Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04085523 · ClinicalTrials.gov registry record · Phase 2
A Dose Escalation Trial Evaluating Safety, Efficacy, and Pharmacokinetics of TransCon CNP Administered Once Weekly in Prepubertal Children With Achondroplasia
A Phase 2 study, sponsored by Ascendis Pharma A/S.
- Completed
- Registry status
- Phase 2
- Development phase
- 57
- Enrollment target
NCT04085523: Completed Phase 2 study, sponsored by Ascendis Pharma A/S.
NCT04085523 is a Phase 2 study that has completed, run by Ascendis Pharma A/S. The registered enrollment target is 57 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04085523, a Phase 2 study, has completed, sponsored by Ascendis Pharma A/S.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 57 participants
- Enrollment target
Study Summary
The trial is a multicenter, double-blind, randomized, placebo-controlled, dose escalation trial of weekly TransCon CNP administered subcutaneously in prepubertal children 2 to 10 years old, inclusive, with Achondroplasia.
Primary Outcome
The primary efficacy analysis compared the difference in the primary efficacy endpoint between the TransCon CNP treatment group and the pooled placebo group using an ANCOVA model with the annualized height velocity (AHV) at Week 52 as the response variable, treatment (dose groups and placebo) and sex as factors, baseline age and baseline height SDS as the covariates, and based on the Full Analysis Set.
Interventions
- DRUG TransCon CNP
- DRUG Placebo for TransCon CNP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2020-06-24 |
| Est. Completion | 2024-10-01 |
| Phase | Phase 2 |
What the finished NCT04085523 record still lists
NCT04085523 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 2 interventions - of which TransCon CNP is the first listed.
NCT04085523 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04085523 about?
NCT04085523 is a clinical study titled "A Dose Escalation Trial Evaluating Safety, Efficacy, and Pharmacokinetics of TransCon CNP Administered Once Weekly in Prepubertal Children With Achondroplasia". The trial is a multicenter, double-blind, randomized, placebo-controlled, dose escalation trial of weekly TransCon CNP administered subcutaneously in prepubertal children 2 to 10 years old, inclusive, with Achondroplasia.
What is the current status of trial NCT04085523?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 57 participants. The study started on 2020-06-24. Estimated completion is 2024-10-01.
What interventions are being tested in trial NCT04085523?
The interventions under investigation include: TransCon CNP (DRUG), Placebo for TransCon CNP (DRUG).
Who is sponsoring clinical trial NCT04085523?
This trial is sponsored by Ascendis Pharma A/S, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04085523's enrollment target sits among peer trials
57 1141st of 2000 higher than 855 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03521830 · 57 participants · Phase 2
Nivolumab Alone or Plus Relatlimab or Ipilimumab for Patients With Locally-Advanced Unresectable or Metastatic Basal Cell Carcinoma
- NCT03587701 · 57 participants · Phase 2
Effects of Anakinra in Subjects With Corticosteroid-resistant/Intolerant Meniere's Disease and Autoimmune Inner Ear Disease
- NCT04104126 · 57 participants · NA
Blood Flow Restriction Therapy in Achilles Injury
- NCT04703842 · 57 participants · Phase 1
Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Reduced Ejection Fraction
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI