NCT05063994

Comparison of Chronocort Versus Standard Hydrocortisone Replacement Therapy in Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia

A Randomized, Double-Blind, Active-Controlled, Phase 3 Study of Chronocort Compared With Immediate-Release Hydrocortisone Replacement Therapy in Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Neurocrine UK Limited · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

This study is a randomized, double-blind, active-controlled, phase III study of Chronocort® compared with immediate-release hydrocortisone replacement therapy in participants aged 16 years and over with Congenital Adrenal Hyperplasia.

Detailed description

The study will compare the efficacy, safety and tolerability of twice daily Chronocort with twice daily immediate release hydrocortisone replacement therapy (IRHC) (Cortef®) in participants aged 16 years and over with known classic Congenital Adrenal Hyperplasia (CAH) due to 21 hydroxylase deficiency.

Conditions

• Congenital Adrenal Hyperplasia

Interventions

Type	Name	Description
DRUG	Chronocort	Over-encapsulated hydrocortisone modified-release capsule for oral administration.
DRUG	Cortef	Over-encapsulated hydrocortisone immediate-release tablet for oral administration.
OTHER	Placebo	Matching placebo

Timeline

• Start date: 2022-05-24
• Primary completion: 2024-02-02
• Completion: 2024-02-02
• First posted: 2021-10-01
• Last updated: 2025-02-25
• Results posted: 2025-02-24

Locations

21 sites across 3 countries: United States, France, Japan

Regulatory

• FDA-regulated drug study