A Clinical Trial to Investigate Long-term Safety, Tolerability, and Efficacy of Weekly Subcutaneous Doses With TransCon CNP in Children and Adolescents With Achondroplasia
Condition(s) studied
Investigational drug(s) / intervention(s)
TransCon CNP: TransCon CNP drug product is a lyophilized powder in a single-use vial. Prior to use, the lyophilized powder is reconstituted with sterile water for injection and administered by subcutaneous injection via syringe and needle.
Study summary
TransCon CNP administered once-weekly in children and adolescents with achondroplasia who have completed a prior TransCon CNP clinical trial. Participants who complete a prior TransCon CNP trial and meet all eligibility criteria will be invited to continue into the long-term open label extension trial to receive 100 µg CNP/kg/week of TransCon CNP. Trial treatment will be completed when the participant reaches 16 years of age for females and 18 years of age for males and have femur and tibial epiphyseal closure. TransCon CNP treatment will continue if femur and tibial epiphyseal closure is not confirmed at the age of 16 years for females, and 18 years for males. Treatment with TransCon CNP will be completed once femur and tibial epiphyseal closure is confirmed by radiographic imaging. The trial duration is individual for each trial participant. Visits will occur every 12-14 weeks throughout the trial.
Eligibility
Primary outcome measure(s)
- Safety and Tolerability — Through trial completion, an average of 10 years
Incidence of Treatment-Emergent Adverse Events - Height Z-scores — Through trial completion, an average of 10 years
Number of standard deviations
Trial sites (19)
| Facility | City | Region | Status |
|---|---|---|---|
| Ascendis Pharma Investigational Site | Little Rock | Arkansas | |
| Ascendis Investigational Site | Aurora | Colorado | |
| Ascendis Investigational Site | Wilmington | Delaware | |
| Ascendis Investigational Site | Saint Paul | Minnesota | |
| Ascendis Pharma Investigational Site | Columbia Falls | Montana | |
| Ascendis Pharma Investigational Site | Buffalo | New York | |
| Ascendis Investigational Site | Houston | Texas | |
| Ascendis Pharma Investigational Site | Madison | Wisconsin | |
| Ascendis Pharma Investigational Site | Parkville | Victoria | |
| Ascendis Investigational Site | Linz | Austria | |
| Ascendis Investigational Site | Montreal | Canada | |
| Ascendis Pharma Investigational Site | Copenhagen | Denmark | |
| Ascendis Pharma Investigational Site | Paris | France | |
| Ascendis Investigational Site | Berlin | Germany | |
| Ascendis Pharma Investigational Site | Dublin | Ireland | |
| Ascendis Investigational Site | Auckland | New Zealand | |
| Ascendis Investigational Site | Coimbra | Portugal | |
| Ascendis Investigational Site | Vitoria-Gasteiz | Spain | |
| Ascendis Investigational Site | London | United Kingdom |
More Ascendis Pharma Growth Disorders A/S trials in the UK
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05929807 on ClinicalTrials.gov ↗ ← All trials in the UK