43 completed, 16 recruiting, 15 terminated, 6 withdrawn. 92 Phase 2, 21 Phase 1, 15 Phase 3.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 |
|---|---|---|---|---|---|---|
| Hyaluronidase Injections for Sclerodactyly in Patients With Scleroderma hyaluronidase - Scleroderma, Sclerodactyly | Phase 2 | Not yet recruiting | Stanford University | 10 | 2026-12-01 | 2026-11-06 |
| FAPI PET in Systemic Sclerosis Interstitial Lung Disease FAPI tracer - Systemic Sclerosis (SSc), Scleroderma | Phase 2 | Not yet recruiting | University of California, Los Angeles | 120 | 2026-11-01 | 2026-11-12 |
| 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 |
| Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE) Tibulizumab, Placebo - Systemic Sclerosis (SSc), Scleroderma | Phase 2 | Active not recruiting | Zura Bio Inc | 80 | 2025-02-06 | 2026-07-20 |
| 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 |
| Phase 2 Study Evaluating Rapcabtagene Autoleucel in Participants With Diffuse Cutaneous Systemic Sclerosis rapcabtagene autoleucel, rituximab - Scleroderma, Diffuse | Phase 2 | Active not recruiting | Novartis Pharmaceuticals | 96 | 2024-10-29 | 2026-09-02 |
| A Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis Placebo, Ianalumab - Diffuse Cutaneous Systemic Sclerosis | Phase 2 | Active not recruiting | Novartis Pharmaceuticals | 203 | 2024-10-09 | 2026-11-09 |
| KYSA-5: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Systemic Sclerosis KYV-101, Standard lymphodepletion regimen - Systemic Sclerosis, Systemic Sclerosis - Diffuse Cutaneous | Phase 1 / Phase 2 | Terminated | Kyverna Therapeutics | 3 | 2024-08-06 | 2026-08-31 |
| 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 |
| Open Label Extension Study of Brentuximab Vedotin in Early dcSSc Brentuximab vedotin - Diffuse Cutaneous Systemic Sclerosis | Phase 2 | Completed | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | 3 | 2024-02-14 | 2026-09-30 |
| 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 |
| An Open-label Extension Trial of HZNP-HZN-825-301 in Adult Participants With Diffuse Cutaneous Systemic Sclerosis (Diffuse Cutaneous SSc) HZN-825 - Diffuse Cutaneous Systemic Sclerosis, Sclerosis, Systemic | Phase 2 | Terminated | Amgen | 174 | 2022-11-04 | 2026-01-05 |
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Scleroderma, Systemic (57) · Lung Diseases, Interstitial (16) · Connective Tissue Diseases (7) · Skin Diseases (7) · Arthritis, Rheumatoid (6) · Raynaud Disease (5) · Autoimmune Diseases (4) · Pulmonary Fibrosis (4) · Scleroderma, Limited (4) · Dermatomyositis (3) · Hypertension, Pulmonary (3) · Lupus Erythematosus, Systemic (3) · Myositis (3) · Polymyositis (3)
Skin and Connective Tissue Diseases (92) · Connective Tissue Diseases (85) · Skin Diseases (85) · Scleroderma, Systemic (35) · Lung Diseases (19) · Respiratory Tract Diseases (19) · Pathological Conditions, Signs and Symptoms (14) · Cardiovascular Diseases (13) · Vascular Diseases (11) · Immune System Diseases (10) · Musculoskeletal Diseases (9) · Pathologic Processes (9) · Autoimmune Diseases (7) · Joint Diseases (7) · Skin Diseases, Vascular (7)
Cyclophosphamide (7) · Rituximab (7) · Mycophenolic Acid (6) · Bosentan (4) · Brentuximab Vedotin (3) · Imatinib Mesylate (3) · Immunoglobulins, Intravenous (3) · Whole-Body Irradiation (3) · fludarabine (3) · fludarabine phosphate (3) · Abatacept (2) · Acetylcysteine (2) · Albumins (2) · Antilymphocyte Serum (2) · Filgrastim (2)
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's (4) · Novartis Pharmaceuticals (3) · University of Michigan (3) · Actelion (2) · Amgen (2) · Bristol-Myers Squibb (2) · CSL Behring (2) · Dinesh Khanna, MD, MS (2) · Johns Hopkins University (2) · Kadmon, a Sanofi Company (2) · Northwestern University (2) · Stanford University (2) · United Therapeutics (2) · University Hospital, Bordeaux (2) · University of California, Los Angeles (2)
United States (62) · United Kingdom (21) · Italy (15) · Spain (15) · Canada (14) · Germany (13) · Poland (13) · France (12) · Australia (9) · Mexico (9) · Argentina (7) · Belgium (6) · Netherlands (6) · South Korea (6) · Switzerland (6)
Dinesh Khanna, MD (2) · George Georges (2) · James Seibold, MD (2) · Alexandre WS Silva, PhD (1) · Armando Gabrielli, MD,professor (1) · Arnold E. Postlethwaite, MD (1) · Barbara Troupin, MD, MBA (1) · Brett King, MD, PhD (1)
PMID 41217519, PMID 11934971, PMID 15692967, PMID 16790698, PMID 17469162, PMID 17485423, PMID 17717203, PMID 17901414, PMID 18512816, PMID 18641099, PMID 19776222, PMID 19892673, PMID 19950289, PMID 20506355, PMID 20740615, PMID 23039171, PMID 23402088, PMID 23494072, PMID 23554239, PMID 24054756, PMID 24067785, PMID 24459219, PMID 24850877, PMID 25452309, PMID 25826322, PMID 26071192, PMID 27370878, PMID 27469583, PMID 28012804, PMID 28038680, PMID 28270187, PMID 28387950, PMID 28544580, PMID 28619061, PMID 29073351, PMID 29099620, PMID 29121645, PMID 30127049, PMID 30277862, PMID 30651141, PMID 31342624, PMID 31430058, PMID 31481106, PMID 31858338, PMID 32612255, PMID 33350170, PMID 33765691, PMID 33998674, PMID 34966900, PMID 35650639
2023 (4), 2025 (2), 1UM1AI110557 (1), 2015 (1), 2018 (1), 2019 (1), R01AI041721 (1), R01AR047219 (1), R01HL089758 (1), R01HL089901 (1), R01HL174555 (1), R21AR066305 (1), R34HL122558 (1), UM1AI109565 (1)