To Assess the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva
NCT ID: NCT05090891
Last Updated: 2025-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
98 participants
INTERVENTIONAL
2022-05-05
2033-01-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
INCB000928
INCBG000928 will be administered QD orally.
Placebo
Placebo will be administered QD orally.
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.
INCB000928
INCBG000928 will be administered QD orally.
Placebo
Placebo will be administered QD orally.
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.
INCB000928
INCBG000928 will be administered QD orally.
Placebo
Placebo will be administered QD orally.
Interventions
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INCB000928
INCBG000928 will be administered QD orally.
Placebo
Placebo will be administered QD orally.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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:
2 Years
99 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Amanda McBride, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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University of California San Francisco Medical Center
San Francisco, California, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Children'S Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Penn Medicine - Perelman Center For Advanced Medicine
Philadelphia, Pennsylvania, United States
Hospital Italiano de Buenos Aires
Ciudad Autonoma Buenos Aires, , Argentina
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Murdoch Children'S Research Institute
Parkville, Victoria, Australia
Albert Einstein Israelite Hospital
São Paulo, , Brazil
University Health Network Toronto General Hospital
Toronto, Ontario, Canada
Centro de Estudios Reumatologicos
Santiago, , Chile
Beijing Childrens Hospital Capital Medical University
Beijing, , China
Tongji Hospital of Tongji University
Shanghai, , China
Shanghai Childrens Medical Center
Shanghai, , China
Childrens Hospital of Fudan University
Shanghai, , China
Ap-Hp Hopital Lariboisiere
Paris, , France
Hopital Necker-Enfants Malades
Paris, , France
Uniklinik Koln
Cologne, , Germany
Ospedale Pediatrico G. Gaslini
Genova, , Italy
Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore
Rome, , Italy
Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra
Tlalpan, , Mexico
Amsterdam Umc - Vu Medisch Centrum (Vumc)
Amsterdam, , Netherlands
Starship Childrens Hospital
Auckland, , New Zealand
Groote Schuur Hospital Radiation Oncology
Cape Town, , South Africa
Seoul National University Hospital
Seoul, , South Korea
Hospital Universitario Ramon Y Cajal
Madrid, , Spain
Royal Manchester Childrens Hospital - Department of Paediatric Endocrinology
Manchester, , United Kingdom
Royal National Orthopaedic Hospital
Stanmore, , United Kingdom
Countries
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Central Contacts
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Related Links
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To Assess the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva (Progress)
Other Identifiers
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2023-504129-38-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
2021-002286-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
INCB 00928-201
Identifier Type: -
Identifier Source: org_study_id
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