Clinical trials: Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).
The purpose of this study is to evaluate long-term safety and tolerability of ianalumab in participants with systemic lupus erythematosus who have previously completed the treatment period in one of the two SIRIUS-SLE core…
- Trial name
- SIRIUS-SLE LTE (NCT06133972)
- Testing
- Ianalumab
- Where
- 164 sites in United States, Argentina and 27 more
- Volunteers
- 550 people
- Sponsor
- Novartis Pharmaceuticals
Systemic Lupus Erythematosus
Efficacy and Safety Study of R935788 Tablets to Treat Systemic Lupus Erythematosus
Approximately 225 patients meeting study entry requirements will be enrolled and randomized (2:1, active versus placebo superimposed on background treatment) to R788 or placebo.
- Trial name
- SOLEIL (NCT00752999)
- Testing
- Fostamatinib Disodium (R935788)
- Sponsor
- Rigel Pharmaceuticals
Lupus Erythematosus, Systemic
A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus
This is a Phase II/III open label, single-arm, multicenter, extension study to evaluate the safety and efficacy of rituximab when administered on a scheduled basis every 6 months over the course of 1 year with reassessment of…
- Trial name
- VOYAGER (NCT00381810)
- Testing
- Rituximab, Methylprednisolone, Acetaminophen
- Where
- 11 sites in United States
- Volunteers
- 31 people
- Sponsor
- Genentech, Inc.
Autoimmune Thrombocytopenia
Inaticabtagene Autoleucel Injection in the Treatment of Refractory Systemic Lupus Erythematosus-related Immune Thrombocytopenia
This is a single-arm, open-label，phase I clinical study to evaluate the safety and tolerability of Inaticabtagene Autoleucel Injection in treatment of refractory systemic lupus erythematosus-related immune thrombocytopenia.
- Trial name
- NCT06826430
- Testing
- Inaticabtagene autoleucel Injection
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Juventas Cell Therapy Ltd.
Systemic Lupus Erythematosus
CHABLIS7.5: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without Nephritis
The purpose of this study is to evaluate the clinical efficacy of blisibimod as measured by a composite responder index in subjects who, despite corticosteroid use, continue to have seropositive, clinically-active Systemic Lupus…
- Trial name
- NCT02514967
- Testing
- Blisibimod
- Where
- 3 sites in Georgia
- Volunteers
- 3 people
- Sponsor
- Anthera Pharmaceuticals
Lupus Nephritis
Atacicept in Lupus Nephritis Patients Taking Stable Regimen of Mycophenolate Mofetil
The sponsor electively terminated the study because the risk mitigation measures, deemed necessary after an unforeseen safety event, could not be effectively implemented within this protocol while maintaining study timelines…
- Trial name
- NCT01369628
- Testing
- Atacicept
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- EMD Serono
SLE - Systemic Lupus Erythematosus
MB-CART19.1 in Refractory SLE
This is a phase l/ll open-label, multicentre, interventional single-arm trial of MB-CART19.1 in patients with refractory SLE systemic lupus erythematosus.
- Trial name
- NCT06189157
- Testing
- MB-CART19.1
- Where
- 3 sites in Germany
- Volunteers
- 29 people
- Sponsor
- Miltenyi Biomedicine GmbH
Lupus Nephritis
Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis
This trial will evaluate efficacy, safety, and tolerability of subcutaneous (s.c.) ianalumab given every 4 weeks (q4w) or every 12 weeks (q12w) compared to placebo, in combination with SoC, in adult participants with active LN
- Trial name
- SIRIUS-LN (NCT05126277)
- Testing
- ianalumab s.c. q4w, ianalumab s.c. q12w
- Where
- 145 sites in United States, Argentina and 25 more
- Volunteers
- 452 people
- Sponsor
- Novartis Pharmaceuticals
Systemic Lupus Erythematosus, Healthy Participants
An Investigational Study of Experimental Medication BMS-986165 in Healthy Participants to Study Electrocardiogram Effects
This is a study to investigate the experimental medication BMS-986165 in healthy participants in order to study the effects it has on electrocardiogram results.
- Trial name
- NCT03541564
- Testing
- BMS-986165, Moxifloxacin
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Lupus Nephritis
Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin
The purpose of this study is assess the long-term safety and tolerability of voclosporin compared with placebo for up to an additional 24 months following completion of treatment in the AURORA 1 study in subjects with lupus…
- Trial name
- AURORA 2 (NCT03597464)
- Testing
- Voclosporin
- Where
- United States
- Volunteers
- 216 people
- Sponsor
- Aurinia Pharmaceuticals Inc.
Systemic Lupus Erythematosus
Exploratory Study of Changes in Disease Activity and Biomarkers With ABR-215757 in Patients With Mild Active Systemic Lupus Erythematosus (SLE)
This is an exploratory open label single arm study to evaluate changes in disease activity and biomarkers in patients with mild active SLE, during treatment with ABR-215757 given as add-on to standard therapy.
- Trial name
- NCT00997100
- Testing
- paquinimod (ABR-215757)
- Where
- 4 sites in Denmark, Sweden
- Volunteers
- 13 people
- Sponsor
- Active Biotech AB
Systemic Lupus Erythematosus
A Study to Evaluate the Efficacy and Safety of Rontalizumab in Patients With Moderately to Severely Active Systemic Lupus Erythematosus
This is a Phase II, randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of rontalizumab compared with placebo in patients with moderately to severely active systemic lupus…
- Trial name
- NCT00962832
- Testing
- Rontalizumab
- Where
- 79 sites in United States, Argentina and 4 more
- Volunteers
- 238 people
- Sponsor
- Genentech, Inc.
Systemic Lupus Erythematosus
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered Mosunetuzumab to Participants With Systemic Lupus Erythematosus
This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of mosunetuzumab in participants with systemic lupus erythematosus (SLE).
- Trial name
- NCT05155345
- Testing
- Mosunetuzumab, Tocilizumab
- Where
- 3 sites in United States, Moldova and 1 more
- Volunteers
- 15 people
- Sponsor
- Hoffmann-La Roche
Lupus Erythematosus, Systemic
Multiple Ascending Dose Study of MHS552 in Adults Participants With Systemic Lupus Erythematosus (SLE)
The purpose of this two-part multiple ascending dose study is to evaluate the safety and tolerability of multiple doses of MHS552 in adults with mild to moderately active Systemic Lupus Erythematosus (SLE).
- Trial name
- NCT05203419
- Testing
- MHS552
- Where
- Germany
- Volunteers
- 8 people
- Sponsor
- Novartis Pharmaceuticals
Lupus Nephritis
Phase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants With Lupus Nephritis (SIRIUS-LN Extension)
The purpose of this up to 6-year extension study is the evaluation of the efficacy and safety 1. after study treatment withdrawal in patients with lupus nephritis (LN) who achieved response (complete renal response [CRR] or…
- Trial name
- SIRIUS-LN ext (NCT06711887)
- Testing
- Ianalumab
- Where
- 51 sites in United States, Brazil and 16 more
- Volunteers
- 348 people
- Sponsor
- Novartis Pharmaceuticals
Systemic Lupus Erythematosus (SLE)
A Study to Learn More About the Long-Term Safety of Litifilimab (BIIB059) Injections and it's Effects on Symptoms in Adults With Systemic Lupus Erythematosus (SLE)
In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with systemic lupus erythematosus (SLE).
- Trial name
- EMERALD (NCT05352919)
- Testing
- Litifilimab
- Where
- 214 sites in United States, Argentina and 26 more
- Volunteers
- 864 people
- Sponsor
- Biogen
Systemic Lupus Erythematosus
A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus
The purpose of this study is to evaluate the ability of dapirolizumab pegol (DZP) as an add-on treatment to standard of care (SOC) medication to achieve clinically relevant long term improvement of moderate to severe disease…
- Trial name
- PHOENYCS FLY (NCT06617325)
- Testing
- DZP
- Where
- 245 sites in United States, Argentina and 21 more
- Volunteers
- 450 people
- Sponsor
- UCB Biopharma SRL
Lupus Erythematosus, Systemic
Long-term Safety and Tolerability of Cenerimod in Adults With Systemic Lupus Erythematosus
The goal of this clinical study is to learn about the long-term safety and tolerability of cenerimod in adult patients with moderate to severe symptoms of systemic lupus erythematosus.
- Trial name
- OPUS OLE (NCT06475742)
- Testing
- Cenerimod
- Where
- 122 sites in United States, Argentina and 24 more
- Volunteers
- 680 people
- Sponsor
- Viatris Innovation GmbH
Active Systemic Lupus Erythematosus
Efficacy and Safety 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 anifrolumab versus placebo in adult participants with moderately to severely active, autoantibody-positive systemic lupus…
- Trial name
- NCT02446899
- Testing
- Anifrolumab
- Where
- 113 sites in United States, Argentina and 13 more
- Volunteers
- 373 people
- Sponsor
- AstraZeneca
Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN)
A Phase IIa Study of ICG318 CAR-T in Refractory Systemic Lupus Erythematosus With or Without Lupus Nephritis
This Phase IIa, open-label, single-arm study includes an initial Safety Run-In followed by dose expansion to evaluate the safety, tolerability, cellular kinetics, pharmacodynamics, and preliminary clinical activity of a single…
- Trial name
- NCT07328581
- Testing
- ICG318, BCMA-CD19-IL-15/IL-15 sushi Compound CAR T following lymphodepletion
- Where
- 4 sites in United States
- Volunteers
- 20 people
- Sponsor
- iCell Gene Therapeutics