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. — PIVOINE

Fibrodysplasia Ossificans Progressiva (FOP) Clinical Trial

Official title:
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 Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Fibrodysplasia Ossificans Progressiva (FOP)

Clinical Trial Details

NCT number	NCT05027802
Study type	Interventional
Source	Ipsen
Contact
Status	Active, not recruiting
Phase	Phase 3
Start date	March 14, 2022
Completion date	January 3, 2025

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05090891` - To Assess the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva	Phase 2
Completed	`NCT06064656` - A Non-Interventional Study of Clinical Characteristics and Mortality of US Patients With Fibrodysplasia Ossificans Progressiva (FOP)
Recruiting	`NCT02745158` - The Fibrodysplasia Ossificans Progressiva (FOP) Connection Registry	N/A