Clinical trials: Scleroderma Systemic, open to volunteers
Digital Ulcers in Systemic Sclerosis
Safety and Tolerability of TOP-N53 Applied on Digital Ulcers in Patients With Systemic Sclerosis
The main goal of this clinical trial is to learn about how safe the new drug TOP-N53 solution is when it is applied to open wounds on the fingertip (digital ulcers) in people with an uncommon illness that results in hard…
- Trial name
- TOP-N53-02 (NCT06954597)
- Testing
- TOP-N53, Sildenafil, TOP-N53 vehicle
- Where
- 6 sites in France, Switzerland
- Volunteers
- 15 people
- Sponsor
- Topadur Pharma AG
Scleroderma, Mildly Elevated Pulmonary Pressures
Sildenafil for Early Pulmonary Vascular Disease in Scleroderma
This is a Phase II randomized, double-blind, placebo-controlled trial of sildenafil in men and women with Scleroderma with mildly elevated pulmonary pressures (SSc-MEP) to determine whether sildenafil may be an effective…
- Trial name
- SEPVADIS (NCT04797286)
- Testing
- Sildenafil
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Johns Hopkins University
Autoimmune Bullous Dermatosis, Dysimmune Dermatological Diseases
Clinico-biological Collection of Autoimmune, Dysimmune or Auto-inflammatory Dermatological Diseases
The aim of this project is to start a biological and clinical collection of patients presenting autoimmune, dysimmune or auto-inflammatory dermatological diseases.
- Conditions
- Autoimmune Bullous Dermatosis, Dysimmune Dermatological Diseases, Auto-inflammatory Dermatological Diseases, Skin Diseases
- Trial name
- TekAPo (NCT06387654)
- Testing
- Blood sampling, Remainders of samples taken as part of the treatment
- Where
- France
- Volunteers
- 800 people
- Sponsor
- University Hospital, Toulouse
Scleroderma, Systemic Sclerosis
Preventive Effect of Clopidogrel on the Systemic Sclerosis Development Risk
Systemic sclerosis (SSc) is a severe autoimmune disease associating dysimmunity, vasculopathy and fibrosis. No curative treatment is available. Pre-clinical abnormalities can be found such as specific autoantibodies.
- Trial name
- PSSIT (NCT05098704)
- Testing
- clopidogrel treatment
- Where
- 11 sites in France
- Volunteers
- 90 people
- Sponsor
- University Hospital, Bordeaux
Systemic Sclerosis, Scleroderma
RESET-SSc: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T Cell Therapy, in Subjects With Systemic Sclerosis
RESET-SSc: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T cell therapy, in Subjects with Systemic Sclerosis
- Conditions
- Systemic Sclerosis, Scleroderma, Interstitial Lung Diseases
- Trial name
- NCT06328777
- Testing
- CABA-201
- Where
- 10 sites in United States
- Volunteers
- 37 people
- Sponsor
- Cabaletta Bio
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 Sclerosis Associated Interstitial Lung Disease, Scleroderma, Systemic
A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease
This study investigates the efficacy and safety of belimumab compared to placebo, in addition to standard therapy, for the treatment of participants with systemic sclerosis associated interstitial lung disease (SSc-ILD).
- Trial name
- BLISSc-ILD (NCT05878717)
- Testing
- Belimumab
- Where
- 134 sites in United States, Argentina and 16 more
- Volunteers
- 300 people
- Sponsor
- GlaxoSmithKline
Systemic Lupus Erythematosus (SLE), Idiopathic Inflammatory Myopathy (IIM)
A Study of OL-108 in Relapsed/Refractory Autoimmune Diseases
This study aims to characterize the safety, tolerability, pharmacokinetics, and preliminary efficacy of OL-108 in relapsed/refractory autoimmune diseases.
- Conditions
- Systemic Lupus Erythematosus (SLE), Idiopathic Inflammatory Myopathy (IIM), Systemic Sclerosis (SSc), ANCA Associated Vasculitis (AAV)
- Trial name
- NCT06980597
- Testing
- OL-108
- Where
- 2 sites in China
- Volunteers
- 44 people
- Sponsor
- Beijing GoBroad Hospital
Systemic Sclerosis
A Study of Nemolizumab for the Treatment of Adults With Systemic Sclerosis
The main purpose of the study is to investigate the efficacy on cutaneous thickness and the safety of Nemolizumab in adult patients with systemic sclerosis after a 52-week treatment period and to select the optimal dose for this…
- Trial name
- NCT07047690
- Testing
- Nemolizumab
- Where
- 3 sites in United States, Switzerland
- Volunteers
- 162 people
- Sponsor
- Galderma R&D
Systemic Lupus Erythematosus, Rheumatoid Arthritis
Early Clinical Study of UTAA91 Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases
This clinical trial is designed as a single - arm, open - label, single - center, investigator - initiated early - phase clinical study.
- Conditions
- Systemic Lupus Erythematosus, Rheumatoid Arthritis, Dry Syndrome, Idiopathic Inflammatory Myopathies
- Trial name
- NCT06970951
- Testing
- UTAA91 injection
- Where
- China
- Volunteers
- 15 people
- Sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Systemic Lupus Erythematosus, Rheumatoid Arthritis (RA)
A Phase 1 Study of QLS2416 Injection in Participants With Autoimmune Diseases
The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and efficacy of QLS2416 injection in participants with autoimmune diseases (AID).
- Conditions
- Systemic Lupus Erythematosus, Rheumatoid Arthritis (RA), Primary Sjögren's Syndrome (pSS), Systemic Sclerosis (SSc)
- Trial name
- NCT07906145
- Testing
- QLS2416 Injection
- Volunteers
- 76 people
- Sponsor
- Shanghai Qilu Pharmaceutical Research and Development Center LTD
Autoimmune Diseases, Systemic Lupus Erthematosus (SLE)
Allogeneic CD19/BCMA CAR-T for B Cell-Related Autoimmune Disease
This is an exploratory, open-label, single-arm Phase 1 clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of QT-219C.
- Conditions
- Autoimmune Diseases, Systemic Lupus Erthematosus (SLE), Multi-Drug Resistant Nephrotic Syndrome, IgA Nephropathy (IgAN)
- Trial name
- NCT07507201
- Testing
- UCAR T-cell
- Where
- China
- Volunteers
- 15 people
- Sponsor
- The Children's Hospital of Zhejiang University School of Medicine
Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE)
Study Investigating the Safety of Anti-CD19 CAR-T Cells Therapy Produced at Gustave Roussy for Adults With Severe and Refractory Systemic Autoimmune Rheumatic Diseases
This is an open-label, single-dose, prospective, monocenter, Phase I interventional study (not first-in-human) to assess the safety, tolerability, and preliminary efficacy of autologous anti-CD19 CAR-T cells as an advanced…
- Conditions
- Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE), Sjogren's Disease With Dry Eyes, Systemic Sclerosis (SSc)
- Trial name
- CELL-ATTACK 1 (NCT07544225)
- Testing
- anti-CD19 CAR-T cells
- Where
- France
- Volunteers
- 6 people
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
D013493
Objective Assessment of Skin Damage Using ADHELASKIN in Patients With Systemic Sclerosis
Systemic sclerosis (SSc) is an autoimmune disease characterized by skin fibrosis, which clinically manifests as thickening, hardening, and loss of elasticity of the skin.
- Trial name
- OBSKINS (NCT07543679)
- Testing
- ADHELASKIN (Tactinnov° - Ecole centrale de Lyon)
- Where
- France
- Volunteers
- 100 people
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne
Systemic Lupus Erythematosus, Systemic Sclerosis (SSc)
CAR T-cell Therapy Targeting CD19 and BCMA in Patients With Relapse/Refractory Autoimmune Diseases
CAR T-cell Therapy Targeting CD19 and BCMA in Patients With Relapse/Refractory Autoimmune Diseases
- Conditions
- Systemic Lupus Erythematosus, Systemic Sclerosis (SSc), Inflammatory Myopathy, ANCA-Associated Vasculitis (AAV)
- Trial name
- NCT06941129
- Testing
- UCAR T-cell
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Systemic Sclerosis, Digital Ulcer
Mesenchymal Stromal Cells as Treatment for Digital Ulcers in Systemic Sclerosis
The MANUS Trial aims to examine the safety, feasibility and potential efficacy of intramuscularly injected allogeneic mesenchymal stromal cells as treatment for digital ulcers of systemic sclerosis.
- Trial name
- MANUS (NCT03211793)
- Testing
- Mesenchymal stromal cells
- Where
- Netherlands
- Volunteers
- 20 people
- Sponsor
- UMC Utrecht
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
Systemic Sclerosis With Lung Involvement, Systemic Sclerosis
Mycophenolate Mofetil in Systemic Sclerosis With Subclinical Interstitial Lung Disease
The goal of this pilot study is to assess the feasibility of a larger study on the efficacy of mycophenolate mofetil in people diagnosed with systemic sclerosis with mild lung involvement.
- Conditions
- Systemic Sclerosis With Lung Involvement, Systemic Sclerosis, Interstitial Lung Disease
- Trial name
- SSc-mILD (NCT05785065)
- Testing
- Mycophenolate Mofetil
- Where
- 3 sites in Canada
- Volunteers
- 35 people
- Sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
Systemic Sclerosis
A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacabtagene- Autoleucel / Zola-cel), CD19-CAR T Cells, Versus Standard of Care in Participants With Active Systemic Sclerosis
The purpose of this study is to compare the efficacy and safety of BMS-986353 versus standard of care in participants with active Systemic Sclerosis
- Trial name
- Breakfree-SSc (NCT07335562)
- Testing
- BMS-986353, Fludarabine, Cyclophosphamide
- Where
- 56 sites in United States, Belgium and 8 more
- Volunteers
- 92 people
- Sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
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