Clinical trials: SLE
Systemic Lupus Erythematosus (SLE)
A Study in Participants With Active Systemic Lupus Erythematosus With Inadequate Response to Glucocorticoids and ≥2 Immunosuppressants
The purpose of this study is to characterize the efficacy and safety of current standard of care treatment options in participants with active systemic lupus erythematosus (SLE; including lupus nephritis) with inadequate response…
- Trial name
- BENCHMARK-SLE (NCT07175285)
- Testing
- Current standard of care treatment options
- Where
- 66 sites in United States, Argentina and 11 more
- Volunteers
- 223 people
- Sponsor
- Bristol-Myers Squibb
Systemic Lupus Erythematosus (SLE)
Clinical Study of Cizutamig in Systemic Lupus Erythematosus
The purpose of this study is to assess the safety, tolerability, PK, PD, immunogenicity, and preliminary clinical activity of Cizutamig in patients with Systemic Lupus Erythematosus
- Trial name
- NCT07215663
- Testing
- Cizutamig
- Where
- 17 sites in China
- Volunteers
- 47 people
- Sponsor
- Candid Therapeutics
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
Systemic Lupus Erythematosus (SLE)
INTERSTELLAR - International Study Evaluating Lupus Outcomes After Anifrolumab Real World Use
INTERSTELLAR study will generate critical prospective real-world evidence on the benefits of adding Anifrolumab to standard of care treatment for SLE in routine clinical practice, to inform physicians, payers and patients.
- Trial name
- INTERSTELLAR (NCT06314282)
- Where
- 32 sites in Argentina, China and 10 more
- Volunteers
- 200 people
- Sponsor
- AstraZeneca
Systemic Lupus Erthematosus (SLE), Progressive Multiple Sclerosis (PMS)
A Basket Study of CTA313 in Participants With Active Autoimmune Diseases
The goal of the ALLNEW clinical trial is to learn if CTA313 UCART is safe and effective for patients with immune mediated disorders.
- Conditions
- Systemic Lupus Erthematosus (SLE), Progressive Multiple Sclerosis (PMS), Autoimmune Encephalitis
- Trial name
- ALLNEW (NCT07783269)
- Testing
- CTA313 UCAR T Cell Infusion
- Volunteers
- 81 people
- Sponsor
- Imviva Bio
Systemic Lupus Erythematosus (SLE)
A Phase 2 Study on the Safety and Efficacy of the Anti-BAFF-R Monoclonal Antibody, ESG206, in Patients With Systemic Lupus Erythematosus
This is a multicenter, randomized, double-blind, placebo-controlled Phase II study designed to evaluate the efficacy and safety of ESG206 in participants with Systemic Lupus Erythematosus (SLE).
- Trial name
- NCT07760155
- Testing
- ESG206
- Where
- 20 sites in China
- Volunteers
- 40 people
- Sponsor
- Shanghai Escugen Biotechnology Co., Ltd
Systemic Lupus Erythematosus (SLE)
SG301-SC Injection Safety Study in Subjects With Systemic Lupus Erythematosus
This is a randomized, double-blind, placebo-controlled phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single dose in healthy volunteers and multiple doses of SG301 SC…
- Trial name
- NCT06144710
- Testing
- SG301 SC Injection
- Where
- 10 sites in China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Hangzhou Sumgen Biotech Co., Ltd.
SLE - Systemic Lupus Erythematosus
IASO-782 in Systemic Lupus Erythematosus
his study is a randomized, double-blinded, and placebo-controlled phase Ia clinical study in subjects with SLE. The study is designed to assess the safety and tolerability of IASO-782 for the treatment of SLE.
- Trial name
- NCT07483346
- Testing
- IASO-782 injection
- Where
- 4 sites in China
- Volunteers
- 20 people
- Sponsor
- Shanghai IASO Biotechnology Co., Ltd
SLE, LN
A Study of Anti-CD19/BCMA Universal CAR-T Cell Therapy RD06-05 in Patients With Autoimmune Diseases.
An Exploratory, Single-Arm, Open-Label, Dose-Escalation Study of the Safety, Tolerability, PK, PD, and Efficacy of Anti-CD19/BCMA Universal CAR-T Therapy RD06-05 in Autoimmune Diseases (including SLE/LN, AAV/AAGN, Anti-GBM, MN…
- Conditions
- SLE, LN, ANCA Associated Vasculitis, ANCA-Associated Glomerulonephritis
- Trial name
- NCT07203404
- Testing
- RD06-05 CART Cell Injection
- Where
- China
- Volunteers
- 96 people
- Sponsor
- Nanjing Bioheng Biotech Co., Ltd.
SLE - Systemic Lupus Erythematosus
A Study to Evaluate the Safety,Tolerability,Pharmacokinetics and Pharmacodynamics of Cenerimod in Adult Chinese Participants With Moderate-to-severe Systemic Lupus Erythematosus (SLE)
The goal of this clinical trial is to learn about the safety, how the body processes the drug, and its effects of a drug called cenerimod in adult Chinese participants (aged 18-75) with moderate to severe Systemic Lupus…
- Trial name
- NCT07266090
- Testing
- cenerimod 4 mg
- Where
- 7 sites in China
- Volunteers
- 15 people
- Sponsor
- Viatris Pharmaceuticals Co., Ltd.
Rheumatoid Arthritis (RA), Systemic Lupus Erthematosus (SLE)
BAFF CAR-T Cells (LMY-922) for Treatment of Refractory Autoimmune Disease
Therapy with chimeric antigen receptor T (CAR-T) cells has demonstrated activity against refractory autoimmune disease, however not all disease responds or remains in response to CD19 targeted CAR-T cells.
- Conditions
- Rheumatoid Arthritis (RA), Systemic Lupus Erthematosus (SLE), Dermatomyositis (DM), Systemic Sclerosis (SSc)
- Trial name
- NCT07729995
- Testing
- LMY-922
- Where
- United States
- Volunteers
- 94 people
- Sponsor
- Luminary Therapeutics
Systemic Lupus Erythematosus (SLE), Alopecia Areata (AA)
A Phase 1 Trial to Evaluate the Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of VIS171 in Participants With Autoimmune Disease(s)
The purpose of this trial is to measure safety and tolerability of subcutaneous (SC) VIS171 in combination with standard of care in participants with autoimmune disease(s).
- Conditions
- Systemic Lupus Erythematosus (SLE), Alopecia Areata (AA), Immune-mediated Focal Segmental Glomerulosclerosis (FSGS)
- Trial name
- NCT06799520
- Testing
- VIS171
- Where
- 6 sites in Bulgaria, Moldova and 2 more
- Volunteers
- 30 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
SLE
Phase 2 Placebo-Controlled Study to Assess the Safety and Efficacy of ESK-001 in Active Systemic Lupus Erythematosus
The purpose of this study is to assess the clinical efficacy, safety, PK, and PD of multiple dose levels of ESK-001 compared with placebo in adult patients with SLE.
- Trial name
- LUMUS (NCT05966480)
- Testing
- Envudeucitinib
- Where
- 169 sites in United States, Argentina and 19 more
- Volunteers
- 408 people
- Sponsor
- Alumis Inc
SLE (Systemic Lupus), RA - Rheumatoid Arthritis
Phase 1a/b Tolerability of NTR-1011 in Healthy Adults and Adult Patients With SLE and RA
The goal of this clinical trial is to inform the safety and tolerability of NTR-1011 in treating adult patients diagnosed with systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA).
- Trial name
- LIBERATE-I (NCT07237659)
- Testing
- NTR1011
- Where
- 7 sites in United States
- Volunteers
- 24 people
- Sponsor
- Neutrolis
SLE - Systemic Lupus Erythematosus, Systemic Sclerosis
CD19/BCMA-Targeted Universal CAR-T Cell Injection for the Treatment of Autoimmune Diseases
This is a single-arm, open-label, investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of RD06-05 in patients with autoantibody-mediated autoimmune…
- Conditions
- SLE - Systemic Lupus Erythematosus, Systemic Sclerosis, ANCA Associated Vasculitis, Idiopathic Inflammatory Myopathies
- Trial name
- NCT07596680
- Testing
- RD06-05 CAR-T Cell Injection
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Nanjing Bioheng Biotech Co., Ltd.
Systemic Lupus Erythematosus, SLE
An Ascending Dose Study of PIT565 in Participants With Systemic Lupus Erythematosus (SLE).
The purpose of the study is to determine the safety, tolerability, and pharmacokinetics of PIT565 in participants with SLE
- Trial name
- NCT06335979
- Testing
- PIT565
- Where
- 11 sites in China, Germany and 4 more
- Volunteers
- 54 people
- Sponsor
- Novartis Pharmaceuticals
Systemic Lupus Erythematosus, SLE (Systemic Lupus)
A Study in Participants With Mild-to-moderate Systemic Lupus Erythematosus
The main purpose of this study is to evaluate the safety and tolerability of CUG252 following multiple ascending doses in participants with Systemic Lupus Erythematosus (SLE).
- Conditions
- Systemic Lupus Erythematosus, SLE (Systemic Lupus), Autoimmune
- Trial name
- NCT05866861
- Testing
- CUG252
- Where
- 11 sites in United States
- Volunteers
- 40 people
- Sponsor
- Cugene Inc.
Systemic Lupus Erythematosus (SLE)
AZAHAR Study To Describe Anifrolumab in a Real-World Setting
AZAHAR is an observational retrospective and longitudinal study with adults patients with SLE who initiated treatment with anifrolumab from June 1, 2023 to May 31, 2024.
- Trial name
- AZAHAR (NCT06626945)
- Where
- 13 sites in Spain
- Volunteers
- 152 people
- Sponsor
- AstraZeneca
Systemic Lupus Erythematosus (SLE) or Cutaneous Lupus Erythematosus
A Phase 1/2a Study of DB-2304 in Healthy Adults and SLE/CLE Participants
A Phase 1/2a Study of DB-2304 in Healthy Participants and Participants with Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus
- Trial name
- NCT06625671
- Testing
- DB-2304, Prednisone
- Where
- 7 sites in United States, Australia
- Volunteers
- 148 people, healthy volunteers welcome
- Sponsor
- DualityBio Inc.
Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM)
A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
This is a phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and anti-B-cell activity of FT819 following treatment with or without auxiliary medicinal product (AMP) in participants with moderate-to-severe…
- Conditions
- Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM), Systemic Sclerosis (SSc), Systemic Lupus Erythematosus (SLE)
- Trial name
- NCT06308978
- Testing
- FT819, Fludarabine, Cyclophosphamide
- Where
- 21 sites in United States, France and 2 more
- Volunteers
- 244 people
- Sponsor
- Fate Therapeutics