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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	2 Years - 99 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Female and male participants: - Cohort 1: ≥ 12 years of age.

- Cohort 2: 6 to < 12 years of age.

- Cohort 3: 2 to < 6 years of age (after eDMC review of interim 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05090891
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Incyte Corporation
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Amanda McBride, MD
Principal Investigator Affiliation	Incyte Corporation
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Argentina, Australia, Brazil, Canada, Chile, China, France, Germany, Italy, Mexico, Netherlands, New Zealand, South Africa, South Korea, Spain, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Fibrodysplasia Ossificans Progressiva (FOP)
Study Website:	View Trial Website

Arms & Interventions

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 < 6 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

Drug: - INCB000928

INCBG000928 will be administered QD orally.

Drug: - Placebo

Placebo will be administered QD orally.

Contact a Trial Team

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San Francisco 5391959, California 5332921

Status

Withdrawn

Address

University of California San Francisco Medical Center

San Francisco 5391959, California 5332921, 94143

Site Contact

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