drugset / Trial / NCT06873035

An Interventional Study of Infigratinib in Children With Hypochondroplasia

NCT06873035

Phase 2/3 Enrolling by invitation 24 enrolled QED Therapeutics, a BridgeBio company
RandomizedParallel-groupOpen-labelTreatment

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, who have completed at least 26 weeks of participation in QED-sponsored ACCEL (QBGJ398-004).

Timeline

Start
2025-04-22
Primary completion
2027-01
Completion
2027-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Infigratinib Small molecule 0.128 mg/kg Oral
Subject Infigratinib Small molecule 0.25 mg/kg Oral

Indications