Clinical trials: SLE - Systemic Lupus Erythematosus
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
A Pilot Study of CC-220 to Treat Systemic Lupus Erythematosus.
The purpose of this study is to determine whether CC-220 is effective for the treatment of skin, joint and serological manifestations of systemic lupus erythematosus.
- Trial name
- NCT02185040
- Testing
- CC-220
- Where
- 35 sites in United States
- Volunteers
- 42 people
- Sponsor
- Celgene
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
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
Systemic Lupus Erythematosus, Lupus Nephritis
UB-VV410 in Subjects With Active Refractory Systemic Lupus Erythematosus or Lupus Nephritis
This is an open-label investigator-initiated trial (IIT) to assess the safety, efficacy, and PK（pharmacokinetic）/PD（pharmacodynamics ） of UB-VV410 in adult subjects with clinically active treatment-refractory SLE.
- Trial name
- NCT07109986
- Testing
- UB-VV410
- Where
- China
- Volunteers
- 21 people
- Sponsor
- Nanjing IASO Biotechnology Co., Ltd.
Systemic Lupus Erythematosus
Efficacy and Safety of Belimumab in Black Race Patients With Systemic Lupus Erythematosus (SLE)
The purpose of this study is to evaluate the efficacy, safety, and tolerability of belimumab in adult patients of black race with systemic lupus erythematosus (SLE; lupus).
- Trial name
- EMBRACE (NCT01632241)
- Testing
- Belimumab 10 mg/kg plus standard therapy, Standard therapy
- Where
- 96 sites in United States, Brazil and 4 more
- Volunteers
- 503 people
- Sponsor
- Human Genome Sciences Inc., a GSK Company
SLE - Systemic Lupus Erythematosus
IASO-782 in Systemic Lupus Erythematosus
his study is a randomized, double-blinded, and placebo-controlled phase Ia clinical study in subjects with SLE. The study is designed to assess the safety and tolerability of IASO-782 for the treatment of SLE.
- Trial name
- NCT07483346
- Testing
- IASO-782 injection
- Where
- 4 sites in China
- Volunteers
- 20 people
- Sponsor
- Shanghai IASO Biotechnology Co., Ltd
Systemic Lupus Erythematosus
An Adaptive Phase II Study to Evaluate the Efficacy, Pharmacodynamics, Safety and Tolerability of GSK2586184
This is an adaptive, dose ranging, Phase II study to investigate the relationship between repeat doses of GSK2586184 and the pharmacodynamic effect and clinical efficacy in patients with active systemic lupus erythematosus (SLE).
- Trial name
- NCT01777256
- Testing
- GSK2586184 50 mg, GSK2586184 100 mg, GSK2586184 200 mg
- Where
- 53 sites in Argentina, Chile and 14 more
- Volunteers
- 51 people
- Sponsor
- GlaxoSmithKline
Systemic Lupus Erythematosus
A Study of Obexelimab in Patients With Systemic Lupus Erythematosus
This study aims to examine the efficacy and safety of obexelimab in participants with systemic lupus erythematosus (SLE).
- Trial name
- SunStone (NCT06559163)
- Testing
- Obexelimab
- Where
- 110 sites in United States, Belgium and 16 more
- Volunteers
- 190 people
- Sponsor
- Zenas BioPharma (USA), LLC
SLE (Systemic Lupus), Sjogren's Syndrome
Safety and Efficacy of CD19 Targeted CAR-T Therapy for Refractory Autoimmune Disease
This is a single arm study to evaluate the efficacy and safety of CD19 targeted CAR-T cells therapy for patients with Refractory Autoimmune Disease
- Conditions
- SLE (Systemic Lupus), Sjogren's Syndrome, Systemic Scleroderma, Dermatomyositis
- Trial name
- NCT06056921
- Testing
- CD19 targeted CAR-T cells
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Chongqing Precision Biotech Co., Ltd
Systemic Lupus Erythematosus
Anifrolumab PK Study for Systemic Lupus Erythematosus (SLE)
To assess the pharmacokinetic parameters of anifrolumab in Chinese participants with active systemic lupus erythematosus(SLE).
- Trial name
- NCT05001698
- Testing
- Anifrolumab
- Where
- 3 sites in China
- Volunteers
- 15 people
- Sponsor
- AstraZeneca
Systemic Lupus Erythematosus
PRV-3279-2a Trial in Systemic Lupus
The PREVAIL-2 study was designed to assess the safety and potential efficacy of PRV-3279 in flare prevention in systemic lupus erythematosus (SLE) participants with active disease after amelioration induced by corticosteroid…
- Trial name
- PREVAIL-2 (NCT05087628)
- Testing
- PRV-3279
- Where
- 36 sites in United States, China and 2 more
- Volunteers
- 28 people
- Sponsor
- Provention Bio, a Sanofi Company
Systemic Lupus Erythematosus
Retrospective Medical Chart Review Study to Describe the Experience of SLE Patients Treated With Anifrolumab in the Early Access Programs.
The ERYTHRO study is a retrospective medical chart review study of patients in the AMANA and ATUc Early Access Programs (EAPs) across a number of countries, to assess anifrolumab usage and patient experience in treating SLE in a…
- Trial name
- ERYTHRO (NCT06046534)
- Testing
- None (Observational study)
- Where
- 15 sites in France, Greece and 5 more
- Volunteers
- 46 people
- Sponsor
- AstraZeneca
Systemic Lupus Erythematosus, Rheumatoid Arthritis
A Phase I Study of ICP-022 in Healthy Subjects
This is a single center, randomized, double-blind, placebo-controlled, dose escalation study in healthy subjects to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ICP-022 following oral single and…
- Trial name
- NCT03189017
- Testing
- ICP-022
- Where
- Australia
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Innocare Pharma Australia Pty Ltd
Systemic Lupus Erythematosus
A Two-part Study to Investigate the Interaction and Pharmacokinetics of GSK2586184
This study is a Phase I, two-part, open-label study designed to evaluate the effect of repeated doses of GSK2586184 on the pharmacokinetics (PK) of Simvastatin and Rosuvastatin in healthy volunteers (Cohort A), and to evaluate…
- Trial name
- NCT01953835
- Testing
- GSK2586184 standard formulation, Simvastatin, Rosuvastatin
- Where
- United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Lupus Erythematosus, Systemic, Lupus Erythematosus
A Crossover Study to Compare RAYOS to IR Prednisone to Improve Fatigue and Morning Symptoms for SLE
To compare the effect of RAYOS® versus immediate-release (IR) prednisone on fatigue as measured by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F).
- Conditions
- Lupus Erythematosus, Systemic, Lupus Erythematosus, Fatigue
- Trial name
- RIFLE (NCT03098823)
- Testing
- RAYOS, Prednisone
- Where
- 21 sites in United States
- Volunteers
- 62 people
- Sponsor
- Ampel BioSolutions, LLC
Systemic Lupus Erythematosus (SLE)
A Study to Evaluate the Safety, Tolerability, and PK Profile of Single and Multiple Doses TJ202 in Patient With Systemic Lupus Erythematosus
A Multicenter, Randomized, Double-blind, Placebo-Controlled, Phase 1 Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of Single and Multiple Doses of TJ202 in Patients with Systemic Lupus…
- Trial name
- NCT05140824
- Testing
- TJ202 injection
- Where
- 2 sites in China
- Volunteers
- 1 people
- Sponsor
- TJ Biopharma Co., Ltd.
Systemic Lupus Erythematosus
Belimumab Treatment Holiday and Treatment Re-start Study in Lupus Patients
This study will assess the effect of a 24-week withdrawal followed by a 28-week reintroduction of belimumab 10 mg/kg plus standard of care medications in subjects with stable low systemic lupus erythematosus (SLE) disease…
- Trial name
- NCT02119156
- Testing
- Belimumab
- Where
- 20 sites in United States, China and 2 more
- Volunteers
- 80 people
- Sponsor
- GlaxoSmithKline
Lupus Erythematosus, Systemic, Lupus Nephritis
A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)
The purpose of this study is to evaluate the efficacy, safety and drug levels of CC-97540 in participants with active systemic lupus erythematosus (SLE) including lupus nephritis with inadequate response to glucocorticoids and at…
- Trial name
- NCT07015983
- Testing
- CC-97540, Fludarabine, Cyclophosphamide
- Where
- 97 sites in United States, Argentina and 14 more
- Volunteers
- 89 people
- Sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Systemic Lupus Erythematosus
Anifrolumab Early Access Program
To provide early access (ie, before marketing authorisation) to anifrolumab 300 mg IV Q4W while receiving standard therapy in adult patients with moderate-to-severe active SLE
- Trial name
- AMANA (NCT04750057)
- Testing
- Anifrolumab
- Sponsor
- AstraZeneca