Clinical Trials Logo
  1. Home
  2. Achondroplasia
  3. NCT05246033

A Dose Escalation Trial Evaluating Safety, Efficacy, and Pharmacokinetics of Multiple Subcutaneous Doses of TransCon CNP Administered Once Weekly in Children With Achondroplasia

Achondroplasia Clinical Trial

Official title:
ACcomplisH China: A Phase 2, Multicenter, Randomized, Placebo-controlled, Dose Escalation Trial Evaluating Safety, Efficacy, and Pharmacokinetics of Multiple Subcutaneous Doses of TransCon CNP Administered Once Weekly in Children With Achondroplasia

Clinical Trial Summary

Purpose of the study: The main purpose of this study is to determine the safety and evaluate the effect of a once weekly dose of TransCon CNP in prepubertal children with achondroplasia in China. Study Treatments: TransCon CNP is an investigational (new) drug, which means that it is currently being tested, and therefore is considered experimental. TransCon CNP is designed to provide a sustained exposure of active CNP by subcutaneous (under the skin) injection once weekly. The Randomized Period of this study is a double-blinded and placebo-controlled. "Placebo-controlled" means that some participants will receive injections that don't contain any TransCon CNP (placebo injection - no active ingredient). "Double-blinded" means that neither the participant nor the study doctor will know which treatment the participant will be receiving, except in an emergency. After completion of the Randomized Period the trial participant may be invited to take part of the Open-Label Period of this study. "Open-label" means that all participants will receive injections that contain TransCon CNP; regardless of which treatment (TransCon CNP or placebo) was assigned during the 52 weeks (1 year) Randomized Period/blinded treatment period. It also means that both the participant and the study doctor will know which treatment, and which dose the participant receives.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05246033
Study type Interventional
Source Ascendis Pharma A/S
Contact
Status Active, not recruiting
Phase Phase 2
Start date January 5, 2022
Completion date March 2024
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05353192 - A Study to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone in Children With Achondroplasia Phase 4
Recruiting NCT05328050 - Registry for Patients With Achondroplasia / Hypochondroplasia (OMPR-Ach/Hy)
Completed NCT05659719 - A Study to Learn About Recifercept in Patients With Achondroplasia
Active, not recruiting NCT04554940 - A Clinical Trial to Evaluate Safety of Vosoritide in At-risk Infants With Achondroplasia Phase 2
Completed NCT01435629 - A Survey Collecting Data on Adult Height in Patients With Achondroplasia Treated With Somatropin N/A
Enrolling by invitation NCT06164951 - A Study to Evaluate the Efficacy and Safety of Infigratinib in Children and Adolescents With Achondroplasia Phase 3
Completed NCT01516229 - Special Survey for Long Term Application N/A
Completed NCT03872531 - Lifetime Impact Study for Achondroplasia
Active, not recruiting NCT05598320 - A Clinical Trial to Evaluate Efficacy and Safety of TransCon CNP Compared With Placebo in Children With Achondroplasia Phase 2/Phase 3
Terminated NCT05813314 - Bioequivalence Study to Compare Two Injection Devices for BMN 111 in Healthy Participants Phase 1
Recruiting NCT04265651 - Study of Infigratinib in Children With Achondroplasia Phase 2
Recruiting NCT05603936 - Adaption and Testing of the Quality of Life in Short Stature Youth (QoLISSY) Questionnaire for Parents With Children From 0-4
Completed NCT03780153 - The Norwegian Adult Achondroplasia Study
Active, not recruiting NCT04085523 - A Dose Escalation Trial Evaluating Safety, Efficacy, and Pharmacokinetics of TransCon CNP Administered Once Weekly in Prepubertal Children With Achondroplasia Phase 2
Enrolling by invitation NCT05929807 - A Clinical Trial to Investigate Long-term Safety, Tolerability, and Efficacy of Weekly Subcutaneous Doses With TransCon CNP in Children and Adolescents With Achondroplasia Phase 2/Phase 3
Not yet recruiting NCT06433557 - A Phase 2 Clinical Trial to Evaluate Efficacy, Safety, and Tolerability of Navepegritide in Combination With Lonapegsomatropin in Children With Achondroplasia Phase 2
Completed NCT03875534 - A Multi-center, Longitudinal, Observational Study of Children With Achondroplasia
Terminated NCT03794609 - Observational Study Investigating Clinical & Anthropometric Characteristics of Children With Achondroplasia.
Completed NCT03583697 - A Clinical Trial to Evaluate the Safety and Efficacy of BMN 111 in Infants and Young Children With Achondroplasia Phase 2
Active, not recruiting NCT03989947 - An Extension Study to Evaluate Safety and Efficacy of BMN 111 in Children With Achondroplasia Phase 2