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Pharmacokinetics, Safety and Tolerability of Crinecerfont in Participants With Congenital Adrenal Hyperplasia Who Are Less Than 2 Years Old

Pharmacokinetics, Safety and Tolerability of Crinecerfont in Participants With Congenital Adrenal Hyperplasia Who Are Less Than 2 Years Old

Recruiting
23 years and younger
All
Phase 2
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Overview

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

Key Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study details
    Congenital Adrenal Hyperplasia

NCT07187375

Neurocrine Biosciences

1 February 2026

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