Status: Recruiting
Interventional Study of Infigratinib in Children < 3 Years Old With Achondroplasia (ACH)
This is a Phase 2, multicenter, randomized, placebo-controlled study to evaluate the safety and efficacy of infigratinib in participants \< 3 years old with ACH. The purposes of the SAD and Phase 2 portions are to identify and confirm the dose of infigratinib to be used in the Phase 2b portion, based on safety and PK. The purpose of the Phase 2b, placebo-controlled portion is to evaluate the safety and efficacy of infigratinib in children \< 3 years old with ACH at the selected dose.
Participants needed: 77
Trial details
Phase: Phase 2Age: 0-32Biological sex: AllType: InterventionalSponsor: QED Therapeutics, a BridgeBio companyUpdated: Jul 13, 2026Locations: 12
Eligibility criteria
Diagnosis of ACH confirmed by genetic testing. If prospective participants had p... [+6]
Participants who have hypochondroplasia or diagnosis of genetic condition other... [+9]