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

RecruitingPhase 2Ages 2 Years - 99 YearsAllIncyte Corporation
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Female and male participants: * Cohort 1: โ‰ฅ 12 years of age. * Cohort 2: 6 to \< 12 years of age. * Cohort 3: 2 to \< 12 years of age (after eDMC review of safety 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 โ‰ฅ 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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What it tests

  • INCB000928
  • Placebo
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Where

24 sites
Mayo Clinic Rochester
Rochester, United States
Children'S Hospital of Philadelphia
Philadelphia, United States
Penn Medicine - Perelman Center For Advanced Medicine
Philadelphia, United States
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
Royal North Shore Hospital
St Leonards, Australia
Murdoch Children'S Research Institute
Parkville, Australia
Albert Einstein Israelite Hospital
Sรฃo Paulo, Brazil
University Health Network Toronto General Hospital
Toronto, Canada

โ€ฆand 16 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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