NCT05027802View on ClinicalTrials.gov

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.

PHASE3CompletedINTERVENTIONAL
Enrollment

61

Participants

Timeline

Start Date

March 14, 2022

Primary Completion Date

November 30, 2024

Study Completion Date

November 30, 2024

Conditions
Fibrodysplasia Ossificans Progressiva (FOP)
Interventions
DRUG

Palovarotene

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

Trial Locations (13)

2065

Royal North Shore Hospital, Saint Leonards

16147

Istituto Giannina Gaslini, Genoa

19104

Children's Hospital of Philidelphia, Philadelphia

The Perelman School of Medicine - The University of Pennsylvania, Philadelphia

28034

Hospital Universitario Ramon y Cajal, Colmenar Viejo

55905

Mayo Clinic, Rochester

75015

Groupe Hospitalier Necker Enfants Malades, Paris

90737

Norrlands Universitetssjukhus, Umeå

94143

University of California San Francisco (UCSF), San Francisco

C1181ACH

Hospital Italiano de Buenos Aires, Buenos Aires

05652-900

Hospital Israelita Albert Einstein, Morumbi

M5T 2S8

Toronto General Hospital, Toronto

HA7 4LP

Royal National Orthopaedic Hospital, London

Sponsors

Lead Sponsor

Ipsen
All Listed Sponsors
lead

Ipsen

INDUSTRY

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. | Biotech Hunter | Biotech Hunter