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

Description

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)

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Study Overview

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Study Details

Study overview

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).

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva

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

Condition
Fibrodysplasia Ossificans Progressiva (FOP)
Intervention / Treatment

-

Contacts and Locations

San Francisco

University of California San Francisco Medical Center, San Francisco, California, United States, 94143

Rochester

Mayo Clinic Rochester, Rochester, Minnesota, United States, 55905

Philadelphia

Children'S Hospital of Philadelphia, Philadelphia, Pennsylvania, United States, 19104

Philadelphia

Penn Medicine - Perelman Center For Advanced Medicine, Philadelphia, Pennsylvania, United States, 19104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

12 Years to 99 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Incyte Corporation,

Kurt Brown, MD, STUDY_DIRECTOR, Incyte Corporation

Study Record Dates

2028-04-28