Clinical Trial

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

Study acronym: CAHtalyst
Active, Not Recruiting Phase 3
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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 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).
Protocol Amendment History 22 amendments
This ClinicalTrials.gov record has been amended 22 times since 2020-07-24; most recent amendment 2026-04-20.
Status change: Recruiting → Active, Not Recruiting 2023-02-10
Status change: Not Yet Recruiting → Recruiting 2020-07-29
Trial Details
NCT Number NCT04490915
Lead Sponsor Neurocrine Biosciences
Conditions Congenital Adrenal Hyperplasia
Enrollment 182 participants
Start Date 2020-12-16
Primary Completion 2023-07-19 (estimated)
Study Completion 2027-08 (estimated)
Updated on ClinicalTrials.gov 2026-05-11