Clinical trials: SLE (Systemic Lupus)
Systemic Lupus Erythematosus
The WILLOW Study With M5049 in SLE and CLE (SCLE and/or DLE) (WILLOW)
The purpose of this Proof of Concept (PoC) and Dose-finding (DF) basket study is to evaluate the efficacy and safety of orally administered Enpatoran over 24 weeks in systemic lupus erythematosus (SLE) and cutaneous lupus…
- Trial name
- NCT05162586
- Testing
- Enpatoran low dose, Enpatoran medium dose, Enpatoran high dose
- Where
- 153 sites in United States, Argentina and 20 more
- Volunteers
- 456 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Systemic Lupus Erythematosus, Arthritis
Biomarker-Linked Outcomes of Cellcept in Lupus Arthritis
We hypothesize that mycophenolate mofetil(Cellcept)is safe and effective for lupus arthritis. In this study, patients with lupus will be randomly assigned to receive mycophenolate mofetil or placebo (inert pills) for three…
- Trial name
- NCT00594932
- Testing
- mycophenolate mofetil
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Oklahoma Medical Research Foundation
Systemic Lupus Erythematosus
A Continuation Trial for Subjects With Lupus Who Completed Protocol HGS1006-C1056 in the United States
This is a continuation study to provide continuing treatment to subjects who completed study HGS1006-C1056 in the United States, to evaluate the long-term safety and efficacy of belimumab(LymphoStat-B™) in subjects with SLE…
- Trial name
- NCT00724867
- Testing
- Belimumab 1 mg/kg, Belimumab 10 mg/kg
- Where
- 51 sites in United States
- Volunteers
- 268 people
- Sponsor
- Human Genome Sciences Inc., a GSK Company
Systemic Lupus Erythematosus Arthritis
Abatacept for SLE Arthritis (IM101-330)
This research trial is for patients who have been diagnosed with systemic lupus erythematosus (SLE) with swollen, tender joints (which is called inflammatory polyarthritis) because of the SLE.
- Trial name
- NCT02429934
- Testing
- abatacept also known as Orencia also known as CTLA4-Ig
- Where
- 2 sites in United States
- Volunteers
- 28 people
- Sponsor
- University of California, Los Angeles
Systemic Lupus Erythematosus
A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus
The reason for this study is to see how effective and safe the study drug known as baricitinib is in participants with systemic lupus erythematosus (SLE).
- Trial name
- SLE-BRAVE I (NCT03616912)
- Testing
- Baricitinib
- Where
- 184 sites in United States, Australia and 16 more
- Volunteers
- 830 people
- Sponsor
- Eli Lilly and Company
Systemic Lupus Erythematosus
Study to Determine if Gardasil Vaccine is Safe and Effective in Lupus Patients
Cervical neoplasia is increased in women with SLE most likely due to cervical infection with human papilloma virus (HPV). 70% of cervical cancer is caused by HPV types 16 and 18.
- Trial name
- GARDASIL (NCT01741012)
- Testing
- Gardasil
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- Wayne State University
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
Lupus Nephritis, Systemic Lupus Erythematosus
A Study to Evaluate Ocrelizumab in Patients With Nephritis Due to Systemic Lupus Erythematosus (BELONG)
This is a Phase III, randomized, double-blind, placebo-controlled, multicentre, parallel-group study designed to evaluate the efficacy and safety of ocrelizumab added to SOC (corticosteroid plus one of two immunosuppressant…
- Trial name
- BELONG (NCT00626197)
- Testing
- Corticosteroids, Cyclophosphamide, Mycophenolate Mofetil
- Volunteers
- 381 people
- Sponsor
- Genentech, Inc.
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
Congenital Heart Block, Neonatal Lupus
Preventive Approach to Congenital Heart Block With Hydroxychloroquine
Women with antibodies to proteins called SSA/Ro and or SSB/La face a 2% chance of having a child with a life threatening heart condition regardless of whether they have very active lupus, are in remission, or have only vague…
- Conditions
- Congenital Heart Block, Neonatal Lupus, Autoantibody-Associated Heart Block
- Trial name
- PATCH (NCT01379573)
- Testing
- Hydroxychloroquine
- Where
- United States
- Volunteers
- 74 people
- Sponsor
- NYU Langone Health
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
Systemic Lupus Erythematosus (SLE)
Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE)
The purpose of this study is to determine if Rozibafusp Alfa could be a useful therapeutic agent in the current treatment landscape where subjects with SLE have ongoing disease activity despite treatment with standard of care…
- Trial name
- NCT04058028
- Testing
- Rozibafusp Alfa
- Where
- 147 sites in United States, Argentina and 17 more
- Volunteers
- 244 people
- Sponsor
- Amgen
Active Systemic Lupus Erythematosus
Efficacy and Safety of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus
The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment regimen of two doses of anifrolumab versus placebo in adult subjects with moderately to severely active, autoantibody-positive systemic…
- Trial name
- NCT02446912
- Testing
- Anifrolumab
- Where
- 145 sites in United States, Argentina and 16 more
- Volunteers
- 460 people
- Sponsor
- AstraZeneca
Systemic Lupus Erythematosus
Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus (SLE)
The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the treatment of subjects with Systemic Lupus Erythematosus (SLE).
- Trial name
- EMBODY2 (NCT01261793)
- Testing
- Epratuzumab
- Where
- 133 sites in United States, Brazil and 14 more
- Volunteers
- 791 people
- Sponsor
- UCB Pharma
Lupus Erythematosus, Systemic
A Phase II Study to Evaluate Safety and Efficacy of ALX-0061 in Subjects With Systemic Lupus Erythematosus
Primary objective: To assess the efficacy and safety of different dose regimens of ALX-0061 administered subcutaneously (s.c.) to subjects with moderate to severe active, seropositive systemic lupus erythematosus (SLE) compared…
- Trial name
- NCT02437890
- Testing
- ALX-0061
- Where
- 118 sites in United States, Argentina and 15 more
- Volunteers
- 312 people
- Sponsor
- Ablynx, a Sanofi company
Systemic Lupus Erythematosus
Efficacy and Safety of MK-6194 in Adult Participants With Systemic Lupus Erythematosus (MK-6194-006)
The purpose of this study is to evaluate the efficacy and safety of MK-6194 in adult participants with systemic lupus erythematosus.
- Trial name
- NCT06161116
- Testing
- MK-6194
- Where
- 127 sites in United States, Argentina and 15 more
- Volunteers
- 149 people
- Sponsor
- Merck Sharp & Dohme LLC
Lupus Erythematosus, Systemic
A Study of Tabalumab (LY2127399) Using Two Different Injection Methods in Participants With Lupus
The purpose of this study is to evaluate the amount of tabalumab in the blood after it is given by two different injection methods - A traditional syringe or a spring loaded syringe for 12 weeks.
- Trial name
- NCT02041091
- Testing
- Tabalumab Auto-Injector, Tabalumab Prefilled Syringe
- Where
- 44 sites in United States, Puerto Rico and 1 more
- Volunteers
- 226 people
- Sponsor
- Eli Lilly and Company
Systemic Lupus Erythematosus
Safety and Effectiveness of BENLYSTA (Belimumab) in Systemic Lupus Erythematosus (SLE) Registry
The purpose of this prospective, observational cohort study is to evaluate the incidence of adverse events of special interest (AESI) and effectiveness in participants with active, autoantibody-positive SLE treated with and…
- Trial name
- SABLE (NCT01729455)
- Testing
- Benlysta, Standard of Care (SoC) Therapy
- Where
- 179 sites in United States, Argentina and 11 more
- Volunteers
- 3,138 people
- Sponsor
- GlaxoSmithKline