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

Part of paid clinical trials in Oakland, California.

Sponsor
QED Therapeutics, a BridgeBio company
Study ID
NCT07393373
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

  • Hypochondroplasia

Eligibility Criteria

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

Interventions

  • Infigratinib — DRUG
    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.

Study Details

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.

Key Dates

Start date
Apr 23, 2026
Status verified
May 2026
Primary completion
May 31, 2036
Completion
May 31, 2036

Study Design

Enrollment
135 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Rollover subjects
    Children who have completed QED-sponsored interventional study with infigratinib

Primary Outcome Measure

Incidence of treatment emergent adverse events (TEAE) and serious TEAE [ Time Frame: 10 years ]

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

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