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TransCon CNP for Achondroplasia (AttaCH Trial)

Phase 2 & 3
Waitlist Available
Research Sponsored by Ascendis Pharma Growth Disorders A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through trial completion, an average of 10 years
Awards & highlights
No Placebo-Only Group

Summary

This trial uses TransCon CNP to help children and adolescents with achondroplasia grow their bones properly. It is for those who have already been part of a previous trial. The treatment continues for an extended period.

Who is the study for?
This trial is for children and adolescents with achondroplasia who have already been part of a previous TransCon CNP study. They must be able to receive weekly injections, have parental consent, and meet safety criteria from the prior trial. Those unable to complete the study or at risk due to other conditions are excluded.
What is being tested?
The long-term safety, tolerability, and effectiveness of TransCon CNP given once a week are being tested in young patients with achondroplasia until they reach skeletal maturity (16 years for females, 18 years for males), confirmed by radiographic imaging.
What are the potential side effects?
Specific side effects aren't listed here but may include reactions related to subcutaneous injection or hypersensitivity to ingredients like trehalose, tris[hydroxymethyl]aminomethane, succinate, and methoxy polyethylene glycol.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through trial completion, an average of 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through trial completion, an average of 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Height Z-scores
Safety and Tolerability
Secondary study objectives
Annualized Growth Velocity

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT04085523
36%
Pyrexia
27%
Nasal congestion
27%
Cough
18%
Gastroenteritis
18%
Fatigue
18%
Rhinorrhoea
18%
Vomiting
18%
Epistaxis
18%
Otitis media
9%
Vitamin D deficiency
9%
Snoring
9%
Upper respiratory tract infection
9%
Pain in extremity
9%
Ear Pain
9%
COVID-19
9%
Viral infection
9%
Injection Site Reaction
9%
Headache
9%
Abdominal Pain Upper
100%
80%
60%
40%
20%
0%
Study treatment Arm
TransCon CNP 20 mcg
TransCon CNP 6 mcg
TransCon CNP 100 mcg
Placebo
TransCon CNP 50 mcg

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: TransCon CNP 100 mcgExperimental Treatment1 Intervention
TransCon CNP 100 mcg delivered once weekly by subcutaneous injection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TransCon CNP
2020
Completed Phase 2
~60

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Achondroplasia focus on promoting bone growth by targeting specific molecular pathways. TransCon CNP, a C-type Natriuretic Peptide, works by inhibiting the FGFR3 pathway, which is overactive in Achondroplasia due to mutations in the FGFR3 gene. This inhibition helps normalize bone growth, addressing the root cause of the condition. Other treatments, such as growth hormone therapy, stimulate overall growth but do not specifically target the FGFR3 pathway. Understanding these mechanisms is crucial for patients and healthcare providers to select the most effective treatment that directly addresses the genetic abnormalities in Achondroplasia.

Find a Location

Who is running the clinical trial?

Ascendis Pharma Growth Disorders A/SLead Sponsor
3 Previous Clinical Trials
178 Total Patients Enrolled
3 Trials studying Achondroplasia
178 Patients Enrolled for Achondroplasia
Silas Gylvin, MDStudy DirectorAscendis Pharma
1 Previous Clinical Trials
57 Total Patients Enrolled
1 Trials studying Achondroplasia
57 Patients Enrolled for Achondroplasia
Adebola Giwa, MDStudy DirectorAscendis Pharma
2 Previous Clinical Trials
317 Total Patients Enrolled
2 Trials studying Achondroplasia
317 Patients Enrolled for Achondroplasia
Vibeke BreinholtStudy DirectorAscendis Pharma
1 Previous Clinical Trials
24 Total Patients Enrolled
1 Trials studying Achondroplasia
24 Patients Enrolled for Achondroplasia

Media Library

TransCon CNP (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05929807 — Phase 2 & 3
Achondroplasia Research Study Groups: TransCon CNP 100 mcg
Achondroplasia Clinical Trial 2023: TransCon CNP Highlights & Side Effects. Trial Name: NCT05929807 — Phase 2 & 3
TransCon CNP (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05929807 — Phase 2 & 3
~93 spots leftby Jan 2039