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Last Updated: December 24, 2024

CLINICAL TRIALS PROFILE FOR PALOVAROTENE


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All Clinical Trials for palovarotene

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02190747 ↗ An Efficacy and Safety Study of Palovarotene to Treat Preosseous Flare-ups in FOP Subjects Completed Clementia Pharmaceuticals Inc. Phase 2 2014-07-14 Fibrodysplasia ossificans progressiva (FOP) is a rare, severely disabling disease characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) that result in abnormal bone formation in muscles, tendons, and ligaments. Flare-ups begin early in life and may occur spontaneously or after soft tissue trauma, vaccinations, or influenza infections. Recurrent flare-ups progressively restrict movement by locking joints leading to cumulative loss of function and disability. Mouse models of FOP have demonstrated the ability of retinoic acid receptor (RAR) gamma agonists to prevent heterotopic ossification (HO) following injury. The purpose of the study is to evaluate whether palovarotene, an RAR gamma agonist, will prevent HO during and following a flare-up in subjects with FOP.
NCT02279095 ↗ An Open-Label Extension Study of Palovarotene Treatment in Fibrodysplasia Ossificans Progressiva (FOP) Active, not recruiting Clementia Pharmaceuticals Inc. Phase 2 2014-10-27 Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by heterotopic ossification (HO), i.e., abnormal bone formation, often associated with painful, recurrent episodes of soft tissue swelling (flare-ups). Lesions begin in early childhood and lead to progressive ankyloses of major joints with resultant loss of movement. In this study, the ability of different palovarotene dosing regimens to prevent the formation of new HO will be evaluated in adult and pediatric participants with FOP.
NCT02521792 ↗ In-Home Evaluation of Episodic Administration of Palovarotene in Fibrodysplasia Ossificans Progressiva (FOP) Subjects Terminated Clementia Pharmaceuticals Inc. Phase 2 2015-12-07 Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) that result in abnormal bone formation (heterotopic ossification or HO) in muscles, tendons, and ligaments. Flare-ups begin early in life and may occur spontaneously or after soft tissue trauma, vaccinations, or influenza infections. Recurrent flare-ups progressively restrict movement by locking joints leading to cumulative loss of function and disability. Mouse models of FOP have demonstrated the ability of retinoic acid receptor gamma (RARĪ³) agonists such as palovarotene to prevent HO following injury. This 36-month study will evaluate the long-term safety and efficacy of episodic treatment with palovarotene for flare-ups in FOP subjects who successfully complete two flare-up treatment periods (6 weeks duration) and two follow-up periods (6 weeks duration) in Study PVO-1A-202.
NCT02979769 ↗ An Open-Label Extension Study of Palovarotene to Prevent Heterotopic Ossification in People With Fibrodysplasia Ossificans Progressiva (FOP) in France Active, not recruiting Clementia Pharmaceuticals Inc. Phase 2 2016-11-28 Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by heterotopic ossification (HO), i.e., abnormal bone formation, often associated with painful, recurrent episodes of soft tissue swelling (flare-ups). Lesions begin in early childhood and lead to progressive ankyloses of major joints with resultant loss of movement. In this study, the ability of different palovarotene dosing regimens to prevent the formation of new HO will be evaluated in adult and pediatric participants with FOP in France.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for palovarotene

Condition Name

Condition Name for palovarotene
Intervention Trials
Fibrodysplasia Ossificans Progressiva 6
Dry Eye Disease 1
Exostoses, Multiple Hereditary 1
Fibrodysplasia Ossificans Progressiva (FOP) 1
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Condition MeSH

Condition MeSH for palovarotene
Intervention Trials
Myositis Ossificans 7
Osteochondromatosis 1
Osteochondroma 1
Exostoses, Multiple Hereditary 1
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Clinical Trial Locations for palovarotene

Trials by Country

Trials by Country for palovarotene
Location Trials
United States 21
France 6
United Kingdom 5
Canada 4
Australia 3
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Trials by US State

Trials by US State for palovarotene
Location Trials
Pennsylvania 5
California 5
Minnesota 3
Massachusetts 2
Texas 1
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Clinical Trial Progress for palovarotene

Clinical Trial Phase

Clinical Trial Phase for palovarotene
Clinical Trial Phase Trials
Phase 3 2
Phase 2 5
Phase 1 3
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Clinical Trial Status

Clinical Trial Status for palovarotene
Clinical Trial Phase Trials
Completed 4
Active, not recruiting 3
Terminated 2
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Clinical Trial Sponsors for palovarotene

Sponsor Name

Sponsor Name for palovarotene
Sponsor Trials
Clementia Pharmaceuticals Inc. 9
Ipsen 2
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Sponsor Type

Sponsor Type for palovarotene
Sponsor Trials
Industry 11
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