Open-Label, Long-Term, Extension Study of Infigratinib in Children With Hypochondroplasia
Enrolling by invitation · Phase 2
Conditions studied: Hypochondroplasia
In brief
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.
Key facts
- Study ID
- NCT07393373
- Run by
- QED Therapeutics, a BridgeBio company
- People needed
- 135
- Starts
- 2026-04-23
- Expected to finish
- 2036-05-31
- Last updated by the study team
- 2026-05-26
Who can join
Age: 3 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Inclusion Criteria for Participants Rolling Over from ACCEL 2/3
- Pediatric participants with HCH who have completed ACCEL 2/3
- Negative pregnancy test in girls ≥10 years of age or girls of any age who have experienced menarche
You may not qualify if…
- Exclusion Criteria for Participants Rolling Over from ACCEL 2/3
- Participant has concurrent medical condition that, in the view of the PI and/or sponsor, would interfere with study participation or safety evaluations
- Participants who developed a medical condition that requires the initiation of treatment with a prohibited medication
- Participants who prematurely discontinued ACCEL 2/3
- Participants who have reached final height or near final height
- Current participation in an ongoing clinical study with a sponsor other than QED
Where it is running
- 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 - The Royal Children's Hospital Melbourne — 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 Oslo University Hospital — Oslo, Norway
- Hospital Pediátrico de Coimbra — Coimbra, Portugal
- KK Women's and Children's Hospital — Singapore, Singapore
- Unidad de Cirugía Artroscopica, Hopsital MIKS — Vitoria-Gasteiz, Spain
- Astrid Lindgren Children's Hospital — Solna, Sweden
- 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
Full record on ClinicalTrials.gov
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