Clinical trials: SLE (Systemic Lupus)
Systemic Lupus Erythematosus (SLE), Sjogren's Syndrome
Universal CAR-T Cells (BRL-301) in Relapse or Refractory Autoimmune Diseases
This is an investigator initiated trial to assess the efficacy and safety of BRL-301 in the relapse or refractory autoimmune diseases of China.
- Conditions
- Systemic Lupus Erythematosus (SLE), Sjogren's Syndrome, Systemic Sclerosis, Inflammatory Myopathy
- Trial name
- NCT05859997
- Testing
- BRL-301
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Bioray Laboratories
System; Lupus Erythematosus
Individual Patient Expanded Access IND of Autologous HB-adMSCs for the Treatment of Systemic Lupus Erythematosus (SLE)
This protocol is part of an FDA Individual Patient Expanded Access IND. This study is to be conducted according to US and International Standards of Good Clinical Practice (FDA Title 21 part 312 and International Conference on…
- Trial name
- NCT04907175
- Testing
- HB-adMSCs
- Where
- United States
- Sponsor
- Hope Biosciences Research Foundation
Systemic Lupus Erythematosus
Clinical Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus Erythematosus
International trial to evaluate the biological activity and safety of cenerimod (ACT-334441) in systemic lupus erythematosus (SLE) patients.
- Trial name
- NCT02472795
- Testing
- Cenerimod
- Where
- 18 sites in United States, Belarus and 4 more
- Volunteers
- 105 people
- Sponsor
- Viatris Innovation GmbH
Systemic Lupus Erythematosus
Study of Subcutaneous (SC) Belimumab in Pediatric Participants With Systemic Lupus Erythematosus (SLE)
The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and pharmacodynamics (PD) of repeat doses of 200 milligrams per milliliter (mg/mL) belimumab administered via SC injection in pediatric participants 5 to…
- Trial name
- NCT04179032
- Testing
- Belimumab
- Where
- 11 sites in United States, Argentina and 5 more
- Volunteers
- 25 people
- Sponsor
- GlaxoSmithKline
Systemic Lupus Erythematosus
A Study of Nipocalimab in Adult Participants With Active Systemic Lupus Erythematosus
The purpose of this study is to evaluate the efficacy of nipocalimab versus placebo in participants with active systemic lupus erythematosus (SLE).
- Trial name
- NCT04882878
- Testing
- Nipocalimab, Standard-of-care treatment
- Where
- 86 sites in United States, Argentina and 10 more
- Volunteers
- 228 people
- Sponsor
- Janssen Research & Development, LLC
Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM)
A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
This is a phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and anti-B-cell activity of FT819 following treatment with or without auxiliary medicinal product (AMP) in participants with moderate-to-severe…
- Conditions
- Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM), Systemic Sclerosis (SSc), Systemic Lupus Erythematosus (SLE)
- Trial name
- NCT06308978
- Testing
- FT819, Fludarabine, Cyclophosphamide
- Where
- 21 sites in United States, France and 2 more
- Volunteers
- 244 people
- Sponsor
- Fate Therapeutics
Systemic Lupus Erythematosus
A Study of AMG 557 in Adults With Systemic Lupus Erythematosus
This is a Phase 1, randomized, placebo-controlled, double-blind, dose-escalation study of repeat SC doses of AMG 557 in adults with Systemic Lupus Erythematosus.
- Trial name
- NCT00774943
- Testing
- AMG 557
- Where
- 12 sites in United States, Canada
- Volunteers
- 58 people
- Sponsor
- Amgen
Systemic Lupus Erythematosus
Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus (0733-271)(TERMINATED)
Women with Systemic Lupus Erythematosus (SLE) are prone to cardiovascular disease. Early detection of improvement of endothelial function with simvastatin could be a clue for future intervention trials.
- Trial name
- NCT00739050
- Testing
- simvastatin
- Volunteers
- 4 people
- Sponsor
- Organon and Co
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
A Study of Telitacicept in Subjects With Childhood-onset Systemic Lupus Erythematosus
This is a multi-center, open-label, phase 1 study.
- Trial name
- NCT05687526
- Testing
- Telitacicept
- Where
- 12 sites in China
- Volunteers
- 16 people
- Sponsor
- RemeGen Co., Ltd.
Systemic Lupus Erythematosus
A Study of Belimumab in Subjects With Systemic Lupus Erythematosus
The purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on quality of life of two different doses of belimumab administered in addition to standard therapy in subjects with active…
- Trial name
- BLISS-76 (NCT00410384)
- Testing
- Belimumab 1 mg/kg, Belimumab 10 mg/kg
- Where
- 146 sites in United States, Austria and 17 more
- Volunteers
- 819 people
- Sponsor
- Human Genome Sciences Inc.
Systemic Lupus Erythematosus
A Study of Belimumab in Chinese Pediatric Participants With Systemic Lupus Erythematosus
This study will evaluate the pharmacokinetic characteristics and safety of belimumab subcutaneous (SC) in Chinese pediatric participants with SLE who have completed 48 weeks belimumab Intravenous (IV) treatment in 213560 study…
- Trial name
- NCT05917288
- Testing
- Belimumab, Standard of care
- Where
- 6 sites in China
- Volunteers
- 16 people
- Sponsor
- GlaxoSmithKline
System; Lupus Erythematosus
FLARE Lupus Research Study Systemic Lupus Erythematosus
The first phase of this pilot study will assess changes in quality of life at the end of a 16-week Mymee program in patients with moderate to severe SLE.
- Trial name
- FLARE (NCT03426384)
- Testing
- Mymee Program
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Mymee Inc.
Lupus Erythematosus, Systemic
Subcutaneous Treatment In Randomized Subjects To Evaluate Safety And Efficacy In Generalized Lupus Erythematosus
The objective of this study is to evaluate and compare efficacy of 3 dose levels of PF-04236921 to placebo in subjects with generalized lupus using a measure called the Systemic Lupus Erythematosus (SLE) Responder Index.
- Trial name
- BUTTERFLY (NCT01405196)
- Testing
- PF-04236921
- Where
- 113 sites in United States, Argentina and 11 more
- Volunteers
- 183 people
- Sponsor
- Pfizer
Systemic Lupus Erythematosus, SLE
An Ascending Dose Study of PIT565 in Participants With Systemic Lupus Erythematosus (SLE).
The purpose of the study is to determine the safety, tolerability, and pharmacokinetics of PIT565 in participants with SLE
- Trial name
- NCT06335979
- Testing
- PIT565
- Where
- 11 sites in China, Germany and 4 more
- Volunteers
- 54 people
- Sponsor
- Novartis Pharmaceuticals
Systemic Lupus Erythematosus, Lupus Erythematosus
A Study of Imvotamab in Severe Systemic Lupus Erythematosus
The purpose of this study is to determine the safety and tolerability of imvotamab in patients with severe systemic lupus erythematosus who have failed prior therapies.
- Trial name
- NCT06041568
- Testing
- Imvotamab
- Where
- 10 sites in United States, Poland and 1 more
- Volunteers
- 17 people
- Sponsor
- IGM Biosciences, Inc.
Systemic Lupus Erythematosus
CHABLIS-SC2: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without Nephritis
The purpose of this study is to evaluate the clinical efficacy of blisibimod as measured by a composite responder index in subjects who, despite corticosteroid use, continue to have autoantibody positive, clinically-active…
- Trial name
- NCT02074020
- Testing
- Blisibimod
- Sponsor
- Anthera Pharmaceuticals
SLE - Systemic Lupus Erythematosus
A Study to Evaluate the Safety,Tolerability,Pharmacokinetics and Pharmacodynamics of Cenerimod in Adult Chinese Participants With Moderate-to-severe Systemic Lupus Erythematosus (SLE)
The goal of this clinical trial is to learn about the safety, how the body processes the drug, and its effects of a drug called cenerimod in adult Chinese participants (aged 18-75) with moderate to severe Systemic Lupus…
- Trial name
- NCT07266090
- Testing
- cenerimod 4 mg
- Where
- 7 sites in China
- Volunteers
- 15 people
- Sponsor
- Viatris Pharmaceuticals Co., Ltd.
Systemic Lupus Erythematosus
A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus
The purpose of this study is to evaluate the efficacy and safety of MEDI-546 compared to placebo in subjects with chronic, moderately-to-severely active systemic lupus erythematosus (SLE) with an inadequate response to standard…
- Trial name
- NCT01438489
- Testing
- Anifrolumab 300 mg, Anifrolumab 1000 mg
- Where
- 79 sites in United States, Brazil and 12 more
- Volunteers
- 626 people
- Sponsor
- MedImmune LLC
Systemic Lupus Erythematosus (With and Without Nephritis), Idiopathic Inflammatory Myopathy
A Study to Investigate the Safety and Preliminary Efficacy of ALLO-329, an Allogeneic CAR T-cell Therapy, in Adults With Autoimmune Disease
This is a first-in-human, single-arm, open-label study evaluating the safety, tolerability, and preliminary efficacy of ALLO-329 in adults with autoimmune diseases: systemic lupus erythematosus (SLE) with and without renal…
- Conditions
- Systemic Lupus Erythematosus (With and Without Nephritis), Idiopathic Inflammatory Myopathy, Systemic Sclerosis
- Trial name
- RESOLUTION (NCT07085104)
- Testing
- ALLO-329, Cyclophosphamide, Fludarabine
- Where
- 17 sites in United States, Canada
- Volunteers
- 66 people
- Sponsor
- Allogene Therapeutics