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.

NCT Number	NCT07169279
Lead Sponsor	QED Therapeutics, a BridgeBio company
Conditions	Achondroplasia
Enrollment	77 participants
Start Date	2025-11-19
Primary Completion	2030-03 (estimated)
Study Completion	2032-03 (estimated)
Updated on ClinicalTrials.gov	2026-07-13