Argentina;Brazil;Bulgaria;Chile;Czechia;Germany;Italy;Japan;Korea, Republic of;Mexico;Peru;Philippines;Poland;Russian Federation;South Africa;Spain;United Kingdom;Czech Republic;Ukraine
373NCT01946880November 20, 201313/9/2013Randomized MMF Withdrawal in Systemic Lupus Erythematosus (SLE)An Investigator-Initiated, Phase II, Randomized, Withdrawal Study of Mycophenolate Mofetil (MMF) in Patients With Stable, Quiescent Systemic Lupus Erythematosus (SLE)Systemic Lupus Erythematosus;SLEDrug: Mycophenolate Mofetil;Drug: Hydroxychloroquine or Chloroquine;Drug: PrednisoneNational Institute of Allergy and Infectious Diseases (NIAID)Autoimmunity Centers of Excellence;Rho Federal Systems Division, Inc.Terminated18 Years70 YearsAll102Phase 2United States
374JPRN-UMIN0000122272013/11/0606/11/2013A phase II randomized trial of evaluation for boltezomib in refractory Systemic lupus erythematosus Systemic lupus erythmatosusbortezomib(1.3mg/m2)
2times/week total 8times.
saline
Tohoku university hospitalNULLComplete: follow-up complete20years-old65years-oldMale and Female14Phase 2Japan
375NCT01894360October 14, 20133/7/2013A Study to Estimate the Relative Bioavailability, Tolerability and Safety of a Single Dose of Belimumab Self-Administered Subcutaneously (SC) by Healthy SubjectsA Randomized, Parallel-Group, Open-Label Study to Estimate the Relative Bioavailability, Tolerability and Safety of a Single Dose of Belimumab Administered Subcutaneously to Healthy Subjects by Prefilled Syringe or AutoinjectorSystemic Lupus ErythematosusDrug: Belimumab 200 mg/mLGlaxoSmithKlineNULLCompleted18 Years55 YearsAll81Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
376NCT01953835October 4, 201326/9/2013A Two-part Study to Investigate the Interaction and Pharmacokinetics of GSK2586184A Two-part Healthy Volunteer Study to Investigate Both the Interaction of GSK2586184 With Rosuvastatin and Simvastatin and to Compare the Pharmacokinetics of Two Different Formulations of GSK2586184Systemic Lupus ErythematosusDrug: GSK2586184 standard formulation;Drug: Simvastatin;Drug: Rosuvastatin;Drug: GSK2586184 new formulationGlaxoSmithKlineNULLCompleted18 Years65 YearsAll37Phase 1United States
377EUCTR2012-004619-30-CZ29/08/201319/06/2013A Study to Evaluate Long-term Safety of MEDI-546 in Adults with Systemic Lupus ErythematosusA Phase 2, Open-label Extension Study to Evaluate Long-term Safety of MEDI-546 in Adults with Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 20.0 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
MedImmune, LLC, a wholly owned subsidiary of AstraZenecaNULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;Taiwan;Ukraine;Colombia;Czech Republic;Hungary;Mexico;Brazil;Poland;Romania;Peru;Bulgaria;Korea, Republic of
378EUCTR2012-004619-30-HU27/08/201328/06/2013A Study to Evaluate Long-term Safety of MEDI-546 in Adults with Systemic Lupus ErythematosusA Phase 2, Open-label Extension Study to Evaluate Long-term Safety of MEDI-546 in Adults with Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 18.0Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: anifrolumab
Product Code: Medi-546
INN or Proposed INN: anifrolumab
Product Name: anifrolumab
Product Code: Medi-546
INN or Proposed INN: anifrolumab
MedImmune, LLC, a wholly owned subsidiary of AstraZenecaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 2United States;Taiwan;Ukraine;Colombia;Hungary;Czech Republic;Mexico;Brazil;Poland;Romania;Peru;Bulgaria;Korea, Republic of
379NCT02084238August 20138/3/2014Low-dose IL-2( Interleukin-2) Treatment in SLESafety and Efficiency Study of Low-dose IL-2 Treatment in Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: Interleukin-2Peking University People's HospitalMonash UniversityCompleted18 Years65 YearsAll40N/AChina
380EUCTR2011-005667-25-RO21/06/201321/07/2014Belimumab Assessment of Safety in SLE (BASE)A Randomized, Double-Blind, Placebo-Controlled 52-Week Studyto Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab