24 completed, 7 unknown, 5 recruiting, 4 terminated. 43 Phase 3, 15 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 43 | Completed 24, Unknown 7, Recruiting 5, Terminated 4, Active not recruiting 2, Withdrawn 1 |
| Phase 2 | 15 | Completed 6, Recruiting 3, Terminated 3, Unknown 2, Withdrawn 1 |
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 |
|---|---|---|---|---|---|---|
| A Study to Investigate the Long-term Safety and Efficacy of Belimumab in Adults With Interstitial Lung Disease (ILD) Associated With Systemic Sclerosis (SSc) and Other Connective Tissue Diseases (CTD) (BLISSconneCTD-OLE) Belimumab - Connective Tissue Diseases | Phase 3 | Recruiting | GlaxoSmithKline | 514 | 2024-12-12 | 2026-09-09 |
| 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 |
| Safety and Efficacy of Baricitinib on Skin Tightening in Diffuse Cutaneous Systemic Sclerosis: A Comparative Study With Methotrexate tab baricitinib 4 mg daily, tab methotrexate 25 mg weekly with folic acid 5 mg weekly - Diffuse Cutaneous Systemic Sclerosis | Phase 3 | Recruiting | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | 24 | 2024-01-01 | 2025-04-20 |
| 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 |
| A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progressive Pulmonary Fibrosis BMS-986278, BMS-986278 Placebo - Progressive Pulmonary Fibrosis | Phase 3 | Active not recruiting | Bristol-Myers Squibb | 1057 | 2023-10-25 | 2026-04-23 |
| 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 |
| ADRCs in The Treatment of Hand Dysfunction Due to Scleroderma ADRCs, Standard Care, Placebo - Scleroderma, Diffuse | Phase 3 | Unknown | Paracrine, INC. | 174 | 2023-02-28 | 2022-09-28 |
| 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 |
| 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 |
| Rituxmab Versus IL-6 in Treating ILD Rituximab, IL6 inhibitor - Interstitial Lung Disease, Scleroderma | Phase 2 / Phase 3 | Completed | Assiut University | 60 | 2021-12-01 | 2023-11-15 |
| CompRehensive Phenotypic Characterization of Patients With Scleroderma-Associated ILD and PH Opsumit 10 Mg Tablet - Interstitial Lung Disease, Scleroderma | Phase 2 / Phase 3 | Withdrawn | Franz Rischard, DO | 2018-09-01 | 2025-02-20 | |
| 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 |
| Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis Lenabasum 5 mg, Lenabasum 20 mg, Placebo oral capsule - Diffuse Cutaneous Systemic Sclerosis | Phase 3 | Terminated | Corbus Pharmaceuticals Inc. | 365 | 2017-12-18 | 2021-03-29 |
| 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 |
| Efficacy of Botulinum Toxin In Scleroderma-Associated Raynaud's Syndrome Onabotulinumtoxin A, sterile saline solution - Scleroderma, Raynaud's Syndrome | Phase 3 | Completed | Johns Hopkins University | 40 | 2015-01-01 | 2016-12-22 |
| 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 |
| Rituximab Versus Cyclophosphamide in Connective Tissue Disease-ILD Rituximab, Cyclophosphamide - Interstitial Lung Disease, Scleroderma | Phase 2 / Phase 3 | Completed | Royal Brompton & Harefield NHS Foundation Trust | 104 | 2014-11-01 | 2021-10-07 |
| Exparel as a Nerve Block for Severe Hand Pain liposomal bupivacaine - CREST Syndrome, Peripheral Vascular Disease | Phase 2 / Phase 3 | Terminated | Jose Soberon, MD | 13 | 2014-11-01 | 2024-05-21 |
| 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 |
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Scleroderma, Systemic (21) · Lung Diseases, Interstitial (13) · Raynaud Disease (10) · Connective Tissue Diseases (5) · Pulmonary Fibrosis (5) · Arthritis, Rheumatoid (4) · Autoimmune Diseases (4) · Dermatomyositis (2) · Hypertension, Pulmonary (2) · Lupus Erythematosus, Systemic (2) · Mixed Connective Tissue Disease (2) · Myositis (2) · Polymyositis (2) · Scleroderma, Limited (2)
Skin Diseases (43) · Skin and Connective Tissue Diseases (43) · Connective Tissue Diseases (38) · Scleroderma, Systemic (22) · Lung Diseases (16) · Respiratory Tract Diseases (16) · Cardiovascular Diseases (13) · Vascular Diseases (13) · Embolism and Thrombosis (10) · Livedoid Vasculopathy (10) · Skin Diseases, Vascular (10) · Thrombosis (10) · Peripheral Vascular Diseases (9) · Pathological Conditions, Signs and Symptoms (8) · Pathologic Processes (7)
Cyclophosphamide (4) · Nitroglycerin (4) · Rituximab (4) · Bosentan (3) · Tadalafil (3) · Acetylcysteine (2) · Sildenafil Citrate (2) · belimumab (2) · Alginic Acid (1) · Antilymphocyte Serum (1) · Botulinum Toxins (1) · Botulinum Toxins, Type A (1) · COVID-19 Vaccines (1) · Domperidone (1) · Filgrastim (1)
Federal University of São Paulo (4) · MediQuest Therapeutics (4) · Actelion (3) · Johns Hopkins University (3) · Sanjay Gandhi Postgraduate Institute of Medical Sciences (3) · Assistance Publique - Hôpitaux de Paris (2) · GlaxoSmithKline (2) · Khon Kaen University (2) · Allergan (1) · Assiut University (1) · AstraZeneca (1) · Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh (1) · Bristol-Myers Squibb (1) · Cabaletta Bio (1) · Corbus Pharmaceuticals Inc. (1)
United States (18) · France (8) · United Kingdom (7) · Brazil (6) · Canada (5) · India (5) · Israel (5) · Japan (5) · South Korea (5) · Spain (5) · Australia (4) · China (4) · Germany (4) · Italy (4) · Argentina (3)
Vikas Agarwal, MD, DM (2) · Alexandre WS Silva, PhD (1) · Aman Sharma, MD (1) · Armando Gabrielli, MD,professor (1) · Chingching Foocharoen, M.D. (1) · Chingching Foocharoen, MD (1) · Chris Denton, MD (1) · Cristiane Kayser (1) · Darshan S Bhakuni, MD (1) · Dr MD. Fahad Hossain, MBBS, MD (1) · Fernando V Andrigueti, MD (1) · Franz P. Rischard, DO (1) · Fredrick M Wigley, M.D. (1)
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