Clinical trials: SLE - Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Efavaleukin Alfa in Participants With Systemic Lupus Erythematosus
To evaluate the safety and tolerability of subcutaneous (SC) dose administrations of Efavaleukin Alfa in participants with systemic lupus erythematosus (SLE).
- Trial name
- NCT03451422
- Testing
- Efavaleukin Alfa
- Where
- 15 sites in United States, France and 2 more
- Volunteers
- 35 people
- Sponsor
- Amgen
Systemic Lupus Erythematosus (SLE)
Omega-3 Replacement With Krill Oil in Disease Management of SLE
A randomized, double-blind controlled, multicenter study in SLE patients given AKBM-3031or placebo for 24 weeks (randomized period) and followed by an open label extension (OLE) treatment with AKBM-3031 for the next 24 weeks.
- Trial name
- ORKIDS (NCT03626311)
- Testing
- AKBM-3031
- Where
- 19 sites in United States, Canada
- Volunteers
- 76 people
- Sponsor
- Aker BioMarine Human Ingredients AS
Lupus Nephritis
Obe-cel in Severe, Refractory Systemic Lupus Erythematosus (SLE) With Active Lupus Nephritis (LN)
The purpose of this trial is to evaluate the efficacy and safety of obecabtagene autoleucel (obe-cel) administered once following lymphodepletion in participants with severe, refractory systemic lupus erythematosus (SLE) and…
- Trial name
- LUMINA (NCT07053800)
- Testing
- Obecabtagene autoleucel
- Where
- 16 sites in United States, Brazil and 3 more
- Volunteers
- 35 people
- Sponsor
- Autolus Limited
Lupus Nephritis, Systemic Lupus Erythematosus
A Study of KZR-616 in Patients With SLE With and Without Lupus Nephritis
This was a Phase 1b/2, multi-center study in which patients received KZR-616, administered as a subcutaneous (SC) injection weekly for 13 weeks (Phase 1b) or 24 weeks (Phase 2).
- Trial name
- MISSION (NCT03393013)
- Testing
- KZR-616
- Where
- 36 sites in United States, Australia and 6 more
- Volunteers
- 69 people
- Sponsor
- Kezar Life Sciences, Inc.
Systemic Lupus Erythematosus
Study of TRU-015 in Subjects With Membranous Nephropathy Secondary to Systemic Lupus Erythematosus
The purpose of this study is to determine how the body absorbs and chemically changes a single infusion of TRU-015 in subjects with kidney disease caused by lupus.
- Trial name
- NCT00479622
- Testing
- TRU-015
- Where
- 6 sites in United States
- Volunteers
- 20 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
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 Ultra-Fast CD19 CAR-T Therapy for Refractory SLE
This is an investigator-initiated trial aimed at assessing the safety and efficacy of ultra-fast autologous CD19-targeted CAR-T cells in the treatment of refractory systemic lupus erythematosus.
- Trial name
- NCT07331467
- Testing
- CD19 CAR-T cells
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Chongqing Precision Biotech Co., Ltd
Healthy Volunteers, Rheumatoid Arthritis
A Study of Intravenous CPTX2309 in Healthy Participants and Participants With Moderate to Severe Rheumatoid Arthritis (RA) or Systemic Lupus Erythematosus (SLE)
The purpose of this study is to assess the safety and tolerability of CPTX2309 in healthy adult participants and adult participants with moderate to severe rheumatoid arthritis or systemic lupus erythematosus.
- Conditions
- Healthy Volunteers, Rheumatoid Arthritis, Systemic Lupus Erythematosus
- Trial name
- NCT06917742
- Testing
- CPTX2309
- Where
- 3 sites in Australia
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Capstan Therapeutics
Systemic Lupos Erythematosus, SLE
A Phase 1, Single-Ascending-Dose, Safety, Tolerability, Pharmacokinetic(PK), and Pharmacodynamic(PD) Study of BIIB068 in Healthy Participants
The primary objective of the study is to evaluate the safety and tolerability of single oral doses of BIIB068 in healthy participants.
- Trial name
- NCT02829541
- Testing
- BIIB068
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Biogen
Systemic Lupus Erythematosus, Lupus Nephritis (LN)
An Exploratory Clinical Study of YTS109 Cell for R/R Autoimmune Diseases
This study evaluates the safety and efficacy of YTS109 cells in adults with relapsed/refractory autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), including LN and SLE-ITP, Sjogren's Syndrome, etc.
- Conditions
- Systemic Lupus Erythematosus, Lupus Nephritis (LN), Sjogren's Syndrome, Inflammatory Myopathy
- Trial name
- NCT07236762
- Testing
- YTS109 cell
- Where
- China
- Volunteers
- 18 people
- Sponsor
- China Immunotech (Beijing) Biotechnology Co., Ltd.
Systemic Lupus Erythematosus
A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)
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-52 (NCT00424476)
- Testing
- Belimumab 1 mg/kg, Belimumab 10 mg/kg
- Where
- 92 sites in Argentina, Australia and 11 more
- Volunteers
- 865 people
- Sponsor
- Human Genome Sciences Inc.
Systemic Lupus Erythematosus
Study of RC18 Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE)
The purpose of this study is to initially access the safety and effectivity of RC18 combined with standard treatment and Placebo combined with standard therapy in subjects with Moderate to severe SLE, Besides ,to provide dose…
- Trial name
- NCT02885610
- Testing
- RC18 80 mg plus standard therapy, RC18 160 mg plus standard therapy, RC18 240 mg plus standard therapy
- Where
- China
- Volunteers
- 249 people
- Sponsor
- RemeGen Co., Ltd.
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
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
Systemic Lupus Erythematosus
A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of AMG 623 in Subjects With Systemic Lupus Erythematosus
This study is to evaluate the safety of AMG 623 in subjects with systemic lupus erythematosus. All subjects will receive 4 weekly doses of study drug over a 3 week period, and then will be followed for an additional 28 weeks, for…
- Trial name
- NCT02411136
- Testing
- AMG 623
- Volunteers
- 64 people
- Sponsor
- Amgen
Lupus Erythematosus, Systemic, Lupus Nephritis
A Study of Rapcabtagene Autoleucel in Active, Refractory Systemic Lupus Erythematosus (SLE) or Lupus Nephritis (LN) Patients (AUTOGRAPH - SLE/LN)
The purpose of this study is to evaluate the efficacy and safety of rapcabtagene autoleucel (administered once following lymphodepletion) in patients with active, refractory systemic lupus erythematosus (SLE) or active…
- Trial name
- NCT06581198
- Testing
- rapcabtagene autoleucel
- Where
- 107 sites in United States, Argentina and 24 more
- Volunteers
- 179 people
- Sponsor
- Novartis Pharmaceuticals
Systemic Lupus Erythematosus (SLE)
Acthar for the Treatment of Systemic Lupus Erythematosus (SLE) in Patients With a History of Persistently Active Disease
This Phase 4 study is being performed to examine the effects of Acthar for the indicated use of treatment of SLE. This study will enroll patients with steroid-dependent, persistently active SLE with arthritic and/or cutaneous…
- Trial name
- NCT01753401
- Testing
- Acthar, Steroid Drug
- Where
- 22 sites in United States
- Volunteers
- 38 people
- Sponsor
- Mallinckrodt
Systemic Lupus Erythematosus, SLE (Systemic Lupus)
A Study in Participants With Mild-to-moderate Systemic Lupus Erythematosus
The main purpose of this study is to evaluate the safety and tolerability of CUG252 following multiple ascending doses in participants with Systemic Lupus Erythematosus (SLE).
- Conditions
- Systemic Lupus Erythematosus, SLE (Systemic Lupus), Autoimmune
- Trial name
- NCT05866861
- Testing
- CUG252
- Where
- 11 sites in United States
- Volunteers
- 40 people
- Sponsor
- Cugene Inc.
Systemic Lupus Erythematosus
A Study of GNC-038 Tetra-specific Antibody Injection in Patients With Systemic Lupus Erythematosus
This study is a randomized, controlled, phase I clinical study with safety, efficacy, and pharmacokinetic/pharmacodynamic characteristics in patients with systemic lupus erythematosus.
- Trial name
- NCT06857214
- Testing
- GNC-038, Belimumab
- Where
- China
- Volunteers
- 84 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
Systemic Lupus Erythematosus
PEARL-SC Trial: A Study of the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus
The purpose of this study is to evaluate the efficacy, safety and tolerability of three different doses of A-623 administered in addition to standard therapy in subjects with active SLE disease
- Trial name
- PEARL-SC (NCT01162681)
- Testing
- A-623
- Where
- 74 sites in United States, Argentina and 9 more
- Volunteers
- 547 people
- Sponsor
- Anthera Pharmaceuticals