Clinical trials: SLE
Systemic Lupus Erythematosus (Sle), Primary Ovarian Insufficiency (Poi)
Gonadotropin-releasing Hormone Agonist (GnRHa) in Ovarian Preservation in SLE Subjects Receiving Cyclophosphamide as Determined by Questionnaires
Background: Systemic lupus erythematosus (SLE) is a disease that affects females nine times more often than males. People with SLE are often treated with cyclophosphamide (CYC).
- Trial name
- NCT05567198
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
SLE, SLE (Systemic Lupus)
A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Systemic Lupus Erythematosus
Phase 1b, open-label study of CLN-978 administered subcutaneously in patients with Moderate to Severe Systemic Lupus Erythematosus (SLE).
- Trial name
- NCT06613360
- Testing
- CLN-978
- Where
- 24 sites in United States, Australia and 7 more
- Volunteers
- 24 people
- Sponsor
- Cullinan Therapeutics Inc.
SLE (Systemic Lupus), Lupus Erythematosus, Systemic
A Safety and Efficacy Study Evaluating CTX112 in Adult Subjects With Refractory Autoimmune Disease
This is a single-arm, open-label, multicenter, ascending dose Phase 1 study evaluating the safety and preliminary efficacy of CTX112 in adult subjects with refractory autoimmune diseases, including active systemic lupus…
- Conditions
- SLE (Systemic Lupus), Lupus Erythematosus, Systemic, Lupus Nephritis, Systemic Sclerosis
- Trial name
- NCT06925542
- Testing
- CTX112
- Where
- 17 sites in United States, Germany and 1 more
- Volunteers
- 80 people
- Sponsor
- CRISPR Therapeutics
SLE
Prediction of SLE Flares Using Patient-Reported Outcomes and Machine Learning
This study aims to Develop a low-cost, PRO-based ML tool can: - Reduce lab costs - Enable telemedicine monitoring - Detect flares early - Improve care in resource-limited settings.
- Trial name
- SLE-PROM-ML (NCT07890662)
- Testing
- Patient-Reported Questionnaire (PROs)
- Where
- Egypt
- Volunteers
- 500 people
- Sponsor
- Sohag University
Systemic Lupus Erythematosus (SLE), Rheumatoid Arthritis (RA)
A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases
This is an open-label, multi-ascending dose (MAD) phase 1 study, with dose expansion at selected doses, in adult patients with select autoimmune rheumatic diseases including systemic lupus erythematosus (SLE) or rheumatoid…
- Trial name
- NCT06647069
- Testing
- SAR448501
- Where
- 8 sites in Australia, Bosnia and Herzegovina and 3 more
- Volunteers
- 62 people
- Sponsor
- Sanofi
Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc)
A Clinical Study of YTS109 Cell in R/R Autoimmune Diseases
This study evaluates the safety and efficacy of YTS109 cells in adults with relapsed/refractory autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc), etc.
- Conditions
- Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc), Inflammatory Myopathy, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
- Trial name
- NCT06978647
- Testing
- YTS109 cell
- Where
- China
- Volunteers
- 12 people
- Sponsor
- China Immunotech (Beijing) Biotechnology Co., Ltd.
Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN)
A Clinical Study of YTS109 Cell for R/R Autoimmune Diseases
This study evaluates the safety and efficacy of YTS109 cells in adults with relapsed/refractory autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), including LN and SLE-ITP, Sjogren's Syndrome, etc.
- Conditions
- Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN), Systemic Sclerosis (SSc), Inflammatory Myopathy
- Trial name
- NCT07104721
- Testing
- YTS109 cell
- Where
- China
- Volunteers
- 18 people
- Sponsor
- China Immunotech (Beijing) Biotechnology Co., Ltd.
Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN)
A Clinical Study of YTS109 Cells for the Treatment of R/R Autoimmune Diseases
This study evaluates the safety and efficacy of YTS109 cells in adults with relapsed/refractory autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), including LN and SLE-ITP, Sjogren's Syndrome, etc.
- Conditions
- Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN), Sjogren's Syndrome (SS), Inflammatory Myopathy
- Trial name
- NCT07123519
- Testing
- YTS109 cell
- Where
- China
- Volunteers
- 18 people
- Sponsor
- China Immunotech (Beijing) Biotechnology Co., Ltd.
Systemic Lupus Erythematosus (SLE), Sjogren's Syndrome (SS)
A Clinical Study of TI-0032-III Injection in Patients With Relapsed and Refractory Autoimmune Diseases
This is an open-label, dose escalation study in patients with relapsed and refractory autoimmune diseases. Study drug, TI-0032-III injection, is composed of lipid nanoparticles (LNPs) targeting T cells that encapsulate circular…
- Conditions
- Systemic Lupus Erythematosus (SLE), Sjogren's Syndrome (SS), Systemic Sclerosis (SSc), Inflammatory Myopathy
- Trial name
- in vivo CAR-T (NCT07413341)
- Testing
- TI-0032-III injection
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Therorna
Systemic Lupus Erythematosus (SLE)
A Study of LCAR-AIO in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus
This is a prospective, single-arm, open-label, dose-exploration and expansion clinical study of LCAR-AIO in adult subjects with relapsed/refractory systemic lupus erythematosus.
- Trial name
- NCT06653556
- Testing
- LCAR-AIO T cells
- Where
- China
- Volunteers
- 3 people
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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
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.
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
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.
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
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
SLE; Drug
Phase 1b/2a Study to Evaluate Safety and Efficacy of KPG-818 in SLE
The clinical trial is titled "A Phase 1b/2a Multicenter Study to Assess the Safety and Tolerability, Pharmacokinetics, and Preliminary Efficacy of KPG-818 in Patients with Systemic Lupus Erythematosus".
- Trial name
- Lupus (NCT04643067)
- Testing
- KPG-818 low dose in phase 1b, KPG-818 mid dose in phase 1b, KPG-818 high dose in phase 1b
- Where
- 18 sites in United States
- Volunteers
- 64 people
- Sponsor
- Kangpu Biopharmaceuticals, Ltd.
Healthy Volunteers, Systemic Lupus Erythematosus (SLE)
A Study of KK4277 in Healthy Volunteers and Patients With Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus
Part 1 : To evaluate the safety and tolerability of a single intravenous (IV) or subcutaneous (SC) dose of KK4277 in healthy Japanese or non-Asian adult males.
- Conditions
- Healthy Volunteers, Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)
- Trial name
- NCT05411016
- Testing
- KK4277
- Where
- 23 sites in Japan, South Korea
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- Kyowa Kirin Co., Ltd.
SLE - Systemic Lupus Erythematosus
The Primary Objective of the Trial is to Evaluate the Effect of the Addition of Belantamab Mafodotin to Standard of Care Therapy on the Titres of Serum Anti-dsDNA Antibodies in Patients With Previously Treated SLE.
The primary objective of the trial is to evaluate the effect of the addition of belantamab mafodotin to standard of care therapy on the titres of serum anti-dsDNA antibodies in patients with previously treated SLE.
- Trial name
- Bela-SLE (NCT07844200)
- Testing
- belantamab mafodotin to the existing stable standard background therapy
- Volunteers
- 12 people
- Sponsor
- Medical Association for the Study of Cancer Biology and Treatment