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An Interventional Study of Infigratinib in Children With Hypochondroplasia

NCT06873035 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-12-15

No results posted yet for this study

Summary

ACCEL2/3 is a Phase 2/3 study. The purpose of the Phase 2 portion of the study (ACCEL2/3) is to evaluate the efficacy and safety, of infigratinib in children with hypochondroplasia (HCH) receiving infigratinib, at one of two doses, of who have completed at least 26 weeks of participation in QED-sponsored ACCEL (QBGJ398-004).

Conditions

Interventions

DRUG

infigratinib 0.128 mg/kg/day

Oral infigratinib 0.128 mg/kg/day

DRUG

infigratinib 0.25 mg/kg/day

Oral infigratinib 0.25 mg/kg/day

Sponsors & Collaborators

  • QED Therapeutics, a BridgeBio company

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-04-22
Primary Completion
2027-01-31
Completion
2027-01-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • France
  • Norway
  • Portugal
  • Singapore
  • Spain
  • Sweden
  • 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 NCT06873035 on ClinicalTrials.gov