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

Completed · Phase 3 · Has a placebo group

Conditions studied: Congenital Adrenal Hyperplasia

In brief

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.

Key facts

Study ID

NCT05063994

Run by

Neurocrine UK Limited

People needed

55

Starts

2022-05-24

Expected to finish

2024-02-02

Last updated by the study team

2025-02-25

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female participants must be aged 16 years or older at the time of signing the informed consent/assent.
• In participants aged <18 years, height velocity must be less than 2 cm/year in the last year and puberty must be completed (Tanner stage V).
• Participants with known classic CAH due to 21 hydroxylase deficiency diagnosed in childhood with documented (at any time) elevated 17-OHP and with or without elevated A4 and currently treated with hydrocortisone, prednisone, prednisolone or dexamethasone (or a combination of the aforementioned glucocorticoids) and on stable glucocorticoid therapy for a minimum of 3 months.
• Participants who are receiving fludrocortisone must be on a documented stable dose for a minimum of 3 months prior to enrollment and must have stable renin levels at screening.
• Female participants of childbearing potential and all male participants must agree to the use of an accepted method of contraception during the study.
• A female participant is eligible to participate if she is not pregnant, not breastfeeding, and she is either not a woman of childbearing potential (WOCBP) or has a negative pregnancy test at entry into the study. Note: females presenting with oligomenorrhea or amenorrhea who are aged ≤55 years should be considered potentially fertile and therefore should undergo pregnancy testing like all other female participants.
• Capable of giving signed informed consent/assent which includes compliance with requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

You may not qualify if…

• Clinical or biochemical evidence of hepatic or renal disease e.g. creatinine >2 times the upper limit of normal (ULN) or elevated liver function tests (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] >2 times the ULN).
• History of bilateral adrenalectomy.
• History of malignancy (other than basal cell carcinoma successfully treated >26 weeks prior to entry into the study).
• Participants who have type 1 diabetes or receive regular insulin, have uncontrolled diabetes, or have a screening HbA1c greater than 8%.
• Persistent signs of adrenal insufficiency or the participant does not tolerate treatment at the end of the 4-week run-in period.
• Participants with any other significant medical or psychiatric conditions that in the opinion of the Investigator would preclude participation in the study.
• Participants on regular daily inhaled, topical, nasal or oral steroids for any indication other than CAH.
• Co-morbid condition requiring daily administration of a medication or consumption of any material that interferes with the metabolism of glucocorticoids.
• Participants who are receiving <10 mg hydrocortisone dose at screening or the hydrocortisone dose equivalent.
• Participants anticipating regular prophylactic use of additional steroids e.g. for strenuous exercise.
• Participation in another clinical study of an investigational or licensed drug or device within the 12 weeks prior to screening.
• Inclusion in any natural history or translational research study that would require evaluation of androgen levels during the study period outside of this protocol's assessments.
• Participants who have previously been exposed to Chronocort in any Diurnal study.
• Participants who routinely work night shifts and so do not sleep during the usual night-time hours.
• Participants, who in the opinion of the Investigator, will be unable to comply with the requirements of the protocol.
• Participants with a known hypersensitivity to any of the components of the Chronocort capsules, the Cortef tablets, or the placebo capsules.
• Participants with congenital galactosemia, malabsorption of glucose and galactose, or who are lactase deficient.
• Participants with a body weight of 45 kg or less.

Where it is running

• Diurnal Investigational Site in Los Angeles — Los Angeles, California, United States
• Diurnal Investigational Site in Orange — Orange, California, United States
• Diurnal Investigational Site in Jacksonville — Jacksonville, Florida, United States
• Diurnal Investigational Site in Iowa — Iowa City, Iowa, United States
• Diurnal Investigational Site in Maryland — Bethesda, Maryland, United States
• Diurnal Investigational Site in Michigan — Ann Arbor, Michigan, United States
• Diurnal Investigational Site in Rochester — Rochester, Minnesota, United States
• Diurnal Investigational Site in Nevada — Las Vegas, Nevada, United States
• Diurnal Investigational Site in Dallas — Dallas, Texas, United States
• Diurnal Investigational Site in Seattle — Seattle, Washington, United States
• Diurnal Investigational Site in Milwaukee — Milwaukee, Wisconsin, United States
• Diurnal Investigational Site in Caen — Caen, Normandy, France
• Diurnal Investigational Site in Pessac — Bordeaux, France
• Diurnal Investigational Site in Bron — Lyon, France
• Diurnal Investigational Site in Paris — Paris, France
• Diurnal Investigational Site in Toulouse (Children's Hospital) — Toulouse, France
• Diurnal Investigational Site in Toulouse — Toulouse, France
• Diurnal Investigational Site in Asahi-ku — Yokohama, Kanagawa, Japan
• Diurnal Investigational Site in Yushima — Bunkyō-Ku, Tokyo, Japan
• Diurnal Investigational Site in Okura — Setagaya-Ku, Tokyo, Japan
• Diurnal Investigational Site in Toyama — Shinjuku-Ku, Tokyo, Japan

Full record on ClinicalTrials.gov

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