Clinical trials: System Lupus Erythematosus
Systemic Lupus Erythematosus
Safety, Tolerability, and Pharmacokinetics of Single Doses of HC022 in Healthy Subjects.
The primary objective of this phase Ia study is to evaluate the safety and tolerability of single-ascending, subcutaneous (SC) doses of HC022 in healthy subjects.
- Trial name
- NCT06657703
- Testing
- HC022
- Where
- 3 sites in China
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- HC Biopharma Inc.
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.
Lupus Erythematosus, Systemic
Double-Blinded, Randomized, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Biochemical Activity of Intravenous Cpn10 Administration in Subjects With Mild to Moderate SLE.
The primary objective of the study is to evaluate the safety, tolerability, and efficacy of 4 weeks intravenous treatment with Cpn10 in subjects with mild to moderate active SLE.
- Trial name
- NCT01838694
- Testing
- Ala-Cpn10
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- Invion, Inc.
Lupus Erythematosus, Systemic
A Safety and Tolerability Study of MEDI-570 in Systemic Lupus Erythematosus
The purpose of this study is to evaluate the safety and tolerability of MEDI-570 in adult subjects with moderately to severely active systemic lupus erythematosus (SLE).
- Trial name
- NCT01127321
- Testing
- MEDI-570 0.03 MG, MEDI-570 0.1 MG, MEDI-570 0.3 MG
- Where
- 17 sites in United States, Canada and 3 more
- Volunteers
- 44 people
- Sponsor
- MedImmune LLC
Lupus Erythematosus, Systemic
An Open-label Study to Evaluate the Long-term Safety of MEDI-546, for the Treatment of SLE, in Adults
The purpose of this study is to evaluate the long-term safety of anifrolumab (MEDI-546) in adults with moderate to severe active systemic lupus erythematosus (SLE).
- Trial name
- NCT01753193
- Testing
- Anifrolumab
- Where
- 57 sites in United States, Brazil and 11 more
- Volunteers
- 218 people
- Sponsor
- MedImmune LLC
Systemic Lupus Erythematosus
Safety and Effectiveness of BENLYSTA (Belimumab) in Systemic Lupus Erythematosus (SLE) Registry
The purpose of this prospective, observational cohort study is to evaluate the incidence of adverse events of special interest (AESI) and effectiveness in participants with active, autoantibody-positive SLE treated with and…
- Trial name
- SABLE (NCT01729455)
- Testing
- Benlysta, Standard of Care (SoC) Therapy
- Where
- 179 sites in United States, Argentina and 11 more
- Volunteers
- 3,138 people
- Sponsor
- GlaxoSmithKline
Lupus Nephritis
An Investigational Study to Evaluate the Safety and Effectiveness of BMS-986165 With Background Treatment in Participants With Lupus Nephritis
The purpose of this study is to evaluate the safety and effectiveness of BMS-986165 compared with placebo with regard to measures of kidney function in participants with lupus nephritis (LN).
- Trial name
- NCT03943147
- Testing
- BMS-986165, Mycophenolate Mofetil
- Where
- 100 sites in United States, Australia and 14 more
- Volunteers
- 16 people
- Sponsor
- Bristol-Myers Squibb
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
Active Systemic Lupus Erythematosus
Efficacy and Safety 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 anifrolumab versus placebo in adult participants with moderately to severely active, autoantibody-positive systemic lupus…
- Trial name
- NCT02446899
- Testing
- Anifrolumab
- Where
- 113 sites in United States, Argentina and 13 more
- Volunteers
- 373 people
- Sponsor
- AstraZeneca
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
Refractory Systemic Lupus Erythematosus
A Study of GC012F Injection in Subjects With Refractory Systemic Lupus Erythematosus
This is a single-arm, open-label, multicenter, phase 1/2 clinical study to assess the safety and efficacy of GC012F Injection in subjects with refractory Systemic Lupus Erythematosus (SLE).
- Trial name
- NCT06530849
- Testing
- GC012F Injection
- Where
- 2 sites in China
- Volunteers
- 20 people
- Sponsor
- Gracell Biotechnologies (Shanghai) Co., Ltd.
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
A Study of ICP-022 in Patients With Systemic Lupus Erythematosus (SLE)
The purpose of the study is to assess the Safety, Tolerability, PK/PD and preliminary Efficacy of ICP-022 in Subjects with Systemic Lupus Erythematosus (SLE)
- Trial name
- NCT04305197
- Testing
- ICP-022
- Where
- 11 sites in China
- Volunteers
- 60 people
- Sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
Lupus Erythematosus
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ABT-199 in Female Patients With Systemic Lupus Erythematosus (SLE)
To assess the safety, tolerability and pharmacokinetics of ABT-199 in female subjects with Systemic Lupus Erythematosus.
- Trial name
- NCT01686555
- Testing
- ABT-199
- Where
- 15 sites in United States, Germany and 2 more
- Volunteers
- 97 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Systemic Lupus Erythematosus, Healthy
A Single Ascending Dose Study in Healthy Participants and Multiple Dose Study of JNJ-55920839 in Participants With Mild to Moderate Systemic Lupus Erythematosus
The purpose of this study is to assess the safety and tolerability of JNJ-55920839 following single ascending intravenous (IV) dose administration in healthy participants and a single subcutaneous dose in healthy participants and…
- Trial name
- NCT02609789
- Testing
- JNJ-55920839
- Where
- 16 sites in United States, Belgium and 5 more
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Lupus Nephritis
A Study to Evaluate Efficacy of CellCept (Mycophenolate Mofetil) in Patients With Lupus Nephritis
This study will compare the efficacy of CellCept [0.5-2 grams per day (g/day) orally (p.o.)] and cyclophosphamide [0.5-1 grams per square meter (g/m2) quarterly] as maintenance treatment for patients with lupus nephritis.
- Trial name
- NCT02081183
- Testing
- Mycophenolate mofetil (MMF), Cyclophosphamide, Maintenance Phase, Cyclophosphamide, Induction Phase
- Where
- 2 sites in Venezuela
- Volunteers
- 16 people
- Sponsor
- Hoffmann-La Roche
Healthy
Study of Belimumab Administered Subcutaneously to Healthy Subjects
The purpose of this study is to measure the amount of belimumab in the blood when given as an injection under the skin (subcutaneously; SC) and to evaluate the safety and tolerability of multiple injections under the skin in…
- Trial name
- NCT01583530
- Testing
- Single Dose Group: Belimumab IV 240 mg, Single Dose Group: Belimumab SC 2 x 120 mg, Single Dose Group: Belimumab SC 1 x 240 mg
- Where
- 4 sites in United States
- Volunteers
- 118 people, healthy volunteers welcome
- Sponsor
- Human Genome Sciences Inc.
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 FLY (NCT06617325)
- Testing
- DZP
- Where
- 242 sites in United States, Argentina and 21 more
- Volunteers
- 450 people
- Sponsor
- UCB Biopharma SRL
Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN)
A 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 (SLE), Lupus Nephritis (LN), Systemic Sclerosis (SSc), Inflammatory Myopathy
- Trial name
- NCT07104721
- Testing
- YTS109 cell
- Where
- China
- Volunteers
- 18 people
- Sponsor
- China Immunotech (Beijing) Biotechnology Co., Ltd.
Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Systemic
A Study of Skin and Systemic Biomarkers In Patients With Active Cutaneous Lupus Erythematosus And In Healthy Volunteers
The purpose of this study is to obtain skin, blood, and urine samples from patients with active cutaneous lupus lesions and from healthy participants.
- Conditions
- Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Systemic, Lupus Erythematosus, Discoid, Healthy
- Trial name
- NCT02034344
- Testing
- Skin biopsy, Blood collection, Urine collection
- Where
- 21 sites in United States, Germany and 4 more
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC