Clinical trials: Systemic Lupus, Skin Lupus
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, SLE
Phase 1b/2a in SLE With Budoputug
The purpose of the study is to determine the safety, tolerability, and pharmacokinetics of budoprutug in participants with SLE
- Conditions
- Systemic Lupus Erythematosus, SLE, B Cells
- Trial name
- NCT06570434
- Testing
- budoprutug
- Sponsor
- Tenet Medicines
Lupus Nephritis
Phase I Study in China - Tolerability of a Single Dose of Abatacept 30 mg/kg
The purpose of this study is to determine whether abatacept at a dose 30 mg/kg via intravenous infusion is safe and well tolerated in the treatment of lupus nephritis in mainland Chinese subjects with systemic lupus erythematosus…
- Trial name
- NCT00705367
- Testing
- Abatacept
- Where
- China
- Volunteers
- 13 people
- Sponsor
- Bristol-Myers Squibb
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.
Lupus Erythematosus, Systemic
A Research Study to Evaluate the Efficacy and Safety of Cenerimod in Subjects Suffering From Systemic Lupus Erythematosus
The goal of this clinical trial is to see how well cenerimod reduces symptoms of Systemic Lupus Erythematous in adult patients with moderate to severe symptoms.
- Trial name
- OPUS-2 (NCT05672576)
- Testing
- Cenerimod
- Where
- 147 sites in United States, Chile and 16 more
- Volunteers
- 451 people
- Sponsor
- Viatris Innovation GmbH
Lupus Erythematosus, Systemic
TAB08 in Patients With Systemic Lupus Erythematosus (SLE), Not Adequately Controlled With Current Treatment
The purpose of this study is to assess whether TAB08 may be beneficial compared to placebo in patients with active Systemic Lupus Erythematosus, not adequately controlled with current concomitant treatment.
- Trial name
- NCT02711813
- Testing
- TAB08
- Where
- Russia
- Volunteers
- 60 people
- Sponsor
- Theramab LLC
Systematic Lupus Erythematosus, Cutaneous Lupus Erythematosus
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)
The purpose of this global, multicenter, Phase 3 study is to evaluate the efficacy and safety of enpatoran over 24 weeks in participants with active cutaneous manifestations of lupus erythematosus with or without systemic…
- Trial name
- NCT07355218
- Testing
- Enpatoran, Standard of care (SoC)
- Where
- 57 sites in United States, Australia and 15 more
- Volunteers
- 202 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Active Systemic Lupus Erythematosus
Long Term Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus
The purpose of this study is to characterise long-term safety and tolerability of intravenous anifrolumab.
- Trial name
- TULIP SLE LTE (NCT02794285)
- Testing
- Anifrolumab
- Where
- 175 sites in United States, Argentina and 22 more
- Volunteers
- 559 people
- Sponsor
- AstraZeneca
Systemic Lupus Erythematosus, SLE
An Ascending Dose Study of PIT565 in Participants With Systemic Lupus Erythematosus (SLE).
The purpose of the study is to determine the safety, tolerability, and pharmacokinetics of PIT565 in participants with SLE
- Trial name
- NCT06335979
- Testing
- PIT565
- Where
- 11 sites in China, Germany and 4 more
- Volunteers
- 54 people
- Sponsor
- Novartis Pharmaceuticals
Systemic Lupus Erythematosus
The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)
The purpose of the study is to evaluate the long term safety and efficacy of orally administered M5049 in participants with subacute cutaneous lupus erythematosus (SCLE), discoid lupus erythematosus (DLE) and/or systemic lupus…
- Trial name
- NCT05540327
- Testing
- M5049 low dose, M5049 medium dose, M5049 high dose
- Where
- 122 sites in United States, Argentina and 20 more
- Volunteers
- 381 people
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
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.
Lupus Erythematosus, Systemic, Lupus Erythematosus
Mobile Study to Measure and Predict Lupus Disease Activity Using Digital Signals
OASIS: A mobile study to measure and predict lupus (SLE) disease activity using digital signals The OASIS study is exploring how patient reported data and digital biomarkers, like activity level and heart rate variability, can be…
- Trial name
- OASIS (NCT04449653)
- Where
- United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Progentec Diagnostics, Inc.
Lupus Nephritis
A Study to Compare the Efficacy and Safety of Tacrolimus Capsules and Cyclophosphamide Injection in Treatment of Lupus Nephritis
The objective of this study is to evaluate the efficacy and safety of Tacrolimus capsules for induction remission in patients with lupus nephritis, and compare the efficacy and safety with Cyclophosphamide injections.
- Trial name
- NCT02457221
- Testing
- Tacrolimus capsules, Cyclophosphamide injections, Prednisone
- Where
- 35 sites in China
- Volunteers
- 314 people
- Sponsor
- Astellas Pharma China, Inc.
ANCA-Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM)
FT839 in Autoimmune Diseases
The primary objectives of this trial are to evaluate the safety and tolerability and to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose of FT839 with or without rituximab and/or background therapy and/or…
- Conditions
- ANCA-Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM), Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE)
- Trial name
- NCT07800871
- Testing
- FT839
- Where
- United States
- Volunteers
- 446 people
- Sponsor
- Fate Therapeutics
Lupus Nephritis
Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin
The purpose of this study is assess the long-term safety and tolerability of voclosporin compared with placebo for up to an additional 24 months following completion of treatment in the AURORA 1 study in subjects with lupus…
- Trial name
- AURORA 2 (NCT03597464)
- Testing
- Voclosporin
- Where
- United States
- Volunteers
- 216 people
- Sponsor
- Aurinia Pharmaceuticals Inc.
Systemic Lupus Erythematosus
Exploratory Study of Changes in Disease Activity and Biomarkers With ABR-215757 in Patients With Mild Active Systemic Lupus Erythematosus (SLE)
This is an exploratory open label single arm study to evaluate changes in disease activity and biomarkers in patients with mild active SLE, during treatment with ABR-215757 given as add-on to standard therapy.
- Trial name
- NCT00997100
- Testing
- paquinimod (ABR-215757)
- Where
- 4 sites in Denmark, Sweden
- Volunteers
- 13 people
- Sponsor
- Active Biotech AB
Lupus Nephritis, Lupus Erythematosus
Treatment of Lupus Nephritis With Allogeneic Mesenchymal Stem Cells
The purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells (MSCs) obtained from bone marrow for the treatment of adults with active proliferative lupus nephritis.
- Trial name
- MSV_LE (NCT03673748)
- Testing
- Mesenchymal stem cells (MSC)
- Where
- Spain
- Volunteers
- 20 people
- Sponsor
- Red de Terapia Celular
Systemic Lupus Erythematosus
A Study of CM313 Injection in Subjects With Systemic Lupus Erythematosus
A study of CM313 in subjects with systemic lupus erythematosus
- Trial name
- NCT05465707
- Testing
- CM313 2 mg/kg, CM313 4 mg/kg, CM313 8 mg/kg
- Volunteers
- 40 people
- Sponsor
- Keymed Biosciences Co.Ltd
Systemic Lupus Erythematosus
Study of Subcutaneous (SC) Belimumab in Pediatric Participants With Systemic Lupus Erythematosus (SLE)
The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and pharmacodynamics (PD) of repeat doses of 200 milligrams per milliliter (mg/mL) belimumab administered via SC injection in pediatric participants 5 to…
- Trial name
- NCT04179032
- Testing
- Belimumab
- Where
- 11 sites in United States, Argentina and 5 more
- Volunteers
- 25 people
- Sponsor
- GlaxoSmithKline
Lupus Erythematosus, Systemic
A Study of Ustekinumab in Chinese Participants With Active Systemic Lupus Erythematosus
The purpose of this study is to evaluate the efficacy of ustekinumab in Chinese participants with active systemic lupus erythematosus (SLE) who have not adequately responded to one or more standard-of-care treatments.
- Trial name
- NCT04060888
- Testing
- Ustekinumab (approximately 6 mg/kg), Ustekinumab 90 milligram (mg)
- Sponsor
- Janssen Research & Development, LLC