Caring for Patients with Fibrodysplasia Ossificans Progressiva?

Consider the OPTIMA Trial

Currently, there are limited treatment options and no cure for fibrodysplasia ossificans progressiva (FOP). The aim of the OPTIMA Clinical Trial is to measure the safety, tolerability, and effectiveness of an investigational drug in preventing the formation of new heterotopic ossification (HO), or bone growth in tissues, in adults with FOP.

In 2 previous clinical trials with healthy volunteers, the investigational drug was found to be well-tolerated. In a Phase II clinical trial (LUMINA-1), researchers found that the investigational drug significantly reduced the number of new HO lesions in adults with FOP.

This Phase III trial aims to continue this research and confirm the data from LUMINA-1 involving the investigational drug in a trial open to 66 people with FOP worldwide.

Your patients may be able to participate if they:

Are 18 years old or older at screening

Have a clinical diagnosis of FOP, with documentation of ACVR1 FOP-causing mutation (patients will be tested during the screening period)

Experienced flare-up activity within the last year

Are willing to undergo CT imaging procedures

Please note: Other protocol-defined inclusion/exclusion criteria apply.

The trial team will check your patient’s full medical history to see if they meet all inclusion criteria. To learn more about this study, visit the About OPTIMA section

If you have patients who meet the criteria for this clinical trial, please discuss the OPTIMA Trial with them and contact the nearest clinical site to refer them: Site Finder

With your support, we hope to advance treatments for people with FOP.