Extension Study of Infigratinib in Children With Achondroplasia (ACH)

  • STATUS
    Recruiting
  • End date
    Feb 1, 2032
  • participants needed
    280
  • sponsor
    QED Therapeutics, Inc.
Updated on 26 April 2022

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. Treatment-naïve subjects must have at least a 6-month period of growth assessment in the PROPEL study (Protocol QBGJ398 001) and will be enrolled in this OLE study only after a dose to be explored further is identified in Phase 2 Study QBGJ398-201.

Details
Condition Achondroplasia
Treatment Infigratinib
Clinical Study IdentifierNCT05145010
SponsorQED Therapeutics, Inc.
Last Modified on26 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Pediatric subjects with ACH who have completed study activities in a previous QED-sponsored interventional study with infigratinib
Subjects and parent(s) or legally authorized representatives (LARs) are willing and able to comply with study visits and study procedures
Subjects are able to swallow oral medication
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 LAR 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
Subjects who developed a medical condition that will require the initiation of treatment with a prohibited medication
Subjects that have reached final height or near final height
Key Inclusion Criteria for Treatment Naïve Subjects
Subject must be 3 to <18 years of age (inclusive) at screening and have growth potential
Subjects who have a diagnosis of ACH, documented clinically and confirmed by genetic testing
Subjects have at least a 6-month period of growth assessment in the PROPEL study (Protocol QBGJ398 001) before study entry
In girls ≥10 years of age or girls of any age who have experienced menarche, having a negative pregnancy test
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 LAR and the subject's assent, when applicable, before any study-specific activity is performed
Exclusion Criteria for Treatment Naïve Subjects
Subjects who have hypochondroplasia or short stature condition other than ACH (e.g., trisomy 21, pseudoachondroplasia, psychosocial short stature)
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
Subjects who have a history of malignancy
Subjects who are currently receiving treatment with agents that are known strong inducers or inhibitors of cytochrome P450 (CYP) 3A4
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
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