Long-Term Extension Study to Assess Safety and Effectiveness of Atumelnant for Congenital Adrenal Hyperplasia

What this Trial Is About

Researchers are studying the long-term safety, tolerability, and efficacy of atumelnant CRN04894 in people with congenital adrenal hyperplasia CAH. This open-label extension study includes participants who completed a prior Crinetics atumelnant CAH study and were judged by investigators to have an acceptable benefit-risk profile and potential benefit from continued treatment. Approximately 150 to 200 participants are expected to enroll. Participants will receive atumelnant orally during an open-label treatment period lasting up to two years. The dose will not exceed the highest dose explored in the previous parent study. This study follows one treatment group only, with no placebo or comparator groups. During the study, participants will undergo regular safety and efficacy assessments including monitoring for adverse events, adrenal insufficiency, adrenal crisis, and hospitalizations related to CAH. Blood tests will measure hormone levels such as androstenedione and 17-hydroxyprogesterone, and glucocorticoid dosing will be tracked over time. The study aims to follow participants for up to 108 weeks to evaluate these outcomes.

An Extension Study to Evaluate Safety and Efficacy of Atumelnant in Participants With Congenital Adrenal Hyperplasia