drugset / Trial / NCT06079398

A Clinical Trial to Evaluate Efficacy and Safety of TransCon CNP Compared With Placebo in Infants (0 to <2 Years of Age) With Achondroplasia

NCT06079398

Phase 2 Recruiting 72 enrolled Ascendis Pharma A/S
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This trial is a Phase 2, multicenter, double-blind, randomized (ratio 2:1 TransCon CNP vs. placebo), placebo-controlled trial, designed to evaluate the safety, tolerability, and efficacy of 100 μg CNP/kg of Navepegritide (TransCon CNP) administered SC once-weekly for 52 weeks in infants with genetically verified heterozygous ACH, aged 0 to \< 2 years at the time of randomization.

Timeline

Start
2024-01-23
Primary completion
2027-12
Completion
2028-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Navepegritide Protein / enzyme biologic 100 ug/kg Subcutaneous

Indications