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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Incyte Corporation
Study ID
NCT05090891
Phase
PHASE2
Status
Recruiting
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Conditions

  • Fibrodysplasia Ossificans Progressiva (FOP)

Eligibility Criteria

Sex
ALL
Age
2 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • INCB000928 — DRUG
    INCBG000928 will be administered QD orally.
  • Placebo — DRUG
    Placebo will be administered QD orally.

Study Details

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).

Key Dates

Start date
May 5, 2022
Status verified
May 2026
Primary completion
Jul 30, 2027
Completion
Jan 20, 2033

Study Design

Enrollment
98 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Mayo Clinic RochesterRochesterMinnesota55905-
Children'S Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
Penn Medicine - Perelman Center For Advanced MedicinePhiladelphiaPennsylvania19104-

Find similar trials in Rochester, MN

By research site
Mayo Clinic Rochester· Rochester, MNChildren'S Hospital of Philadelphia· Philadelphia, PAPenn Medicine - Perelman Center For Advanced Medicine· Philadelphia, PA

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