Clinical trials: System Lupus Erythematosus
Lupus Nephritis (LN)
C-CAR168 CAR T Cell Therapy for Refractory Autoimmune Disease
This multi-center, open-label, Phase 1/2 study aims to evaluate the safety, tolerability, and preliminary efficacy of C-CAR168, an autologous anti-CD20/BCMA CAR-T therapy, in patients with autoimmune diseases refractory to…
- Trial name
- NCT06935474
- Testing
- C-CAR168
- Where
- United States
- Sponsor
- AbelZeta Inc.
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, Cutaneous Lupus Erythematosus
A Study to Evaluate VIB7734 in Participants With Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE), Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and Dermatomyositis
The purpose of this study is to evaluate the safety and tolerability of escalating, multiple subcutaneous (SC) doses of VIB7734 in participants with Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)…
- Conditions
- Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus, Sjogren's Syndrome, Systemic Sclerosis
- Trial name
- NCT03817424
- Testing
- VIB7734
- Where
- 30 sites in United States, Poland and 1 more
- Volunteers
- 31 people
- Sponsor
- Amgen
Lupus Nephritis
A Study of Mycophenolate Mofetil (CellCept) in Management of Patients With Lupus Nephritis.
This 2 arm study assessed the efficacy of Mycophenolate Mofetil (MMF; CellCept) compared to cyclophosphamide in inducing a response in patients with lupus nephritis, and the long term efficacy of MMF compared to azathioprine in…
- Trial name
- NCT00377637
- Testing
- Mycophenolate mofetil (MMF), Cyclophosphamide, Azathioprine
- Where
- 108 sites in United States, Argentina and 15 more
- Volunteers
- 370 people
- Sponsor
- Hoffmann-La Roche
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
- 18 sites in United States, Canada
- Volunteers
- 66 people
- Sponsor
- Allogene Therapeutics
Active Systemic Lupus Erythematosus
Efficacy and Safety of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus
The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment regimen of two doses of anifrolumab versus placebo in adult subjects with moderately to severely active, autoantibody-positive systemic…
- Trial name
- NCT02446912
- Testing
- Anifrolumab
- Where
- 145 sites in United States, Argentina and 16 more
- Volunteers
- 460 people
- Sponsor
- AstraZeneca
Lupus Nephritis
Long-term Follow-up for Evaluating the Safety of CS20AT04 in Subject with Lupus Nephritis
This observation study is planned to evaluate the safety and efficacy of the subjects who received CS20AT04 in the phase 1 clinical trial.
- Trial name
- NCT04522505
- Where
- South Korea
- Volunteers
- 6 people
- Sponsor
- Corestemchemon, Inc.
Systemic Lupus Erythematosus
A Study to Assess the Safety and PK/PD of LBL-047 in Healthy Adults and Patients With Systemic Lupus Erythematosus
A Double-blind, Randomized, Placebo-controlled, Dose-escalation Phase I Study to Assess the Safety and PK/PD of LBL-047 Subcutaneous Injection in Healthy Adults and Patients with Systemic Lupus Erythematosus.
- Trial name
- NCT07323173
- Testing
- LBL-047 for Injection
- Where
- 12 sites in China
- Volunteers
- 117 people, healthy volunteers welcome
- Sponsor
- Nanjing Leads Biolabs Co.,Ltd
Systemic Lupus Erythematosus
Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis
The purpose of this clinical research study is to learn if addition of abatacept is safe and improves the effectiveness of treatment of patients with active lupus nephritis who are also taking mycophenolate mofetil (MMF) and…
- Trial name
- NCT00430677
- Testing
- Corticosteroids (prednisone or prednisolone), Abatacept, Mycophenolate mofetil (MMF)
- Where
- 84 sites in United States, Argentina and 16 more
- Volunteers
- 423 people
- Sponsor
- Bristol-Myers Squibb
Systemic Lupus Erythematosus
A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus
The purpose of this study is to evaluate the ability of dapirolizumab pegol (DZP) as an add-on treatment to standard of care (SOC) medication to achieve clinically relevant long term improvement of moderate to severe disease…
- Trial name
- PHOENYCS GO (NCT04294667)
- Testing
- DZP
- Where
- 177 sites in United States, Argentina and 23 more
- Volunteers
- 321 people
- Sponsor
- UCB Biopharma SRL
Lupus Nephritis
Study of Safety, Efficacy and Tolerability of Secukinumab Versus Placebo, in Combination With SoC Therapy, in Patients With Active Lupus Nephritis
This was a pivotal, randomized, double-blind, placebo-controlled trial evaluating at Week 52 the efficacy and safety of secukinumab versus placebo in patients with active lupus nephritis (ISN/RPS Class III or IV, with or without…
- Trial name
- SELUNE (NCT04181762)
- Testing
- secukinumab
- Where
- 105 sites in United States, Argentina and 32 more
- Volunteers
- 275 people
- Sponsor
- Novartis Pharmaceuticals
Lupus Erythematosus, Systemic
A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus
The goal of this clinical trial is to see how well cenerimod reduces symptoms of Systemic Lupus Erythematosus in adult patients with moderate to severe symptoms.
- Trial name
- OPUS-1 (NCT05648500)
- Testing
- Cenerimod
- Where
- 198 sites in United States, Argentina and 15 more
- Volunteers
- 470 people
- Sponsor
- Viatris Innovation GmbH
Systemic Lupus Erythematosus
Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users
Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users (PRIMULA Lac) is a Post Marketing Requirements (PMR) study designed to fulfill the FDA post-marketing requirements.
- Trial name
- PRIMULA Lac (NCT06594068)
- Testing
- Anifrolumab
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- AstraZeneca
Systemic Lupus Erythematosus (SLE)
To Evaluate the Efficacy and Safety of SG301 SC Injection in Systemic Lupus Erythematosus
This was a multicenter, randomized, double-blind, placebo-controlled Phase 2 clinical study. The primary objective was to evaluate the efficacy of SG301 SC injection in participants with Systemic Lupus Erythematosus (SLE) based…
- Trial name
- NCT07447986
- Testing
- SG301 SC Injection
- Where
- 40 sites in China
- Volunteers
- 120 people
- Sponsor
- Hangzhou Sumgen Biotech Co., Ltd.
Systemic Lupus Erythematosus
A Study Evaluating the Effects of GLPG3667 Administered as Oral Treatment in Adult Participants With Active Systemic Lupus Erythematosus
A study evaluating the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GLPG3667 administered orally once daily for 48 weeks in approximately 180 adult participants with active Systemic Lupus…
- Trial name
- GALACELA (NCT05856448)
- Testing
- GLPG3667
- Where
- 84 sites in United States, Argentina and 10 more
- Volunteers
- 186 people
- Sponsor
- Lakefront Biotherapeutics NV
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
Japanese phase1 Study of Belimumab (IV vs SC)
This study is an open-label, randomized, 2 parallel group, single dose study in healthy Japanese males to assess the pharmacokinetics and safety/tolerability of single intravenous administration and single subcutaneous…
- Trial name
- NCT01516450
- Testing
- GSK1550188 IV, GSK1550188 SC
- Where
- Japan
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
SLE - Systemic Lupus Erythematosus
Allogeneic UCB-derived CAR-T for SLE
The purpose of this clinical trial is to learn if allogeneic, umbilical cord blood-derived chimeric antigen receptor T-cell (UCAR-T) targeting CD19 and BCMA works to treat refractory SLE in adults.
- Trial name
- NCT07274059
- Testing
- allogeneic umbilical cord blood-derived CAR-T targeting CD19 and BCMA
- Where
- 2 sites in China
- Volunteers
- 48 people
- Sponsor
- Chengdu Ucello Biotechnology Co., Ltd.
Lupus Nephritis
A Study of CellCept (Mycophenolate Mofetil) in Patients With Lupus Nephritis.
This 2 arm study will compare the efficacy and safety of CellCept plus corticosteroids, versus cyclophosphamide plus corticosteroids in the induction phase followed by azathioprine in the maintenance phase, in maintaining…
- Trial name
- NCT00425438
- Testing
- Mycophenolate Mofetil, Corticosteroids, Azathioprine
- Where
- 11 sites in China
- Volunteers
- 52 people
- Sponsor
- Hoffmann-La Roche
Idiopathic Inflammatory Myopathies(IIM), Immune Thrombocytopenia(ITP)
An Exploratory Study of CD19/CD22/BCMA CAR-T Cells (BZE2204) in Subjects With Relapsed or Refractory Autoimmune Diseases
This is a single arm, open-label, dose escalation and expansion study to evaluate the safety, tolerability and preliminary efficacy of autologous chimeric antigen receptor T (CAR-T) cells targeting CD19/CD22/BCMA(BZE2204) in…
- Conditions
- Idiopathic Inflammatory Myopathies(IIM), Immune Thrombocytopenia(ITP), Systemic Lupus Erythematosus(SLE)
- Trial name
- NCT07174843
- Testing
- CD19/CD22/BCMA CAR-T cells(BZE2204)
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Shanghai Cell Therapy Group Co.,Ltd