Extension Study of Infigratinib in Children With Achondroplasia (ACH)

Launched by QED THERAPEUTICS, INC. · Nov 22, 2021

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Eligibility criteria

• Key Rollover Subjects Inclusion Criteria:
• • 1. Pediatric subjects with ACH who have completed a previous QED-sponsored interventional study with infigratinib.
• • 2. Subjects and parent(s), legal guardian(s), or caregiver(s) are willing and able to comply with study visits and study procedures.
• • 3. Subjects are able to swallow oral medication.
• • 4. Negative pregnancy test in girls ≥10 years of age or girls of any age who have experienced menarche.
• • 5. 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.
• • 6. 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.
• Key Rollover Subjects Exclusion Criteria:
• • 1. 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.
• • 2. Subjects who developed a medical condition that will require the initiation of treatment with a prohibited medication.
• • 3. Subjects prematurely discontinued a prior QED-sponsored interventional study with infigratinib
• • 4. Current participation in an ongoing clinical study with a sponsor other than QED
• • 5. Subjects that have reached final height or near final height.
• • Key Inclusion Criteria for Treatment Naïve Subjects
• • 1. Subject must be 3 to \<18 years of age at screening and have growth potential.
• • 2. Subjects and parent(s), legal guardian(s), or caregiver(s) are willing and able to comply with study visits and study procedures.
• • 3. Subjects are able to swallow oral medication.
• • 4. Subjects who have a diagnosis of ACH, documented clinically and confirmed by genetic testing.
• • 5. Subjects have at least a 6-month period of growth assessment in the PROPEL study (Protocol QBGJ398 001) before study entry.
• • 6. Negative pregnancy test in girls ≥10 years of age or girls of any age who have experienced menarche.
• • 7. 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.
• • 8. 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.
• • Key Exclusion Criteria for Treatment Naïve Subjects
• • 1. Subjects who have hypochondroplasia or short stature condition other than ACH (e.g., trisomy 21, pseudoachondroplasia, psychosocial short stature).
• • 2. Subjects who have significant concurrent disease or condition that, in the view of the PI and/or sponsor, would represent an increased risk to the subject or would interfere with study participation or safety evaluations.
• • 3. Subjects who have a history of malignancy.
• • 4. Subjects who are currently receiving treatment with agents that are known strong inducers or inhibitors of cytochrome P450 (CYP) 3A4.
• • 5. Subjects who discontinued treatment with prohibited medications for at least 5 half-lives before screening are eligible.
• • 6. Subjects who have received treatment with growth hormone, insulin-like growth factor 1 (IGF 1), anabolic steroids or any investigational or approved drug for the treatment of ACH in the previous 6 months.
• • 7. Subjects who have significant abnormality in screening laboratory results.
• • 8. Subjects who have had a fracture within 12 months of screening.