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Interventional Study of Infigratinib in Children < 3 Years Old With Achondroplasia (ACH)

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Primary completion moved earlier from Mar 2032 to Mar 2030
    • Study sites: 13 to 12
    • Secondary endpoints: 39 to 42
    v8
  2. Site details revised at 1 of 13 sitesv7
  3. Site details revised at 1 of 13 sitesv6
  4. Site details revised at 1 of 13 sitesv5
  5. Site details revised at 3 of 13 sitesv4
Show 2 earlier versionsHide 2 earlier versions
  1. Start date changed from estimate of Nov 2025 to Nov 19, 2025
    • Eligibility criteria expanded, about 42 words
    v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Oct 2025 to Nov 2025
    • Site details revised at 13 of 13 sites
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a Phase 2, multicenter, randomized, placebo-controlled study to evaluate the safety and efficacy of infigratinib in participants \< 3 years old with ACH. The purposes of the SAD and Phase 2 portions are to identify and confirm the dose of infigratinib to be used in the Phase 2b portion, based on safety and PK. The purpose of the Phase 2b, placebo-controlled portion is to evaluate the safety and efficacy of infigratinib in children \< 3 years old with ACH at the selected dose.
Trial Details
NCT Number NCT07169279
Lead Sponsor QED Therapeutics, a BridgeBio company
Conditions
(from sponsor)		 Achondroplasia
Related terms Achondroplasia, Bone Diseases, Dwarfism, Growth Disorders, Mucopolysaccharidosis IV, Musculoskeletal Diseases, Osteochondrodysplasias
Enrollment 77 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov