At a glance
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A Phase 2b, Multicenter, Double-Blind, Randomized, Placebo-controlled Trial Evaluating Efficacy and Safety of Subcutaneous Doses of TransCon CNP Administered Once Weekly for 52 Weeks in Children With Achondroplasia Followed by an Open Label Extension Period
In Brief
A Phase 3 clinical trial evaluating TransCon CNP and Placebo for TransCon CNP for Achondroplasia. Completed, enrolled 84 participants across 10 sites in 7 countries.
Detailed Summary
The purpose of this clinical trial is to evaluate efficacy and safety of once weekly SC doses of 100 µg CNP/kg compared to placebo on Annualized Growth Velocity after a 52-week randomized treatment period in children aged 2 to 11 years with genetically confirmed Achondroplasia. The double-blind, placebo-controlled treatment period is followed by an Open Label Extension (OLE) period of a 52-week duration.
Study Details
Timeline
Interventions
Once-weekly subcutaneous injection of 100 µg/kg TransCon CNP
Once-weekly subcutaneous injection of 100 µg/kg placebo for TransCon CNP