Summary:
A research study for adults with classic congenital adrenal hyperplasia (CAH).
Study Purpose:
The primary purpose of the CAHtalyst Study is to evaluate the effectiveness of an investigational medication called crinecerfont compared to placebo in reducing daily glucocorticoid dosing and improving adrenal-related hormones in adults diagnosed with classic CAH. The investigational medication is an oral capsule taken twice daily with breakfast and an evening meal. Participation in this study lasts approximately 20 months and consists of 21 study visits. If you qualify for this clinical research study, you will receive the investigational medication (or placebo), study-related exams, and study-related laboratory tests at no cost. Compensation for time and travel may also be available.
Eligibility Criteria:
- Be male or female at least 18 years of age
- Have a medically confirmed diagnosis of classic CAH
- Be on a glucocorticoid dose regimen that has been stable for at least one month – this dose must be higher than a certain dose level and must be intended for long-term use
- Not have a condition other than CAH that requires long-term treatment with a glucocorticoid medication
- Not have a significant medical condition or chronic disease other than CAH
- Be willing and able to attend all study visits and follow all instructions for the research study
Other protocol-defined inclusion and exclusion criteria may apply.