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

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 – 2
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
72 (estimated)
Sponsor
Ascendis Pharma A/S · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Written, signed informed consent by the parent(s)/caregiver(s) of the participant, and as required by the institutional review board/human research ethics committee/independent ethics committee (IRB/HREC/IEC). * Male or female younger than 2 years of age at the time of randomi…
Contacts

Ascendis Registry Inquiries

+45 61242484

asnd_registryinquiries@ascendispharma.com

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