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

NCT07393373 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2026-02-06

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Infigratinib

Infigratinib to be administered by mouth and initiated at the last dose level received in the ACCEL 2/3 study or at the dose selected to be further evaluated after proof-of-concept is established for Phase 2 portion of ACCEL 2/3.

Sponsors & Collaborators

  • QED Therapeutics, a BridgeBio company

    lead INDUSTRY

Principal Investigators

  • QED Therapeutics SVP, Clinical Development · QED Therapeutics, a BridgeBio company

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2026-04-21
Primary Completion
2036-05-31
Completion
2036-05-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • France
  • Norway
  • Portugal
  • Singapore
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT07393373 on ClinicalTrials.gov