Status:
RECRUITING
Pharmacokinetics, Safety and Tolerability of Crinecerfont in Participants With Congenital Adrenal Hyperplasia Who Are Less Than 2 Years Old
Lead Sponsor:
Neurocrine Biosciences
Conditions:
Congenital Adrenal Hyperplasia
Eligibility:
All Genders
Up to 23 years
Phase:
PHASE2
Brief Summary
The main objective for this study is to evaluate the pharmacokinetics (PK) of crinecerfont in pediatric participants 0 to \<2 years of age with congenital adrenal hyperplasia (CAH).
Eligibility Criteria
Inclusion
- Key
- Be a female or male between 0 to \<2 years of age at screening.
- Have a medically confirmed diagnosis of classic CAH (salt wasting or simple virilizing) due to 21-hydroxylase deficiency (21-OHD).
- Be on a clinically stable regimen of hydrocortisone (and fludrocortisone, if applicable) treatment.
- Key
Exclusion
- Have a known or suspected diagnosis of any of the other forms of classic CAH.
- Have any condition besides CAH that requires chronic daily therapy with orally administered steroids.
- Have any other clinically significant medical condition or chronic disease.
- Note: Other protocol-defined inclusion and exclusion criteria may apply.
Key Trial Info
Start Date :
September 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 4 2029
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT07187375
Start Date
September 30 2025
End Date
October 4 2029
Last Update
November 3 2025
Active Locations (2)
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1
Neurocrine Clinical Site
Berlin, Germany, 13353
2
Neurocrine Clinical Site
Heidelberg, Germany, 69120