ATTACH (ASND0039)
Research type
Research Study
Full title
AttaCH: A Phase 2, Multicenter, Long-Term, Open Label Extension Trial Evaluating Safety, Tolerability, and Efficacy of Subcutaneous Doses of TransCon CNP Administered Once Weekly in Children and Adolescents with Achondroplasia
IRAS ID
1012249
Contact name
Claus Strange
Contact email
Sponsor organisation
Ascendis Pharma Growth Disorders A/S
Clinicaltrials.gov Identifier
Research summary
The aim of this open-label extension study is to assess the long-term safety and effectiveness of once-weekly navepegritide in children and adolescents with Achondroplasia (ACH) who have completed a previous navepegritide (previously called TransCon CNP) study.
Participants aged 2 years and over can enter this study having completed a previous navepegritide (TransCon CNP) study and who meet the criteria for this long-term study. Participants will receive approximately 100mcg of CNP per kg per week (in a once-weekly under-the-skin injection of navepegritide) either at home or in clinic, until they reach near-adult height. This is assessed by physical examination and x-ray to confirm bone maturity. Study visits will occur every 12-14 weeks and assessments will include physical and skeletal examination, x-rays, ECG (to assess heart function), blood tests for safety and how navepegritide is handled by the body, assessment of growth and physical function, questionnaires about how ACH affects daily life, and completion of a study diary.REC name
London - Riverside Research Ethics Committee
REC reference
25/LO/0810
Date of REC Opinion
2 Dec 2025
REC opinion
Further Information Favourable Opinion