Clinical trials: Systemic Lupus Erythematosus
Adolescent Lupus Nephritis, Pediatric Lupus Nephritis
Long-Term Voclosporin Treatment in Adolescent and Pediatric Subjects With Lupus Nephritis
The purpose of this study is to assess the long-term safety and tolerability of voclosporin for up to an additional 12 months following completion of treatment in the AUR-VCS-2020-03 study (VOCAL) in adolescent and pediatric…
- Trial name
- VOCAL-EXT (NCT05962788)
- Testing
- voclosporin
- Where
- 6 sites in United States, Colombia and 3 more
- Volunteers
- 4 people
- Sponsor
- Aurinia Pharmaceuticals Inc.
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
NIS to Examine Disease Activity in SLE Patients Treated With Subcutaneous Anifrolumab in Routine Care
VIOLET is a prospective, single-arm, multi-centre, non-interventional study (NIS) evaluating real-world clinical and patient-reported outcome (PRO) data in adult patients who are initiated on subcutaneous anifrolumab treatment of…
- Trial name
- VIOLET (NCT07424261)
- Where
- 21 sites in Germany
- Volunteers
- 125 people
- Sponsor
- AstraZeneca
Lupus Erythematosus, Systemic
A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus
The purpose of this study is to evaluate the efficacy of ustekinumab as measured by a reduction in disease activity for subjects with active Active Systemic Lupus Erythematosus (SLE - chronic disorder of connective tissue in…
- Trial name
- NCT02349061
- Testing
- Ustekinumab IV, Ustekinumab SC, Concomitant Medication
- Where
- 43 sites in United States, Argentina and 7 more
- Volunteers
- 102 people
- Sponsor
- Janssen Research & Development, LLC
Lupus Nephritis
A Study to Evaluate the Safety and Efficacy of Obinutuzumab Compared With Placebo in Participants With Lupus Nephritis (LN)
This Phase II study will compare the efficacy and safety of obinutuzumab plus mycophenolate mofetil (MMF)/mycophenolic acid (MPA) with placebo plus MMF/MPA in participants with proliferative LN.
- Trial name
- NCT02550652
- Testing
- Mycophenolate Mofetil/Mycophenolic Acid, Obinutuzumab, Methylprednisolone
- Where
- 46 sites in United States, Argentina and 10 more
- Volunteers
- 126 people
- Sponsor
- Hoffmann-La Roche
Systemic Lupus Erythematosus
The Systemic Lupus Erythematosus (SLE) Activity Gene Expression (SAGE) Study
The goal of this study is to enable the study sponsor to develop a new blood test method for clinicians to accurately predict which individuals with lupus will flare, when the flare will occur, and flare severity.
- Trial name
- SAGE (NCT00671047)
- Testing
- non-interventional
- Where
- 12 sites in United States, Canada
- Volunteers
- 1,000 people
- Sponsor
- XDx
Systemic Lupus Erythematosus, Lupus Nephritis
A Phase 1 Study of SYNCAR-001 + STK-009 Without Conditioning Chemotherapy (Lymphodepletion) in Subjects With Severe, Refractory Systemic Autoimmune Rheumatic Disease
This is a phase 1 study of SYNCAR-001 + STK-009 in patients with severe, refractory systemic autoimmune rheumatic disease.
- Conditions
- Systemic Lupus Erythematosus, Lupus Nephritis, Systemic Sclerosis
- Trial name
- NCT06544330
- Testing
- SYNCAR-001, STK-009
- Where
- 6 sites in United States
- Volunteers
- 48 people
- Sponsor
- Synthekine
Systemic Sclerosis Cutaneous Lupus E Myopathies Systemic Lupus Erythematosus
Rollover Study for Participants Who Have Completed a Previous Clinical Study With Anifrolumab (Saphnelo) and Clinically Benefited From Continued Treatment
The purpose of this study is to provide continued access to anifrolumab to eligible participants who are continuing to derive clinical benefit from treatment at the end of a parent clinical study, as assessed by the Investigator…
- Trial name
- ROSY-S (NCT07691970)
- Testing
- Anifrolumab
- Where
- 153 sites in United States, Argentina and 33 more
- Volunteers
- 1,072 people
- Sponsor
- AstraZeneca
Systemic Lupus Erythematosus
A DOSE-RANGING STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-06700841 IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)
Assessment of PF-06700841 in participants with moderate to severe active, generalized Systemic Lupus Erythematosus (SLE) that have inadequate response to standard of care.
- Trial name
- NCT03845517
- Testing
- PF-06700841 15 mg, PF-06700841 30 mg, PF-06700841 45 mg
- Where
- 164 sites in United States, Argentina and 24 more
- Volunteers
- 350 people
- Sponsor
- Pfizer
Systemic Lupus Erythematosus
A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE)
The reason for this long term study is to see how safe and effective the study drug known as baricitinib is in participants with systemic lupus erythematosus (SLE) who have completed the final treatment visit of study I4V-MC-JAHZ…
- Trial name
- SLE-BRAVE-X (NCT03843125)
- Testing
- Baricitinib
- Where
- 297 sites in United States, Argentina and 30 more
- Volunteers
- 1,147 people
- Sponsor
- Eli Lilly and Company
Systemic Lupus Erythematosus
The Anifrolumab PRIM Program
Pregnancy and infant outcomes in anifrolumab exposed pregnancies using PRegnancy outcomes Intensive Monitoring (PRIM) data: The anifrolumab PRIM program
- Trial name
- PRIM (NCT06795893)
- Testing
- Anifrolumab
- Where
- Sweden
- Volunteers
- 240 people
- Sponsor
- AstraZeneca
Systemic Lupus Erythematosus
A Study to Evaluate Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus (BEGIN)
This is a Phase III, randomized, double blind, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy and safety of ocrelizumab compared to placebo when combined with a single stable background…
- Trial name
- BEGIN (NCT00539838)
- Testing
- Prednisone, Immunosuppressive regime (azathioprine, mycophenolate mofetil or methotrexate), Methylprednisolone
- Volunteers
- 33 people
- Sponsor
- Genentech, Inc.
Systemic Lupus Erythematosus, Active Refractory Rheumatoid Arthritis
A Phase 2 Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases
The main objective is to assess the safety and tolerability of inebilizumab in adult participants with active and refractory systemic lupus erythematosus (SLE) with nephritis (Subprotocol A) and to assess the safety and…
- Trial name
- NCT06570798
- Testing
- Inebilizumab, Blinatumomab
- Where
- 58 sites in United States, Australia and 8 more
- Volunteers
- 220 people
- Sponsor
- Amgen
Lupus Nephritis
A Study to Assess Effectiveness and Safety of Efgartigimod in Chinese Patients With Lupus Nephritis (ZL-1103-013)
The purpose of the study is to evaluate the efficacy and safety of efgartigimod IV in Chinese patients with active lupus nephritis (LN).
- Trial name
- NCT05810948
- Testing
- efgartigimod IV
- Where
- 31 sites in China
- Volunteers
- 73 people
- Sponsor
- argenx
Systemic Lupus Erythematosus, Arthritic Psoriasis
A Study to Evaluate BMS-986165 Tablet Formulation Relative to BMS-986165 Capsule Formulation and the Effect of a High-Fat/ High-Calorie Meal and Increased Gastric pH on the BMS-986165 Tablet Formulation
The purpose of this study is to evaluate BMS-986165 tablet formulation versus BMS-986165 capsule formulation. This study will also evaluate the effect of a high-fat/ high-calorie meal and increased gastric pH on the BMS-986165…
- Conditions
- Systemic Lupus Erythematosus, Arthritic Psoriasis, Psoriasis, Inflammatory Bowel Diseases
- Trial name
- NCT03254784
- Testing
- BMS-986165 Capsule, BMS-986165 Tablet
- Where
- United States
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Systemic Lupus Erythematosus
Web-based Genetic Research on Lupus
The goal of this new lupus research study is two-fold: first, to understand the genetic associations found between people's DNA and this disease, and second, to apply this understanding to drug development efforts with the…
- Trial name
- NCT02530944
- Where
- United States
- Volunteers
- 5,000 people
- Sponsor
- 23andMe, Inc.
Systemic Lupus Erythematosus
A IMMA Master Protocol: A Study of LY3361237 in Participants With at Least Moderately Active Systemic Lupus Erythematosus
The main purpose of this study is to assess the efficacy and safety of LY3361237 in participants with at least moderately active systemic lupus erythematosus (SLE). Study will last up to 34 weeks and may include up to 15 visits.
- Trial name
- NCT05123586
- Testing
- LY3361237
- Where
- 50 sites in United States, Argentina and 6 more
- Volunteers
- 85 people
- Sponsor
- Eli Lilly and Company
Lupus Nephritis
A Study to Evaluate the Safety and Efficacy of Tacrolimus for Lupus Nephritis Under Actual Use Situations
To evaluate the safety and efficacy of tacrolimus for lupus nephritis under actual-use.
- Trial name
- TRUST (NCT01410747)
- Testing
- Tacrolimus
- Where
- 8 sites in Japan
- Volunteers
- 1,484 people
- Sponsor
- Astellas Pharma Inc
Lupus Erythematosus, Discoid
A Pooled Analysis of the HGS1006-C1056 (BLISS-52) and HGS1006-C1057 (BLISS-76) Studies
Efficacy and Safety of Belimumab in a Subgroup of Systemic Lupus Erythematosus (SLE) Patients with Higher Disease Activity (anti-dsDNA positive and low complement): A Pooled Analysis of the HGS1006-C1056 (BLISS-52) and…
- Trial name
- NCT01858792
- Testing
- Belimumab 1 mg/kg, Belimumab 10 mg/kg
- Volunteers
- 1 people
- Sponsor
- Human Genome Sciences Inc., a GSK Company
Systemic Lupus Erythematosus (SLE)
A Clinical Study of Dual-Target, Universal CAR-T Cell Therapy for Refractory Systemic Lupus Erythematosus
This study is a single-arm, open-label clinical study designed to evaluate the safety and tolerability of QT-019B in subjects with refractory SLE and to determine the RD.
- Trial name
- NCT07444307
- Testing
- QT-019B Cell Injection
- Where
- 3 sites in China
- Volunteers
- 18 people
- Sponsor
- Hangzhou Qihan Biotech Co., Ltd.