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Open-Label, Long-Term, Extension Study of Infigratinib in Children With Hypochondroplasia
Sponsor: QED Therapeutics, a BridgeBio company
Summary
Phase 2, multicenter, OLE study to evaluate the long-term safety, tolerability, and efficacy of infigratinib, an FGFR (fibroblast growth factor receptor) 1-3-selective tyrosine kinase inhibitor, in participants with Hypochondroplasia (HCH) who previously completed ACCEL 2/3, and potentially additional participants who completed ACCEL. Participants rolling over directly from the observational ACCEL study must have had at least a 6-month period of growth assessment in that study.
Official title: Phase 2, Open-Label, Long-Term, Extension (OLE) Study of Infigratinib, an FGFR 1-3-Selective Tyrosine Kinase Inhibitor, in Children With Hypochondroplasia: ACCEL OLE
Key Details
Gender
All
Age Range
3 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
135
Start Date
2026-04-21
Completion Date
2036-05-31
Last Updated
2026-02-06
Healthy Volunteers
No
Conditions
Interventions
Infigratinib
Infigratinib to be administered by mouth and initiated at the last dose level received in the ACCEL 2/3 study or at the dose selected to be further evaluated after proof-of-concept is established for Phase 2 portion of ACCEL 2/3.
Locations (25)
UCSF Benioff Children's Hospital
Oakland, California, United States
Childrens Hospital Colorado
Aurora, Colorado, United States
Children's National Hospital
Washington D.C., District of Columbia, United States
Johns Hopkins School of Medicine
Baltimore, Maryland, United States
University of Missouri
Columbia, Missouri, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Wisconsin Madison - Waisman Center Bone Dysplasia Clinic
Madison, Wisconsin, United States
Murdoch Children's Research Institute
Parkville, Victoria, Australia
London Health Sciences Centre - Children's Hospital of Western Ontario
London, Ontario, Canada
Children's Hospital of Eastern Ontario Research Institute
Ottawa, Ontario, Canada
Université de Montréal - Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada
Hôpital Femme Mère Enfant
Bron, France
Hôpital Universitaire Necker-Enfants Malades
Paris, France
Centre Hospitalier Universitaire (CHU) de Toulouse - Hôpital des Enfants
Toulouse, France
Haukeland University Hospital
Bergen, Norway
Paediatric Clinical Research Unit at Osla University Hospital
Oslo, Norway
Hospital Pediátrico de Coimbra
Coimbra, Portugal
KK Women's and Children's Hospital
Singapore, Singapore
UCA Hospital MiKS
Vitoria-Gasteiz, Spain
Astrid Lindgren Children's Hospital
Solna, Sweden
The Portland Hospital for Women and Children
London, England, United Kingdom
Manchester University
Manchester, England, United Kingdom
Sheffield Children's Hospital
Sheffield, England, United Kingdom
Glasgow Clinical Research Facility, Queen Elizabeth University Hospital
Glasgow, Scotland, United Kingdom