Global Safety and Efficacy Registration Study of Crinecerfont for Congenital Adrenal Hyperplasia (CAHtalyst)

 Congenital Adrenal Hyperplasia / Posted 4 months ago

Brief Summary:
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 subjects with classic CAH due to 21-hydroxylase deficiency. The study consists of a 6 month randomized, double blind, placebo-controlled period, followed by 1 year of treatment with crinecerfont. Duration of participation is approximately 20 months.
  • Inclusion Criteria :
    • 18 Years and older
    • Be willing and able to adhere to the study procedures, including all requirements at the study center and return for the follow-up visit.
    • Have a medically confirmed diagnosis of classic 21-hydroxylase deficiency CAH.
    • Be on a stable regimen of steroidal treatment for CAH.
    • Patients of childbearing potential must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) or other highly effective contraception during the study.
  • Exclusion Criteria :
    • Have a diagnosis of any of the other known forms of classic CAH.
    • Have a history of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic glucocorticoid therapy.
    • Have a clinically significant unstable medical condition or chronic disease other than CAH.
    • Have a history of cancer unless considered cured.
    • Are pregnant.
    • Have a known history of clinically significant arrhythmia or abnormalities on ECG.
    • Have a known hypersensitivity to any corticotropin releasing hormone antagonists.
    • Have received any other investigational drug within 30 days before initial screening or plan to use an investigational drug (other than the study drug) during the study.
    • Have current substance dependence, or current substance (drug) or alcohol abuse.
    • Have had a blood loss ≥550 mL or donated blood or blood products within 8 weeks prior to the study.
  • Study end date : February 2024
  • Wales-Based Study Contact : Please speak to your clinician
Contact details

Neurocrine Clinical Site, Woodland House Cardiff,CF14 4HH  Show Phone Number medinfo@neurocrine.com

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