A Multicenter, 12-Month, Randomized, Double Blind, Placebo-Controlled Phase 3 Efficacy and Safety Study of Daily Oral LUM-201 in Naïve-to-Treatment, Prepubertal Children with Growth Hormone Deficiency
A Multicenter, 12-Month, Randomized, Double Blind, Placebo-Controlled Phase 3 Efficacy and Safety Study of Daily Oral LUM-201 in Naïve-to-Treatment, Prepubertal Children with Growth Hormone Deficiency (GHD)
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Clinical Trial Information
Trial Contact: Tilme, Linda; Garcia de Djuro, Ginette; Casillas, Bridey L
Trial Phone: 321.843.5278 ; 321.841.1361 ; 321.841.9772
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IRB No: 25.112.05
Protocol Abbrev: LUM-201-10
Principal Investigator: Joshua H Yang, MD
Phase: Drug: Phase III
Age Group: Pediatric
ClinicalTrials.gov ID: NCT06948214
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Objective
To evaluate the effect of LUM-201 1.6 mg/kg/day on growth rates over 12 months in prepubertal children with GHD
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Key Eligibility
– must be prepubertal
– have no history of prior pediatric GHD treatment
– must meet the specific inclusion criteria outlined in the protocol
