HomeTrialNCT04806451
🔬NCT04806451Phase 3ACTIVE NOT RECRUITING

Global Safety and Efficacy Registration Study of Crinecerfont in Pediatric Participants With Classic Congenital Adrenal Hyperplasia (CAHtalyst Pediatric Study)

Study Summary

This is a Phase 3 study to evaluate the efficacy, safety, and tolerability of crinecerfont versus placebo administered for 28 weeks in approximately 81 pediatric participants with classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. The study consists of a 28-week double blind, placebo-controlled period, followed by 24 weeks of open-label 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 14 months for the core study and will be a variable amount of time per participant for the OLE (estimated to be approximately 3 years).

Interventions / Drugs
View on ClinicalTrials.gov ↗
Study Details
Enrollment103 participants
Primary Completion
Lead SponsorNeurocrine Biosciences
Data Retrieved2026-04-11 04:22:17.614701+00:00
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