Clinical trials: System Lupus Erythematosus
Lupus Nephritis
An Exploratory Maintenance Trial of BI 655064 in Patients With Lupus Nephritis
The main objectives of this trial are to evaluate the long term efficacy and safety of different doses of BI 655064 versus placebo as add-on therapy to Standard of Care (SOC) during maintenance therapy for lupus nephritis.
- Trial name
- NCT03385564
- Testing
- BI 655064
- Where
- 36 sites in United States, Australia and 14 more
- Volunteers
- 69 people
- Sponsor
- Boehringer Ingelheim
Systemic Lupus Erythematosus
A Study to Evaluate the Safety and Tolerability of Dapirolizumab Pegol in Study Participants With Systemic Lupus Erythematosus
The purpose of this study is to evaluate long-term safety and tolerability of dapirolizumab pegol treatment.
- Trial name
- NCT04976322
- Testing
- Dapirolizumab pegol
- Where
- 123 sites in United States, Argentina and 22 more
- Volunteers
- 760 people
- Sponsor
- UCB Biopharma SRL
Lupus Nephritis
Study to Assess Real-world Effectiveness of Belimumab for Treatment of Adults With LN
The purpose of the OBSErve-LN study is to assess the real-world use and effectiveness of belimumab in routine practice for the treatment of adults with active LN in multiple countries of interest.
- Trial name
- OBSErve-LN (NCT06527872)
- Testing
- None (Observational study)
- Where
- 7 sites in United States, France and 2 more
- Volunteers
- 300 people
- Sponsor
- GlaxoSmithKline
Systemic Lupus Erythematosus
A Study to Evaluate the Long-Term Safety of MEDI-545 in Adult Participants With Systemic Lupus Erythematosus or Myositis
The objective of this study is to assess the safety and tolerability of sifalimumab in adult participants with active systemic lupus erythematosus (SLE) or active dermatomyositis (DM) or polymyositis (PM) who participated in the…
- Trial name
- NCT00979654
- Testing
- Sifalimumab
- Where
- 28 sites in United States, Brazil and 2 more
- Volunteers
- 118 people
- Sponsor
- MedImmune LLC
Systemic Lupus Erythematosus (SLE)
Descartes-08 for Patients With Systemic Lupus Erythematosus
This is a Phase II study to evaluate the safety, tolerability and manufacturing feasibility of Descartes-08 CAR T-cells in patients with Systematic Lupus erythematosus (SLE).
- Trial name
- SLE-001 (NCT06038474)
- Testing
- Descartes-08
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Cartesian Therapeutics
Systemic Lupus Erythematosus
Safety and Tolerability of Intravenous Dose of MEDI-546 in Japanese Subjects With Systemic Lupus Erythematosus.
The purpose of this study is to assess safety, tolerability, pharmacokinetics and pharmacodynamics of MEDI-546 in Japanese SLE patients.
- Trial name
- NCT01559090
- Testing
- MEDI-546
- Where
- 6 sites in Japan
- Volunteers
- 17 people
- Sponsor
- AstraZeneca
Systemic Lupus Erythematosus
A Long-Term Study of the Safety and Tolerability of Repeated Administration of CEP-33457 in Participants With Systemic Lupus Erythematosus
The primary objective of this study is to evaluate the long term safety and tolerability of repeated administration of subcutaneous (SC) CEP-33457 for injection every 4 weeks over 72 weeks (18 doses) in participants with systemic…
- Trial name
- NCT01240694
- Testing
- CEP-33457
- Where
- 85 sites in United States, Belgium and 9 more
- Volunteers
- 136 people
- Sponsor
- Cephalon, Inc.
Systemic Lupus Erythematosus
The WILLOW Study With M5049 in SLE and CLE (SCLE and/or DLE) (WILLOW)
The purpose of this Proof of Concept (PoC) and Dose-finding (DF) basket study is to evaluate the efficacy and safety of orally administered Enpatoran over 24 weeks in systemic lupus erythematosus (SLE) and cutaneous lupus…
- Trial name
- NCT05162586
- Testing
- Enpatoran low dose, Enpatoran medium dose, Enpatoran high dose
- Where
- 153 sites in United States, Argentina and 20 more
- Volunteers
- 456 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Systemic Lupus Erythematosus
Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus (SLE) Patients With Active Disease
The primary objective of the study is to assess the dose response and the dose frequency of epratuzumab in patients with SLE.
- Trial name
- NCT00624351
- Testing
- Epratuzumab
- Where
- 53 sites in United States, Belgium and 9 more
- Volunteers
- 227 people
- Sponsor
- UCB Pharma
Lupus Nephritis
A Study of Nipocalimab in Adult Participants With Active Lupus Nephritis
The purpose of this study is to evaluate the efficacy of nipocalimab versus placebo in participants with active Lupus Nephritis (LN).
- Trial name
- NCT04883619
- Testing
- Nipocalimab, Standard-of-care treatment
- Sponsor
- Janssen Research & Development, LLC
Inflammation, Systemic Lupus Erythematosus
Dose-escalation Trial of Anti-C5aR Antibody in Healthy Subjects
This trial is conducted in Europe. The aim of this trial is to develop a complement system targeted monoclonal antibody (mAb) to be used in treatment of subjects with chronic autoimmune diseases.
- Conditions
- Inflammation, Systemic Lupus Erythematosus, Rheumatoid Arthritis, Healthy
- Trial name
- NCT02151409
- Testing
- NNC 0151-0000-0000
- Where
- Netherlands
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Systemic Lupus Erythematosus
A Continuation Trial for Subjects With Lupus Who Completed Protocol HGS1006-C1056 in the United States
This is a continuation study to provide continuing treatment to subjects who completed study HGS1006-C1056 in the United States, to evaluate the long-term safety and efficacy of belimumab(LymphoStat-B™) in subjects with SLE…
- Trial name
- NCT00724867
- Testing
- Belimumab 1 mg/kg, Belimumab 10 mg/kg
- Where
- 51 sites in United States
- Volunteers
- 268 people
- Sponsor
- Human Genome Sciences Inc., a GSK Company
Systemic Lupus Erythematosus
A Study Describing the Efficacy and Safety of Belimumab Administered in Adult Participants With Early Systemic Lupus Erythematosus (SLE)
This is a prospective, open-label, single arm 3-year clinical study to describe the short-term and long-term efficacy and safety of belimumab in participants with autoantibody positive early SLE with ongoing disease activity…
- Trial name
- NCT06411249
- Testing
- Belimumab (GSK1550188)
- Where
- 104 sites in United States, Argentina and 9 more
- Volunteers
- 302 people
- Sponsor
- GlaxoSmithKline
Systemic Lupus Erythematosus, Sjögren's Disease
A Study of BMS-986553 in Participants With Refractory Autoimmune Diseases
The purpose of this study is to evaluate the safety and tolerability of BMS-986553, CD19 in vivo Chimeric Antigen Receptor (CAR) T cells, in participants with refractory autoimmune diseases including systemic lupus erythematosus…
- Conditions
- Systemic Lupus Erythematosus, Sjögren's Disease, Rheumatoid Arthritis, Idiopathic Inflammatory Myopathies
- Trial name
- NCT07873931
- Testing
- BMS-986553
- Where
- 23 sites in United States, Belgium and 4 more
- Volunteers
- 60 people
- Sponsor
- Bristol-Myers Squibb
Systemic Lupus Erythematosus
Study of LJP 394 (Abetimus Sodium) in Lupus Patients
The primary purpose of this study is to assess the safety and pharmacodynamic effect of LJP 394 at doses of 100 mg, 300 mg and 900 mg on anti-dsDNA antibody levels in patients with SLE.
- Trial name
- NCT00390091
- Testing
- abetimus sodium (LJP 394)
- Where
- 2 sites in United States
- Sponsor
- La Jolla Pharmaceutical Company
Lupus Erythematosus, Systemic
NIS to Examine Disease Activity in SLE Patients Treated With Subcutaneous Anifrolumab in Routine Care
VIOLET is a prospective, single-arm, multi-centre, non-interventional study (NIS) evaluating real-world clinical and patient-reported outcome (PRO) data in adult patients who are initiated on subcutaneous anifrolumab treatment of…
- Trial name
- VIOLET (NCT07424261)
- Where
- 21 sites in Germany
- Volunteers
- 125 people
- Sponsor
- AstraZeneca
Systemic Lupus Erythematosus
The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)
The purpose of the study is to evaluate the long term safety and efficacy of orally administered M5049 in participants with subacute cutaneous lupus erythematosus (SCLE), discoid lupus erythematosus (DLE) and/or systemic lupus…
- Trial name
- NCT05540327
- Testing
- M5049 low dose, M5049 medium dose, M5049 high dose
- Where
- 122 sites in United States, Argentina and 20 more
- Volunteers
- 381 people
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Systemic Lupus Erythematosus
A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus
The reason for this study is to see how effective and safe the study drug known as baricitinib is in participants with systemic lupus erythematosus (SLE).
- Trial name
- SLE-BRAVE I (NCT03616912)
- Testing
- Baricitinib
- Where
- 184 sites in United States, Australia and 16 more
- Volunteers
- 830 people
- Sponsor
- Eli Lilly and Company
Systemic Lupus Erythematosus
Efficacy and Safety of Belimumab in Black Race Patients With Systemic Lupus Erythematosus (SLE)
The purpose of this study is to evaluate the efficacy, safety, and tolerability of belimumab in adult patients of black race with systemic lupus erythematosus (SLE; lupus).
- Trial name
- EMBRACE (NCT01632241)
- Testing
- Belimumab 10 mg/kg plus standard therapy, Standard therapy
- Where
- 96 sites in United States, Brazil and 4 more
- Volunteers
- 503 people
- Sponsor
- Human Genome Sciences Inc., a GSK Company
Lupus Nephritis, Systemic Lupus Erythematosus
A Study to Evaluate Ocrelizumab in Patients With Nephritis Due to Systemic Lupus Erythematosus (BELONG)
This is a Phase III, randomized, double-blind, placebo-controlled, multicentre, parallel-group study designed to evaluate the efficacy and safety of ocrelizumab added to SOC (corticosteroid plus one of two immunosuppressant…
- Trial name
- BELONG (NCT00626197)
- Testing
- Corticosteroids, Cyclophosphamide, Mycophenolate Mofetil
- Volunteers
- 381 people
- Sponsor
- Genentech, Inc.