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

Last updated: March 28, 2025
Sponsor: Incyte Corporation
Overall Status: Active - Recruiting

Phase

2

Condition

Myositis

Treatment

placebo

Placebo

INCB000928

Clinical Study ID

NCT05090891
INCB 00928-201
  • Ages 2-99
  • All Genders

Study 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

Inclusion

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 withoutrequiring intubation.

  • Further inclusion criteria apply.

Exclusion

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 theinvestigator's judgment, interfere with full participation in the study, pose asignificant 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.

Study Design

Total Participants: 98
Treatment Group(s): 3
Primary Treatment: placebo
Phase: 2
Study Start date:
May 05, 2022
Estimated Completion Date:
December 23, 2032

Connect with a study center

  • Hospital Italiano de Buenos Aires

    Buenos Aires, C1199ABD
    Argentina

    Site Not Available

  • Hospital Italiano de Buenos Aires

    Ciudad Autonoma Buenos Aires, C1199ABB
    Argentina

    Site Not Available

  • Royal North Shore Hospital

    St Leonards, New South Wales 02065
    Australia

    Completed

  • Murdoch Children'S Research Institute

    Parkville, Victoria 03052
    Australia

    Active - Recruiting

  • Westmead Hospital

    Westmead, 02145
    Australia

    Site Not Available

  • Albert Einstein Israelite Hospital

    San Paolo, 05652-900
    Brazil

    Active - Recruiting

  • Toronto General Hospital

    Toronto, Ontario M5G 2C4
    Canada

    Active - Recruiting

  • University Health Network Toronto General Hospital

    Toronto, Ontario M5G 2C4
    Canada

    Active - Recruiting

  • Centro de Estudios Reumatologicos

    Santiago, 7501126
    Chile

    Active - Recruiting

  • Hospital San Juan de Dios

    Santiago Province, 3360000
    Chile

    Site Not Available

  • Centro de Estudios Reumatologicos

    Santiago Region Metropolitana,
    Chile

    Site Not Available

  • Hospital San Juan de Dios

    Santiago Region Metropolitana,
    Chile

    Active - Recruiting

  • Investigative Site CL001

    Santiago Region Metropolitana, 3360000
    Chile

    Active - Recruiting

  • Investigative Site CL001

    Teno, 3360000
    Chile

    Site Not Available

  • Beijing Childrens Hospital Capital Medical University

    Beijing, 100045
    China

    Active - Recruiting

  • Beijing Children'S Hospital, Capital Medical University

    Shanghai, 200065
    China

    Active - Recruiting

  • Childrens Hospital of Fudan University

    Shanghai, 201102
    China

    Active - Recruiting

  • Shanghai Childrens Medical Center

    Shanghai, 200127
    China

    Active - Recruiting

  • Tongji Hospital of Tongji University

    Shanghai, 200065
    China

    Active - Recruiting

  • Ap-Hp Hopital Lariboisiere

    Paris, 75010
    France

    Active - Recruiting

  • Hopital Lariboisiere - Aphp

    Paris, 75010
    France

    Active - Recruiting

  • Hopital Necker-Enfants Malades

    Paris, 75015
    France

    Active - Recruiting

  • Hospital Necker

    Paris, 75015
    France

    Active - Recruiting

  • Uniklinik Koln

    Koln, 50931
    Germany

    Active - Recruiting

  • Universitatsklinikum Koeln

    Koln, 50937
    Germany

    Site Not Available

  • Ospedale Pediatrico G. Gaslini

    Genova, 16147
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario Agostino Gemelli Irccs

    Rome, 00137
    Italy

    Site Not Available

  • Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore

    Rome, 00168
    Italy

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra

    Tlalpan, 14389
    Mexico

    Active - Recruiting

  • Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra Ibarra

    Tlalpan, 14389
    Mexico

    Site Not Available

  • Investigative Site MX001

    Tlalpan, 14389
    Mexico

    Site Not Available

  • Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra

    Tlapan, 14389
    Mexico

    Site Not Available

  • Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra Ibarra

    Tlapan, 14389
    Mexico

    Site Not Available

  • Amsterdam Umc

    Amsterdam, 1081 HV
    Netherlands

    Site Not Available

  • Amsterdam Umc - Vu Medisch Centrum (Vumc)

    Amsterdam, 1081 HV
    Netherlands

    Active - Recruiting

  • Starship Childrens Hospital

    Auckland, 01023
    New Zealand

    Active - Recruiting

  • Centro Hospitalar Universitario de Lisboa Norte, Hospital Santa Maria

    Lisboa, 1649-035
    Portugal

    Site Not Available

  • Centro Hospitalar de Lisboa Norte E.P.E. - Hospital de Santa Maria

    Lisboa, 1649-035
    Portugal

    Site Not Available

  • Centro Hospitalar Universitario de Lisboa Norte, Hospital Santa Maria

    Lisbon, 1649-035
    Portugal

    Active - Recruiting

  • Irkutsk State Medical University

    Irkutsk, 664003
    Russian Federation

    Site Not Available

  • Nasonova Research Institute of Rheumatology

    Moscow, 115478
    Russian Federation

    Site Not Available

  • Saint Petersburg State Pediatric Medical University

    St. Petersburg, 194100
    Russian Federation

    Site Not Available

  • Groote Schuur Hospital

    Cape Town, 07700
    South Africa

    Site Not Available

  • Groote Schuur Hospital Radiation Oncology

    Cape Town, 07925
    South Africa

    Active - Recruiting

  • Red Cross Children'S Hospital

    Cape Town, 07700
    South Africa

    Active - Recruiting

  • Groote Schuur Hospital

    Observatory, 07925
    South Africa

    Active - Recruiting

  • Groote Schuur Hospital Radiation Oncology

    Observatory, 07925
    South Africa

    Site Not Available

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034
    Spain

    Active - Recruiting

  • Ege University Faculty of Medicine

    Izmir, 35100
    Turkey

    Completed

  • Ege University School of Medicine

    Izmir, 35100
    Turkey

    Site Not Available

  • Royal Manchester Childrens Hospital - Department of Paediatric Endocrinology

    Manchester, M13 9PL
    United Kingdom

    Site Not Available

  • Royal National Orthopaedic Hospital

    Stanmore, HA7 4LP
    United Kingdom

    Active - Recruiting

  • University of California San Francisco Medical Center

    San Francisco, California 94143
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Mayo Clinic Rochester

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Children'S Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Penn Medicine - Perelman Center For Advanced Medicine

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • University of Pennsylvania Hospital

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

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