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

  • STATUS
    Recruiting
  • End date
    Dec 2, 2024
  • participants needed
    60
  • sponsor
    Incyte Corporation
Updated on 3 July 2022

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).

Details
Condition Fibrodysplasia Ossificans Progressiva (FOP)
Treatment Placebo, INCB000928
Clinical Study IdentifierNCT05090891
SponsorIncyte Corporation
Last Modified on3 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Female and male adults and adolescents ≥ 12 years of age with a 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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