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NCT06873035

An Interventional Study of Infigratinib in Children With Hypochondroplasia

Enrolling by Invitation
PHASE2Ages 3–18InterventionalTreatment
QED 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

Hypochondroplasia

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NCT06873035

Where you'd take part

This study runs at 24 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Astrid Lindgren Children's Hospital

    Solna, Sweden, Swedenno site contact published

  • Centre Hospitalier Universitaire (CHU) de Toulouse - Hôpital des Enfants

    Toulouse, France, Franceno site contact published

  • Children's Hospital of Eastern Ontario Research Institute

    Ottawa, Ontario, Canadano site contact published

  • Children's National Hospital

    Washington D.C., District of Columbiano site contact published

  • Childrens Hospital Colorado

    Aurora, Coloradono site contact published

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohiono site contact published

  • Glasgow Clinical Research Facility, Queen Elizabeth University Hospital

    Glasgow, Scotland, United Kingdomno site contact published

  • Haukeland University Hospital

    Bergen, Norway, Norwayno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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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