NCT07393373

Open-Label, Long-Term, Extension Study of Infigratinib in Children With Hypochondroplasia

Phase 2, Open-Label, Long-Term, Extension (OLE) Study of Infigratinib, an FGFR 1-3-Selective Tyrosine Kinase Inhibitor, in Children With Hypochondroplasia: ACCEL OLE

• Status: Enrolling By Invitation
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 135 (estimated)
• Sponsor: QED Therapeutics, a BridgeBio company · Industry
• Sex: All
• Age: 3 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

Phase 2, multicenter, OLE study to evaluate the long-term safety, tolerability, and efficacy of infigratinib, an FGFR (fibroblast growth factor receptor) 1-3-selective tyrosine kinase inhibitor, in participants with Hypochondroplasia (HCH) who previously completed ACCEL 2/3, and potentially additional participants who completed ACCEL. Participants rolling over directly from the observational ACCEL study must have had at least a 6-month period of growth assessment in that study.

Conditions

• Hypochondroplasia

Interventions

Type	Name	Description
DRUG	Infigratinib	Infigratinib to be administered by mouth and initiated at the last dose level received in the ACCEL 2/3 study or at the dose selected to be further evaluated after proof-of-concept is established for Phase 2 portion of ACCEL 2/3.

Timeline

• Start date: 2026-04-21
• Primary completion: 2036-05-31
• Completion: 2036-05-31
• First posted: 2026-02-06
• Last updated: 2026-02-06

Locations

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

Regulatory

• FDA-regulated drug study