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DESCRIPTION Open-label, Phase II extension study evaluating the safety and efficacy of palovarotene on new bone formation during and after a flare-up

  • All participants experiencing a flare-up will receive palovarotene
  • All adult participants and teenagers who are nearly grown (have achieved 90% skeletal maturity – called the adult cohort) will also receive a daily dose of palovarotene between flare-ups
ELIGIBILITY CRITERIA The study is open to everyone who participated in and completed the Phase II double-blind, placebo-controlled study (PVO-1A-201)

Additionally, the study will accept new participants who:

  • Reside in the Argentina, US, Canada, UK, or France due to regulatory requirements
  • Have had at least two self-reported flare-ups in the last two years but cannot have had flare-up symptoms in the last four weeks at time of enrollment
  • Have achieved 90% skeletal maturity (if under age 18) as measured by height assessments and by X-rays of the hands/wrists and knees at enrollment screening, which is the standard measurement for bone growth maturity
  • Have some movement limitations in joints but not complete locking of most joints as determined by the site principal investigator using a standardized assessment
  • Have the most common mutation, R206H, associated with FOP as confirmed by genetic testing performed at enrollment screening
  • Meet all other enrollment criteria
DESIGN Up to 60 participants will be enrolled:

  • Up to 40 participants who completed the Phase II study (PVO-1A-201)
  • Up to 20 new adult cohort participants who did not participate in PVO-1A-201

Between eligible flare-ups (adult cohort):

  • All participants are treated with low chronic dose of palovarotene daily
  • Site visits at enrollment screening and at months 12 and 24
  • Telephone/home contact every three months

For eligible flare-ups (all subjects):

  • All participants are treated with palovarotene for 12 weeks at an acute dose (to be determined by weight)
  • Site visits at the onset of an eligible flare-up and at the end of treatment
  • Telephone/home contact every two weeks
  • No placebo will be administered
CLINICALTRIALS.GOV IDENTIFIER: NCT02279095
TRIAL ID NUMBER PVO-1A-202
PVO-1A-204 (France only)
CONTACT CLEMENTIA Please contact our call center:

  • US/Canada: +1-800-750-8710
  • Italy: 800-879-880
  • Spain: 900-838-561
  • UK: 0-808-189-3399
  • France: 00-33-7-85-98-05-46

Email Us: ClinicalTrials@clementiapharma.com

Phase II Part B Study Information (PDF)

Find a Trial

To find out if you or a loved one may be eligible to participate in the Phase II extension study of palovarotene for the treatment of FOP, please contact the trial site closest to you.

Palovarotene Program for FOP Update (Edited Version of Presentation Provided to Study Participants: June 2016)