Recruiting
Phase 2

INCB000928

Sponsor:

Incyte Corporation

Code:

NCT05090891

Conditions

Fibrodysplasia Ossificans Progressiva (FOP)

Eligibility Criteria

Sex: All

Age: 2 - 70+

Healthy Volunteers: Not accepted

Interventions

INCB000928

Placebo

Study Details

Brief summary:

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).

Conditions

Fibrodysplasia Ossificans Progressiva (FOP)

Study ID

NCT05090891

Start date

May 5, 2022

Status verified date

May, 2026

Completion date

Jan 20, 2033

Anticipated

Primary completion date

Jul 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

98 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1

Participants (≥ 12 years of age) will receive INCB000928 or placebo as defined in the protocol for 24 weeks (double-blind period). Participants who complete the double-blind period will continue into open-label extension period for an additional 292 weeks.

experimental: Cohort 2

Participants (6 to < 12 years of age) will receive INCB000928 or placebo as defined in the protocol for 24 weeks (double-blind period). Participants who complete the double-blind period will continue into open-label extension period for an additional 292 weeks.

experimental: Cohort 3

Participants (2 to < 12 years of age) will receive INCB000928 or placebo as defined in the protocol for 24 weeks (double-blind period). Participants who complete the double-blind period will continue into open-label extension period for an additional 292 weeks.

Interventions

INCB000928

INCBG000928 will be administered QD orally.

Placebo

Placebo will be administered QD orally.

Primary outcome measure

  • Double Blind Period: Occurrence of new heterotopic ossification (HO) lesions from baseline [ Time Frame: Week 24 ]

Central Contacts and Locations

Central contacts

Incyte Corporation Call Center (US)

1.855.463.3463medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

+800 00027423eumedinfo@incyte.com

Locations

Mayo Clinic Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Children'S Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

More Information

Sponsor

Incyte Corporation

Last update posted

May 22, 2026

Last verified

May, 2026

Keywords

  • fibrodysplasia ossificans progressiva (FOP)
  • heterotopic ossification

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Incyte Corporation on 2026-05-22.