Clinical trials: Systemic Lupus Erythematosus (Sle)
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.
Lupus Nephritis
Evaluate the Safety of CS20AT04 Inj. in Subjects With Lupus Nephritis
The purpose of conducting phase 1 trial to evaluate the safety and tolerability of allogenic bone marrow-derived mesenchymal stem cells(CS20AT04) in subjects with lupus nephritis.
- Trial name
- NCT03174587
- Testing
- allogenic bone marrow derived mesenchymal stem cells
- Where
- South Korea
- Volunteers
- 7 people
- Sponsor
- Corestemchemon, Inc.
Lupus Erythematosus, Systemic
A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus
The goal of this clinical trial is to see how well cenerimod reduces symptoms of Systemic Lupus Erythematosus in adult patients with moderate to severe symptoms.
- Trial name
- OPUS-1 (NCT05648500)
- Testing
- Cenerimod
- Where
- 198 sites in United States, Argentina and 15 more
- Volunteers
- 470 people
- Sponsor
- Viatris Innovation GmbH
Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Systemic
A Study of the Safety and Pharmacokinetics of CNTO 136 in Patients With Cutaneous Lupus Erythematosus and Systemic Lupus Erythematosus
The main purpose of this study was to evaluate the safety and pharmacokinetics (PK, the action of a drug in the body over a period of time) of multiple intravenous (IV) administrations of CNTO 136 in patients with cutaneous lupus…
- Trial name
- NCT01702740
- Testing
- 1 mg/kg CNTO 136, 4 mg/kg CNTO 136, 10 mg/kg CNTO 136
- Volunteers
- 49 people
- Sponsor
- Centocor Research & Development, Inc.
Systemic Lupus Erythematosus
Safety and Tolerability of Intravenous Dose of MEDI-546 in Japanese Subjects With Systemic Lupus Erythematosus.
The purpose of this study is to assess safety, tolerability, pharmacokinetics and pharmacodynamics of MEDI-546 in Japanese SLE patients.
- Trial name
- NCT01559090
- Testing
- MEDI-546
- Where
- 6 sites in Japan
- Volunteers
- 17 people
- Sponsor
- AstraZeneca
Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathy
A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1)
The purpose of this study is to establish the tolerability, preliminary efficacy, and pharmacokinetics of CC-97540 in participants with severe, refractory autoimmune diseases (Breakfree-1).
- Conditions
- Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathy, Systemic Sclerosis, Rheumatoid Arthritis
- Trial name
- NCT05869955
- Testing
- CC-97540, Fludarabine, Cyclophosphamide
- Where
- 46 sites in United States, Belgium and 4 more
- Volunteers
- 270 people
- Sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Immunologic Diseases, Autoimmune Diseases
Safety and Efficacy Study of LJP 394 (Abetimus Sodium) to Treat Lupus Kidney Disease
The purpose of this study is to determine whether LJP 394 (abetimus sodium) is safe and effective in delaying and reducing renal flares in patients with lupus nephritis.
- Conditions
- Immunologic Diseases, Autoimmune Diseases, Systemic Lupus Erythematosus, Lupus Nephritis
- Trial name
- NCT00035308
- Testing
- Abetimus sodium (LJP 394)
- Where
- 82 sites in United States, Austria and 8 more
- Volunteers
- 330 people
- Sponsor
- La Jolla Pharmaceutical Company
Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus
A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus
In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with cutaneous lupus erythematosus (CLE).
- Trial name
- AMETHYST (NCT05531565)
- Testing
- Litifilimab
- Where
- 315 sites in United States, Argentina and 28 more
- Volunteers
- 450 people
- Sponsor
- Biogen
Systemic Lupus Erythematosus
Anifrolumab Malignancy and Serious Infections Study
This is an observational study, in which the main research question is to evaluate the risk of malignancies and serious infections among moderate/severe SLE patients who receive anifrolumab compared with a comparable population…
- Trial name
- SIMA (NCT07000110)
- Testing
- Anifrolumab
- Where
- 4 sites in Denmark, France and 2 more
- Volunteers
- 3,506 people
- Sponsor
- AstraZeneca
Systemic Lupus Erythematosus
A Study to Evaluate the Safety and Tolerability of Dapirolizumab Pegol in Study Participants With Systemic Lupus Erythematosus
The purpose of this study is to evaluate long-term safety and tolerability of dapirolizumab pegol treatment.
- Trial name
- NCT04976322
- Testing
- Dapirolizumab pegol
- Where
- 123 sites in United States, Argentina and 22 more
- Volunteers
- 760 people
- Sponsor
- UCB Biopharma SRL
Systemic Lupus Erythematosus
Study to Compare Properties of Epratuzumab When Given as an Injection Under the Skin or Directly Into the Blood
To assess how the absolute bioavailability, dose proportionality, pharmacokinetics, safety and tolerability of epratuzumab compared when given as a subcutaneous (sc) injection as to when given as an intravenous (iv) infusion in…
- Trial name
- NCT02306629
- Testing
- Epratuzumab sc, Epratuzumab iv
- Where
- United Kingdom
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- UCB Biopharma S.P.R.L.
Lupus Erythematosus, Systemic
NIS to Examine Disease Activity in SLE Patients Treated With Subcutaneous Anifrolumab in Routine Care
VIOLET is a prospective, single-arm, multi-centre, non-interventional study (NIS) evaluating real-world clinical and patient-reported outcome (PRO) data in adult patients who are initiated on subcutaneous anifrolumab treatment of…
- Trial name
- VIOLET (NCT07424261)
- Where
- 21 sites in Germany
- Volunteers
- 125 people
- Sponsor
- AstraZeneca
Systemic Lupus Erythematosus (SLE)
Study the Efficacy and Safety of VAY736 and CFZ533 in SLE Patients
This study is designed to evaluate the safety, tolerability, pharmacokinetics and therapeutic efficacy of treatment with either VAY736 (ianalumab) or CFZ533 (iscalimab) in patients with systemic lupus erythematosus (SLE) to…
- Trial name
- NCT03656562
- Testing
- VAY736, CFZ533
- Where
- 31 sites in Argentina, Australia and 13 more
- Volunteers
- 107 people
- Sponsor
- Novartis Pharmaceuticals
Systemic Lupus Erythematosus
Clinical Study of ZM001 Injection in the Treatment of Refractory Systemic Lupus Erythematosus
This is an open, single-arm, phase I clinical study of ZM001 in patients with refractory systemic lupus erythematosus
- Trial name
- NCT06852573
- Testing
- ZM001 Injection
- Volunteers
- 18 people
- Sponsor
- Beijing Immunochina Medical Science & Technology Co., Ltd.
Lupus Nephritis, Systemic Lupus Erythematosus
A Study of KZR-616 in Patients With SLE With and Without Lupus Nephritis
This was a Phase 1b/2, multi-center study in which patients received KZR-616, administered as a subcutaneous (SC) injection weekly for 13 weeks (Phase 1b) or 24 weeks (Phase 2).
- Trial name
- MISSION (NCT03393013)
- Testing
- KZR-616
- Where
- 36 sites in United States, Australia and 6 more
- Volunteers
- 69 people
- Sponsor
- Kezar Life Sciences, Inc.
System; Lupus Erythematosus
FLARE Lupus Research Study Systemic Lupus Erythematosus
The first phase of this pilot study will assess changes in quality of life at the end of a 16-week Mymee program in patients with moderate to severe SLE.
- Trial name
- FLARE (NCT03426384)
- Testing
- Mymee Program
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Mymee Inc.
Systemic Lupus Erythematosus
A Study of GSK4527363 in Healthy Participants, Systemic Lupus Erythematosus (SLE) Participants, Healthy Chinese, and Japanese Participants and CTD-ILD Participants
This study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of GSK4527363 in healthy participants (Part A), participants with active SLE (Part B), healthy participants of Chinese and…
- Trial name
- NCT06576271
- Testing
- GSK4527363, Belimumab
- Where
- 28 sites in United States, Argentina and 4 more
- Volunteers
- 142 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Lupus Erythematosus, Systemic
Relationship Between Data Obtained With the LuGENE® Multiparameter Transcriptomics Blood Test and Clinical and Standard Laboratory Features of Patients With SLE (ReLATE)
This is an open label study to determine the association of the data obtained with LuGENE®, a transcriptomic-based LDT, with standard evaluation of patients diagnosed with SLE, including clinical involvement, SLEDAI score…
- Trial name
- ReLATE (NCT05845593)
- Testing
- Decision Support Test
- Where
- 11 sites in United States
- Volunteers
- 200 people
- Sponsor
- Ampel BioSolutions, LLC
Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)
A Long-Term Extension (LTE) Study Of Enpatoran In Cutaneous Manifestations Of Lupus With Or Without Systemic Disease [Elowen-LTE]
The purpose of this study is to evaluate the long-term safety and efficacy of orally administered enpatoran in participants with cutaneous manifestations of lupus erythematosus who have completed the Elowen-1 (MS504908_0001)…
- Trial name
- NCT07840287
- Testing
- Enpatoran
- Where
- 2 sites in United States, Germany
- Volunteers
- 404 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Systemic Lupus Erythematosus
Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus
Systemic Lupus Erythematosus (SLE) is an immune-mediated disease associated with inflammation of multiple organ systems. This study will assess how safe and effective upadacitinib is in treating adult participants with moderately…
- Trial name
- SELECT-SLE (NCT05843643)
- Testing
- Upadacitinib
- Where
- 369 sites in United States, Argentina and 36 more
- Volunteers
- 1,014 people
- Sponsor
- AbbVie