Clinical trials: SLE - Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
Anifrolumab Malignancy and Serious Infections Study
This is an observational study, in which the main research question is to evaluate the risk of malignancies and serious infections among moderate/severe SLE patients who receive anifrolumab compared with a comparable population…
- Trial name
- SIMA (NCT07000110)
- Testing
- Anifrolumab
- Where
- 4 sites in Denmark, France and 2 more
- Volunteers
- 3,506 people
- Sponsor
- AstraZeneca
Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathy
A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1)
The purpose of this study is to establish the tolerability, preliminary efficacy, and pharmacokinetics of CC-97540 in participants with severe, refractory autoimmune diseases (Breakfree-1).
- Conditions
- Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathy, Systemic Sclerosis, Rheumatoid Arthritis
- Trial name
- NCT05869955
- Testing
- CC-97540, Fludarabine, Cyclophosphamide
- Where
- 46 sites in United States, Belgium and 4 more
- Volunteers
- 270 people
- Sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
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.
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.
Lupus Erythematosus, Systemic
A Study to Evaluate the Efficacy and Safety of CC-220 in Subjects With Active Systemic Lupus Erythematosus
The purpose of this Phase 2, multicenter, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of an oral treatment regimen of CC-220 versus placebo in adult subjects with active systemic lupus…
- Trial name
- NCT03161483
- Testing
- CC-220
- Where
- 184 sites in United States, Argentina and 13 more
- Volunteers
- 289 people
- Sponsor
- Celgene
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, Lupus Erythematosus, Systemic
A Study to Evaluate the Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of TAK-079 in Combination With Standard Background Therapy in Participants With Moderate to Severe Systemic Lupus Erythematosus (SLE)
The purpose of this study is to evaluate the safety and tolerability of TAK-079 in comparison with matching placebo, administered once every 3 weeks over a 12-week dosing period in participants with active SLE who are receiving…
- Trial name
- NCT03724916
- Testing
- TAK-079
- Where
- 19 sites in United States
- Volunteers
- 23 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
System Lupus Erythematosus
A Study of SCTB35 in Patients with Systemic Lupus Erythematosus
This study is a multicenter Phase Ib/II clinical trial aimed at evaluating the safety, tolerability and efficacy of SCTB35 in patients with systemic lupus erythematosus (SLE).
- Trial name
- NCT06841042
- Testing
- SCTB35 injection
- Where
- 14 sites in China
- Volunteers
- 168 people
- Sponsor
- Sinocelltech Ltd.
Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathies
Preliminary Clinical Study of UTAA09 Injection in the Treatment of Relapsed/Refractory Autoimmune Diseases
To evaluate the safety of UTAA09 injection in the treatment of relapsed/refractory (R/R) autoimmune disease (AID). To evaluate the pharmacokinetic (PK) profile of UTAA09 injection in patients with R/R AID.
- Conditions
- Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathies, Systemic Sclerosis, Sjogren's Syndrome
- Trial name
- NCT06417398
- Testing
- T cell injection targeting CD19 chimeric antigen receptor
- Volunteers
- 10 people
- Sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.
SLE (Systemic Lupus), RA - Rheumatoid Arthritis
Phase 1a/b Tolerability of NTR-1011 in Healthy Adults and Adult Patients With SLE and RA
The goal of this clinical trial is to inform the safety and tolerability of NTR-1011 in treating adult patients diagnosed with systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA).
- Trial name
- LIBERATE-I (NCT07237659)
- Testing
- NTR1011
- Where
- 7 sites in United States
- Volunteers
- 24 people
- Sponsor
- Neutrolis
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.
Systemic Lupus Erythematosus
Effectiveness of Belimumab Treatment in a Subpopulation of Systemic Lupus Erythematosus (SLE) Patients: a Pooled Analysis of BLISS-52 and BLISS-76
This pooled analysis will assess data from the Phase 3 belimumab registration studies BLISS-52 (aka BEL110752) and BLISS-76 (aka BEL110751). The analysis was pre-planned and agreed prior to the unblinding of either study.
- Trial name
- NCT01914770
- Testing
- Belimumab 1 mg/kg, Belimumab 10 mg/kg
- Volunteers
- 1,016 people
- Sponsor
- GlaxoSmithKline
Difficult to Treat Systemic Lupus Erythematosus
Clinical Study Evaluating the Safety and Efficacy of IC19 CAR-T Cell Therapy for Refractory Systemic Lupus Erythematosus
This study is an open label, single arm exploratory clinical trial of IC19 CAR-T cell therapy for refractory systemic lupus erythematosus.
- Trial name
- IC19 CAR-T (NCT06886919)
- Testing
- Engineering of chimeric antigen receptors targeting CD19 in allogeneic T cells
- Volunteers
- 6 people
- Sponsor
- Beijing Immunochina Medical Science & Technology Co., Ltd.
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 (SLE), Cutaneous Lupus Erythematosus (CLE)
A Long-Term Extension (LTE) Study Of Enpatoran In Cutaneous Manifestations Of Lupus With Or Without Systemic Disease [Elowen-LTE]
The purpose of this study is to evaluate the long-term safety and efficacy of orally administered enpatoran in participants with cutaneous manifestations of lupus erythematosus who have completed the Elowen-1 (MS504908_0001)…
- Trial name
- NCT07840287
- Testing
- Enpatoran
- Where
- 2 sites in United States, Germany
- Volunteers
- 404 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Systemic Lupus Erythematosus
A Study of rhuMAb IFNalpha in Adults With Systemic Lupus Erythematosus
This is a Phase I, randomized, placebo-controlled, double-blind, dose-escalation study of single and repeat doses of rhuMAb IFNalpha, administered through the SC or IV route, in adults with Systemic Lupus Erythematosus.
- Trial name
- NCT00541749
- Testing
- rhuMAb IFNalpha
- Volunteers
- 60 people
- Sponsor
- Genentech, Inc.
Systemic Lupus Erythematosus (SLE)
A Phase 2 Efficacy and Safety Study of Dapirolizumab Pegol (DZP) in Systemic Lupus Erythematosus
The purpose is to evaluate the efficacy and safety of three different doses of Dapirolizumab Pegol (DZP) versus placebo in adult subjects with moderately to severely active systemic Lupus Erythematosus.
- Trial name
- NCT02804763
- Testing
- Dapirolizumab pegol (DZP)
- Where
- 71 sites in United States, Bulgaria and 11 more
- Volunteers
- 182 people
- Sponsor
- UCB Biopharma S.P.R.L.
Healthy Volunteers
First Safety Study in Humans of a Single Dose of CPG 52364
Determine the safety and tolerability of the study drug, CPG 52364, when given as liquid or capsule. Another purpose is to determine how the drug enters and leaves the blood stream and body tissues over time.
- Trial name
- NCT00547014
- Testing
- 52364 3 mg, 52364 10 mg, 52364 30 mg
- Where
- United States
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Pfizer
Systemic Lupus Erythematosus
A Study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545 in Patients With Systemic Lupus Erythematosus.
The purpose of the study is to evaluate the safety and tolerability of MEDI-545 in Japanese adult SLE patients. This will be done by collecting the data from 3 cohorts of IV doses and 1 cohort of SC doses.
- Trial name
- NCT01031836
- Testing
- MEDI-545, MEDI-545 600
- Where
- 7 sites in Japan
- Volunteers
- 30 people
- Sponsor
- AstraZeneca
Immunologic Diseases, Autoimmune Diseases
Safety and Efficacy Study of LJP 394 (Abetimus Sodium) to Treat Lupus Kidney Disease
The purpose of this study is to determine whether LJP 394 (abetimus sodium) is safe and effective in delaying and reducing renal flares in patients with lupus nephritis.
- Conditions
- Immunologic Diseases, Autoimmune Diseases, Systemic Lupus Erythematosus, Lupus Nephritis
- Trial name
- NCT00035308
- Testing
- Abetimus sodium (LJP 394)
- Where
- 82 sites in United States, Austria and 8 more
- Volunteers
- 330 people
- Sponsor
- La Jolla Pharmaceutical Company