NCT06873035
An Interventional Study of Infigratinib in Children With Hypochondroplasia
Enrolling by Invitation
PHASE2Ages 3–18InterventionalTreatmentQED Therapeutics, a BridgeBio company
~24 participants
Updated 2026-07-16 on ClinicalTrials.gov
What's tested:infigratinib 0.128 mg/kg/dayinfigratinib 0.25 mg/kg/day
At a glance
Recruiting sites
0 of 24 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline (BL) in Annualized Height Velocity (AHV; cm/year)
Measured over 26 weeks
+1 more outcome measured
Conditions
Where it's being run
24 sites across 19 statesFrance3
Ontario2
Norway2
England2
California1
Colorado1
District of Columbia1
Maryland1
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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.
Exclusion
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 the view of the investigator and/or sponsor, would interfere with study participation or safety evaluations.
History and/or current evidence of extensive ectopic tissue calcification.
History of malignancy.
Having received or planning to receive treatment with any other investigational or approved product for the treatment of ACH, HCH, or short stature.
Regular long-term treatment (≥3 weeks) with supraphysiologic doses of glucocorticoid.
Previous limb-lengthening surgery at any time or planned/expected to have limb-lengthening or guided growth surgery while participating in the study.
Participants receiving medications which could increase serum phosphorus and/or calcium concentrations
Clinically significant abnormality in any laboratory test result at screening.
Pregnant or breastfeeding at the screening visit or planning to become pregnant (self or partner) at any time during the study.
Allergy to any components of the study drug.
Concurrent circumstance, disease, or condition that would interfere with study participation.
What this trial measures
- Change from baseline (BL) in Annualized Height Velocity (AHV; cm/year)26 weeks
- Incidence, severity, and seriousness of adverse events (AEs) that require dose reduction or discontinuationat least 26 weeks