12 completed, 4 recruiting, 3 active not recruiting, 2 terminated. 8 Phase 2, 5 Phase 3, 3 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 8 | Completed 3, Active not recruiting 2, Terminated 2, Recruiting 1 |
| Phase 3 | 5 | Active not recruiting 2, Completed 2, Not yet recruiting 1 |
| Phase 1 | 3 | Completed 3 |
Follow Myositis Ossificans: new trials by email Literature Review of Myositis Ossificans trials Research Report on Myositis Ossificans
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 Safety, Pharmacokinetics (PK), and Efficacy of Garetosmab in Children and Adolescents With Fibrodysplasia Ossificans Progressiva (FOP) garetosmab - Fibrodysplasia Ossificans Progressiva, FOP | Phase 3 | Not yet recruiting | Regeneron Pharmaceuticals | 18 | 2027-02-02 | 2026-10-20 |
| IL1 Inhibition in FOP Anti-IL1 Therapy - Fibrodysplasia Ossificans Progressiva (FOP) | Recruiting | University of California, San Francisco | 11 | 2025-04-01 | 2026-08-06 | |
| A Study to Document and to Further Describe Long-term Safety and Effectiveness of Palovarotene in Participants With Fibrodysplasia Ossificans Progressiva (FOP) Fibrodysplasia Ossificans Progressiva | Recruiting | Ipsen | 100 | 2024-12-05 | 2026-10-01 | |
| A Study of Andecaliximab in Participants With Fibrodysplasia Ossificans Progressiva (FOP) Andecaliximab, Placebo - Fibrodysplasia Ossificans Progressiva | Phase 2 / Phase 3 | Active not recruiting | Ashibio Inc | 92 | 2024-10-25 | 2025-10-14 |
| A Non-Interventional Study of Clinical Characteristics and Mortality of US Patients With Fibrodysplasia Ossificans Progressiva (FOP) Non-Interventional - Fibrodysplasia Ossificans Progressiva (FOP) | Completed | Regeneron Pharmaceuticals | 131 | 2023-06-29 | 2025-07-03 | |
| A Study to Assess Safety, Tolerability and Efficacy of Garetosmab Versus Placebo Administered Intravenously (IV) in Adult Participants With Fibrodysplasia Ossificans Progressiva (FOP) Garetosmab, Placebo - Fibrodysplasia Ossificans Progressiva | Phase 3 | Active not recruiting | Regeneron Pharmaceuticals | 63 | 2022-11-21 | 2026-07-17 |
| To Assess the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva INCB000928, Placebo - Fibrodysplasia Ossificans Progressiva (FOP) | Phase 2 | Recruiting | Incyte Corporation | 98 | 2022-05-05 | 2026-10-22 |
| A Rollover Study to Further Evaluate the Safety and Efficacy of Palovarotene Capsules in Male and Female Participants Aged ≥14 Years With Fibrodysplasia Ossificans Progressiva (FOP) Who Have Completed the Relevant Parent Studies. Palovarotene - Fibrodysplasia Ossificans Progressiva (FOP) | Phase 3 | Completed | Ipsen | 61 | 2022-03-14 | 2025-06-22 |
| Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of INCB000928 in Participants With Impaired Renal Function and Hemodialysis INCB000928 - Renal Impairment, Hemodialysis | Phase 1 | Completed | Incyte Corporation | 48 | 2021-12-14 | 2023-05-15 |
| A Study to Assess the Effectiveness and Safety of 2 Dosage Regimens of Oral Fidrisertib (IPN60130) for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP). IPN60130, Placebo - Fibrodysplasia Ossificans Progressiva | Phase 2 | Terminated | Clementia Pharmaceuticals Inc. | 113 | 2021-12-01 | 2026-04-24 |
| Study of Single-Ascending Doses of DS-6016a in Healthy Japanese Subjects DS-6016a, Placebo - Fibrodysplasia Ossificans Progressiva | Phase 1 | Completed | Daiichi Sankyo Co., Ltd. | 48 | 2021-04-01 | 2022-08-03 |
| An International Cross-sectional Survey to Evaluate the Burden of Fibrodysplasia Ossificans Progressiva (FOP) on Patients and Their Families. Fibrodysplasia Ossificans Progressiva | Completed | Ipsen | 411 | 2021-01-18 | 2021-05-21 | |
| Saracatinib Trial TO Prevent FOP AZD0530 Difumarate, Matching placebo - Fibrodysplasia Ossificans Progressiva | Phase 2 | Active not recruiting | Amsterdam UMC, location VUmc | 20 | 2020-08-05 | 2026-09-02 |
| Study Evaluating the Effect of Food on the Pharmacokinetics of Palovarotene and the Effect of Palovarotene on the Pharmacokinetics of the CYP3A4 Substrate Midazolam in Two Cohorts of Healthy Adult Subjects Palovarotene, midazolam - Fibrodysplasia Ossificans Progressiva | Phase 1 | Completed | Clementia Pharmaceuticals Inc. | 48 | 2019-01-03 | 2021-04-02 |
| A Study to Examine the Safety, Tolerability and Effects on Abnormal Bone Formation of REGN2477 in Patients With Fibrodysplasia Ossificans Progressiva REGN2477, Matching placebo - Fibrodysplasia Ossificans Progressiva | Phase 2 | Completed | Regeneron Pharmaceuticals | 44 | 2018-02-26 | 2022-12-02 |
| An Efficacy and Safety Study of Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva. Palovarotene - Fibrodysplasia Ossificans Progressiva | Phase 3 | Completed | Clementia Pharmaceuticals Inc. | 107 | 2017-11-30 | 2023-11-29 |
| In-Home Evaluation of Episodic Administration of Palovarotene in Fibrodysplasia Ossificans Progressiva (FOP) Subjects Palovarotene - Fibrodysplasia Ossificans Progressiva | Phase 2 | Terminated | Clementia Pharmaceuticals Inc. | 6 | 2015-12-07 | 2020-10-19 |
| The Fibrodysplasia Ossificans Progressiva (FOP) Registry Fibrodysplasia Ossificans Progressiva (FOP) | Recruiting | The International FOP Association | 800 | 2015-07-01 | 2026-04-08 | |
| A Natural History Study of Fibrodysplasia Ossificans Progressiva (FOP) Fibrodysplasia Ossificans Progressiva | Completed | Clementia Pharmaceuticals Inc. | 114 | 2014-12-18 | 2020-06-26 | |
| An Open-Label Extension Study of Palovarotene Treatment in Fibrodysplasia Ossificans Progressiva (FOP) Palovarotene dose level 1, Palovarotene dose level 2, Palovarotene dose level 3 - Fibrodysplasia Ossificans Progressiva | Phase 2 | Completed | Clementia Pharmaceuticals Inc. | 58 | 2014-10-09 | 2025-02-19 |
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Ossification, Heterotopic (12) · Hallux Valgus (2) · Mucopolysaccharidosis IV (2) · Genetic Diseases, Inborn (1) · Inflammation (1) · Kidney Failure, Chronic (1) · Muscular Diseases (1) · Musculoskeletal Diseases (1) · Myositis (1) · Osteochondroma (1) · Renal Insufficiency (1)
Muscular Diseases (22) · Musculoskeletal Diseases (22) · Myositis (22) · Pathologic Processes (13) · Pathological Conditions, Signs and Symptoms (13) · Carbohydrate Metabolism, Inborn Errors (2) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (2) · Connective Tissue Diseases (2) · Foot Deformities (2) · Lysosomal Storage Diseases (2) · Metabolic Diseases (2) · Metabolism, Inborn Errors (2) · Mucinoses (2) · Mucopolysaccharidoses (2) · Nutritional and Metabolic Diseases (2)
Palovarotene (5) · Interleukin 1 Receptor Antagonist Protein (1) · Midazolam (1) · andecaliximab (1) · canakinumab (1) · saracatinib (1)
Clementia Pharmaceuticals Inc. (7) · Regeneron Pharmaceuticals (5) · Ipsen (3) · Incyte Corporation (2) · Amsterdam UMC, location VUmc (1) · Ashibio Inc (1) · Daiichi Sankyo Co., Ltd. (1) · Novartis Pharmaceuticals (1) · The International FOP Association (1) · University of California, San Francisco (1)
United States (19) · France (9) · United Kingdom (9) · Australia (7) · Italy (7) · Argentina (6) · Canada (6) · Spain (6) · Brazil (4) · Japan (4) · Netherlands (4) · China (3) · South Korea (3) · Sweden (3) · Chile (2)
Amanda McBride, MD (1) · Edward Hsiao, MD, PhD (1) · Elisabeth MW Eekhoff, MD, PhD (1) · Mark Hamilton, PhD (1)
PMID 36526263, PMID 37957586, PMID 36583535, PMID 37156007, PMID 42770123, PMID 31053156, PMID 31655222, PMID 32515349, PMID 32557665, PMID 32727600, PMID 34331548, PMID 35650602, PMID 35854638, PMID 37770652, PMID 37804430, PMID 39216107, PMID 39381032, PMID 40403126, PMID 41360500, PMID 41562506, PMID 41806277, PMID 42805227
2014 (2), 2023 (2), 2016 (1), 2017 (1), 2019 (1), R01AR083628 (1)