Extension Study of Infigratinib in Children With Achondroplasia (ACH)
Enrolling by invitation · Phase 2
Conditions studied: Achondroplasia
In brief
This is a Phase 2, multicenter, open-label, extension (OLE) study to evaluate the long-term safety, tolerability, and efficacy of infigratinib, an FGFR 1-3-selective tyrosine kinase inhibitor, in subjects with ACH who previously completed a QED-sponsored interventional study, and potentially in additional subjects who are naïve to infigratinib treatment. Quality of Life assessments for this subject population will also be evaluated. Treatment-naïve subjects must have at least a 6-month period of growth assessment in study QBGJ398-001 (PROPEL) and will be enrolled in this OLE study only after a dose to be explored further is identified in Phase 2 Study QBGJ398-201 and subjects are not otherwise eligible to enroll in another QED-sponsored Phase 2 or Phase 3 ACH study.
Key facts
- Study ID
- NCT05145010
- Run by
- QED Therapeutics, a BridgeBio company
- People needed
- 300
- Starts
- 2021-12-06
- Expected to finish
- 2032-02-01
- Last updated by the study team
- 2025-10-31
Who can join
Age: 3 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
Where it is running
- USCF Benioff Children's Hospital, Oakland — Oakland, California, United States
- Children's Hospital Colorado — Aurora, Colorado, United States
- Nemours Alfred I. Dupont Hospital for Children — Wilmington, Delaware, United States
- Johns Hopkins University — 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 Hospital and UW Health Clinics — Madison, Wisconsin, United States
- Hospital de Pediatría SAMIC Prof. Dr. Juan P. Garrahan — Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina
- Murdoch Children's Hospital — Parkville, Victoria, Australia
- Stollery Children's Hospital — Edmonton, Alberta, Canada
- Children's Hospital - London Health Sciences Centre — London, Ontario, Canada
- Children's Hospital of Eastern Ontario — Ottawa, Ontario, Canada
- Centre Hospitalier Universitaire Sainte-Justine — Montreal, Quebec, Canada
- Hopital Femme Mere Enfant — Lyon, France
- Hopital Necker-Enfants Malades — Paris, France
- Hopital des Enfants — Toulouse, France
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milan, Italy
- Policlinico A. Gemelli IRCCS — Roma, Italy
- Haukeland University Hospital — Bergen, Norway
- Oslo University Hospital — Oslo, Norway
- KK Women's and Children's Hosptial — Singapore, Singapore
- Hospital Universitario La Paz — Madrid, Spain
- Hospital Universitario Virgen de la Victoria — Málaga, Spain
- Hospital Vithas San José — Vitoria-Gasteiz, Álava, Spain
Full record on ClinicalTrials.gov
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