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A Clinical Trial to Evaluate Efficacy and Safety of TransCon CNP Compared With Placebo in Children With Achondroplasia

NCT05598320 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2026-01-15

No results posted yet for this study

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.

Conditions

Interventions

DRUG

TransCon CNP

Once-weekly subcutaneous injection of 100 µg/kg TransCon CNP

DRUG

Placebo for TransCon CNP

Once-weekly subcutaneous injection of 100 µg/kg placebo for TransCon CNP

Sponsors & Collaborators

  • Ascendis Pharma Growth Disorders A/S

    lead INDUSTRY

Principal Investigators

  • Medical Director, MD · Ascendis Pharma A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-03
Primary Completion
2024-08-09
Completion
2025-08-13
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Denmark
  • Ireland
  • New Zealand
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05598320 on ClinicalTrials.gov