This is a Phase 3 study to evaluate the efficacy, safety, and tolerability of crinecerfont versus placebo administered for 24 weeks in approximately 165 adult participants with classic CAH due to 21-hydroxylase deficiency. The study consists of a 24-week randomized, double-blind, placebo-controlled period, followed by 1 year of active treatment with crinecerfont. Subsequently, participants may elect to participate in the open-label extension (OLE) period. The duration of participation in the study is approximately 20 months for the core study and will be a variable amount of time per participant for the OLE (estimated to be approximately 3 years).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
182
CRF type 1 receptor antagonist
Non-active dosage form
Neurocrine Clinical Site
Los Angeles, California, United States
Neurocrine Clinical Site
San Diego, California, United States
Neurocrine Clinical Site
San Francisco, California, United States
Neurocrine Clinical Site
Aurora, Colorado, United States
Neurocrine Clinical Site
Atlanta, Georgia, United States
Percent Change From Baseline in Glucocorticoid Daily Dose at Week 24
Least square (LS) mean and standard error (SE) were calculated using analysis of covariance (ANCOVA) model.
Time frame: Baseline, Week 24
Change From Baseline in Serum Androstenedione at Week 4
Time frame: Baseline, Week 4
Number of Participants Who Achieved a Reduction to Physiologic Glucocorticoid Dose While Maintaining Androstenedione Control at Week 24
Time frame: Week 24
Change From Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at Week 24
Time frame: Baseline, Week 24
Percent Change From Baseline in Body Weight at Week 24
Time frame: Baseline, Week 24
Change From Baseline in Percent Total Fat Mass at Week 24
Time frame: Baseline, Week 24
Change From Baseline in Serum 17-hydroxyprogesterone (17-OHP) at Week 4
Time frame: Baseline, Week 4
Change From Baseline in Blood Pressure at Week 24
Time frame: Baseline, Week 24
Change From Baseline in Glucose Tolerance at Week 24
Time frame: Baseline, Week 24
Change From Baseline in Waist Circumference at Week 24
Time frame: Baseline, Week 24
Change From Baseline in Menstrual Regularity at Week 24
Time frame: Baseline, Week 24
Change From Baseline in Testicular Adrenal Rest Tumor (TART) Volume at Week 24
Time frame: Baseline, Week 24
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Neurocrine Clinical Site
Indianapolis, Indiana, United States
Neurocrine Clinical Site
Bethesda, Maryland, United States
Neurocrine Clinical Site
Boston, Massachusetts, United States
Neurocrine Clinical Site
Ann Arbor, Michigan, United States
Neurocrine Clinical Site
Minneapolis, Minnesota, United States
...and 60 more locations