Phase
Condition
Myositis
Treatment
placebo
Placebo
INCB000928
Clinical Study ID
Ages 2-99 All Genders
Study Summary
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
Connect with a study center
Hospital Italiano de Buenos Aires
Buenos Aires, C1199ABD
ArgentinaSite Not Available
Hospital Italiano de Buenos Aires
Ciudad Autonoma Buenos Aires, C1199ABB
ArgentinaSite Not Available
Royal North Shore Hospital
St Leonards, New South Wales 02065
AustraliaCompleted
Murdoch Children'S Research Institute
Parkville, Victoria 03052
AustraliaActive - Recruiting
Westmead Hospital
Westmead, 02145
AustraliaSite Not Available
Albert Einstein Israelite Hospital
San Paolo, 05652-900
BrazilActive - Recruiting
Toronto General Hospital
Toronto, Ontario M5G 2C4
CanadaActive - Recruiting
University Health Network Toronto General Hospital
Toronto, Ontario M5G 2C4
CanadaActive - Recruiting
Centro de Estudios Reumatologicos
Santiago, 7501126
ChileActive - Recruiting
Hospital San Juan de Dios
Santiago Province, 3360000
ChileSite Not Available
Centro de Estudios Reumatologicos
Santiago Region Metropolitana,
ChileSite Not Available
Hospital San Juan de Dios
Santiago Region Metropolitana,
ChileActive - Recruiting
Investigative Site CL001
Santiago Region Metropolitana, 3360000
ChileActive - Recruiting
Investigative Site CL001
Teno, 3360000
ChileSite Not Available
Beijing Childrens Hospital Capital Medical University
Beijing, 100045
ChinaActive - Recruiting
Beijing Children'S Hospital, Capital Medical University
Shanghai, 200065
ChinaActive - Recruiting
Childrens Hospital of Fudan University
Shanghai, 201102
ChinaActive - Recruiting
Shanghai Childrens Medical Center
Shanghai, 200127
ChinaActive - Recruiting
Tongji Hospital of Tongji University
Shanghai, 200065
ChinaActive - Recruiting
Ap-Hp Hopital Lariboisiere
Paris, 75010
FranceActive - Recruiting
Hopital Lariboisiere - Aphp
Paris, 75010
FranceActive - Recruiting
Hopital Necker-Enfants Malades
Paris, 75015
FranceActive - Recruiting
Hospital Necker
Paris, 75015
FranceActive - Recruiting
Uniklinik Koln
Koln, 50931
GermanyActive - Recruiting
Universitatsklinikum Koeln
Koln, 50937
GermanySite Not Available
Ospedale Pediatrico G. Gaslini
Genova, 16147
ItalySite Not Available
Fondazione Policlinico Universitario Agostino Gemelli Irccs
Rome, 00137
ItalySite Not Available
Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore
Rome, 00168
ItalyActive - Recruiting
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofActive - Recruiting
Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra
Tlalpan, 14389
MexicoActive - Recruiting
Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra Ibarra
Tlalpan, 14389
MexicoSite Not Available
Investigative Site MX001
Tlalpan, 14389
MexicoSite Not Available
Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra
Tlapan, 14389
MexicoSite Not Available
Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra Ibarra
Tlapan, 14389
MexicoSite Not Available
Amsterdam Umc
Amsterdam, 1081 HV
NetherlandsSite Not Available
Amsterdam Umc - Vu Medisch Centrum (Vumc)
Amsterdam, 1081 HV
NetherlandsActive - Recruiting
Starship Childrens Hospital
Auckland, 01023
New ZealandActive - Recruiting
Centro Hospitalar Universitario de Lisboa Norte, Hospital Santa Maria
Lisboa, 1649-035
PortugalSite Not Available
Centro Hospitalar de Lisboa Norte E.P.E. - Hospital de Santa Maria
Lisboa, 1649-035
PortugalSite Not Available
Centro Hospitalar Universitario de Lisboa Norte, Hospital Santa Maria
Lisbon, 1649-035
PortugalActive - Recruiting
Irkutsk State Medical University
Irkutsk, 664003
Russian FederationSite Not Available
Nasonova Research Institute of Rheumatology
Moscow, 115478
Russian FederationSite Not Available
Saint Petersburg State Pediatric Medical University
St. Petersburg, 194100
Russian FederationSite Not Available
Groote Schuur Hospital
Cape Town, 07700
South AfricaSite Not Available
Groote Schuur Hospital Radiation Oncology
Cape Town, 07925
South AfricaActive - Recruiting
Red Cross Children'S Hospital
Cape Town, 07700
South AfricaActive - Recruiting
Groote Schuur Hospital
Observatory, 07925
South AfricaActive - Recruiting
Groote Schuur Hospital Radiation Oncology
Observatory, 07925
South AfricaSite Not Available
Hospital Universitario Ramon Y Cajal
Madrid, 28034
SpainActive - Recruiting
Ege University Faculty of Medicine
Izmir, 35100
TurkeyCompleted
Ege University School of Medicine
Izmir, 35100
TurkeySite Not Available
Royal Manchester Childrens Hospital - Department of Paediatric Endocrinology
Manchester, M13 9PL
United KingdomSite Not Available
Royal National Orthopaedic Hospital
Stanmore, HA7 4LP
United KingdomActive - Recruiting
University of California San Francisco Medical Center
San Francisco, California 94143
United StatesSite Not Available
Mayo Clinic
Rochester, Minnesota 55905
United StatesActive - Recruiting
Mayo Clinic Rochester
Rochester, Minnesota 55905
United StatesActive - Recruiting
Children'S Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
Penn Medicine - Perelman Center For Advanced Medicine
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
University of Pennsylvania Hospital
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
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