NCT06873035

An Interventional Study of Infigratinib in Children With Hypochondroplasia

A Phase 2/3, Multicenter, Open-Label Phase Followed by a Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Infigratinib in Children With Hypochondroplasia: ACCEL 2/3

• Status: Enrolling By Invitation
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: QED Therapeutics, a BridgeBio company · Industry
• Sex: All
• Age: 3 Years – 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

ACCEL 2/3 is a Phase 2/3 study that comprises of 2 portions. The Phase 2 portion is an open-label, portion in children with HCH aged 5 to 11 years old followed by a Phase 3 portion which is double-blind, placebo-controlled in children with HCH aged \>3 years old to \<18 years old.

Conditions

• Hypochondroplasia

Interventions

Type	Name	Description
DRUG	infigratinib 0.128 mg/kg/day	Oral infigratinib 0.128 mg/kg/day
DRUG	infigratinib 0.25 mg/kg/day	Oral infigratinib 0.25 mg/kg/day

Timeline

• Start date: 2025-04-22
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2025-03-12
• Last updated: 2025-12-15

Locations

22 sites across 10 countries: United States, Australia, Canada, France, Norway, Portugal, Singapore, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study