Extension Study of Infigratinib in Children With Achondroplasia (ACH)
Status:
Recruiting
Trial end date:
2032-02-01
Target enrollment:
Participant gender:
Summary
This is a Phase 2, multicenter, open-label, extension (OLE) study to evaluate the long-term
safety, tolerability, and efficacy of infigratinib, an FGFR 1-3-selective tyrosine kinase
inhibitor, in subjects with ACH who previously completed a QED-sponsored interventional
study, and potentially in additional subjects who are naïve to infigratinib treatment.
Treatment-naïve subjects must have at least a 6-month period of growth assessment in the
PROPEL study (Protocol QBGJ398 001) and will be enrolled in this OLE study only after a dose
to be explored further is identified in Phase 2 Study QBGJ398-201.