Clinical trials: System Lupus Erythematosus
Lupus Nephritis
A Study to Compare the Efficacy and Safety of Tacrolimus Capsules and Cyclophosphamide Injection in Treatment of Lupus Nephritis
The objective of this study is to evaluate the efficacy and safety of Tacrolimus capsules for induction remission in patients with lupus nephritis, and compare the efficacy and safety with Cyclophosphamide injections.
- Trial name
- NCT02457221
- Testing
- Tacrolimus capsules, Cyclophosphamide injections, Prednisone
- Where
- 35 sites in China
- Volunteers
- 314 people
- Sponsor
- Astellas Pharma China, Inc.
ANCA-Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM)
FT839 in Autoimmune Diseases
The primary objectives of this trial are to evaluate the safety and tolerability and to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose of FT839 with or without rituximab and/or background therapy and/or…
- Conditions
- ANCA-Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM), Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE)
- Trial name
- NCT07800871
- Testing
- FT839
- Where
- United States
- Volunteers
- 446 people
- Sponsor
- Fate Therapeutics
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
Lupus Nephritis, Lupus Erythematosus
Treatment of Lupus Nephritis With Allogeneic Mesenchymal Stem Cells
The purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells (MSCs) obtained from bone marrow for the treatment of adults with active proliferative lupus nephritis.
- Trial name
- MSV_LE (NCT03673748)
- Testing
- Mesenchymal stem cells (MSC)
- Where
- Spain
- Volunteers
- 20 people
- Sponsor
- Red de Terapia Celular
Systemic Lupus Erythematosus
A Study of CM313 Injection in Subjects With Systemic Lupus Erythematosus
A study of CM313 in subjects with systemic lupus erythematosus
- Trial name
- NCT05465707
- Testing
- CM313 2 mg/kg, CM313 4 mg/kg, CM313 8 mg/kg
- Volunteers
- 40 people
- Sponsor
- Keymed Biosciences Co.Ltd
Lupus
Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythematosus
Study evaluating the safety and efficacy of a novel biologic in the treatment of systemic lupus erythematosus in male and female adults.
- Trial name
- NCT02265744
- Testing
- BMS-931699
- Where
- 121 sites in United States, Argentina and 21 more
- Volunteers
- 730 people
- Sponsor
- Bristol-Myers Squibb
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
Lupus Erythematosus, Systemic
A Study of Ustekinumab in Chinese Participants With Active Systemic Lupus Erythematosus
The purpose of this study is to evaluate the efficacy of ustekinumab in Chinese participants with active systemic lupus erythematosus (SLE) who have not adequately responded to one or more standard-of-care treatments.
- Trial name
- NCT04060888
- Testing
- Ustekinumab (approximately 6 mg/kg), Ustekinumab 90 milligram (mg)
- Sponsor
- Janssen Research & Development, LLC
Systemic Lupos Erythematosus, SLE
A Phase 1, Single-Ascending-Dose, Safety, Tolerability, Pharmacokinetic(PK), and Pharmacodynamic(PD) Study of BIIB068 in Healthy Participants
The primary objective of the study is to evaluate the safety and tolerability of single oral doses of BIIB068 in healthy participants.
- Trial name
- NCT02829541
- Testing
- BIIB068
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Biogen
Systemic Lupus Erythematosus
Relma-cel for Moderate to Severe Active Systemic Lupus Erythematosus
To assess the safety tolerability pharmacokinetics and pharmacodynamics of Relma-cel in moderate or severe active systemic lupus erythematosus (SLE) subjects in China.
- Trial name
- NCT06297408
- Testing
- Relma-cel
- Volunteers
- 24 people
- Sponsor
- Shanghai Ming Ju Biotechnology Co., Ltd.
Systemic Lupus Erythematosus
Study of CD19 CAR-T Therapy for Refractory SLE
This is an investigator-initiated trial aimed at assessing the safety and efficacy of PTOC1 cells Injection in the treatment of refractory systemic lupus erythematosus.
- Trial name
- NCT07403097
- Testing
- PTOC1
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Chongqing Precision Biotech Co., Ltd
Systemic Lupus Erythematosus
Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users
Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users (PRIMULA Lac) is a Post Marketing Requirements (PMR) study designed to fulfill the FDA post-marketing requirements.
- Trial name
- PRIMULA Lac (NCT06594068)
- Testing
- Anifrolumab
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- AstraZeneca
Lupus Erythematosus, Discoid, Lupus Erythematosus, Systemic
Safety and Efficacy of Topical R333 in Patients With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) Lesions
The purpose of this study is to determine the safety, efficacy and tolerability of topical R333 ointment in Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) patients with active discoid lesions.
- Trial name
- SKINDLE (NCT01597050)
- Testing
- R932333
- Where
- 15 sites in United States, Canada
- Volunteers
- 54 people
- Sponsor
- Rigel Pharmaceuticals
Systemic Lupus Erythematosus (SLE)
F182112 Phase Ib Clinical Study for the Treatment of Patients With Systemic Lupus Erythematosus
The investigational drug is an injectable recombinant humanized anti-BCMA/CD3 bispecific antibody (code: F182112) that can simultaneously target the immune effector cell antigen CD3 and the antigen BCMA.
- Trial name
- NCT07829614
- Testing
- F182112
- Where
- China
- Volunteers
- 64 people
- Sponsor
- Shandong New Time Pharmaceutical Co., LTD
Systemic Lupus Erythematosus
Abatacept in the Treatment and Prevention of Active Systemic Lupus Erythematosus (SLE) Flares in Combination With Prednisone
The purpose of this clinical research study is to learn whether Abatacept can treat and prevent lupus flares; specifically, in patients with active lupus flares in at least one of three organ systems: skin (discoid lesions)…
- Trial name
- NCT00119678
- Testing
- Abatacept, Prednisone
- Where
- 52 sites in United States, Australia and 13 more
- Volunteers
- 183 people
- Sponsor
- Bristol-Myers Squibb
Systemic Lupus Erythematosus, Lupus Nephritis
A Study of KITE-363 in Participants With Refractory Autoimmune Diseases
This study will have two Phases: Phase 1a and Phase 1b. The goal of this clinical study is to learn more about the study drug KITE-363, to establish dosing, tolerability, safety, and preliminary efficacy of KITE-363 in…
- Conditions
- Systemic Lupus Erythematosus, Lupus Nephritis, Systemic Sclerosis, Idiopathic Inflammatory Myopathy
- Trial name
- NCT07038447
- Testing
- KITE-363, Fludarabine, Cyclophosphamide
- Where
- 10 sites in United States, Australia and 2 more
- Volunteers
- 52 people
- Sponsor
- Kite, A Gilead Company
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.
Inflammation, Systemic Lupus Erythematosus
An Investigation of NNC 0151-0000-0000 in Subjects With Systemic Lupus Erythematosus (SLE)
This trial is conducted in the United States of America (USA). The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics and signs of bioactivity of increasing repeated doses of NNC 151-0000-0000…
- Trial name
- NCT01018238
- Testing
- NNC 0151-0000-0000
- Where
- United States
- Sponsor
- Novo Nordisk A/S
Systemic Lupus Erythematosus, Systemic Sclerosis (SSc)
A Study of ATG-201 in Adult Participants With Autoimmune Diseases
This is a phase I, open-label study of ATG-201 in participants with autoimmune diseases.
- Conditions
- Systemic Lupus Erythematosus, Systemic Sclerosis (SSc), Sjogren's Disease, Autoimmune Diseases
- Trial name
- ATTRACT (NCT07732309)
- Testing
- ATG-201
- Where
- 22 sites in China
- Volunteers
- 149 people
- Sponsor
- Antengene Biologics Limited