Three new Clementia sites now open for Part B of the Phase 2 Open-label Extension Trial

Approval of 3 New Sites!

The participation of individuals living with FOP in clinical studies and trials is key to FOP drug development efforts. 

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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 crawley.kerry@mayo.edu. 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 jesica.rappi@hospitalitaliano.org.ar.

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 genevieve.baujat@nck.aphp.fr.

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/.

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