To Assess the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva
Incyte Corporation · NCT05090891
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 2–99 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 2
- Target enrollment
- 98
- US sites recruiting
- 2
- Study start
- May 5, 2022
- Record last updated
- October 22, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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).
Being studied: INCB000928; Placebo
Conditions: Fibrodysplasia Ossificans Progressiva (FOP)
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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.
Recruiting US locations
Mayo Clinic Rochester
Rochester, MN 55905
Children'S Hospital of Philadelphia
Philadelphia, PA 19104
Study contacts (from the official record)
- Incyte Corporation Call Center (US) · 1.855.463.3463 · medinfo@incyte.com
- Incyte Corporation Call Center (ex-US) · +800 00027423 · eumedinfo@incyte.com