FOP Clinical Trial News

Two pharmaceutical companies are conducting worldwide FOP clinical trials

It’s an exciting time in FOP research as not one, but two pharmaceutical companies with investigational drugs to treat FOP are now conducting worldwide clinical trials.* The decision to enroll in a clinical trial is an important one, and not everyone who wants to enroll will meet the entrance criteria. Clinical trial participation is a commitment that is not to be taken lightly, and there are many factors for you and your family or other caregivers to consider. Eligible individuals who do participate will be helping to speed up the drug development process and will have access to potential treatments for FOP that are not yet on the market. Patients taking part in clinical trials will also receive specialized, multi-disciplinary medical care throughout the entire clinical trial.  

Below is an overview of both trials - Clementia MOVE and Regeneron LUMINA-1. While the MOVE trial is no longer recruiting patients, the LUMINA-1 trial of drug REGN2477 is still seeking patients. Learn more.

 MOVE Trial

  Drug: Palovarotene

  Company: Clementia

  Trial Phase: Phase 3 (pivotal)

  Enrollment Age: >4 years of age

  Control Group: Natural History Study

  Inclusion Criteria**: No flare symptoms in prior 4 weeks

  Method of Administration: Pill (oral)

  Dosing Regimen: Daily

  Trial Status: Active, Not Recruiting





 LUMINA-1 Trial

  Drug: REGN2477

  Company: Regeneron

  Trial Phase: Phase 2 (first in people with FOP)

  Enrollment Age: 18-60 years of age

  Control Group: 2-Period***

    1) Placebo controlled

    2) Open-label

  Inclusion Criteria**: FOP disease activity within 1 year of screening visit****

  Method of Administration: IV Infusion (in vein)

  Dosing Regimen: Every 4 weeks

  Trial Status: Recruiting

** See below for additional study participation criteria or visit
*** For the first 6 months, 1/2 of the subjects will receive placebo and 1/2 of subjects will receive REGN2477. After 6 months of a placebo control, all study participants will then receive REGN2477 for 6 months.
**** Current flare-up symptoms acceptable

The best resource for helping you to make a decision about participating in an FOP clinical trial is your physician. If you have general questions about clinical trials, please contact us at [email protected].

* A third potential treatment for FOP is in a clinical trial; the trial is being run by Kyoto University and is only available in Japan.



Recorded Webinars

Clementia's MOVE Trial
Learn more about Clementia's MOVE Trial led by the principal investigator, Dr. Ed Hsiao, at the University of California, San Francisco MOVE Trial site. Please note the following corrections: Slide 6 - Total number of flare ups is 42 (not 18); Slide 7 - Total number of flare ups is 140 (not 106); Slide 11 - Sweden is currently enrolling (not The Netherlands).

Regeneron's LUMINA-1 Trial
Learn more about Regeneron's LUMINA-1 Trial led by the principal investigator, Dr. Bob Pignolo, at the Mayo Clinic LUMINA-1 Trial site. Please note the following update: Slide 21 - Go to their page on to find the recruiting status of “A Study to Examine the Safety, Tolerability and Effects on Abnormal Bone Formation of REGN2477 in Patients With Fibrodysplasia Ossificans Progressiva (LUMINA-1)."

Clinical Studies and Trials: Your Choice, Your Role, Your Responsibility
Adam Sherman, Director of Research Development & Partnerships, provides an overview of the drug development and approval process and the role that clinical studies and trials play. Learn more about how to select which study or trial is right for you.

The IFOPA does not endorse nor recommend specific clinical trials. Please speak with your doctor if you are interested in participating in a clinical trial.

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