An Interventional Study of Infigratinib in Children With Hypochondroplasia (NCT06873035) | Clinical Trial Compass
By InvitationPhase 2/3
An Interventional Study of Infigratinib in Children With Hypochondroplasia
United States24 participantsStarted 2025-04-22
Plain-language summary
ACCEL2/3 is a Phase 2/3 study. The purpose of the Phase 2 portion of the study (ACCEL2/3) is to evaluate the efficacy and safety, of infigratinib in children with hypochondroplasia (HCH) receiving infigratinib, at one of two doses, of who have completed at least 26 weeks of participation in QED-sponsored ACCEL (QBGJ398-004).
Who can participate
Age range3 Years – 18 Years
SexALL
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Key Inclusion Criteria:
* Participants must have completed at least 26 weeks and still be on the observational study (QBGJ398-004).
* Phase 2 portion: Participants 5-11 years of age (inclusive).
* Phase 3 portion: Participants 3 to \<18 years of age at screening with growth potential
* Diagnosis of HCH documented clinically by the presence of disproportionate short stature and confirmed with a molecular test.
* Participants are able to swallow oral medication.
* Participants and parent(s), legal guardian(s), or caregiver(s) are willing and able to comply with study visits and study procedures.
* Participants are ambulatory and able to stand without assistance. Sex and Contraceptive/Barrier Requirements
* Negative pregnancy test in girls ≥10 years of age or girls of any age who have experienced menarche.
* If sexually active, participants whether male or female, must be willing to use a highly effective method of contraception, as relevant, while taking study drug and for 1 month after the last dose of study drug.
* Signed informed consent.
Key Exclusion Criteria:
* Participants who have ACH or a short stature condition other than HCH.
* Significant concurrent disease or condition that, in the view of the investigator and/or sponsor, would confound assessment of efficacy or safety of infigratinib.
* Current evidence of clinically significant corneal or retinal disorder/keratopathy confirmed by ophthalmic examination.
* Concurrent circumstance, disease, or condition that, in…
What they're measuring
1
Change from baseline (BL) in Annualized Height Velocity (AHV; cm/year)
Timeframe: 26 weeks
2
Incidence, severity, and seriousness of adverse events (AEs) that require dose reduction or discontinuation