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

QED Therapeutics, a BridgeBio company

Status and phase

Invitation-only

Phase 2

Conditions

Hypochondroplasia

Treatments

Drug: Infigratinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT07393373

QBGJ398-205

Details and patient eligibility

About

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.

Enrollment

135 estimated patients

Sex

All

Ages

3 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Inclusion Criteria for Participants Rolling Over from ACCEL 2/3
1. Pediatric participants with HCH who have completed ACCEL 2/3
2. Negative pregnancy test in girls ≥10 years of age or girls of any age who have experienced menarche

Exclusion criteria

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