Clinical trials: Systemic Lupus Erythematosus
Systemic Lupus Erythematosus, Systemic Sclerosis
An Clinical Study of YTS109 Cell Injection in Subjects With Recurrent/Refractory Autoimmune Disease
An exploratory clinical study of the safety and efficacy of YTS109 cell injection in subjects with recurrent/refractory autoimmune disease
- Conditions
- Systemic Lupus Erythematosus, Systemic Sclerosis, Inflammatory Myopathy, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
- Trial name
- NCT06379646
- Testing
- YTS109
- Where
- China
- Volunteers
- 6 people
- Sponsor
- China Immunotech (Beijing) Biotechnology Co., Ltd.
Systemic Lupus Erythematosus, Scleroderma
Efficacy and Safety of HN2301 in Autoimmune Diseases（AIDs）
This is an open lable and single arm study, is designed to evaluate the safety and preliminary efficacy of HN2301 in Autoimmune Disease（AID）
- Conditions
- Systemic Lupus Erythematosus, Scleroderma, Rheumatoid Arthritis
- Trial name
- SLE，SSc，RA (NCT06801119)
- Testing
- HN2301 injection
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Shenzhen MagicRNA Biotechnology Co., Ltd
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
- 74 sites in United States, Australia and 18 more
- Volunteers
- 202 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus
A Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Cutaneous Lupus Erythematosus (CLE)
The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of IMVT-1402 in participants with Cutaneous Lupus Erythematosus.
- Trial name
- NCT06980805
- Testing
- IMVT-1402
- Where
- 86 sites in United States, Argentina and 11 more
- Volunteers
- 56 people
- Sponsor
- Immunovant Sciences GmbH
Systemic Lupus Erythematosus
Efficacy and Safety of Frexalimab (SAR441344) in the Treatment of Systemic Lupus Erythematosus
This is a multinational, randomized, placebo-controlled, parallel treatment, Phase 2, double-blind, 2 arm study evaluating the efficacy and safety of SAR441344 in comparison with placebo in the treatment of participants aged 18…
- Trial name
- APATURA (NCT05039840)
- Testing
- SAR441344 IV, SAR441344 SC
- Where
- 73 sites in United States, Argentina and 14 more
- Volunteers
- 109 people
- Sponsor
- Sanofi
Lupus Erythematosus
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ABT-199 in Female Patients With Systemic Lupus Erythematosus (SLE)
To assess the safety, tolerability and pharmacokinetics of ABT-199 in female subjects with Systemic Lupus Erythematosus.
- Trial name
- NCT01686555
- Testing
- ABT-199
- Where
- 15 sites in United States, Germany and 2 more
- Volunteers
- 97 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
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.
Lupus Nephritis
Evaluation of the Tolerance, Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of MIL62 Injection for Treating Lupus Nephritis
This study is composed of two stages: Part A is a randomized, double-blind, placebo-controlled dose-escalation study (i.e., Phase 1b study).
- Trial name
- NCT07044115
- Testing
- Recombinant Humanized Monoclonal Antibody MIL62 Injection
- Where
- China
- Volunteers
- 41 people
- Sponsor
- Beijing Mabworks Biotech Co., Ltd.
Autoimmune Disease, Systemic Lupus Erythematosus
Safety and Preliminary Efficacy of HN2302 in Patients With Autoimmune Diseases
This is an open-label, single-arm study designed to evaluate the safety and preliminary efficacy of HN2302 in patients with autoimmune diseases, including systemic lupus erythematosus (SLE) and systemic sclerosis (SSc).
- Conditions
- Autoimmune Disease, Systemic Lupus Erythematosus, Systemic Sclerosis (SSc)
- Trial name
- AID (NCT07523282)
- Testing
- HN2302 Injection
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Shenzhen MagicRNA Biotechnology Co., Ltd
Lupus Erythematosus, Systemic
Exploratory Clinical Study of CNCT19 Anti CD19 Cell Therapy in the Treatment of Refractory Autoimmune Diseases
Exploratory clinical study of CNCT19 anti CD19 cell therapy in the treatment of refractory autoimmune diseases,To evaluate the safety and tolerability of CNCT19 in patients with refractory systemic lupus erythematosus (lupus…
- Trial name
- NCT06316791
- Testing
- single dose of CNCT19
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Juventas Cell Therapy Ltd.
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
Systemic Lupus Erythematosus
Exploratory Study of MT-1303 in Systemic Lupus Erythematosus Patients
The purpose of this study is to evaluate the safety/tolerability and to explore the efficacy of MT-1303 in subjects with systemic lupus erythematosus
- Trial name
- NCT02307643
- Testing
- MT-1303 Low dose, MT-1303 High dose
- Where
- 14 sites in Japan
- Volunteers
- 17 people
- Sponsor
- Tanabe Pharma Corporation
Relapsed/Refractory, Systemic Lupus Erythematosus (SLE)
BCMA-CD19 cCAR T Cell Treatment of Relapsed/Refractory Systemic Lupus Erythematosus (SLE)
This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of BCMA-CD19 cCAR T cells in patients with relapsed and/or refractory SLE.
- Trial name
- NCT05474885
- Testing
- BCMA-CD19 cCAR T cells
- Where
- China
- Volunteers
- 15 people
- Sponsor
- iCell Gene Therapeutics
Lupus Erythematosus, Systemic
Safety and Efficacy Study of LymphoStat-B (Belimumab) in Subjects With Systemic Lupus Erythematosus (SLE)
The purpose of this study is to evaluate the safety and efficacy of 3 different doses of belimumab, administered in addition to standard therapy, in patients with active SLE disease.
- Trial name
- NCT00071487
- Testing
- Belimumab 1 mg/kg, Belimumab 4 mg/kg, Belimumab 10 mg/kg
- Where
- 62 sites in United States, Canada
- Volunteers
- 449 people
- Sponsor
- Human Genome Sciences Inc.
Systemic Lupus Erthematosus, Auto Immune Disease
A Study of GR1803 in Systemic Lupus Erythematosus
to evaluate the safety and efficacy of GR1803 in the treatment of patients with systemic lupus erythematosus
- Trial name
- NCT07348055
- Testing
- GR1803 injection
- Where
- China
- Volunteers
- 44 people
- Sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Lupus Erythematosus, Systemic
Long-term Safety and Tolerability of Atacicept (Long-term Follow-Up of Participant Who Participated in ADDRESS II)
This is a multicenter, double-blind, Phase 2b, long-term extension (LTE) to the ADDRESS II core trial (EMR 700461-023) (NCT01972568), to evaluate long-term safety and tolerability of atacicept in participants with systemic lupus…
- Trial name
- NCT02070978
- Testing
- Atacicept 75 mg, Atacicept 150 mg
- Where
- 84 sites in United States, Argentina and 15 more
- Volunteers
- 253 people
- Sponsor
- EMD Serono
Systemic Lupus Erythematosus
A Phase 2B Open-Label, Single-Arm, Repeat-Dose Study to Evaluate the Reliability of an Autoinjector
The primary objective of this study is to assess the suitability of the autoinjector for self-administration of belimumab by subjects with SLE in real-life conditions.
- Trial name
- NCT02124798
- Testing
- Belimumab autoinjector
- Where
- 27 sites in United States
- Volunteers
- 95 people
- Sponsor
- GlaxoSmithKline
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
Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Systemic
A Study of Skin and Systemic Biomarkers In Patients With Active Cutaneous Lupus Erythematosus And In Healthy Volunteers
The purpose of this study is to obtain skin, blood, and urine samples from patients with active cutaneous lupus lesions and from healthy participants.
- Conditions
- Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Systemic, Lupus Erythematosus, Discoid, Healthy
- Trial name
- NCT02034344
- Testing
- Skin biopsy, Blood collection, Urine collection
- Where
- 21 sites in United States, Germany and 4 more
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Systemic Lupus Erythematosus
Phase 1 Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)
The purpose of thie study is to evaluate the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of belimumab (LymphoStat-B™)in subjects with SLE.
- Trial name
- NCT00657007
- Testing
- belimumab
- Where
- 18 sites in United States
- Volunteers
- 70 people
- Sponsor
- Human Genome Sciences Inc.