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NCT05090891PHASE2Recruiting

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

Incyte Corporation

Start Date

5/5/2022

Completion Date

1/20/2033

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

Age Range: 2 years to 99 years

Inclusion Criteria: * Female and male participants: * Cohort 1: ≥ 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 ≥ 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.

Interventions

DRUG

INCB000928

DRUG

Placebo

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Conditions

Fibrodysplasia Ossificans Progressiva (FOP)

Locations

Mayo Clinic Rochester

Rochester, Minnesota 55905

United States

Children'S Hospital of Philadelphia

Philadelphia, Pennsylvania 19104

United States

Penn Medicine - Perelman Center For Advanced Medicine

Philadelphia, Pennsylvania 19104

United States

Hospital Italiano de Buenos Aires

Buenos Aires, CO 1181

Argentina

Royal North Shore Hospital

St Leonards, New South Wales 02065

Australia

Murdoch Children'S Research Institute

Parkville, Victoria 03052

Australia

Albert Einstein Israelite Hospital

São Paulo, 05652-900

Brazil

University Health Network Toronto General Hospital

Toronto, Ontario M5G 2N2

Canada

Centro de Estudios Reumatologicos

Santiago, 7501126

Chile

Beijing Childrens Hospital Capital Medical University

Beijing, 100045

China

Tongji Hospital of Tongji University

Shanghai, 200065

China

Shanghai Childrens Medical Center

Shanghai, 200127

China

Childrens Hospital of Fudan University

Shanghai, 201102

China

Ap-Hp Hopital Lariboisiere

Paris, 75010

France

Hopital Necker-Enfants Malades

Paris, 75015

France

Uniklinik Koln

Cologne, 50931

Germany

Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore

Rome, 00168

Italy

Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra

Tlalpan, 14389

Mexico

Amsterdam Umc - Vu Medisch Centrum (Vumc)

Amsterdam, 1081 HV

Netherlands

Starship Childrens Hospital

Auckland, 01023

New Zealand

Groote Schuur Hospital Radiation Oncology

Cape Town, 07925

South Africa

Seoul National University Hospital

Seoul, 03080

South Korea

Hospital Universitario Ramon Y Cajal

Madrid, 28034

Spain

Royal National Orthopaedic Hospital

Stanmore, HA7 4LP

United Kingdom