Clinical trials: System; Lupus Erythematosus
Systemic Lupus Erythematosus
A Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus Erythematosus
To evaluate the efficacy and safety of sifalimumab compared to placebo in subjects with moderately to severely active Systemic Lupus Erythematosus (SLE).
- Trial name
- NCT01283139
- Testing
- Sifalimumab 200 mg, Sifalimumab 600 mg, Sifalimumab 1,200 mg
- Where
- 107 sites in United States, Argentina and 20 more
- Volunteers
- 834 people
- Sponsor
- MedImmune LLC
Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus
A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus
In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with cutaneous lupus erythematosus (CLE).
- Trial name
- AMETHYST (NCT05531565)
- Testing
- Litifilimab
- Where
- 315 sites in United States, Argentina and 28 more
- Volunteers
- 450 people
- Sponsor
- Biogen
Systemic Lupus Erythematosus
A Study of Belimumab in Subjects With Systemic Lupus Erythematosus
The purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on quality of life of two different doses of belimumab administered in addition to standard therapy in subjects with active…
- Trial name
- BLISS-76 (NCT00410384)
- Testing
- Belimumab 1 mg/kg, Belimumab 10 mg/kg
- Where
- 146 sites in United States, Austria and 17 more
- Volunteers
- 819 people
- Sponsor
- Human Genome Sciences Inc.
Autoimmune Diseases, Rheumatoid Arthritis (RA)
Study of S-4321 in Participants With an Autoimmune or Immune-mediated Disease
This is a multi-center, open-label Ph 1b basket study to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, biomarker response, and preliminary efficacy of multiple doses of S-4321 in…
- Conditions
- Autoimmune Diseases, Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Psoriasis (PsO)
- Trial name
- NCT07455578
- Testing
- S-4321
- Where
- 2 sites in Australia
- Volunteers
- 24 people
- Sponsor
- Seismic Therapeutic AU Pty Ltd
Healthy, Systemic Lupus Erythematosus
A Study of LY4298445 in Healthy Participants and Participants With Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis (RA)
The purpose of this study is to investigate the safety and tolerability of LY4298445 in healthy participants and in participants with systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA).
- Conditions
- Healthy, Systemic Lupus Erythematosus, Rheumatoid Arthritis
- Trial name
- NCT07276958
- Testing
- LY4298445
- Where
- 10 sites in Australia, China and 1 more
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Keratoconjunctivitis Sicca, Sjogren's Syndrome
Six Month Clinical Research Study for Patients With Moderate or Severe Dry Eye Syndrome
A six-month clinical research trial to evaluate the effectiveness of an investigational medication for the treatment of dry eye syndrome in patients that have been diagnosed with moderate to severe dry eye syndrome, an autoimmune…
- Conditions
- Keratoconjunctivitis Sicca, Sjogren's Syndrome, Lupus Erythematosus, Systemic, Arthritis, Rheumatoid
- Trial name
- NCT00025818
- Testing
- Ophthalmic Emulsion
- Where
- 17 sites in United States
- Volunteers
- 290 people
- Sponsor
- Allergan
Lupus Nephritis, Lupus Erythematosus, Systemic
Establishing Clinical Utility of a New Diagnostic Test for Rheumatology Patients
This study will collect high-quality randomized controlled data from a nationally representative sample of practicing rheumatologists to determine how they currently manage patients with SLE (systemic lupus erythematosus) and how…
- Trial name
- NCT04266860
- Testing
- Experimental - Test Results and Education
- Where
- United States
- Volunteers
- 166 people, healthy volunteers welcome
- Sponsor
- Qure Healthcare, LLC
Systemic Lupus Erythematosus
Open Label Extension Study of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE) Subjects
The study is an open-labeled extension study to continue to assess the safety and tolerability of Epratuzumab in moderate to severe SLE subjects who have previously participated in SL0026 [NCT01449071] phase I/II trial.
- Trial name
- NCT01534403
- Testing
- Epratuzumab
- Where
- 6 sites in Japan
- Volunteers
- 17 people
- Sponsor
- UCB Pharma
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
Systemic Lupus Erythematosus
Compassionate Use for Subcutaneous (SC) Belimumab
GlaxoSmithKline (GSK) have submitted a Biologic License Application (BLA) for the subcutaneous formulation of belimumab which is currently under review by the Food and Drug Administration (FDA).
- Trial name
- NCT03125486
- Testing
- SC belimumab 200 mg
- Where
- United States
- Sponsor
- GlaxoSmithKline
Systemic Lupus Erythematosus (SLE)
A Study in Participants With Active Systemic Lupus Erythematosus With Inadequate Response to Glucocorticoids and ≥2 Immunosuppressants
The purpose of this study is to characterize the efficacy and safety of current standard of care treatment options in participants with active systemic lupus erythematosus (SLE; including lupus nephritis) with inadequate response…
- Trial name
- BENCHMARK-SLE (NCT07175285)
- Testing
- Current standard of care treatment options
- Where
- 70 sites in United States, Argentina and 11 more
- Volunteers
- 223 people
- Sponsor
- Bristol-Myers Squibb
Systemic Lupus Erythematosus (SLE), Alopecia Areata (AA)
A Phase 1 Trial to Evaluate the Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of VIS171 in Participants With Autoimmune Disease(s)
The purpose of this trial is to measure safety and tolerability of subcutaneous (SC) VIS171 in combination with standard of care in participants with autoimmune disease(s).
- Conditions
- Systemic Lupus Erythematosus (SLE), Alopecia Areata (AA), Immune-mediated Focal Segmental Glomerulosclerosis (FSGS)
- Trial name
- NCT06799520
- Testing
- VIS171
- Where
- 6 sites in Bulgaria, Moldova and 2 more
- Volunteers
- 30 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, 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
Healthy Subjects (HS), SLE (Systemic Lupus)
First-in-Human Study of ISH0613: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics
The goal of this clinical trial is to learn about a study drug called ISH0613 and how it behaves in healthy adults. This study will also evaluate the safety and tolerability of ISH0613 after a single intravenous (IV) dose.
- Trial name
- NCT07516639
- Testing
- ISH0613 for injection
- Where
- China
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- SUNHO（China）BioPharmaceutical CO., Ltd.
Systemic Lupus Erythematosus
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Efavaleukin Alfa in Participants With Systemic Lupus Erythematosus
To evaluate the safety and tolerability of subcutaneous (SC) dose administrations of Efavaleukin Alfa in participants with systemic lupus erythematosus (SLE).
- Trial name
- NCT03451422
- Testing
- Efavaleukin Alfa
- Where
- 15 sites in United States, France and 2 more
- Volunteers
- 35 people
- Sponsor
- Amgen
Systemic Lupus Erythematosus (SLE)
Omega-3 Replacement With Krill Oil in Disease Management of SLE
A randomized, double-blind controlled, multicenter study in SLE patients given AKBM-3031or placebo for 24 weeks (randomized period) and followed by an open label extension (OLE) treatment with AKBM-3031 for the next 24 weeks.
- Trial name
- ORKIDS (NCT03626311)
- Testing
- AKBM-3031
- Where
- 19 sites in United States, Canada
- Volunteers
- 76 people
- Sponsor
- Aker BioMarine Human Ingredients AS
Lupus Nephritis
Obe-cel in Severe, Refractory Systemic Lupus Erythematosus (SLE) With Active Lupus Nephritis (LN)
The purpose of this trial is to evaluate the efficacy and safety of obecabtagene autoleucel (obe-cel) administered once following lymphodepletion in participants with severe, refractory systemic lupus erythematosus (SLE) and…
- Trial name
- LUMINA (NCT07053800)
- Testing
- Obecabtagene autoleucel
- Where
- 16 sites in United States, Brazil and 3 more
- Volunteers
- 35 people
- Sponsor
- Autolus Limited
Lupus Nephritis, Systemic Lupus Erythematosus
A Study of KZR-616 in Patients With SLE With and Without Lupus Nephritis
This was a Phase 1b/2, multi-center study in which patients received KZR-616, administered as a subcutaneous (SC) injection weekly for 13 weeks (Phase 1b) or 24 weeks (Phase 2).
- Trial name
- MISSION (NCT03393013)
- Testing
- KZR-616
- Where
- 36 sites in United States, Australia and 6 more
- Volunteers
- 69 people
- Sponsor
- Kezar Life Sciences, Inc.
Systemic Lupus Erythematosus
Study of TRU-015 in Subjects With Membranous Nephropathy Secondary to Systemic Lupus Erythematosus
The purpose of this study is to determine how the body absorbs and chemically changes a single infusion of TRU-015 in subjects with kidney disease caused by lupus.
- Trial name
- NCT00479622
- Testing
- TRU-015
- Where
- 6 sites in United States
- Volunteers
- 20 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Lupus Nephritis
Aurinia Renal Response in Active Lupus With Voclosporin
The purpose of this study is to assess the efficacy of voclosporin compared with placebo in achieving renal response after 52 weeks of therapy in subjects with active lupus nephritis.
- Trial name
- AURORA (NCT03021499)
- Testing
- Voclosporin
- Where
- 185 sites in United States, Argentina and 29 more
- Volunteers
- 358 people
- Sponsor
- Aurinia Pharmaceuticals Inc.