Table 3.

PROPEL 2 key inclusion and exclusion criteria.

Key inclusion criteria
1. Signed informed consent by child or parent(s) or LAR(s) and signed informed assent by the child (when applicable) 2. Age 3 to 11 years (inclusive) at screening 3. Diagnosis of ACH documented clinically and confirmed by genetic testing (including p.Gly380Arg and other pathogenic FGFR3 variants associated with achondroplasia) 4. Ambulatory and able to stand without assistance 5. Study participants and parent(s) or LAR(s) are willing and able to comply with study visits and study procedures 6. At least a 6-month period of growth assessment in PROPEL before study entry
Key exclusion criteria
1. Hypochondroplasia or short stature condition other than ACH 2. Females who have had their menarche 3. Height <−2 or >+ 2 SDs for age and sex based on reference tables for growth in children with ACH 4. AHV ⩽ 1.5 cm/year over a period ⩾6 months before screening 5. Concurrent disease or condition that, in the view of the Investigator and/or Study Sponsor, would compound assessment of efficacy or safety of infigratinib 6. Significant abnormality in screening laboratory results 7. Current evidence of corneal or retinal disorder/keratopathy 8. Current treatment with known strong inducers or inhibitors of CYP3A4 and medications that increase serum phosphorus and/or calcium concentration 9. Current evidence of endocrine alterations of calcium/phosphorus homeostasis: inorganic phosphorus outside of normal limits; total serum calcium (corrected) outside of normal limits 10. Treatment with growth hormone, IGF-1, or anabolic steroids in the previous 6 months or long-term treatment (>3 months) at any time 11. Treatment with a CNP analog or treatment targeting FGFR inhibition at any time 12. Regular long-term treatment (>1 month) with oral corticosteroids (low-dose ongoing inhaled steroid for asthma is acceptable) 13. Any other investigational product or investigational medical device for the treatment of ACH or short stature 14. Previous limb-lengthening surgery

ACH, achondroplasia; AHV, annualized height velocity; CNP, C-type natriuretic peptide; CYP, cytochrome P450; FGFR, fibroblast growth factor receptor; IGF, insulin-like growth factor 1; LAR, legally authorized representative; SD, standard deviation.