NCT05027802

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.

Rollover Study; Multicentre, Phase III, Open-label 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 Study PVO-1A-301 or PVO-1A-202/PVO-1A-204 and May Benefit From Palovarotene Therapy.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Ipsen · Industry
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this study is to further evaluate the safety and efficacy of palovarotene in adult and paediatric participants with FOP. The aim of the study is also to ensure treatment continuity to participants who have completed one of the parent studies (Study PVO-1A-301, Study PVO-1A-202 and Study PVO-1A-204) and who, in the investigator's judgement, may benefit from palovarotene therapy.

Conditions

• Fibrodysplasia Ossificans Progressiva (FOP)

Interventions

Type	Name	Description
DRUG	Palovarotene	Palovarotene will be taken orally once daily at approximately the same time each day.

Timeline

• Start date: 2022-03-14
• Primary completion: 2024-11-30
• Completion: 2024-11-30
• First posted: 2021-08-30
• Last updated: 2025-06-22
• Results posted: 2025-06-13

Locations

13 sites across 10 countries: United States, Argentina, Australia, Brazil, Canada, France, Italy, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study