Clinical trials: Lupus Erythematosus, Systemic
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
Rheumatoid Arthritis, Systemic Lupus Erythematosus
A Trial in Healthy Adult Participants and Adults With Autoimmune Disease to Test How HBM7020 is Tolerated and Absorbed in the Body
This first-in-human study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of HBM7020.
- Conditions
- Rheumatoid Arthritis, Systemic Lupus Erythematosus, Systemic Sclerosis, Sjögren's Disease
- Trial name
- NCT07649265
- Testing
- HBM7020
- Where
- Australia
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Lupus Nephritis (LN), Systemic Lupus Erythematosus (SLE)
C-CAR168, an Autologous Anti-CD20/BCMA Chimeric Antigen Receptor T-Cell Therapy, in Participants With Lupus Nephritis Refractory to Standard Therapy
This Phase 2, multicenter, open-label study will evaluate the safety and efficacy of a single infusion of autologous anti-CD20/BCMA chimeric antigen receptor T cells (C-CAR168) following lymphodepleting chemotherapy in…
- Conditions
- Lupus Nephritis (LN), Systemic Lupus Erythematosus (SLE), Autoimmune Diseases
- Trial name
- NCT07729826
- Testing
- C-CAR168
- Volunteers
- 50 people
- Sponsor
- AbelZeta Inc.
Systemic Lupus Erythematosus (SLE), Central Sensitization
Effectiveness of Resonance Frequency Breathing Exercises in Patients With Systemic Lupus Erythematosus and Central Sensitization
Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease characterized by systemic inflammation, fatigue, central sensitization, and chronic pain.
- Conditions
- Systemic Lupus Erythematosus (SLE), Central Sensitization, Chronic Pain
- Trial name
- NCT07868289
- Testing
- Resonance Frequency Breathing, Standard Exercise Program
- Where
- Turkey (Türkiye)
- Volunteers
- 38 people
- Sponsor
- Istanbul University - Cerrahpasa
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
Lupus Erythematosus, Systemic
Synergetic B-cell Immunomodulation in SLE - 2nd Study.
In follow-up of the previous SynBioSe Study the present study is a randomized controlled trial designed to further investigate the long-term clinical and imunological efficacy of combination B-cell targeting by starting treatment…
- Trial name
- SynBioSe-2 (NCT03747159)
- Testing
- Belimumab Injection
- Where
- 4 sites in Netherlands
- Volunteers
- 71 people
- Sponsor
- Leiden University Medical Center
Systemic Lupus Erythematosus, Lupus Nephritis
RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus
RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus
- Trial name
- NCT06121297
- Testing
- CABA-201
- Where
- 23 sites in United States, Canada and 1 more
- Volunteers
- 28 people
- Sponsor
- Cabaletta Bio
Autoimmune Disorders, Systemic Sclerosis
Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders
The goal of Safety Lead-In is to confirm the safety of tafasitamab when given to patients with SSc, SLE, and LN. The goal of Phase 1 is to find the recommended dose of AD-PluReceptor-NK cells in combination with tafasitamab and…
- Conditions
- Autoimmune Disorders, Systemic Sclerosis, Systemic Lupus Erythematosus, Lupus
- Trial name
- NCT06434363
- Testing
- Tafasitamab, Fludarabine phosphate, Cyclophosphamide
- Where
- 2 sites in United States
- Volunteers
- 47 people
- Sponsor
- M.D. Anderson Cancer Center
Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease
The purpose of this global, multicenter, Phase 3 study is to evaluate the efficacy and safety of enpatoran over 24 weeks in participants with active cutaneous manifestations of lupus erythematosus with or without systemic…
- Trial name
- ELOWEN-1 (NCT07332481)
- Testing
- Enpatoran, Standard of care (SoC)
- Where
- 60 sites in United States, Australia and 14 more
- Volunteers
- 202 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Systematic Lupus Erythematosus, Cutaneous Lupus Erythematosus
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)
The purpose of this global, multicenter, Phase 3 study is to evaluate the efficacy and safety of enpatoran over 24 weeks in participants with active cutaneous manifestations of lupus erythematosus with or without systemic…
- Trial name
- NCT07355218
- Testing
- Enpatoran, Standard of care (SoC)
- Where
- 57 sites in United States, Australia and 15 more
- Volunteers
- 202 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Lupus Erythematosus, Systemic
To Evaluate the Effects of Cevostamab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis
The study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of cevostamab in participants with systemic lupus erythematosus (SLE) with or without active lupus nephritis (LN).
- Trial name
- NCT07629583
- Testing
- Cevostamab, Tocilizumab
- Where
- 2 sites in France, Spain
- Volunteers
- 46 people
- Sponsor
- Genentech, Inc.
Autoimmune Disease, Crohn Disease
Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVO
This phase Ib trial studies the side effects of nivolumab and to see how well it works alone and in combination with other treatments, such as ipilimumab, cabozantinib, platinum containing therapy, and fluoropyrimidine, in…
- Conditions
- Autoimmune Disease, Crohn Disease, Dermatomyositis, Hematopoietic and Lymphoid Cell Neoplasm
- Trial name
- NCT03816345
- Testing
- Biospecimen Collection, Cabozantinib, Fluoropyrimidine
- Where
- 52 sites in United States, Canada
- Volunteers
- 300 people
- Sponsor
- National Cancer Institute (NCI)
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, Active Refractory Rheumatoid Arthritis
A Phase 2 Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases
The main objective is to assess the safety and tolerability of inebilizumab in adult participants with active and refractory systemic lupus erythematosus (SLE) with nephritis (Subprotocol A) and to assess the safety and…
- Trial name
- NCT06570798
- Testing
- Inebilizumab, Blinatumomab
- Where
- 58 sites in United States, Australia and 8 more
- Volunteers
- 220 people
- Sponsor
- Amgen
Cutaneous Lupus Erythematosus (CLE), Systemic Lupus Erythematosus
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study With an Open-Label Extension Evaluating the Efficacy and Safety of VENT-03 in Adult Participants With Active Cutaneous Lupus Erythematosus With or Without Systemic Lupus Erythematosus
The goal of this clinical trial is to learn if VENT-03 works to treat patients with cutaneous lupus erythematosus (CLE) who may or may not have systemic lupus erythematosus (SLE).
- Conditions
- Cutaneous Lupus Erythematosus (CLE), Systemic Lupus Erythematosus, SLE, SLE (Systemic Lupus)
- Trial name
- AERIS (NCT07260877)
- Testing
- VENT-03
- Where
- 34 sites in United States, Bulgaria and 6 more
- Volunteers
- 24 people
- Sponsor
- Ventus Therapeutics U.S., Inc.
Systemic Lupus Erythematosus, Gastrointestinal Diseases
Subclinical Gastrointestinal Involvement in Juvenile Systemic Lupus Erythematosus
This cross-sectional case-control study aims to evaluate fecal calprotectin levels and intestinal ultrasound findings for the detection of subclinical gastrointestinal involvement in children with juvenile systemic lupus…
- Trial name
- NCT07858461
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Assiut University
Systemic Lupus Erythematosus
A First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7507062 in Participants With Systemic Lupus Erythematosus
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of RO7507062 in participants with systemic lupus erythematosus (SLE).
- Trial name
- NCT05835986
- Testing
- RO7507062, Tocilizumab
- Where
- 18 sites in Colombia, France and 11 more
- Volunteers
- 70 people
- Sponsor
- Hoffmann-La Roche
Relapsed/Refractory Systemic Lupus Erythematosus (r/r SLE), Relapsed/Refractory IgG4-Related Disease (r/r IgG4-RD)
A Clinical Study to Evaluate LVIVO-TaVec400 for the Treatment of Relapsed/Refractory Autoimmune Diseases
This is a prospective, single-arm, open-label dose-escalation clinical study to evaluate LVIVO-TaVec400 in the treatment of relapsed/refractory autoimmune diseases.
- Conditions
- Relapsed/Refractory Systemic Lupus Erythematosus (r/r SLE), Relapsed/Refractory IgG4-Related Disease (r/r IgG4-RD), Progressive Multiple Sclerosis (PMS), Relapsed/Refractory Myasthenia Gravis(r/r MS)
- Trial name
- NCT07583030
- Testing
- LVIVO-TaVec400 product
- Where
- 4 sites in China
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Systemic Sclerosis Cutaneous Lupus E Myopathies Systemic Lupus Erythematosus
Rollover Study for Participants Who Have Completed a Previous Clinical Study With Anifrolumab (Saphnelo) and Clinically Benefited From Continued Treatment
The purpose of this study is to provide continued access to anifrolumab to eligible participants who are continuing to derive clinical benefit from treatment at the end of a parent clinical study, as assessed by the Investigator…
- Trial name
- ROSY-S (NCT07691970)
- Testing
- Anifrolumab
- Where
- 128 sites in United States, Argentina and 33 more
- Volunteers
- 1,072 people
- Sponsor
- AstraZeneca
Childhood-Onset Systemic Lupus Erythematosus, Refractory SLE
CD19 CAR-T Therapy for Refractory Childhood-Onset Systemic Lupus Erythematosus
This study is evaluating the safety and potential benefits of CD19 chimeric antigen receptor T-cell (CAR-T) therapy in children and young adults with severe systemic lupus erythematosus (SLE) that began during childhood.
- Conditions
- Childhood-Onset Systemic Lupus Erythematosus, Refractory SLE, CD19 CAR-T Cell Therapy
- Trial name
- NCT07855302
- Testing
- SNUH-CD19-CAR-T Cells, Lymphodepleting Chemotherapy
- Where
- South Korea
- Volunteers
- 8 people
- Sponsor
- Seoul National University Hospital