An Interventional Study of Infigratinib in Children With Hypochondroplasia

Part of paid clinical trials in Oakland, California.

Sponsor
QED Therapeutics, a BridgeBio company
Study ID
NCT06873035
Phase
PHASE2/PHASE3
Status
Enrolling By Invitation

Conditions

  • Hypochondroplasia

Eligibility Criteria

Sex
ALL
Age
3 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • infigratinib 0.128 mg/kg/day — DRUG
    Oral infigratinib 0.128 mg/kg/day
  • infigratinib 0.25 mg/kg/day — DRUG
    Oral infigratinib 0.25 mg/kg/day

Study Details

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, who have completed at least 26 weeks of participation in QED-sponsored ACCEL (QBGJ398-004).

Key Dates

First listed
Mar 12, 2025
Start date
Apr 22, 2025
Status verified
May 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 2 Cohort 1
    Oral infigratinib 0.128 mg/kg/day
  • Experimental: Phase 2 Cohort 2
    Oral infigratinib 0.25 mg/kg/day

Primary Outcome Measure

Change from baseline (BL) in Annualized Height Velocity (AHV; cm/year) [ Time Frame: 26 weeks ]

Locations (8)

FacilityCityStateZIPSite coordinators
UCSF Benioff Children's HospitalOaklandCalifornia94609-
Childrens Hospital ColoradoAuroraColorado80045-
Children's National HospitalWashington D.C.District of Columbia20010-
Johns Hopkins School of MedicineBaltimoreMaryland21287-
University of MissouriColumbiaMissouri65201-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-
Vanderbilt University Medical CenterNashvilleTennessee37232-
University of Wisconsin Madison - Waisman Center Bone Dysplasia ClinicMadisonWisconsin53705-

Find similar trials in Oakland, CA

By research site
UCSF Benioff Children's Hospital· Oakland, CAChildrens Hospital Colorado· Aurora, COChildren's National Hospital· Washington D.C., DCJohns Hopkins School of Medicine· Baltimore, MDUniversity of Missouri· Columbia, MOCincinnati Children's Hospital Medical Center· Cincinnati, OH

Related Studies