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

NCT06164951 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2026-03-17

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • QED Therapeutics, a BridgeBio company

    lead INDUSTRY

Principal Investigators

  • QED Therapeutics, Inc. Medical Director, Clinical Development · QED Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-10
Primary Completion
2025-12-18
Completion
2025-12-18
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Canada
  • France
  • Italy
  • Norway
  • Singapore
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06164951 on ClinicalTrials.gov