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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
- INCB000928 (drug)
- Placebo (drug)
Sponsor: Incyte Corporation · Participants: 98 · Started: May 5, 2022
Contact the study team
- Incyte Corporation Call Center (US) · Phone: 1.855.463.3463
- Incyte Corporation Call Center (ex-US) · Phone: +800 00027423
Official record on ClinicalTrials.gov — NCT05090891
Locations in the U.S.
| Minnesota | Mayo Clinic Rochester, Rochester |
| Pennsylvania | Children'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.