Clinical trials: Systemic Lupus
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
A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus
The purpose of this study is to evaluate the efficacy and safety of MEDI-546 compared to placebo in subjects with chronic, moderately-to-severely active systemic lupus erythematosus (SLE) with an inadequate response to standard…
- Trial name
- NCT01438489
- Testing
- Anifrolumab 300 mg, Anifrolumab 1000 mg
- Where
- 79 sites in United States, Brazil and 12 more
- Volunteers
- 626 people
- Sponsor
- MedImmune LLC
Lupus Nephritis
Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis
The purpose of this study is to evaluate (Abatacept) for treatment of lupus nephritis when used on a background of Cellcept (mycophenolate) and prednisone (corticosteroids)
- Trial name
- NCT01714817
- Testing
- BMS-188667, Mycophenolate mofetil, Prednisone
- Where
- 149 sites in United States, Argentina and 21 more
- Volunteers
- 695 people
- Sponsor
- Bristol-Myers Squibb
Systemic Lupus Erythematosus
A Study to Characterize the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab in Adult Type I Interferon Test High Systemic Lupus Erythematosus Subject With Active Skin Manifestations
This study will be conducted to characterize pharmacokinetics, pharmacodynamics, safety, and tolerability of anifrolumab given via the subcutaneous (SC) route of administration in adult Systemic Lupus Erythematosus (SLE) subjects…
- Trial name
- NCT02962960
- Testing
- Anifrolumab
- Where
- 14 sites in United States, Hungary and 2 more
- Volunteers
- 36 people
- Sponsor
- AstraZeneca
Systemic Lupus Erythematosus
GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast Asia
The purpose of this study is to evaluate the efficacy and safety of belimumab in addition to standard therapy compared to placebo in subjects in Northeast Asia with systemic lupus erythematosus (SLE) over a 52 week period.
- Trial name
- NCT01345253
- Testing
- Belimumab
- Where
- 47 sites in China, Japan and 1 more
- Volunteers
- 709 people
- Sponsor
- GlaxoSmithKline
Lupus Erythematosus, Systemic
Subcutaneous Treatment In Randomized Subjects To Evaluate Safety And Efficacy In Generalized Lupus Erythematosus
The objective of this study is to evaluate and compare efficacy of 3 dose levels of PF-04236921 to placebo in subjects with generalized lupus using a measure called the Systemic Lupus Erythematosus (SLE) Responder Index.
- Trial name
- BUTTERFLY (NCT01405196)
- Testing
- PF-04236921
- Where
- 113 sites in United States, Argentina and 11 more
- Volunteers
- 183 people
- Sponsor
- Pfizer
Systemic Lupus Erythematosus
BEL114333, a Continuation Study of BEL113750 in Subjects With Systemic Lupus Erythematosus (SLE) in Northeast Asia, and in Japan Subjects Completing the Open-label Extension of HGS1006-C1115
This study provides subjects who complete the BEL113750 study and subjects who complete the open-label extension of HGS1006-C1115 (referred to as C1115) Study in Japan the option of continuing treatment with belimumab (10 mg/kg…
- Trial name
- NCT01597622
- Testing
- Belimumab
- Where
- 27 sites in Japan, South Korea
- Volunteers
- 142 people
- Sponsor
- GlaxoSmithKline
Lupus Arthritis
A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Arthritis
The study aims to evaluate the safety and clinical effect of daily oral treatment with laquinimod capsules (0.5 milligrams [mg] and 1 mg) in participants with active lupus arthritis.
- Trial name
- NCT01085084
- Testing
- Laquinimod
- Where
- 22 sites in United States, Canada
- Volunteers
- 82 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Lupus Nephritis
A Study to Evaluate the Efficacy and Safety of Rituximab in Subjects With International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 Class III or IV Lupus Nephritis
This was a Phase III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of rituximab in combination with mycophenolate mofetil (MMF) compared with placebo in combination with MMF…
- Trial name
- LUNAR (NCT00282347)
- Testing
- Rituximab, Mycophenolate mofetil, Methylprednisolone
- Volunteers
- 144 people
- Sponsor
- Genentech, Inc.
Systemic Lupus Erythematosus, Active Cutaneous Lupus Erythematosus
Study to Evaluate BIIB059 (Litifilimab) in Cutaneous Lupus Erythematosus (CLE) With or Without Systemic Lupus Erythematosus (SLE)
The primary purpose of the study is to evaluate the efficacy of BIIB059 (litifilimab) in reducing disease activity in participants with systemic lupus erythematosus (SLE) with active cutaneous manifestations and joint involvement…
- Trial name
- LILAC (NCT02847598)
- Testing
- BIIB059 (litifilimab)
- Where
- 128 sites in United States, Argentina and 10 more
- Volunteers
- 264 people
- Sponsor
- Biogen
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 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.
Lupus Erythematosus, Systemic
A Safety and Tolerability Study of MEDI-570 in Systemic Lupus Erythematosus
The purpose of this study is to evaluate the safety and tolerability of MEDI-570 in adult subjects with moderately to severely active systemic lupus erythematosus (SLE).
- Trial name
- NCT01127321
- Testing
- MEDI-570 0.03 MG, MEDI-570 0.1 MG, MEDI-570 0.3 MG
- Where
- 17 sites in United States, Canada and 3 more
- Volunteers
- 44 people
- Sponsor
- MedImmune LLC
Lupus Nephritis
An Exploratory Maintenance Trial of BI 655064 in Patients With Lupus Nephritis
The main objectives of this trial are to evaluate the long term efficacy and safety of different doses of BI 655064 versus placebo as add-on therapy to Standard of Care (SOC) during maintenance therapy for lupus nephritis.
- Trial name
- NCT03385564
- Testing
- BI 655064
- Where
- 36 sites in United States, Australia and 14 more
- Volunteers
- 69 people
- Sponsor
- Boehringer Ingelheim
Systemic Lupus Erythematosus
Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of Care
This study will be conducted to assess the safety, tolerability, and immunogenicity of repeat doses of BOS161721 (20 milligrams [mg], 60 mg, and 120 mg) administered subcutaneously in adult participants with moderately to…
- Trial name
- NCT03371251
- Testing
- BOS161721
- Where
- 68 sites in United States, Argentina and 10 more
- Volunteers
- 143 people
- Sponsor
- Boston Pharmaceuticals
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.
Lupus Nephritis
A Study of Guselkumab in Participants With Active Lupus Nephritis
The purpose of this study is to evaluate the efficacy of guselkumab in participants with active lupus nephritis (LN).
- Trial name
- ORCHID-LN (NCT04376827)
- Testing
- Guselkumab Dose 1, Guselkumab Dose 2, Standard-of-care treatment
- Where
- 60 sites in United States, Argentina and 7 more
- Volunteers
- 33 people
- Sponsor
- Janssen Research & Development, LLC
Systemic Lupus Erythematosus, Rheumatoid Arthritis
Safety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid Arthritis
This is a Phase 1 single and multiple dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06835375 in subjects with seropositive SLE or RA.
- Trial name
- NCT03334851
- Testing
- PF-06835375
- Where
- 17 sites in United States
- Volunteers
- 74 people
- Sponsor
- Pfizer
Systemic Lupus Erythematosus
Belimumab Assessment of Safety in SLE
The purpose of this study is to further enhance the existing knowledge regarding the side effects of belimumab when given with other lupus medicines to adults with active systemic lupus erythematosus (SLE).
- Trial name
- BASE (NCT01705977)
- Testing
- Belimumab 10 mg/kg plus standard therapy, Standard therapy
- Where
- 250 sites in United States, Argentina and 31 more
- Volunteers
- 4,019 people
- Sponsor
- GlaxoSmithKline
IgA Nephropathy, Lupus Nephritis
Phase II Study Assessing Safety and Efficacy of APL-2 in Glomerulopathies
This is a Phase II trial assessing the safety and preliminary efficacy of daily APL-2 subcutaneous infusion administered for 16 weeks with a 6 month safety follow up, in patients with glomerulopathies
- Conditions
- IgA Nephropathy, Lupus Nephritis, Membranous Nephropathy, C3 Glomerulonephritis
- Trial name
- NCT03453619
- Testing
- APL-2
- Where
- 17 sites in United States
- Volunteers
- 21 people
- Sponsor
- Apellis Pharmaceuticals, Inc.