Open-Label, Long-Term, Extension Study of Infigratinib in Children With Hypochondroplasia
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
1 other identifier
interventional
135
10 countries
25
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2026
Longer than P75 for phase_2
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2026
CompletedFirst Posted
Study publicly available on registry
February 6, 2026
CompletedStudy Start
First participant enrolled
April 21, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2036
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2036
February 6, 2026
January 1, 2026
10.1 years
January 19, 2026
January 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of treatment emergent adverse events (TEAE) and serious TEAE
10 years
Changes over time in standing height Z-score in relation to HCH and non-HCH growth charts
10 years
Secondary Outcomes (17)
Changes over time in AHV Z-score
10 years
Changes over time in body proportions
10 years
Changes over time in weight Z-score
10 years
Changes overtime in BMI
10 years
Age of puberty onset and time to Tanner stage ≥4
10 years
- +12 more secondary outcomes
Study Arms (1)
Arm 1: Rollover subjects
EXPERIMENTALChildren who have completed QED-sponsored interventional study with infigratinib
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
UCSF Benioff Children's Hospital
Oakland, California, 94609, United States
Childrens Hospital Colorado
Aurora, Colorado, 80045, United States
Children's National Hospital
Washington D.C., District of Columbia, 20010, United States
Johns Hopkins School of Medicine
Baltimore, Maryland, 21287, United States
University of Missouri
Columbia, Missouri, 65201, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
University of Wisconsin Madison - Waisman Center Bone Dysplasia Clinic
Madison, Wisconsin, 53705, United States
Murdoch Children's Research Institute
Parkville, Victoria, 3052, Australia
London Health Sciences Centre - Children's Hospital of Western Ontario
London, Ontario, N6C 2R5, Canada
Children's Hospital of Eastern Ontario Research Institute
Ottawa, Ontario, K1H 8L1, Canada
Université de Montréal - Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, H3T 1C5, Canada
Hôpital Femme Mère Enfant
Bron, 69677, France
Hôpital Universitaire Necker-Enfants Malades
Paris, 75015, France
Centre Hospitalier Universitaire (CHU) de Toulouse - Hôpital des Enfants
Toulouse, 31059, France
Haukeland University Hospital
Bergen, 5021, Norway
Paediatric Clinical Research Unit at Osla University Hospital
Oslo, 0372, Norway
Hospital Pediátrico de Coimbra
Coimbra, 3000-602, Portugal
KK Women's and Children's Hospital
Singapore, 229899, Singapore
UCA Hospital MiKS
Vitoria-Gasteiz, 01010, Spain
Astrid Lindgren Children's Hospital
Solna, 17164, Sweden
The Portland Hospital for Women and Children
London, England, W1W 5AH, United Kingdom
Manchester University
Manchester, England, M13 9WL, United Kingdom
Sheffield Children's Hospital
Sheffield, England, S10 2TH, United Kingdom
Glasgow Clinical Research Facility, Queen Elizabeth University Hospital
Glasgow, Scotland, G51 4TF, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
QED Therapeutics SVP, Clinical Development
QED Therapeutics, a BridgeBio company
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2026
First Posted
February 6, 2026
Study Start
April 21, 2026
Primary Completion (Estimated)
May 31, 2036
Study Completion (Estimated)
May 31, 2036
Last Updated
February 6, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share