Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

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).

Official Title

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Adult Subjects With Classic Congenital Adrenal Hyperplasia, Followed by Open-Label Treatment

Keywords

Congenital Adrenal Hyperplasia, Adrenogenital Syndrome, Adrenocortical Hyperfunction, Hyperplasia, Crinecerfont

Eligibility

Locations

  • Neurocrine Clinical Site
    San Francisco California 94143 United States
  • Neurocrine Clinical Site
    Los Angeles California 90027 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Neurocrine Biosciences
ID
NCT04490915
Phase
Phase 3 Congenital Adrenal Hyperplasia Research Study
Study Type
Interventional
Participants
About 182 people participating
Last Updated