By InvitationPhase 2

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

United States135 participantsStarted 2026-04-21

Plain-language 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.

Who can participate

Age range3 Years – 18 Years

SexALL

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Inclusion criteria

✓. Pediatric participants with HCH who have completed ACCEL 2/3
✓. Negative pregnancy test in girls ≥10 years of age or girls of any age who have experienced menarche

Exclusion criteria

✕. Participant has concurrent medical condition that, in the view of the PI and/or sponsor, would interfere with study participation or safety evaluations
✕. Participants who developed a medical condition that requires the initiation of treatment with a prohibited medication
✕. Participants who prematurely discontinued ACCEL 2/3
✕. Participants who have reached final height or near final height
✕. Current participation in an ongoing clinical study with a sponsor other than QED

What they're measuring

Incidence of treatment emergent adverse events (TEAE) and serious TEAE

Timeframe: 10 years

Changes over time in standing height Z-score in relation to HCH and non-HCH growth charts

Timeframe: 10 years

Trial details

NCT IDNCT07393373

SponsorQED Therapeutics, a BridgeBio company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2036-05-31

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