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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

Enrolling by Invitation
PHASE2Ages 3–15InterventionalTreatment
Ascendis Pharma Growth Disorders A/S
~140 participants
Updated 2025-10-27 on ClinicalTrials.gov
What's tested:TransCon CNP

At a glance

Recruiting sites
0 of 17 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Tolerability
Measured over Through trial completion, an average of 10 years
+1 more outcome measured

Conditions

Achondroplasia

Explore related trials

Achondroplasia

Where it's being run

17 sites across 17 states
Arkansas1
Colorado1
Delaware1
Minnesota1
Montana1
New York1
Texas1
Wisconsin1

Study leadership

  • Claus Strange · STUDY_DIRECTOR · Ascendis Pharma A/S

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Written, signed informed consent of the parent(s) or legal guardian(s) of the participant, and as required by the institutional review board/human research ethics committee/independent ethics committee (IRB/HREC/IEC). For participants who are below the age of consent, a written assent will be obtained in accordance with applicable requirements as required by IRB/HREC/IEC. Upon reaching the legal age of consent, depending on applicable requirements, these participants will be asked to give their own written consent.
Participants with achondroplasia who have completed a clinical trial with TransCon CNP.
Parent(s)/legal guardian(s) willing and able to administer weekly SC injections of TransCon CNP and to follow the protocol.
Considered eligible based on the safety evaluations performed for evaluating stopping/holding rule criteria during the prior TransCon CNP clinical trial.

Exclusion

Known or suspected hypersensitivity to the investigational product or related products (trehalose, tris\[hydroxymethyl\]aminomethane, succinate, and methoxy polyethylene glycol \[mPEG\]).
Have received any dose of prescription medications, investigational medicinal product (other than TransCon CNP).
Sexually active female participants and female partners of male participants of childbearing potential not using a highly effective form of contraceptive (including oral, injectable, or implantable contraception, or intrauterine device (IUD)) for the entire trial period and for 90 days post end of the trial.
Participants with serum 25-hydroxy-vitamin D (25OHD) levels of \<50 nmol/L (\<20 ng/mL) at Visit 1 must be on treatment regimen of Vitamin D supplementation.
Any disease or condition that, in the opinion of the investigator, may make the participant unlikely to fully complete the trial, may confound interpretation of trial results, or may present undue risk from receiving trial treatment. This could include family situations, complications or manifestations, or medications that might impact safety or be considered confounding.

What this trial measures

  • Safety and TolerabilityThrough trial completion, an average of 10 years

    Incidence of Treatment-Emergent Adverse Events

  • Height Z-scoresThrough trial completion, an average of 10 years

    Number of standard deviations