CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 61 enrolled
Drug / intervention
Palovarotenedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05027802
NCT05027802Phase 3Completed
CompareCT.gov

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.

Ipsen·interventional·Posted Aug 30, 2021·Updated Jun 22, 2025

In Brief

A Phase 3 clinical trial evaluating Palovarotene for Fibrodysplasia Ossificans Progressiva (FOP). Completed, enrolled 61 participants across 13 sites in 10 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFibrodysplasia Ossificans Progressiva (FOP)
CountriesArgentina, Australia, Brazil, Canada, France, Italy, Spain, Sweden, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedAug 30, 2021
Enrollment StartMar 14, 2022
Primary CompletionNov 30, 2024
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 4.8 years ago

Interventions

Palovarotenedrug

Palovarotene will be taken orally once daily at approximately the same time each day.