Congenital Adrenal Hyperplasia Treatment with Crinecerfont – Phase III

Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Adult Subjects with Classic Congenital Adrenal Hyperplasia, Followed by Open-Label Treatment

Protocol Description

This multi-center study is investigating the effectiveness of the drug crinecerfont in reducing daily glucocorticoid dose and adrenal-related hormone levels, as well as other clinical factors related to glucocorticoid use (such as body weight and insulin resistance) in adults with classic congenital adrenal hyperplasia (CAH), a genetic disorder affecting hormone production by the adrenal glands.

Study Level: Phase III

Eligibility Criteria

Subject to certain exclusion criteria, this study is enrolling participants who are at least 18 years of age and who have been diagnosed with classic CAH that is being treated with a daily dose of glucocorticoid.
Males and Females: Ages 18 and older


The study has five stages spanning 19 months, including: a screening period, three study-drug dosing periods and a follow-up period. In the first dosing period, participants will be assigned to take crinecerfont or a placebo twice a day for about six months. In the subsequent dosing stages, lasting up to a year, participants will take crinecerfont at specified dosing levels. Throughout the study, various physical examinations and tests will be given to monitor participants’ health and effects of the study drug, and to adjust participants’ glucocorticoid dosage.
Visits: 21
Duration: 19 months

Status: Open to Enrollment

Source(s) of Support

Neurocrine Biosciences

Primary Investigator

Selma Witchel, MD

Contact Information

For more information about the study or enrollment, please contact:
Clinical Research Coordinator Vibha Chauhan, PhD, CCRP, CCRC