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

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.

Timeline

Start

2026-04-23

Primary completion

2036-05-31

Completion

2036-05-31

Drugs

Indications