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To Assess the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva

RecruitingPhase 2

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva

Who can join

Ages 2 to 99 · All sexes

Full eligibility criteria
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.

About the study

This Phase 2, Randomized, Double-Blind, Placebo-Controlled Study is intended to evaluate the Efficacy, Safety, and Tolerability and PK of INCB000928 administered to participants with a clinical diagnosis of fibrodysplasia ossificans progressiva (FOP).

What is being tested

Sponsor: Incyte Corporation · Participants: 98 · Started: May 5, 2022

Contact the study team

Official record on ClinicalTrials.gov — NCT05090891

Locations in the U.S.

MinnesotaMayo Clinic Rochester, Rochester
PennsylvaniaChildren'S Hospital of Philadelphia, Philadelphia

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.