A Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atumelnant in Adult Participants With Classic Congenital Adrenal Hyperplasia (Calm-CAH)
The purpose of this study is to evaluate the efficacy, safety, PK, and PD of atumelnant in adults with classic CAH due to 21-OHD.
• Male or female, between ≥18 to \<75 years of age at the time of signing the ICF.
• Willing and able to understand and adhere to the study procedures as specified in the protocol and comply with the study treatment.
• Have classic CAH due to 21-OHD confirmed by the Investigator.
• Participants with Visit 2 levels of morning serum A4 as follows:
‣ A4 \>ULN and treated with \<11 mg/m2/day (physiologic) GC doses
⁃ OR normal A4 (\>0.5xULN to ≤1xULN) and treated with ≥14 mg/m2/day GC doses
⁃ OR A4 \>ULN and treated with ≥11 mg/m2/day GC doses.
• On a stable (defined as no dose change of \>5 mg/day hydrocortisone equivalent within 2 months prior to Screening) regimen of GC replacement (e.g., hydrocortisone, prednisolone, prednisone, methylprednisolone, meprednisone, dexamethasone, cortisone acetate) at the time of informed consent.
• If treated with mineralocorticoids (fludrocortisone), the dose should be stable for at least 1 month prior to Screening without orthostatic hypotension, and with serum sodium and potassium in the normal range.
• If on estrogen therapy (any route), the dose must be stable for at least 3 months prior to Screening.