77
Participants
Start Date
October 31, 2025
Primary Completion Date
March 31, 2032
Study Completion Date
March 31, 2032
Infigratinib is provided as a single dose of minitablets for oral administration
"* The initial cohort dose of infigratinib will begin at the protocol-specified starting dose, with subsequent cohort escalation based on protocol specific criteria.~* The target dose is the dose that will provide similar exposure to the dose of 0.25 mg/kg/day in participants 3 years old and older.~* The dose and number of minitablets will be calculated based on individual participant age and weight."
Infigratinib is provided as sprinkle capsules for daily oral administration
"* The cohort dose of infigratinib will be the dose identified in the Single Ascending Dose portion for the age group.~* The dose and number of sprinkle capsules/day will be calculated based on individual participant age and weight. Doses will be adjusted based on age and weight changes approximately every 3 months."
Infigratinib or placebo comparator is provided as sprinkle capsules for daily oral administration
"* The cohort dose of infigratinib or placebo will be the dose confirmed in the Phase 2 portion for the age group.~* The dose and number of sprinkle capsules/day will be calculated based on individual participant age and weight. Doses will be adjusted based on age and weight changes approximately every 3 months."
Infigratinib is provided as sprinkle capsules for daily oral administration
"* The dose of infigratinib will be the dose confirmed in the Phase 2 portion and used in the Phase 2b portion for the age group.~* The dose and number of sprinkle capsules/day will be calculated based on individual participant age and weight. Doses will be adjusted based on age and weight changes approximately every 3 months for the first year and every 6 months thereafter."
Murdoch Children's Research Institute, Parkville
Johns Hopkins University, Baltimore
University of Wisconsin Madison - Waisman Center Bone Dysplasia Clinic, Madison
UCSF Benioff Children's Hospital, Oakland
KK Women's and Children's Hospital, Singapore
Children's Hospital of Eastern Ontario Research Institute, Ottawa
Université de Montréal - Centre Hospitalier Universitaire Sainte-Justine, Montreal
Paediatric Clinical Research Unit at Oslo University Hospital, Oslo
Unidad de Cirugia Artroscopica (UCA), Vitoria-Gasteiz
NHS Greater Glasgow and Clyde, Glasgow
Guy's and Saint Thomas' NHS Foundation Trust, London
Manchester University NHS Foundation Trust, Manchester
Sheffield Children's NHS Foundation Trust, Sheffield
QED Therapeutics, Inc., a Bridgebio company
INDUSTRY