Palovarotene for Stone Man Syndrome
(PIVOINE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing a medication called palovarotene to help people with a rare condition called Fibrodysplasia Ossificans Progressiva (FOP). FOP causes muscles and other soft tissues to turn into bone. Palovarotene aims to stop this abnormal bone growth by blocking certain signals in the body. The study includes both adults and children.
Who Is on the Research Team?
Ipsen Medical Director
Principal Investigator
Ipsen
Are You a Good Fit for This Trial?
This trial is for males and females aged 14 or older with Fibrodysplasia Ossificans Progressiva (FOP) who have finished previous related studies. Participants under 18 must be fully skeletally mature, while those over 18 are presumed so. They should not have any conditions that could risk their safety or affect the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive chronic and flare-up treatment with palovarotene
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Palovarotene
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ipsen
Lead Sponsor
David Loew
Ipsen
Chief Executive Officer since 2020
BA in Business Administration and MBA from the University of St. Gallen, Switzerland
Sandra Silvestri
Ipsen
Chief Medical Officer since 2023
MD, PhD