Clinical trials: SLE - Systemic Lupus Erythematosus
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.
Relapsed/Refractory, Systemic Lupus Erythematosus (SLE)
BCMA-CD19 cCAR T Cell Treatment of Relapsed/Refractory Systemic Lupus Erythematosus (SLE)
This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of BCMA-CD19 cCAR T cells in patients with relapsed and/or refractory SLE.
- Trial name
- NCT05474885
- Testing
- BCMA-CD19 cCAR T cells
- Where
- China
- Volunteers
- 15 people
- Sponsor
- iCell Gene Therapeutics
Systemic Lupus Erythematosus, Lupus
CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy, in Patients With Refractory Systemic Lupus Erythematosus (GALLOP)
This is a Phase 1 study to evaluate the safety and efficacy of a single infusion of CB-010 in patients with refractory Systemic Lupus Erythematosus (SLE) with cohorts for lupus nephritis (LN) and extrarenal lupus (ERL).
- Conditions
- Systemic Lupus Erythematosus, Lupus, Lupus Erythematosus, Lupus Nephritis
- Trial name
- GALLOP (NCT06752876)
- Testing
- CB-010
- Sponsor
- Caribou Biosciences, Inc.
Systemic Lupus Erythematosus
Clinical and Demographic Features of Patients With Moderate to Severe Active Systemic Lupus Erythematosus in Russia
This is a multicenter observational retrospective-prospective study consisting of retrospective and prospective phases. Trial will include 2 visits for obtaining the patient's demographic and clinical data: the 1st is…
- Trial name
- SEVERUS (NCT06759519)
- Where
- 32 sites in Russia
- Volunteers
- 637 people
- Sponsor
- AstraZeneca
Systemic Lupus Erythematosus
PRV-3279-2a Trial in Systemic Lupus
The PREVAIL-2 study was designed to assess the safety and potential efficacy of PRV-3279 in flare prevention in systemic lupus erythematosus (SLE) participants with active disease after amelioration induced by corticosteroid…
- Trial name
- PREVAIL-2 (NCT05087628)
- Testing
- PRV-3279
- Where
- 36 sites in United States, China and 2 more
- Volunteers
- 28 people
- Sponsor
- Provention Bio, a Sanofi Company
Systemic Lupus Erythematosus (SLE)
Universal CAR-T Cells (BRL-301) in Refractory Systemic Lupus Erythematosus
This is an investigator initiated trial to assess the efficacy and safety of BRL-301 in the refractory systemic lupus erythematosus.
- Trial name
- NCT05988216
- Testing
- BRL-301
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Bioray Laboratories
Systemic Lupus Erythematosus (SLE)
Study to Evaluate the Safety, Tolerability and Short Term Efficacy of Extracorporeal Specific Immunoadsorption LupusorbTM Columns for the Treatment of Systemic Lupus Erythematosus (SLE) Patients
Systemic Lupus Erythematosus (SLE) is a chronic, autoimmune, inflammatory disease primarily affecting women of childbearing age, and associated with severe morbidity and mortality of its victims.
- Trial name
- NCT00608127
- Testing
- LupusorbTM
- Where
- Israel
- Volunteers
- 10 people
- Sponsor
- Verto LTD
SLE (Systemic Lupus), Lupus Erythematosus, Systemic
A Safety and Efficacy Study Evaluating CTX112 in Adult Subjects With Refractory Autoimmune Disease
This is a single-arm, open-label, multicenter, ascending dose Phase 1 study evaluating the safety and preliminary efficacy of CTX112 in adult subjects with refractory autoimmune diseases, including active systemic lupus…
- Conditions
- SLE (Systemic Lupus), Lupus Erythematosus, Systemic, Lupus Nephritis, Systemic Sclerosis
- Trial name
- NCT06925542
- Testing
- CTX112
- Where
- 17 sites in United States, Germany and 1 more
- Volunteers
- 80 people
- Sponsor
- CRISPR Therapeutics
Systemic Lupus Erythematosus
Compassionate Use for Subcutaneous (SC) Belimumab
GlaxoSmithKline (GSK) have submitted a Biologic License Application (BLA) for the subcutaneous formulation of belimumab which is currently under review by the Food and Drug Administration (FDA).
- Trial name
- NCT03125486
- Testing
- SC belimumab 200 mg
- Where
- United States
- Sponsor
- GlaxoSmithKline
Lupus Erythematosus, Systemic
To Evaluate the Effects of Cevostamab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis
The study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of cevostamab in participants with systemic lupus erythematosus (SLE) with or without active lupus nephritis (LN).
- Trial name
- NCT07629583
- Testing
- Cevostamab, Tocilizumab
- Where
- 2 sites in France, Spain
- Volunteers
- 46 people
- Sponsor
- Genentech, Inc.
Systemic Lupus Erythematosus
Study of Epratuzumab in Systemic Lupus Erythematosus
Epratuzumab is an investigational antibody designed to help treat Systemic Lupus Erythematosus (SLE). The purpose of the study is to obtain additional long-term information regarding the safety and efficacy of continued…
- Trial name
- NCT00383513
- Testing
- Epratuzumab
- Where
- 10 sites in United States
- Volunteers
- 29 people
- Sponsor
- UCB Pharma
Lupus Erythematosus, Systemic
Clinical Study to Investigate the Safety, Tolerability, and Pharmacokinetics of GR1603 in SLE
A Study to Investigate the Tolerability, Safety,Pharmacokinetics and efficacy of GR1603 in subjects with Systemic Lupus Erythematosus ； GR1603 injection is a monoclonal antibody targeting IFNAR1, which can block IFNAR binding to…
- Trial name
- NCT06015230
- Testing
- low dose GR1603 in phase Ⅰb, high dose GR1603 in phaseⅠb, low dose GR1603 in phase Ⅱ
- Where
- China
- Volunteers
- 136 people
- Sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Systemic Lupus Erythematosus
Open-label Study of Belimumab Plus Standard Therapy in Chinese Pediatric Participants With Active Systemic Lupus Erythematosus (SLE)
This study will be conducted to evaluate the safety, efficacy and pharmacokinetics of belimumab administered in combination with background standard therapy in pediatric participants with active SLE.
- Trial name
- NCT04908865
- Testing
- Belimumab, Standard therapy
- Where
- 9 sites in China
- Volunteers
- 67 people
- Sponsor
- GlaxoSmithKline
Systemic Lupus Erythematosus
A Study to Evaluate the Tolerability, Safety and Effectiveness of Edratide in the Treatment of Lupus
It is thought that Edratide may be able to reduce the symptoms of SLE.
- Trial name
- PRELUDE (NCT00203151)
- Testing
- edratide
- Volunteers
- 340 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.