NCT05299554

Long-term Safety Study of Chronocort in the Treatment of Participants With Congenital Adrenal Hyperplasia

A Phase 3 Open-Label Extension Study to Evaluate the Long-term Safety and Tolerability of Chronocort in the Treatment of Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Neurocrine UK Limited · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

This phase III study is an open-label extension study to be conducted at approximately 21 investigational sites across 3 countries. The study will evaluate the long-term safety and tolerability of Chronocort in participants aged 16 years and over when used as treatment for Congenital Adrenal Hyperplasia (CAH).

Detailed description

Participants in eligible countries completing one of the specified previous Chronocort studies (DIUR-006 and DIUR 014) can either continue Chronocort treatment (if the participant received Chronocort in the feeder study) or switch to Chronocort treatment (if the participant received standard glucocorticoid therapy in the feeder study) in this open-label extension study. All participants choosing to enter this extension study will have the study procedures fully explained and informed consent obtained, prior to, or at the last visit of the feeder study. Participants who agree to take part in this extension study will then undergo the final visit of the feeder study, with the assessments conducted at the final visit also providing the baseline data for this DIUR-015 extension study where relevant (note participants who are withdrawn from treatment due to titration issues in study DIUR-014 are eligible to enter at the discretion of the Investigator, as long as all DIUR-014 safety assessments and the end of study visit are completed). Once all the baseline assessments are completed, participants will be given sufficient Chronocort to use until the next visit (the study pharmacies will be supplied with Chronocort for dispensing to participants according to the Investigators' instructions). Outcome measures in this study will be assessed versus either the 'initial study baseline' (measurements taken at the start of participation in an interventional Chronocort study, regardless of the treatment assignment in this feeder study) or the protocol-defined 'pre-Chronocort baseline' (measurements taken prior to the first dose of continuous Chronocort) or the 'DIUR-015 baseline' (measurements taken at the start of participation in DIUR-015 study).

Conditions

• Congenital Adrenal Hyperplasia

Interventions

Type	Name	Description
DRUG	Chronocort	Hydrocortisone modified-release capsule 5 mg and 10 mg

Timeline

• Start date: 2022-04-01
• Primary completion: 2026-01-15
• Completion: 2026-01-15
• First posted: 2022-03-29
• Last updated: 2026-02-04

Locations

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

Regulatory

• FDA-regulated drug study