Clinical trials: System Lupus Erythematosus
Systemic Lupus Erythematosus (SLE)
To Evaluate the Efficacy and Safety of SG301 SC Injection in Systemic Lupus Erythematosus
This was a multicenter, randomized, double-blind, placebo-controlled Phase 2 clinical study. The primary objective was to evaluate the efficacy of SG301 SC injection in participants with Systemic Lupus Erythematosus (SLE) based…
- Trial name
- NCT07447986
- Testing
- SG301 SC Injection
- Where
- 40 sites in China
- Volunteers
- 120 people
- Sponsor
- Hangzhou Sumgen Biotech Co., Ltd.
Lupus Nephritis, Systemic Lupus Erythematosus
A Phase 2, Open-Label, Single-Arm Trial of FT819 in Participants With Lupus Nephritis
The primary objective of this trial is to evaluate the efficacy and safety of FT819, comprised of allogeneic T cells that express a CD19-targeted CAR, following bendamustine administration in participants with refractory…
- Conditions
- Lupus Nephritis, Systemic Lupus Erythematosus, SLE - Systemic Lupus Erythematosus, Lupus Nephritis - WHO Class III
- Trial name
- RECLAIM-LN (NCT07570862)
- Testing
- FT819
- Where
- 12 sites in United States
- Volunteers
- 53 people
- Sponsor
- Fate Therapeutics
Systemic Lupus Erythematosus
BAFF CAR-T Cells (LMY-920) for Systemic Lupus Erythematosus
This phase 1 study seeks to examine the safety and recommended phase 2 dose (RP2D) of BAFF-ligand CAR-T cells (LMY-920) in adult patients with refractory systemic lupus erythematosus (SLE).
- Trial name
- NCT06340750
- Testing
- LMY-920
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Luminary Therapeutics
Systemic Lupus Erythematosus
Safety of IFNa Kinoid in Systemic Lupus Erythematosus
Interferon alpha (IFNa) is involved in the pathogenesis of systemic lupus erythematosus (SLE)and IFNa levels are associated with the severity of the disease. Blocking IFNa could be an attractive therapeutic strategy.
- Trial name
- NCT01058343
- Testing
- IFN-K
- Where
- 15 sites in Belgium, Bulgaria and 4 more
- Volunteers
- 28 people
- Sponsor
- Neovacs
Systemic Lupus Erythematosus
A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus
The purpose of this study is to evaluate the ability of dapirolizumab pegol (DZP) as an add-on treatment to standard of care (SOC) medication to achieve clinically relevant long term improvement of moderate to severe disease…
- Trial name
- PHOENYCS FLY (NCT06617325)
- Testing
- DZP
- Where
- 245 sites in United States, Argentina and 21 more
- Volunteers
- 450 people
- Sponsor
- UCB Biopharma SRL
Lupus Nephritis
LUPKYNIS Drug-use Results Survey
The purpose of this study is to survey the safety of LUPKYNIS in patients with lupus nephritis under actual use conditions. In addition, information on efficacy will be collected.
- Trial name
- NCT07053891
- Testing
- Voclosporin (LUPKYNIS)
- Where
- Japan
- Volunteers
- 400 people
- Sponsor
- Otsuka Pharmaceutical 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.
Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus
Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic (PK/PD) Profile of ACT100 in Healthy Participants..
This study is a Phase Ia, single-center, randomized, double-blind, dose-escalation, placebo-controlled clinical trial designed to evaluate the safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) profile of ACT100 in…
- Trial name
- NCT07408908
- Testing
- ACT100 Injection
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Systematic Lupus Erythematosus, Cutaneous Lupus Erythematosus
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)
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
- NCT07355218
- Testing
- Enpatoran, Standard of care (SoC)
- Where
- 57 sites in United States, Australia and 15 more
- Volunteers
- 202 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Lupus Nephritis
BIIB023 Proof-of-Concept Study in Participants With Lupus Nephritis
The primary objective of the study is to assess the efficacy of BIIB023 as an add-on treatment to background therapy compared with placebo in combination with background therapy in the treatment of participants with active…
- Trial name
- ATLAS (NCT01499355)
- Testing
- BIIB023, mycophenolate mofetil, oral corticosteroids
- Where
- 58 sites in United States, Argentina and 19 more
- Volunteers
- 276 people
- Sponsor
- Biogen
IgA Nephropathy, Lupus Nephritis (LN)
A Phase 2 Study to Evaluate the Safety, PD, PK, and Clinical Activity of ADX-097 in Participants With IgAN, LN or C3G
A Phase 2 Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Clinical Activity of ADX-097 Administered Subcutaneously in Male and Female Participants Aged 16 Years or Older with Immunoglobulin A Nephropathy…
- Conditions
- IgA Nephropathy, Lupus Nephritis (LN), C3 (Complement Component 3) Glomerulopathy
- Trial name
- NCT06419205
- Testing
- ADX-097
- Where
- 4 sites in United States, Brazil
- Volunteers
- 30 people
- Sponsor
- Akebia Therapeutics
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
A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus
The purpose of this study is to evaluate the efficacy of ustekinumab as measured by a reduction in disease activity for subjects with active Active Systemic Lupus Erythematosus (SLE - chronic disorder of connective tissue in…
- Trial name
- NCT02349061
- Testing
- Ustekinumab IV, Ustekinumab SC, Concomitant Medication
- Where
- 43 sites in United States, Argentina and 7 more
- Volunteers
- 102 people
- Sponsor
- Janssen Research & Development, LLC
Atopic Dermatitis, Healthy
Pilot Tape Harvesting Study
The main objectives of the study are: To determine if RNA recovery from tape harvesting allows for the identification of a disease gene signature (e.g., interferon [IFN] signature for lupus) or other biomarkers that may…
- Conditions
- Atopic Dermatitis, Healthy, Discoid Lupus Erythematosus, Subacute Cutaneous Lupus Erythematosus
- Trial name
- NCT02125695
- Testing
- Skin Taping, Blood Sampling, Skin Biopsy
- Where
- 2 sites in United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Biogen
Difficult to Treat Systemic Lupus Erythematosus
Clinical Study Evaluating the Safety and Efficacy of IC19 CAR-T Cell Therapy for Refractory Systemic Lupus Erythematosus
This study is an open label, single arm exploratory clinical trial of IC19 CAR-T cell therapy for refractory systemic lupus erythematosus.
- Trial name
- IC19 CAR-T (NCT06886919)
- Testing
- Engineering of chimeric antigen receptors targeting CD19 in allogeneic T cells
- Volunteers
- 6 people
- Sponsor
- Beijing Immunochina Medical Science & Technology Co., Ltd.
Lupus Erythematosus, Systemic
Pharmacokinetics Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)
The goal of this study is to evaluate how epratuzumab is processed by the body (pharmacokinetics) and whether 2 dose levels of epratuzumab are safe and effective in patients with SLE.
- Trial name
- NCT00113971
- Testing
- epratuzumab
- Where
- 3 sites in United States
- Volunteers
- 20 people
- Sponsor
- UCB Pharma
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
Autoimmune Diseases
A Study to Investigate the Safety and Pharmacological Effect of a Single Intravenous Infusion of Belantamab in Male and Female Participants Aged 18 to 75 With Autoimmune Disease
The goal of this clinical trial is to assess the safety and tolerability profile of belantamab. The study will also assess how the levels of belantamab change over time and body's reaction to it in participants with stable but…
- Trial name
- NCT06413511
- Testing
- Belantamab
- Sponsor
- GlaxoSmithKline
Systemic Lupus Erythematosus
A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus Erythematosus
The purpose of this study is to evaluate the effectiveness and safety of deucravacitinib compared with placebo in an active moderate to severe Systemic Lupus Erythematosus (SLE) population.
- Trial name
- POETYK SLE-2 (NCT05620407)
- Testing
- Deucravacitinib
- Where
- 180 sites in United States, Argentina and 20 more
- Volunteers
- 513 people
- Sponsor
- Bristol-Myers Squibb
Lupus Erythematosus, Systemic Lupus Erythematosus
Study Evaluating SC291 in Subjects With Severe r/r B-cell Mediated Autoimmune Diseases (GLEAM)
SC291-102 is a Phase 1 study to evaluate SC291 safety and tolerability, preliminary clinical response, cellular kinetics and exploratory assessments for subjects with severe autoimmune diseases.
- Conditions
- Lupus Erythematosus, Systemic Lupus Erythematosus, SLE (Systemic Lupus), Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
- Trial name
- NCT06294236
- Testing
- SC291
- Where
- 5 sites in United States
- Volunteers
- 7 people
- Sponsor
- Sana Biotechnology