A Study to Assess the Effectiveness and Safety of 2 Dosage Regimens of Oral Fidrisertib (IPN60130) for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP).

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

113

Participants

Timeline

Start Date

December 1, 2021

Primary Completion Date

March 30, 2029

Study Completion Date

March 30, 2029

Conditions
Fibrodysplasia Ossificans Progressiva
Interventions
DRUG

IPN60130

Immediate-release capsule containing high dose of the drug substance.

DRUG

IPN60130

Immediate-release capsule containing low dose of the drug substance.

DRUG

Placebo

Placebo will be supplied as powder filled hard capsules

Trial Locations (25)

16147

Irccs Gaslini Institute, Genoa

19104

The Children's Hospital of Philadelphia, Philadelphia

The Perelman School of Medicine - The University of Pennsylvania, Philadelphia

28224

Hospital Universitario Ramon y Cajal, Pozuelo de Alarcón

46026

Hospital Universitario Y Politecnico La Femerge, Valencia

55905

Mayo Clinic, Rochester

75015

Groupe Hospitalier Necker Enfants Malades, Paris

94143

University of California San Francisco (UCSF), San Francisco

Unknown

Hospital Italiano de Buenos Aires, Buenos Aires

Royal North Shore Hospital - New South Wales, Sydney

University Hospitals Leuven, Leuven

University of Alberta, Alberta Health Services (AHS), Edmonton

University Health Network (UHN), Toronto General Hospital (TGH), Toronto

Children's Hospital Capital Institute of Pediatrics (CIP), Beijing

Peking Union Medical College Hospital, Beijing

Shangai Children Medical Center, Shanghai

Tongi University - Tongi Hospital, Shanghai

Hopital Lariboisiere, Paris

Nagoya University Hospital, Nagoya

Aichi Children's Health and Medical Center, Ōbu

The University of Tokyo Hospital, Tokyo

Instituto Nacional De Rehabilitacion, Mexico City

Hospital Center Lisbon North, E.P.E- Hospital Santa Maria, Lisbon

Seoul National University Hospital, Seoul

Norrlands Universitetssjukhus, Umeå

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Ipsen

INDUSTRY

lead

Clementia Pharmaceuticals Inc.

INDUSTRY