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

Last updated: November 3, 2023
Sponsor: Incyte Corporation
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

INCB000928

Placebo

Clinical Study ID

NCT05090891
INCB 00928-201
  • Ages 12-99
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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

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

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: INCB000928
Phase: 2
Study Start date:
May 05, 2022
Estimated Completion Date:
December 02, 2024

Study Description

Connect with a study center

  • Royal North Shore Hospital

    St Leonards, 02065
    Australia

    Active - Recruiting

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034
    Spain

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Mayo Clinic Rochester

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

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