We are committed to working closely with physicians, researchers and affected families throughout the lifecycle of our development programs in the interest of the larger patient and medical communities.

Our Clinical Trials

Our lead product candidate, palovarotene, is an oral small molecule that has shown potent activity in preventing abnormal new bone formation as well as fibrosis in a variety of tissues. We are developing palovarotene for the treatment of fibrodysplasia ossificans progressiva (FOP), multiple osteochondromas (MO) and dry eye disease.

We are currently evaluating palovarotene for the treatment of FOP in our Phase 3 MOVE Trial, and have completed enrollment in our Phase 2 extension study in FOP. We plan to initiate our MO-Ped Trial of palovarotene for the treatment of MO in early 2018.

In addition, palovarotene has been shown to exert multiple effects in various tissues including in ocular tissues, where RARγ agonists generally demonstrate anti-fibrotic properties. Following the completion of preclinical studies, we plan to begin clinical trials of palovarotene in patients with dry eye disease in 2018.

For complete information on our palovarotene studies, please visit clinicaltrials.gov and search for palovarotene.

Phase 3 MOVE Trial

Eligibility Criteria

Participants must:

  • Be clinically diagnosed with FOP and between the ages of 4 and 65 years
  • Have the R206H mutation (genetic testing available)
  • Reside in one of the countries where a clinical site is located, due to regulatory requirements (please see clinicaltrials.gov for an updated list of sites)
  • Have been flare-up free the 4 weeks before enrolling
  • Can undergo all study procedures, including low-dose whole-body CT (WBCT) scans
  • Meet all other enrollment criteria (please see clinicaltrials.gov)

Design

We intend to enroll 80 participants. All participants will take palovarotene daily for 24 months, with increased dosing in the event of a flare up. Participants are required to visit the clinical site at enrollment, and at months 6, 12, 18 and 24 during which they will undergo WBCT scans and other assessments. Safety assessments will be performed at months 3, 9, 15 and 21 at the participant’s home.

  • Chronic treatment: All participants will receive 5 mg of palovarotene once daily for 24 months.
  • Flare-up treatment: In the event of a flare-up, participants will receive 20 mg palovarotene once daily for 4 weeks, followed 10 mg palovarotene once daily for 8 weeks, (which may be extended by the investigator until the flare-up has resolved).
  • All dosing will be weight-adjusted for those under the age of 18 years who have not reached skeletal maturity.
  • No placebo will be administered.

Clinicaltrial.gov Identifier      

NCT03312634

Trial ID Number

PVO-1A-301

Contact Us

To contact Clementia for more information on the MOVE study, please click here.

MOVE Trial FAQ’s

Phase 2 MO-Ped Trial

Eligibility Criteria

Participants must:

  • Be between the ages of between 2-14 years
  • Have symptomatic MO
  • Have confirmed EXT1 or EXT2 mutations
  • Reside in one of the countries where a clinical site is located, due to regulatory requirements

Design

  • We intend to enroll 80 participants per dosing arm (240 participants total).
  • Treatment regimen: Oral palovarotene at multiple doses (5 mg and 2.5 mg) vs. placebo
  • Treatment Period: 24-month treatment with interim analysis at 12 months

Contact Us

To contact Clementia for more information on the MO-Ped study, please click here.