16 recruiting. 16 Phase 2, 5 Phase 1, 3 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 16 | Recruiting 16 |
| Phase 1 | 5 | Recruiting 5 |
| Phase 3 | 3 | Recruiting 3 |
Follow Scleroderma, Diffuse: new trials by email Literature Review of Scleroderma, Diffuse trials Research Report on Scleroderma, Diffuse
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| EncompaSSc: Evaluation of MTX-474 in Participants With Diffuse Cutaneous Systemic Sclerosis (dcSSc) MTX-474, Placebo - Diffuse Cutaneous Systemic Sclerosis | Phase 2 | Recruiting | Mediar Therapeutics | 85 | 2026-04-16 | 2026-10-05 |
| Controlling Hyperactive Immunity With Long-lived Lymphocytes QEL-005 - Diffuse Cutaneous Systemic Sclerosis, Rheumatoid Arthritis (RA) | Phase 1 / Phase 2 | Recruiting | Quell Therapeutics Limited | 16 | 2026-04-10 | 2026-10-19 |
| A Study of Nemolizumab for the Treatment of Adults With Systemic Sclerosis Nemolizumab, Placebo - Systemic Sclerosis | Phase 2 | Recruiting | Galderma R&D | 162 | 2026-02-20 | 2026-03-31 |
| A Phase 1/2 Study of PRO-203 in Healthy Volunteers and Participants With Systemic Sclerosis. PRO-203, Placebo - Healthy Volunteers, Systemic Sclerosis (SSc) | Phase 1 / Phase 2 | Recruiting | Prolium Bioscience, Inc | 44 | 2025-10-27 | 2026-10-09 |
| AlloNK®, an Allogeneic Non-genetically Modified, Cord Blood-derived NK Cell Therapy, in Combination With Rituximab, Studied in Relapsing Forms of B-cell Dependent Rheumatologic Diseases. Allogeneic NK Cells - Refractory Rheumatoid Arthritis (RA), Idiopathic Inflammatory Myopathies (IIMs) | Phase 2 | Recruiting | Artiva Biotherapeutics, Inc. | 90 | 2025-07-09 | 2026-07-31 |
| Extracorporeal Photopheresis in Early Diffuse Cutaneous Systemic Sclerosis Extracorporeal Photopheresis (ECP), UVADEX - Diffuse Cutaneous Systemic Sclerosis | Phase 2 | Recruiting | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | 15 | 2025-05-14 | 2026-10-01 |
| Efficacy and Safety of Telitacicept in the Treatment of Systemic Sclerosis Telitacicept, Mycophenolate Mofetil - Diffuse Cutaneous Systemic Sclerosis | Phase 2 | Recruiting | Second Affiliated Hospital, Zhejiang University, School of Medicine | 38 | 2025-01-06 | 2025-02-11 |
| Anti-CD19 CAR T-Cell Therapy in Refractory Systemic Autoimmune Diseases CAR T cell - Lupus Erythematosus, Systemic, System; Sclerosis | Phase 1 / Phase 2 | Recruiting | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | 8 | 2024-11-29 | 2025-04-11 |
| A Phase 1/2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2) NKX019, Fludarabine, Cyclophosphamide - Systemic Sclerosis, Idiopathic Inflammatory Myopathies | Phase 1 / Phase 2 | Recruiting | Nkarta, Inc. | 240 | 2024-11-04 | 2026-10-30 |
| 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 CABA-201 - Systemic Sclerosis, Scleroderma | Phase 2 / Phase 3 | Recruiting | Cabaletta Bio | 37 | 2024-07-02 | 2026-10-16 |
| Platform Clinical Study for Conquering Scleroderma Amlitelimab, BI 1015550 (Nerandomilast), Placebo - Interstitial Lung Disease Due to Systemic Disease, Scleroderma | Phase 2 | Recruiting | Scleroderma Research Foundation, Inc. | 400 | 2024-04-15 | 2026-08-18 |
| A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease Belimumab, Placebo - Systemic Sclerosis Associated Interstitial Lung Disease, Scleroderma, Systemic | Phase 2 / Phase 3 | Recruiting | GlaxoSmithKline | 300 | 2023-09-13 | 2026-09-08 |
| Preventive Effect of Clopidogrel on the Systemic Sclerosis Development Risk clopidogrel treatment, Placebo - Scleroderma, Systemic Sclerosis | Phase 2 / Phase 3 | Recruiting | University Hospital, Bordeaux | 90 | 2022-06-22 | 2026-07-07 |
| Mesenchymal Stromal Cells as Treatment for Digital Ulcers in Systemic Sclerosis Mesenchymal stromal cells, Placebo - Systemic Sclerosis, Digital Ulcer | Phase 1 / Phase 2 | Recruiting | UMC Utrecht | 20 | 2021-10-06 | 2025-09-10 |
| Sildenafil for Early Pulmonary Vascular Disease in Scleroderma Sildenafil, Placebo - Scleroderma, Mildly Elevated Pulmonary Pressures | Phase 2 | Recruiting | Johns Hopkins University | 30 | 2021-09-20 | 2026-09-28 |
| Autologous Stem Cell Transplantation in Patients With Systemic Sclerosis Cyclophosphamide, Mesna, Rituximab - Systemic Sclerosis, Diffuse Sclerosis Systemic | Phase 2 | Recruiting | Paul Szabolcs | 8 | 2018-07-31 | 2026-08-14 |
Scleroderma, Systemic (12) · Lung Diseases, Interstitial (5) · Arthritis, Rheumatoid (3) · Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (2) · Myositis (2) · Autoimmune Diseases (1) · Connective Tissue Diseases (1) · Dermatomyositis (1) · Hypertension, Pulmonary (1) · Lupus Erythematosus, Systemic (1) · Polymyositis (1) · Scleroderma, Limited (1) · Sjogren's Syndrome (1) · Skin Diseases (1)
Skin and Connective Tissue Diseases (16) · Connective Tissue Diseases (15) · Skin Diseases (15) · Immune System Diseases (5) · Lung Diseases (5) · Respiratory Tract Diseases (5) · Autoimmune Diseases (4) · Cardiovascular Diseases (4) · Musculoskeletal Diseases (4) · Scleroderma, Systemic (4) · Arthritis (3) · Joint Diseases (3) · Muscular Diseases (3) · Nervous System Diseases (3) · Neuromuscular Diseases (3)
Cyclophosphamide (2) · Alemtuzumab (1) · Antilymphocyte Serum (1) · BI 1015550 (1) · Filgrastim (1) · Granulocyte-Macrophage Colony-Stimulating Factor (1) · Immunoglobulins, Intravenous (1) · Immunotherapy, Adoptive (1) · Mesna (1) · Methoxsalen (1) · Mycophenolic Acid (1) · Photopheresis (1) · Rituximab (1) · Sildenafil Citrate (1) · Thiotepa (1)
Artiva Biotherapeutics, Inc. (1) · Cabaletta Bio (1) · Fondazione Policlinico Universitario Agostino Gemelli IRCCS (1) · Galderma R&D (1) · GlaxoSmithKline (1) · Johns Hopkins University (1) · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's (1) · Mediar Therapeutics (1) · Nkarta, Inc. (1) · Paul Szabolcs (1) · Prolium Bioscience, Inc (1) · Quell Therapeutics Limited (1) · Scleroderma Research Foundation, Inc. (1) · Second Affiliated Hospital, Zhejiang University, School of Medicine (1) · UMC Utrecht (1)
United States (9) · France (4) · Italy (4) · Spain (4) · Australia (3) · China (3) · Germany (3) · United Kingdom (3) · Brazil (2) · Mexico (2) · Netherlands (2) · Poland (2) · Romania (2) · South Korea (2) · Argentina (1)
Dr. Janet E Pope, MD PhD (1) · Kevin O'Shea (1) · Maria Antonietta D'Agostino (1) · Marianne Verhaar, MD, PhD (1) · Michael Saddekni, M.D., PgDip, BCMAS (1) · Paul Szabolcs, MD (1) · Salim Mujais (1) · Stephen Mathai, MD (1)
PMID 30127049, PMID 38689245, PMID 39544897, PMID 41217519, PMID 42309868
2025 (2), 2015 (1), 2023 (1)