Clinical trials: System Lupus Erythematosus
System Lupus Erythematosus(SLE)
Study of YKST02 Alone or in Combination With YK012 in Patients With Active or Refractory Systemic Lupus Erythematosus
The purpose of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary efficacy of YKST02 administered alone or in combination with YK012 in…
- Trial name
- NCT07512947
- Testing
- YKST02, YK012
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Safety, Effective
Anti-CD19 CAR-T Cell Therapy in Participants With Moderate to Severe Active Systemic Lupus Erythematosus
This is an open, Phase I, investigator-initiated study (IIT) to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-04 in patients with moderate or severe active SLE.
- Trial name
- NCT06310811
- Testing
- RD06-04 Cells injection
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Systemic Lupus Erythematosus
A First Time in Human Study to Evaluate the Safety and Tolerability of GSK3996401 Following Dosing With GSK4347859 in Healthy Participants
This is a first time in human (FTiH) study which means that this is the first time that GSK4347859 is given to humans. The study is designed to investigate the safety, tolerability, and concentration of GSK3996401 (the activated…
- Trial name
- NCT06188507
- Testing
- GSK4347859
- Where
- 2 sites in United Kingdom
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Lupus Erythematosus, Systemic
Study Evaluating The SBI-087 In Subjects With Systemic Lupus Erythematosus
The purpose of this study is to determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SBI-087 in subjects with Systemic Lupus Erythematosus (SLE).
- Trial name
- NCT00714116
- Testing
- SBI-087
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- Pfizer
Systemic Lupus Erythematosus (SLE), ANCA Associated Vasculitis (AAV)
IMPT-514 in Systemic Lupus Erythematosus, Anca-associated Vasculitis, and Idiopathic Inflammatory Myopathy
This is an exploratory trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of a single dose of IMPT-514, an autologous, anti-CD19/CD20 CAR T therapy, administered as an intravenous (IV)…
- Conditions
- Systemic Lupus Erythematosus (SLE), ANCA Associated Vasculitis (AAV), Idiopathic Inflammatory Myopathy (IIM)
- Trial name
- NCT06462144
- Testing
- IMPT-514 CART Cell Injection
- Where
- 3 sites in China
- Volunteers
- 3 people
- Sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Systemic Lupus Erythematosus
Practice of Treat-to-target on Pediatric Systemic Lupus Erythematosus: a Two-center Retrospective Study
Treat to target (T2T) strategies have proved to be useful in several chronic disorders, including Rheumatoid Arthritis. In systemic lupus erythematosus (SLE), T2T strategy has been proposed in order to control disease activity…
- Trial name
- NCT04942314
- Volunteers
- 600 people
- Sponsor
- Jia Deng
Lupus Nephritis
Pentoxifylline in Lupus Nephritis
Glomerulonephritis is an important manifestation in about 1/2 of patients with Systemic Lupus Nephritis (SLE; lupus). Despite recent national guidelines recommending use of induction therapy with high-dose corticosteroids and…
- Trial name
- Pentoxifylline (NCT03859570)
- Testing
- Pentoxifylline
- Where
- United States
- Sponsor
- MetroHealth Medical Center
Lupus Nephritis
High Quality Evidence of Chinese Lupus Nephritis (HELP)
The investigators are registering LN patients at recruited hospitals and developing a LN database in China. Patients will be follow-up every year, and both baseline and follow-up information will be entered into the registration…
- Trial name
- NCT03001973
- Testing
- No Intervention
- Where
- China
- Volunteers
- 5,000 people
- Sponsor
- Sun Yat-sen University
Systemic Lupus Erythematosus (SLE)
JY231 Injection for the Treatment of Active Systemic Lupus Erythematosus (SLE)
Early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of active systemic lupus erythematosus (SLE)
- Trial name
- JY231 (NCT06675422)
- Testing
- JY231 injection
- Where
- China
- Volunteers
- 20 people
- Sponsor
- 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Autoimmune Diseases, Systemic Lupus Erythematosus
Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases
A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19/BCMA U CAR T cells in patients with autoimmune diseases. 60 patients are planned to be enrolled in the dose-escalation trial.
- Conditions
- Autoimmune Diseases, Systemic Lupus Erythematosus, Systemic Sclerosis, Primary Sjögren Syndrome
- Trial name
- NCT07246096
- Testing
- anti-CD19/BCMA U CAR T cells
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Changhai Hospital
Systemic Lupus Erythematosus
Study of Subcutaneous (SC) Belimumab in Pediatric Participants With Systemic Lupus Erythematosus (SLE)
The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and pharmacodynamics (PD) of repeat doses of 200 milligrams per milliliter (mg/mL) belimumab administered via SC injection in pediatric participants 5 to…
- Trial name
- NCT04179032
- Testing
- Belimumab
- Where
- 11 sites in United States, Argentina and 5 more
- Volunteers
- 25 people
- Sponsor
- GlaxoSmithKline
Systemic Lupus Erythematosus
Immune Mediators and Metabolites to Stratify Systemic Lupus Erythematosus Patients at High Risk of Cardio Vascular Diseases
Accelerated atherosclerosis is an established complication of systemic autoimmune diseases, particularly SLE. Young female patients with SLE are more likely to develop myocardial infarction than matched healthy controls, and CVD…
- Trial name
- ISLE (NCT04276701)
- Testing
- blood sample, Ultrasonography assessment, questionnaires
- Where
- 6 sites in France, Germany
- Volunteers
- 500 people
- Sponsor
- University Hospital, Bordeaux
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
A Prospective Comparative Study Involving Multiple Units to Evaluate the Efficacy and Safety of Telitacicept and Belimumab in the Treatment of Systemic Lupus Erythematosus.
The objective of this observational study is to compare the efficacy and safety of telitacicept versus belimumab in systemic lupus erythematosus (SLE) patients aged 18-65 years.
- Trial name
- NCT07069972
- Where
- China
- Volunteers
- 180 people
- Sponsor
- Yipeng Liu
Lupus Erythematosus
Longitudinal Study of Quality of Life and Activity in Systemic Lupus Erythematosus
Systemic lupus erythematosus is a complex disease whose evaluation in everyday practice and in clinical research requires several aspects to be taken into account, in particular the impact of disease activity on quality of life.
- Trial name
- EQUAL (NCT01904812)
- Testing
- Questionnaire about quality of life and satisfaction
- Where
- France
- Volunteers
- 356 people
- Sponsor
- Centre Hospitalier Universitaire Dijon
Systemic Lupus Erythematosus, Systemic Sclerosis
Autologous Stem Cell Transplant (ASCT) for Autoimmune Diseases
A subset of autoimmune diseases (ADs) in children and young adults are life-threatening and unresponsive to conventional treatments.
- Trial name
- NCT05029336
- Testing
- Depletion of CD3/CD19 in an autologous stem cell transplant
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Stephan Grupp MD PhD
Systemic Lupus Erythematosus (SLE)
Hematological Manifestations in Systemic Lupus Erythematosus Patients
The goal of this observational study is to evaluate hematological abnormalities among patients with systemic lupus erythematosus (SLE) admitted to a tertiary care center in Nepal.
- Trial name
- NCT06936007
- Where
- Nepal
- Volunteers
- 99 people
- Sponsor
- Patan Academy of Health Sciences
Systemic Lupus Erythematosus
Study of Epratuzumab in Systemic Lupus Erythematosus
Epratuzumab is an investigational antibody designed to help treat SLE. The purpose is to evaluate safety and long term efficacy in concert with standard SLE treatments
- Trial name
- NCT00382837
- Testing
- Epratuzumab
- Where
- 54 sites in United States, Belgium and 11 more
- Sponsor
- UCB Pharma
Lupus Nephritis
Study of Daxdilimab (HZN-7734) in Participants With Active Proliferative Lupus Nephritis (LN)
Phase 2, multicenter, double-blind, randomized, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of daxdilimab in patients with active, proliferative lupus nephritis (LN).
- Trial name
- NCT05540665
- Testing
- Daxdilimab
- Where
- 52 sites in United States, Argentina and 10 more
- Volunteers
- 19 people
- Sponsor
- Amgen
Systemic Lupus Erythematosus
Efficacy of Faslodex in Treatment of SLE Clinical, Serologic, and Molecular Studies
SLE(Systemic Lupus Erythematosus) is an autoimmune disese that primarily occurs in women(9:1 compared to men). The disease is activated by genetic and environmental factors, yet the female gender is the strongest risk factor.
- Trial name
- NCT00417430
- Testing
- ICI 182,780 (Faslodex)
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- The Center for Rheumatic Disease, Allergy, & Immunology
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