A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Infigratinib in Children 3 to <18 Years of Age with Achondroplasia: PROPEL 3

Achondroplasia

Change from baseline (BL) in AHV, compared to placebo [Time Frame: Week 52]

Change from BL in height Z-score (in relation to ACH tables), compared to placebo [Time Frame: Week 52], Change from BL in upper to lower body segment ratio, compared to placebo [Time Frame: Week 52], Change from BL in height Z-score (in relation to non-ACH tables), compared to placebo [Time Frame: Week 52], AVH compared to placebo [Time Frame: Week 52], Absolute and change from baseline in upper arm to forearm length ratio (cm), compared to placebo [Time Frame: Week 52], Absolute and change from baseline in upper leg to lower leg length ratio (cm), compared to placebo [Time Frame: Week 52], Absolute and change from baseline in arm span (cm) to standing height ratio, compared to placebo [Time Frame: Week 52], Absolute and change from baseline in head circumference (cm) to standing height ratio, compared to placebo [Time Frame: Week 52], Absolute value and change in body mass index, compared to placebo [Time Frame: Week 52], Incidence of adverse events [Time Frame: Week 52], Change from BL in AHV in children ≥5 years of age, compared to placebo [Time Frame: Week 52], Change from BL in the Physical Functioning Scale of the PedsQL child report compared to placebo [Time Frame: Week 52], Change in psychomotor function assessed by age-appropriate computerized tests (Detection Test), compared to placebo [Time Frame: Week 52], Change from BL in attention assessed by age-appropriate computerized tests (Identification Test) [Time Frame: Week 52], Change from BL in visual learning assessed by age-appropriate computerized tests (One Card Learning Test) [Time Frame: Week 52], Change from BL in working memory assessed by age-appropriate computerized tests (One Back Test) [Time Frame: Week 52], Pharmacokinetic profile of infigratinib by assessment of maximum concentration (Cmax) [Time Frame: Week 52], Pharmacokinetic profile of infigratinib by assessment of time-to-maximum concentration (Tmax) [Time Frame: Week 52], Change from BL in pharmacodynamic parameters by assessing collagen X marker, compared to placebo [Time Frame: Week 52], Evaluate the acceptability and palatability of infigratinib using a 5-point hedonic scale [Time Frame: Week 13]

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