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NCT07536269PHASE2Recruiting

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Crinecerfont in Participants With Classic Congenital Adrenal Hyperplasia (CAH) Who Are Less Than 4 Years Old

Neurocrine Switzerland GmbH

Start Date

7/1/2026

Completion Date

3/1/2028

Summary

The main objective of this study is to assess the safety and tolerability of crinecerfont in pediatric participants 3 months to \<4 years of age with CAH.

Eligibility Criteria

Age Range: No minimum to No maximum

Key Inclusion Criteria: * Have a medically confirmed diagnosis of classic CAH (salt wasting or simple virilizing) due to 21-hydroxylase deficiency (21-OHD) * Have received at least 3 months of hydrocortisone treatment before Day 1, with a stable dose for at least 4 weeks before screening. * Have a body weight of at least 4.5 kilograms (kg) at screening. * Have a newborn screen that is otherwise normal except for elevated 17-OHP or any other abnormality on newborn screen that was cleared upon evaluation by a pediatric specialist. 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.

Interventions

DRUG

Crinecerfont

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Conditions

Congenital Adrenal Hyperplasia

Locations

Neurocrine Clinical Site

San Francisco, California 94143

United States

Neurocrine Clinical Site

Aurora, Colorado 80045

United States

Neurocrine Clinical Site

Hartford, Connecticut 06106

United States

Neurocrine Clinical Site

Atlanta, Georgia 30329

United States

Neurocrine Clinical Site

Chicago, Illinois 60618

United States

Neurocrine Clinical Site

Indianapolis, Indiana 46202

United States

Neurocrine Clinical Site

Ann Arbor, Michigan 48109

United States

Neurocrine Clinical Site

Minneapolis, Minnesota 55454

United States

Neurocrine Clinical Site

Philadelphia, Pennsylvania 19104

United States

Neurocrine Clinical Site

Dallas, Texas 75235

United States

Neurocrine Clinical Site

Seattle, Washington 98101

United States