Extension Study of Infigratinib in Children With Achondroplasia (ACH) (NCT05145010) | Clinical Trial Compass
By InvitationPhase 2
Extension Study of Infigratinib in Children With Achondroplasia (ACH)
United States300 participantsStarted 2021-12-06
Plain-language summary
This is a Phase 2, multicenter, open-label, extension (OLE) study to evaluate the long-term safety, tolerability, and efficacy of infigratinib, an FGFR 1-3-selective tyrosine kinase inhibitor, in subjects with ACH who previously completed a QED-sponsored interventional study, and potentially in additional subjects who are naïve to infigratinib treatment. Quality of Life assessments for this subject population will also be evaluated. Treatment-naïve subjects must have at least a 6-month period of growth assessment in study QBGJ398-001 (PROPEL) and will be enrolled in this OLE study only after a dose to be explored further is identified in Phase 2 Study QBGJ398-201 and subjects are not otherwise eligible to enroll in another QED-sponsored Phase 2 or Phase 3 ACH study.
Who can participate
Age range3 Years – 18 Years
SexALL
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Inclusion criteria
✓. Pediatric subjects with ACH who have completed a previous QED-sponsored interventional study with infigratinib.
✓. Subjects and parent(s), legal guardian(s), or caregiver(s) are willing and able to comply with study visits and study procedures.
✓. Subjects are able to swallow oral medication.
✓. Negative pregnancy test in girls ≥10 years of age or girls of any age who have experienced menarche.
✓. If sexually active, subject must be willing to use a highly effective method of contraception while taking study drug and for 1 month after the last dose of study drug.
✓. The PI, or a person designated by the PI, will obtain written informed consent from each subject's parent(s), legal guardian(s), or caregiver(s) and the subject's assent, when applicable, before any study-specific activity is performed.
Exclusion criteria
✕. Subject has concurrent circumstance, disease, or condition that, in the view of the PI and/or sponsor, would interfere with study participation or safety evaluations.
What they're measuring
1
Incidence of treatment emergent adverse events (TEAE) and serious TEAE
Timeframe: 10 years
2
Changes over time in height Z-score in relation to ACH and non-ACH growth charts