Clinical trials: Systemic Lupus, Skin Lupus
Systemic Lupus Erythematosus
Multiple Ascending Dose Study To Assess The Safety Profile Of SAR113244 Versus Placebo In Lupus Male And Female Patients
Primary Objective: To assess the tolerability and safety of SAR113244 in male and female lupus patients after every 4 (Q4) weeks repeated ascending subcutaneous doses of SAR113244.
- Trial name
- NCT02321709
- Testing
- SAR113244
- Where
- Germany
- Volunteers
- 21 people
- Sponsor
- Sanofi
Systemic Lupus Erythematosus
Safety and Tolerability of Intravenous Dose of MEDI-546 in Japanese Subjects With Systemic Lupus Erythematosus.
The purpose of this study is to assess safety, tolerability, pharmacokinetics and pharmacodynamics of MEDI-546 in Japanese SLE patients.
- Trial name
- NCT01559090
- Testing
- MEDI-546
- Where
- 6 sites in Japan
- Volunteers
- 17 people
- Sponsor
- AstraZeneca
Lupus Nephritis
A Study of ANX009 in Adult Participants With Lupus Nephritis
The main purpose of this study is to determine the safety and tolerability of repeat doses of ANX009 in participants with lupus nephritis (LN).
- Trial name
- NCT05780515
- Testing
- ANX009
- Where
- 7 sites in Philippines, Taiwan
- Volunteers
- 7 people
- Sponsor
- Annexon, Inc.
Systemic Lupus Erythematosus, Connective Tissue Disease
A Study of LY2127399 in Participants With Systemic Lupus Erythematosus
The purpose of this SLE study is to evaluate the efficacy, safety and tolerability of two different doses of LY2127399 administered in participants with active SLE.
- Conditions
- Systemic Lupus Erythematosus, Connective Tissue Disease, Autoimmune Disease
- Trial name
- NCT01196091
- Testing
- LY2127399, Standard of Care
- Where
- 192 sites in United States, Argentina and 21 more
- Volunteers
- 1,164 people
- Sponsor
- Eli Lilly and Company
Lupus Nephritis
A Prospective Observational Registry of Patients Treated With LUPKYNIS® (Voclosporin) in the US
This registry is an observational study designed to assess the utilization and effectiveness of LUPKYNIS in adult patients with lupus nephritis (LN) in the United States (US).
- Trial name
- ENLIGHT-LN (NCT05337124)
- Testing
- LUPKYNIS
- Where
- United States
- Volunteers
- 229 people
- Sponsor
- Aurinia Pharmaceuticals Inc.
Systemic Lupus Erythematosus, Rheumatoid Arthritis
A Study to Learn About a Medicine Called PF-08154225 in Participants With Autoimmune Diseases
The purpose of this study is to learn about the safety and effects of the study medication called PF-08154225 for the potential treatment of autoimmune diseases.
- Conditions
- Systemic Lupus Erythematosus, Rheumatoid Arthritis, Idiopathic Inflammatory Myositis, Systemic Sclerosis
- Trial name
- NCT07782450
- Testing
- PF-08154225
- Volunteers
- 54 people
- Sponsor
- Pfizer
Systemic Lupus Erythematosus
A Phase II Study of M2951 in SLE
M2951 is an investigational drug under evaluation for treatment of autoimmune and inflammatory disorders. The purpose of the study was to assess the Safety and Efficacy of M2951 in participants with Systemic Lupus Erythematosus…
- Trial name
- NCT02975336
- Testing
- M2951
- Where
- 157 sites in United States, Argentina and 17 more
- Volunteers
- 469 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Sjogren Disease, Systemic Lupus Erythematosus
Pharmacokinetics Study of Ianalumab in Chinese Participants With Autoimmune Diseases
The purpose of this pharmacokinetic (PK) study is to describe the PK profile of ianalumab following s.c. administration in Chinese participants with systemic lupus erythematosus (SLE) and/or Sjögren's disease (SjD).
- Trial name
- NCT06411639
- Testing
- ianalumab
- Sponsor
- Novartis Pharmaceuticals
Systemic Lupus Erythematosus
Open-label Study of Belimumab Plus Standard Therapy in Chinese Pediatric Participants With Active Systemic Lupus Erythematosus (SLE)
This study will be conducted to evaluate the safety, efficacy and pharmacokinetics of belimumab administered in combination with background standard therapy in pediatric participants with active SLE.
- Trial name
- NCT04908865
- Testing
- Belimumab, Standard therapy
- Where
- 9 sites in China
- Volunteers
- 67 people
- Sponsor
- GlaxoSmithKline
Lupus Erythematosus, Systemic
A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus
This is a Phase II/III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of rituximab compared with placebo when combined with a single stable background immunosuppressive…
- Trial name
- EXPLORER (NCT00137969)
- Testing
- Rituximab, Prednisone, Acetaminophen
- Where
- 65 sites in United States, Canada
- Volunteers
- 262 people
- Sponsor
- Genentech, Inc.
Systemic Lupus Erythematosus, Lupus Nephritis
A Study of IMPT-514 in Active Refractory Lupus Nephritis (LN) and Systemic Lupus Erythematosus (SLE)
This is a Phase 1/2, multi-center, open-label study evaluating the safety and efficacy of IMPT-514, a bispecific chimeric antigen receptor (CAR) targeting cluster of differentiation (CD)19 and CD20 in participants with active…
- Trial name
- NCT06153095
- Testing
- IMPT-514
- Where
- 4 sites in United States, Australia
- Sponsor
- Lyell Immunopharma, Inc.
System; Lupus Erythematosus, Lupus Erythematosus
Translation of a Diagnostic Test for Lupus Flare Prediction From Bench to Clinic
This study is investigating the development of a diagnostic test intended to predict flares in patients with Systemic Lupus Erythematosus.
- Conditions
- System; Lupus Erythematosus, Lupus Erythematosus, SLE, Lupus Flare
- Trial name
- TOTAL FEEDBACK (NCT04018222)
- Where
- 3 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Progentec Diagnostics, Inc.
REFRACTORY SYSTEMIC LUPUS ERYTHEMATOSUS, Lupus Nephritis
SELECT-SLE: Biomarker-Guided CAR-T Target Selection for Refractory Lupus
study evaluates a biomarker-guided strategy to assign adults with refractory SLE to autologous CAR-T therapy targeting either CD19 or BCMA.
- Trial name
- SELECT-SLE (NCT07523542)
- Testing
- Autologous anti-CD19 CAR-T cells, intravenous single infusion at protocol-defined dose level (1 x 10^6 or 3 x 10^6 CAR-positive viable T cells/kg)., Fludarabine, Cyclophosphamide
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Beijing Biotech
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