Approval of 3 New Sites!
The participation of individuals living with FOP in clinical studies and trials is key to FOP drug development efforts.
Clementia announced in summer 2016 that new subjects could enroll in its Part B extension to the Phase 2 palovarotene trial. Just this week, three additional clinical trial sites have been approved: Mayo Clinic in Rochester, Minnesota, United States; Hospital Italiano in Buenos Aires, Argentina; and Necker Hospital in Paris, France.
These three sites join the existing sites: University of Pennsylvania in Philadelphia; University of California, San Francisco; and Royal National Orthopaedic Hospital in London, United Kingdom.
1. Mayo Clinic – Rochester, Minn., United States
In one of his first accomplishments in his new role at the Mayo Clinic, Dr. Bob Pignolo has established Mayo as a site for Clementia’s clinical trial on palovarotene for FOP. Those interested should contact Kerry Crawley at (507) 266-1944 or [email protected]. Dr Pignolo’s site in the middle of North America may be helpful for those from the Midwest and Canada that have a difficult time traveling to the coasts, but are interested in participating in the trial.
2. Hospital Italiano de Buenos Aires – Buenos Aires, Argentina
Dr. Carmen De Cunto’s clinic at the Hospital Italiano in Buenos Aires has begun enrolling patients in the Phase 2 extension trial for palovarotene in FOP. Those interested should contact Jesica Rappi at (005411) 49590200 ext 4153 or [email protected].
3. Hôpital Necker-Enfants Malades – Paris, France
Dr. Geneviève Baujat’s clinic at the Hôpital Necker in Paris has begun enrolling patients in the Phase 2 extension trial for palovarotene in FOP. Dr. Baujat is enrolling into Part B under a new protocol in France called the PVO-1A-204 study. Those interested should contact Dr. Baujat at 00-33-7-85-98-05-46 or [email protected].
More information about Part B of the Phase 2 Open-label Extension Trial (PVO-1A-202, PVO-1A-204 in France)
There is room for ten new adults as well as teenagers who are nearly grown to enroll in the extension trial. Eligible new participants must:
- Reside in the United States, Canada, United Kingdom, Argentina 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), which means that their bones are almost done growing as measured by height assessments and by X-rays of the hands/wrists and knees at enrollment screening
- 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
- Be able to attend all scheduled site visits during the trial
- Meet all other enrollment criteria
More information is available at https://clinicaltrials.gov/ct2/show/NCT02279095 or http://clementiapharma.com/clinical-trials/phase-ii-part-b/.