Clementia Clinical Program: Opportunity for New Adult and Older Adolescent Subjects to Enroll in Palovarotene Study
MONTREAL, CANADA, August 8, 2016 – Clementia is pleased to announce to the FOP community that the implementation of Part B of its Phase 2 Open-label Extension Trial (PVO-1A-202) is progressing well and enrollment of adult or older adolescent subjects who have not previously participated in palovarotene trials has commenced and is underway.
The Part B amendment explores a modified dosing regimen for palovarotene that includes chronic dosing between flare-ups for adults and older adolescents and acute dosing during an eligible flare-up for all subjects. This modified regimen is higher in dose and longer in duration than what was studied in Part A of the Phase 2 Open-label Extension trial.
Part B was designed to enroll 20 new adult or older adolescent subjects in addition to the existing subjects from Part A. Since Part B was announced in June, nearly all Part A subjects have enrolled, which allows us to focus on the recruitment of the new adult or older adolescent subjects who have never participated in palovarotene trials. Any adult or older adolescent subject, who meets the eligibility criteria can be enrolled into Part B including those currently participating in the Natural History Study.
Eligible new participants must:
- Reside in the US, Canada, UK, France or Argentina (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 four weeks prior to enrollment
- Have achieved 90% skeletal maturity (if under age 18), which means that the bones are almost finished growing as measured by wrist x-ray at enrollment screening
- Have joint movement as assessed by the cumulative analogue joint involvement scale of 6 to 16, inclusive, demonstrating some limitation of movement, but sufficient movement to allow for participation in the trial
- Have the most common mutation, R206H, associated with FOP as confirmed by genetic testing performed at enrollment screening
- Be able to attend all scheduled site visits during the trial
Further details and all enrollment criteria can be found on www.clinicaltrials.gov/ct2/show/NCT02279095.
The University of Pennsylvania in Philadelphia, the University of California San Francisco, and the Royal National Orthopaedic Hospital in London United Kingdom are presently enrolling patients. The Necker Hospital in Paris France and the Hospital Italiano in Buenos Aires will begin enrollment after final approvals are received, expected by end of August.
We recognize and greatly appreciate the effort made by study participants and their families, the FOP community, and the clinical trial teams. None of this would be possible without your commitment. Our goal is to develop the evidence necessary to demonstrate the potential of palovarotene as a safe and effective treatment for FOP and the commencement of Part B moves us closer to that goal.
More information on palovarotene can be found at http://clementiapharma.com/our-pipeline/palovarotene/. Anyone interested in participating in this study should contact the clinical trial site closest to where they live. Detailed enrollment criteria and contact information can be found at www.clinicaltrials.gov/ct2/show/NCT02279095.