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Open-Label, Long-Term, Extension Study of Infigratinib in Children With Hypochondroplasia

StatusEnrolling by Invitation
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv3
  2. Study sites: 25 to 24
    • Start date changed from estimate of Apr 21, 2026 to Apr 23, 2026
    v2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Phase 2, multicenter, OLE study to evaluate the long-term safety, tolerability, and efficacy of infigratinib, an FGFR (fibroblast growth factor receptor) 1-3-selective tyrosine kinase inhibitor, in participants with Hypochondroplasia (HCH) who previously completed ACCEL 2/3, and potentially additional participants who completed ACCEL. Participants rolling over directly from the observational ACCEL study must have had at least a 6-month period of growth assessment in that study.
Trial Details
NCT Number NCT07393373
Lead Sponsor QED Therapeutics, a BridgeBio company
Conditions
(from sponsor)		 Hypochondroplasia
Related terms Bone Diseases, Dwarfism, Genetic Diseases, Inborn, Hypochondroplasia, Mucopolysaccharidosis IV, Musculoskeletal Diseases, Osteochondrodysplasias
Enrollment 135 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov