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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.
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Inclusion and exclusion criteria
Key Rollover Subjects Inclusion Criteria:
Key Rollover Subjects Exclusion Criteria:
Key Inclusion Criteria for Treatment Naïve Subjects
Key Exclusion Criteria for Treatment Naïve Subjects
Primary purpose
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Interventional model
Masking
300 participants in 2 patient groups
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QED Therapeutics SVP, Clinical Development
Data sourced from clinicaltrials.gov
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