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
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