Interventional Study of Infigratinib in Children < 3 Years Old With Achondroplasia (ACH)

Recruiting Phase 2 Interventional Study
Achondroplasia
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
0 – 32 Months
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
77 (estimated)
Sponsor
QED Therapeutics, a BridgeBio company · Industry
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About This Trial
This is a Phase 2, multicenter, randomized, placebo-controlled study to evaluate the safety and efficacy of infigratinib in participants \< 3 years old with ACH. The purposes of the SAD and Phase 2 portions are to identify and confirm the dose of infigratinib to be used in the Phase 2b portion, based on safety and PK. The purpose of the Phase 2b, placebo-controlled portion is to evaluate the safet…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Diagnosis of ACH confirmed by genetic testing. If prospective participants had prior genetic testing, the diagnosis must be confirmed by a report from a certified laboratory, documenting the specific mutation. * Age 0 to 32 months (2 years and 8 months) at screening. * Signed …
Contacts

QED Therapeutics Inc.

18772805655

medinfo@qedtx.com

CONTACT