7 completed, 3 terminated. 5 Phase 2, 3 Phase 1, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 5 | Terminated 3, Completed 2 |
| Phase 1 | 3 | Completed 3 |
| Phase 3 | 1 | Completed 1 |
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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 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 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 |
| Study to Assess Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Palovarotene Ophthalmic Solution in Healthy Adult Subjects Palovarotene, Vehicle - Dry Eye Disease | Phase 1 | Completed | Clementia Pharmaceuticals Inc. | 48 | 2018-08-30 | 2021-02-21 |
| An Efficacy and Safety Study of Palovarotene for the Treatment of MO Palovarotene 2.5 mg, Palovarotene 5.0 mg, Placebo - Exostoses, Multiple Hereditary | Phase 2 | Terminated | Clementia Pharmaceuticals Inc. | 193 | 2018-03-22 | 2022-08-01 |
| 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 |
| Study to Compare the Pharmacokinetics, Safety, and Tolerability Following Administration of Palovarotene in Healthy Japanese and Non-Asian Subjects palovarotene low-dose, palovarotene high-dose - FOP | Phase 1 | Completed | Clementia Pharmaceuticals Inc. | 18 | 2015-09-01 | 2021-04-02 |
| 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 |
| An Efficacy and Safety Study of Palovarotene to Treat Preosseous Flare-ups in FOP Subjects Palovarotene, Placebo - Fibrodysplasia Ossificans Progressiva | Phase 2 | Completed | Clementia Pharmaceuticals Inc. | 40 | 2014-07-14 | 2021-02-16 |
Myositis Ossificans (7) · Ossification, Heterotopic (5) · Dry Eye Syndromes (1) · Exostoses, Multiple Hereditary (1) · Osteochondroma (1)
Palovarotene (7) · Midazolam (1)
United States (8) · France (6) · Australia (5) · United Kingdom (5) · Argentina (4) · Canada (4) · Italy (4) · Japan (3) · Spain (3) · Belgium (2) · Portugal (2) · Sweden (2) · Brazil (1) · China (1) · Mexico (1)
PMID 36526263, PMID 37957586, PMID 36583535, PMID 37156007, PMID 42770123, PMID 31053156, PMID 31655222, PMID 32727600, PMID 34331548, PMID 35854638, PMID 37804430, PMID 40403126, PMID 41188357
2014 (2), 2017 (2)