NCT06164951

A Study to Evaluate the Efficacy and Safety of Infigratinib in Children and Adolescents With Achondroplasia

A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Infigratinib in Children 3 to <18 Years of Age With Achondroplasia: PROPEL 3

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: QED Therapeutics, a BridgeBio company · Industry
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 3, multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of infigratinib in children and adolescents with achondroplasia (ACH) who have completed at least 26 weeks of participation in the QED-sponsored study PROPEL (QBGJ398-001).

Conditions

• Achondroplasia

Interventions

Type	Name	Description
DRUG	Infigratinib 0.25 mg/kg/day	Daily doses of oral Infigratinib (sprinkle capsules) at 2, 3.5, 5, 7, 10 mg
DRUG	Placebo Comparator 0.25 mg/kg/day	Daily doses of oral Placebo Comparator (sprinkle capsules) at 2, 3.5, 5, 7, 10 mg

Timeline

• Start date: 2023-11-10
• Primary completion: 2025-12-18
• Completion: 2025-12-18
• First posted: 2023-12-11
• Last updated: 2026-03-17

Locations

27 sites across 10 countries: United States, Argentina, Australia, Canada, France, Italy, Norway, Singapore, Spain, United Kingdom

Regulatory

• FDA-regulated drug study