12 completed, 4 recruiting, 3 unknown, 2 active not recruiting. 24 Phase 3, 8 Phase 2.
Follow Systemic Sclerosis: new trials by email Literature Review of Systemic Sclerosis trials Research Report on Systemic Sclerosis
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 |
|---|---|---|---|---|---|---|
| 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 BMS-986353, Fludarabine, Cyclophosphamide - Systemic Sclerosis | Phase 3 | Not yet recruiting | Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | 92 | 2027-02-03 | 2026-09-18 |
| A Study to Evaluate the Safety and Efficacy (How Well the Study Treatment Works) of ABBV-2294 in Adult Participants With Systemic Sclerosis That Are Currently Receiving Local Standard of Care Treatment, and to Determine the Best Dose of ABBV-2294 to be Evaluated Further. ABBV-722, Upadacitinib, Placebo for ABBV-722 - Systemic Sclerosis | Phase 2 / Phase 3 | Not yet recruiting | AbbVie | 580 | 2026-12-11 | 2026-11-12 |
| A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis Placebo matching nerandomilast formulation 1, Placebo matching nerandomilast formulation 2, Nerandomilast formulation 1 - Systemic Sclerosis | Phase 3 | Recruiting | Boehringer Ingelheim | 448 | 2026-07-27 | 2026-10-14 |
| Study of the Efficacy of Nintedanib+Tocilizumab in Patients With Systemic Sclerosis and Interstitial Lung Disease Tocilizumab, Nintedanib, Standard therapy - Systemic Sclerosis, Interstitial Lung Disease | Phase 3 | Recruiting | National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland | 86 | 2025-07-01 | 2026-04-08 |
| 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 |
| Determine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY) Anifrolumab (blinded), Placebo (blinded), Anifrolumab (unblinded, open label) - Systemic Sclerosis, Scleroderma | Phase 3 | Active not recruiting | AstraZeneca | 314 | 2023-11-08 | 2026-09-30 |
| Effectiveness of Cannabinoids on Appetite in Scleroderma CBD oil, Placebo - Systemic Sclerosis, Malnutrition | Phase 3 | Completed | Khon Kaen University | 30 | 2022-11-09 | 2025-02-20 |
| A Study of MT-0551 in Patients With Systemic Sclerosis Inebilizumab, Placebo - Systemic Sclerosis | Phase 3 | Active not recruiting | Tanabe Pharma Corporation | 80 | 2022-07-20 | 2025-12-08 |
| 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 |
| COvid-19 Vaccine Booster in Immunocompromised Rheumatic Diseases COVID-19 vaccine - Rheumatoid Arthritis, Autoimmune Rheumatologic Disease | Phase 2 / Phase 3 | Unknown | Paul R Fortin | 287 | 2022-03-09 | 2023-01-17 |
| Effects of Fractional CO2 Laser Treatment on Vaginal Symptoms and Sexual Dysfunction in Women With Systemic Sclerosis CO2 Vaginal Laser - Systemic Sclerosis, Vulvovaginal Signs and Symptoms | Phase 2 / Phase 3 | Completed | IRCCS San Raffaele | 16 | 2020-05-01 | 2024-01-30 |
| Cardiac Safe Transplants for Systemic Sclerosis Rituximab, Fludarabine, Cyclophosphamide - Systemic Sclerosis, Scleroderma | Phase 2 / Phase 3 | Terminated | Northwestern University | 9 | 2018-05-17 | 2020-08-12 |
| Pirfenidone as Treatment of Skin Fibrosis in Systemic Sclerosis Pirfenidone, Placebo oral capsule, Steroids - Systemic Sclerosis | Phase 2 / Phase 3 | Unknown | RenJi Hospital | 72 | 2017-05-01 | 2017-03-01 |
| Study to Compare the Efficacy of Mycophenolate Mofetil in Systemic Sclerosis Related Early Interstitial Lung Disease Mycophenolate mofetil, Placebo - Systemic Sclerosis, Scleroderma | Phase 3 | Completed | Post Graduate Institute of Medical Education and Research, Chandigarh | 41 | 2016-10-01 | 2018-06-06 |
| A Study of the Efficacy and Safety of Tocilizumab in Participants With Systemic Sclerosis (SSc) Placebo, Tocilizumab - Systemic Sclerosis | Phase 3 | Completed | Hoffmann-La Roche | 212 | 2015-11-20 | 2020-03-09 |
| Effects of Probiotics on Gastrointestinal Symptoms and on the Immune System in Patients With Systemic Sclerosis Probiotic, Placebo - Systemic Sclerosis, Scleroderma | Phase 3 | Unknown | Federal University of São Paulo | 76 | 2014-12-01 | 2014-11-27 |
| Gastroesophageal Reflux Treatment in Scleroderma Alginic acid, placebo (for domperidone), Domperidone - Gastroesophageal Reflux Disease, Systemic Sclerosis | Phase 3 | Completed | Khon Kaen University | 80 | 2013-06-01 | 2017-03-27 |
| Rituximab in Systemic Sclerosis Rituximab, Placebo (NaCl) - Systemic Sclerosis | Phase 2 / Phase 3 | Completed | Assistance Publique - Hôpitaux de Paris | 22 | 2013-04-09 | 2025-11-20 |
| Cyclophosphamide Systemic Sclerosis Associated Interstitial Lung Disease Cyclophosphamide, Placebo - Systemic Sclerosis, Scleroderma | Phase 3 | Completed | Assistance Publique - Hôpitaux de Paris | 40 | 2013-01-14 | 2025-09-12 |
| Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients macitentan 3mg, macitentan 10mg, placebo - Systemic Sclerosis, Ulcers | Phase 3 | Completed | Actelion | 289 | 2011-12-01 | 2015-01-06 |
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Scleroderma, Systemic (24) · Scleroderma, Diffuse (13) · Lung Diseases, Interstitial (5) · Arthritis (2) · Autoimmune Diseases (2) · Pulmonary Fibrosis (2) · digital ulcers (2) · Anorexia (1) · Arthritis, Rheumatoid (1) · Connective Tissue Diseases (1) · Gastroesophageal Reflux (1) · Hypertension, Pulmonary (1) · Immune System Diseases (1) · Lupus Erythematosus, Systemic (1) · MASS syndrome (1)
Skin Diseases (24) · Skin and Connective Tissue Diseases (24) · Connective Tissue Diseases (23) · Lung Diseases (7) · Respiratory Tract Diseases (7) · Pathological Conditions, Signs and Symptoms (5) · Pathologic Processes (4) · Cardiovascular Diseases (3) · Joint Diseases (3) · Musculoskeletal Diseases (3) · Vascular Diseases (3) · Fibrosis (2) · Immune System Diseases (2) · Arthritis (1) · Autoimmune Diseases (1)
Cyclophosphamide (3) · Rituximab (3) · tocilizumab (3) · Mycophenolic Acid (2) · fludarabine (2) · nintedanib (2) · Alginic Acid (1) · Antilymphocyte Serum (1) · Bosentan (1) · COVID-19 Vaccines (1) · Domperidone (1) · Filgrastim (1) · Granulocyte Colony-Stimulating Factor (1) · Hydroxymethylglutaryl-CoA Reductase Inhibitors (1) · Iloprost (1)
Actelion (2) · Assistance Publique - Hôpitaux de Paris (2) · Khon Kaen University (2) · AbbVie (1) · AstraZeneca (1) · Boehringer Ingelheim (1) · Cabaletta Bio (1) · Federal University of São Paulo (1) · Hoffmann-La Roche (1) · IRCCS San Raffaele (1) · Juno Therapeutics, Inc., a Bristol-Myers Squibb Company (1) · National Center for Research Resources (NCRR) (1) · National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland (1) · Northwestern University (1) · Paul R Fortin (1)
France (7) · United States (7) · Canada (6) · Italy (6) · Germany (5) · Japan (5) · Poland (5) · Belgium (4) · Hungary (4) · India (4) · Spain (4) · United Kingdom (4) · Bulgaria (3) · China (3) · Denmark (3)
Anna Abou-Raya (1) · Chingching Foocharoen, M.D. (1) · Chingching Foocharoen, MD (1) · Cristiane Kayser (1) · James Seibold, MD (1) · Luc Mouthon, MD, PhD (1)
PMID 20805294, PMID 27163986, PMID 27179107, PMID 31056685, PMID 31813058, PMID 32612255, PMID 32866440, PMID 33294861, PMID 33538094, PMID 33765691, PMID 34851799, PMID 37228011, PMID 41137182, PMID 41217519
2025 (2), 2015 (1), 2023 (1)