The PROPEL Trial

The PROPEL OLE study

The PROPEL OLE study is a 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 3 to < 17 years of age with achondroplasia. The objectives are to evaluate growth, achondroplasia-related medical complications, assessments of health-related quality of life, body pain, functional abilities, cognitive functions, and treatments of study participants. Participants in the PROPEL OLE study must have participated in the PROPEL 3 study to be eligible for the PROPEL OLE study.

The PROPEL Infant and Toddler Study

The PROPEL Infant and Toddler Study will evaluate the safety and efficacy of oral infigratinib in pediatric participants under 3 years of age with achondroplasia. The study has 4 portions: a dose-defining part (the SAD portion), a Phase 2 portion, a Phase 2b portion, and an Extension Portion (Open Label). Patients who have participated in the PROPEL Infant and Toddler Study can, after having completed the infant study, continue in the PROPEL OLE study for long-term follow-up.