At a glance
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A Phase 2, Open-Label Extension, Efficacy and Safety Study of a Retinoic Acid Receptor Gamma (RARγ) Specific Agonist (Palovarotene) in the Treatment of Preosseous Flare-ups in Subjects With Fibrodysplasia Ossificans Progressiva (FOP)
In Brief
A Phase 2 clinical trial evaluating Palovarotene dose level 1, Palovarotene dose level 2, and 2 other interventions for Fibrodysplasia Ossificans Progressiva. Completed, enrolled 58 participants across 8 sites in 5 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
Palovarotene was taken orally once daily at approximately the same time each day.
Palovarotene will be taken orally once daily at approximately the same time each day.
Palovarotene will be taken orally once daily at approximately the same time each day.
Palovarotene will be taken orally once daily at approximately the same time each day.