Clinical trials: Systemic Autoimmune Diseases
Scleroderma, Diffuse, Scleroderma, Systemic
Oral Ifetroban to Treat Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension
The purpose of this phase 2 multicenter, randomized, double-blind, placebo-controlled, study is to assess the safety and efficacy of ifetroban in patients with diffuse cutaneous systemic SSc (dcSSc) or SSc-associated pulmonary…
- Conditions
- Scleroderma, Diffuse, Scleroderma, Systemic, Scleroderma, Limited, Sclerosis, Progressive Systemic
- Trial name
- NCT02682511
- Testing
- Oral Ifetroban
- Where
- 13 sites in United States, India
- Volunteers
- 34 people
- Sponsor
- Cumberland Pharmaceuticals
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
Lupus Nephritis, Lupus Nephritis - WHO Class III
KYSA-3: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Refractory Lupus Nephritis
A Study of Anti-CD19 Chimeric Antigen Receptor T Cell Therapy for Subjects With Refractory Lupus Nephritis
- Conditions
- Lupus Nephritis, Lupus Nephritis - WHO Class III, Lupus Nephritis - WHO Class IV
- Trial name
- NCT06342960
- Testing
- KYV-101 anti-CD19 CAR-T cell therapy, Standard lymphodepletion regimen
- Where
- 6 sites in Germany
- Volunteers
- 2 people
- Sponsor
- Kyverna Therapeutics
Systemic Sclerosis, Systemic Sclerosis - Diffuse Cutaneous
KYSA-5: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Systemic Sclerosis
A Study of Anti-CD19 Chimeric Antigen Receptor T Cell Therapy for Subjects with Systemic Sclerosis
- Conditions
- Systemic Sclerosis, Systemic Sclerosis - Diffuse Cutaneous, Systemic Sclerosis - 2013 ACR/EULAR Classification Criteria
- Trial name
- NCT06400303
- Testing
- KYV-101, Standard lymphodepletion regimen
- Where
- 2 sites in United States
- Volunteers
- 3 people
- Sponsor
- Kyverna Therapeutics
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
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 Evaluating the Efficacy and Safety of Afimetoran Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)
The purpose of this study is to evaluate the effectiveness, safety and tolerability of Afimetoran in participants with active Systemic Lupus Erythematosus (SLE).
- Trial name
- NCT04895696
- Testing
- Afimetoran
- Where
- 147 sites in United States, Argentina and 17 more
- Volunteers
- 248 people
- Sponsor
- Beeline Medicines Corporation
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
Healthy, Idiopathic Inflammatory Myopathies
A Phase 1 Open-label Study to Evaluate Safety in Healthy Participants and Participants With Autoimmune Diseases
The purpose of this study is to determine the safety and tolerability of XmAb657 in healthy participants and participants with autoimmune diseases.
- Conditions
- Healthy, Idiopathic Inflammatory Myopathies, Systemic Sclerosis, Sjögren's Disease
- Trial name
- NCT07284797
- Testing
- XmAb657
- Where
- Australia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Xencor, 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
Systemic Sclerosis (SSc), Scleroderma
Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)
The study is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the effects of tibulizumab over 24 weeks (Period 1) in adult participants with systemic sclerosis, followed by an open-label…
- Trial name
- NCT06843239
- Testing
- Tibulizumab
- Where
- 60 sites in United States, Argentina and 8 more
- Volunteers
- 80 people
- Sponsor
- Zura Bio Inc
Refractory Autoimmune Diseases
A Study of Healthy Donor CD19-targeted Allogeneic CAR T Cells in Participants With Severe, Refractory Autoimmune Diseases
The purpose of this study is to determine the safety, tolerability, optimal dose, and preliminary efficacy of BMS-986515, a healthy donor (HD) allogeneic CD19-targeted CART cell product, in participants with severe, refractory…
- Trial name
- NCT07115745
- Testing
- BMS-986515, Fludarabine, Cyclophosphamide
- Where
- 28 sites in United States, Australia and 8 more
- Volunteers
- 125 people
- Sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Lupus Nephritis, Systemic Lupus Erythematosus
US Zamto-cel Autoimmune Diseases
AID is a phase I multi-cohort study to assess the safety and tolerability of zamtocabtagene autoleucel (zamto-cel) in patients with refractory autoimmune diseases (SLE-Non renal, SLE-LN, SSc/dcSSc) after receiving standard…
- Conditions
- Lupus Nephritis, Systemic Lupus Erythematosus, Systemic Sclerosis (SSc), Diffuse Cutaneous Systemic Sclerosis
- Trial name
- NCT06708845
- Testing
- zamtocabtagene autoleucel, Cyclophosphamide, Fludarabine
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Miltenyi Biomedicine GmbH
Systemic Lupus Erythematosus, Autoimmune Hemolytic Anemia (AIHA)
Evaluation of Safety, Pharmacokinetics and Pharmacodynamics of Arnovie101, an mRNA-LNP-Based In Vivo CAR-T Therapy, for the Treatment of B Cell-Mediated Autoimmune Diseases (SLE and AIHA)
This is an open lable and single arm study designed to evaluate the safety, PK and PD of Arnovie101 in B cell-mediated Autoimmune Disease
- Trial name
- NCT07629596
- Testing
- Arnovie101 Infusion Intravenous
- Where
- China
- Volunteers
- 5 people
- Sponsor
- Circunited BioPharma (Shenzhen) Co., Ltd.
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
Systemic Lupus Erythematosus, Rheumatoid Arthritis
Electromagnetic Immunotherapy Mapping and Cytokine Forecasting Study (QSIT)
The ImmuneNet study is a Phase I/II clinical trial sponsored by Truway Health, Inc. It will test whether gentle, low-frequency electromagnetic resonance (LF-EMR) can influence how immune cells communicate and synchronize with…
- Conditions
- Systemic Lupus Erythematosus, Rheumatoid Arthritis, Multiple Sclerosis, Autoimmune Diseases
- Trial name
- QSIT (NCT07221565)
- Testing
- Low-Frequency Electromagnetic Resonance Therapy (LF-EMR), Low-Dose Naltrexone (LDN)
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Truway Health, Inc.
Systemic Lupus Erythematosus
Safety and Effectiveness of BENLYSTA (Belimumab) in Systemic Lupus Erythematosus (SLE) Registry
The purpose of this prospective, observational cohort study is to evaluate the incidence of adverse events of special interest (AESI) and effectiveness in participants with active, autoantibody-positive SLE treated with and…
- Trial name
- SABLE (NCT01729455)
- Testing
- Benlysta, Standard of Care (SoC) Therapy
- Where
- 179 sites in United States, Argentina and 11 more
- Volunteers
- 3,138 people
- Sponsor
- GlaxoSmithKline
Lupus Nephritis, Autoimmune Diseases
A Phase 1 Study of Prulacabtagene Leucel (Prula-cel, Formerly ADI-001) in Autoimmune Disease
ADI-202300103 is a phase 1 multicenter, open label, dose finding and dose expansion, safety/efficacy study in patients with autoimmune disease.
- Conditions
- Lupus Nephritis, Autoimmune Diseases, Systemic Sclerosis (SSc), Systemic Lupus Erythematosus (SLE)
- Trial name
- NCT06375993
- Testing
- ADI-001, Fludarabine, Cyclophosphamide
- Where
- 2 sites in United States
- Volunteers
- 180 people
- Sponsor
- Adicet Therapeutics
SLE (Systemic Lupus), Systemic Sclerosis
Clinical Study on Targeted CD19 or CD19-BCMA CAR-T Therapy for Autoimmune Diseases
This is an open clinical pharmacological translational Research Study, aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of CD19 or CD19-BCMA CAR-T in patients with active SLE, SSc, AAV…
- Conditions
- SLE (Systemic Lupus), Systemic Sclerosis, ANCA Associated Vasculitis, Idiopathic Inflammatory Myopathies
- Trial name
- NCT06548607
- Testing
- CD19 or CD19-BCMA CAR-T
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Nanjing Bioheng Biotech Co., Ltd.
Systemic Lupus Erythematosus, Systemic Sclerosis
Clinical Study on Targeted CD19CAR-T Therapy for Autoimmune Diseases
This is an open-label, investigator-initiated clinical trial (IIT) aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-04 in patients with active SLE, SSc, AAV, IIM, and pSS
- Conditions
- Systemic Lupus Erythematosus, Systemic Sclerosis, ANCA Associated Vasculitis, Idiopathic Inflammatory Myopathies
- Trial name
- NCT06549296
- Testing
- RD06-04 CART Cell Injection
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Nanjing Bioheng Biotech Co., Ltd.