Clinical trials: SLE
Systemic Lupus Erythematosus
Japanese phase1 Study of Belimumab (IV vs SC)
This study is an open-label, randomized, 2 parallel group, single dose study in healthy Japanese males to assess the pharmacokinetics and safety/tolerability of single intravenous administration and single subcutaneous…
- Trial name
- NCT01516450
- Testing
- GSK1550188 IV, GSK1550188 SC
- Where
- Japan
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Systemic Lupus Erythematosus, Connective Tissue Disease
On Open-Label Study in Participants With Systemic Lupus Erythematosus
The purpose of this SLE study is to evaluate the long-term safety and efficacy of LY2127399 in eligible SLE participants who have completed the core studies (NCT01196091) (NCT01205438).
- Conditions
- Systemic Lupus Erythematosus, Connective Tissue Disease, Autoimmune Disease
- Trial name
- Illuminate-X (NCT01488708)
- Testing
- LY2127399
- Where
- United States
- Volunteers
- 1,518 people
- Sponsor
- Eli Lilly and Company
Systemic Lupus Erythematosus
A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus Erythematosus
The purpose of this study is to evaluate the effectiveness and safety of deucravacitinib compared with placebo in an active moderate to severe Systemic Lupus Erythematosus (SLE) population.
- Trial name
- POETYK SLE-2 (NCT05620407)
- Testing
- Deucravacitinib
- Where
- 180 sites in United States, Argentina and 20 more
- Volunteers
- 513 people
- Sponsor
- Bristol-Myers Squibb
Systemic Lupus Erythematosus
PEARL-SC Trial: A Study of the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus
The purpose of this study is to evaluate the efficacy, safety and tolerability of three different doses of A-623 administered in addition to standard therapy in subjects with active SLE disease
- Trial name
- PEARL-SC (NCT01162681)
- Testing
- A-623
- Where
- 74 sites in United States, Argentina and 9 more
- Volunteers
- 547 people
- Sponsor
- Anthera Pharmaceuticals
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.
Lupus Erythematosus, Systemic
A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus
The purpose of this study is to evaluate how well nipocalimab works as compared to placebo in participants with moderate to severe Systemic lupus erythematosus (SLE, a long-term disease where the immune system mistakenly attacks…
- Trial name
- GARDENIA-SLE (NCT07438496)
- Testing
- Nipocalimab, Standard of care treatment
- Where
- 260 sites in United States, Argentina and 30 more
- Volunteers
- 600 people
- Sponsor
- Janssen Research & Development, LLC
Systemic Lupus Erythematosus
The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)
The purpose of the study is to evaluate the long term safety and efficacy of orally administered M5049 in participants with subacute cutaneous lupus erythematosus (SCLE), discoid lupus erythematosus (DLE) and/or systemic lupus…
- Trial name
- NCT05540327
- Testing
- M5049 low dose, M5049 medium dose, M5049 high dose
- Where
- 122 sites in United States, Argentina and 20 more
- Volunteers
- 381 people
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Lupus, Systemic Lupus Erythematosus
A Study to Evaluate Mosunetuzumab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis
This study will assess how mosunetuzumab works in people who have systemic lupus erythematosus (SLE) who may or may not also have active lupus nephritis (LN).
- Conditions
- Lupus, Systemic Lupus Erythematosus, Lupus Nephritis
- Trial name
- SOLUNA (NCT07598396)
- Testing
- Mosunetuzumab
- Where
- 24 sites in Argentina, Brazil and 4 more
- Volunteers
- 30 people
- Sponsor
- Hoffmann-La Roche
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
Systemic Lupus Erythematosus
A Trial for Subjects With Systemic Lupus Erythematosus Who Have Completed Protocol AN-SLE3321
The purpose of this study is to evaluate the long-term safety of A-623 in subjects with SLE.
- Trial name
- NCT01305746
- Testing
- A-623
- Where
- 71 sites in United States, Argentina and 9 more
- Volunteers
- 382 people
- Sponsor
- Anthera Pharmaceuticals
Systemic Lupus Erythematosus
A Study of AMG 557 in Adults With Systemic Lupus Erythematosus
This is a Phase 1, randomized, placebo-controlled, double-blind, dose-escalation study of repeat SC doses of AMG 557 in adults with Systemic Lupus Erythematosus.
- Trial name
- NCT00774943
- Testing
- AMG 557
- Where
- 12 sites in United States, Canada
- Volunteers
- 58 people
- Sponsor
- Amgen
Systemic Lupus Erythematosus
A Phase Ib Study of QLS4131 in Subjects With Systemic Lupus Erythematosus
The goal of this open label, dose escalation phase 1b clinical trial is to investigate the safety, tolerability, pharmacokinetic, pharmacodynamics, immunogenicity and preliminary clinical efficacy of QLS4131 in subjects with…
- Trial name
- NCT07001839
- Testing
- QLS4131 for Injection.
- Volunteers
- 108 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Systemic Lupus Erythematosus
A Study to Evaluate the Effect of Belimumab on Vaccine Responses in Subjects With Systemic Lupus Erythematosus (SLE)
The purpose of this study is to assess the impact of belimumab on immune response to pneumococcal vaccine in subjects with Systemic Lupus Erythematosus (SLE).
- Trial name
- NCT01597492
- Testing
- Belimumab plus Early Vaccination, Belimumab plus Late Vaccination
- Where
- 15 sites in United States
- Volunteers
- 79 people
- Sponsor
- Human Genome Sciences Inc., a GSK Company
Systemic Lupus Erythematosus
WEUKBRE5716: Steroid-related Damage in Systemic Lupus Erythematosus (Hopkins)
The study is designed to assess the association between steroid exposure and five potentially steroid-related adverse events within a cohort of individuals with systemic lupus erythematosus (SLE).
- Trial name
- NCT01616472
- Testing
- Cumulative corticosteroid exposure
- Volunteers
- 1 people
- Sponsor
- GlaxoSmithKline
Systemic Lupus Erythematosus
A Study to Evaluate the Long-Term Safety of MEDI-545 in Adult Participants With Systemic Lupus Erythematosus or Myositis
The objective of this study is to assess the safety and tolerability of sifalimumab in adult participants with active systemic lupus erythematosus (SLE) or active dermatomyositis (DM) or polymyositis (PM) who participated in the…
- Trial name
- NCT00979654
- Testing
- Sifalimumab
- Where
- 28 sites in United States, Brazil and 2 more
- Volunteers
- 118 people
- Sponsor
- MedImmune LLC
Systemic Lupus Erythematosus
A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Repeat Doses of GSK2586184 and the Effect of Food and Gender
A study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and repeat doses of 800 mg GSK2586184 in healthy subjects.
- Trial name
- JAK116439 (NCT01687309)
- Testing
- GSK2586184 800mg single and repeat dose, GSK2586184 single dose taken with food, GSK2586184 single dose taken without food
- Where
- Belgium
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Lupus Erythematosus, Systemic
Study of VIB7734 for the Treatment of Moderate to Severely Active SLE
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of VIB7734 for the Treatment of Moderate to Severely Active Systemic Lupus Erythematosus in approximately 195 participants.
- Trial name
- RECAST SLE (NCT04925934)
- Testing
- VIB7734
- Where
- 67 sites in United States, Argentina and 9 more
- Volunteers
- 214 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, Systemic Lupus Erythematosus
A Phase 2, Open-Label, Single-Arm Trial of FT819 in Participants With Lupus Nephritis
The primary objective of this trial is to evaluate the efficacy and safety of FT819, comprised of allogeneic T cells that express a CD19-targeted CAR, following bendamustine administration in participants with refractory…
- Conditions
- Lupus Nephritis, Systemic Lupus Erythematosus, SLE - Systemic Lupus Erythematosus, Lupus Nephritis - WHO Class III
- Trial name
- RECLAIM-LN (NCT07570862)
- Testing
- FT819
- Where
- 12 sites in United States
- Volunteers
- 53 people
- Sponsor
- Fate Therapeutics
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