Evaluating INCB000928 for treating Fibrodysplasia Ossificans Progressiva

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional study aims to assess the efficacy, safety, and tolerability of INCB000928 in participants diagnosed with Fibrodysplasia Ossificans Progressiva (FOP). The study is randomized, double-blind, and placebo-controlled, meaning that participants will be assigned to receive either the treatment or a placebo without knowing which they are receiving. The study will include participants from different age cohorts, ranging from 2 to 12 years and older, and will involve imaging assessments to monitor the effects of the treatment. The goal is to gather data on how well INCB000928 works in managing this rare and debilitating condition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Female and male participants:

  * Cohort 1: ≥ 12 years of age.
  * Cohort 2: 6 to \< 12 years of age.
  * Cohort 3: 2 to \< 12 years of age (after eDMC review of safety data from Cohort 2).
* Clinical diagnosis of FOP.
* Willingness to avoid pregnancy or fathering children based on the criteria below.
* Willing and able to undergo low-dose WBCT (excluding the head) imaging without requiring intubation.
* Further inclusion criteria apply.

Exclusion Criteria:

* Pregnant or breast-feeding.
* CAJIS score ≥ 24.
* FOP disease severity that in the investigator's opinion precludes participation.
* Any clinically significant medical condition other than FOP that would, in the investigator's judgment, interfere with full participation in the study, pose a significant risk to the participant, or interfere with interpretation of study data.
* Chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment.
* HIV, HBV, or HCV infection. Note:
* Further exclusion criteria apply.

Where it's running

• Mayo Clinic Rochester
  Rochester, Minnesota, United States Recruiting
• Children'S Hospital of Philadelphia
  Philadelphia, Pennsylvania, United States Recruiting
• Beijing Childrens Hospital Capital Medical University
  Beijing, China Recruiting
• Tongji Hospital of Tongji University
  Shanghai, China Recruiting
• Shanghai Childrens Medical Center
  Shanghai, China Recruiting
• Childrens Hospital of Fudan University
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Incyte Corporation Call Center (US)
• Email: medinfo@incyte.com
• Phone: 1.855.463.3463

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Observing the effects of anti-IL1 therapies on flare activity in FOP patients

  This study is testing if using certain anti-inflammatory medications can help kids and teens with Fibrodysplasia Ossificans Progressiva manage their flare-ups and bone growth issues.

  Recruiting University of California, San Francisco · San Francisco, California · NCT06724562

• Global registry for patients with Fibrodysplasia Ossificans Progressiva

  This study is creating a global registry to collect information from people with Fibrodysplasia Ossificans Progressiva and their caregivers to help improve understanding and treatment of the condition.

  Recruiting The International FOP Association · North Kansas City, Missouri · NCT02745158

• Documenting long-term safety and effectiveness of palovarotene in patients with fibrodysplasia ossificans progressiva

  This study is trying to see how safe and effective the medication palovarotene is for children and adults with fibrodysplasia ossificans progressiva who are already using it.

  Recruiting at 4 sites Ipsen · San Francisco, California and 4 other locations · NCT06089616

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.