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

Completed · Phase 3

Conditions studied: Congenital Adrenal Hyperplasia

In brief

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).

Key facts

Study ID

NCT05299554

Run by

Immedica Pharma AB

People needed

76

Starts

2022-04-01

Expected to finish

2026-01-15

Last updated by the study team

2026-06-18

Who can join

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

You may qualify if…

• Participants with Congenital Adrenal Hyperplasia (CAH) who have successfully completed Chronocort study DIUR-006 (sites in France and US only) or study DIUR-014.
• Participants who are capable of giving signed informed consent/assent, which includes compliance with the requirements and restrictions listed in the study's informed consent form (ICF) and in the protocol.

You may not qualify if…

• Participants with 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).
• Participants with a history of malignancy (other than basal cell carcinoma successfully treated >26 weeks prior to entry into the study).
• Participants with a history of bilateral adrenalectomy.
• Participants with any other significant medical or psychiatric conditions that in the opinion of the Investigator would preclude participation in the study.
• Participants with a co-morbid condition requiring daily administration of a medication or consumption of any material that interferes with the metabolism of glucocorticoids.
• Participants on regular daily inhaled, topical, nasal, or oral steroids for any indication other than CAH.
• 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 3 months prior to inclusion in this study, except for another clinical study with the current formulation of Chronocort.
• Females who are pregnant or lactating.
• Participants, who in the opinion of the Investigator, will be unable to comply with the requirements of the protocol.
• Participants who routinely work night shifts and so do not sleep during the usual night-time hours.
• Participants with a body weight of 50 kg or less (Note: this exclusion criterion is only applicable for French sites).

Where it is running

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

Full record on ClinicalTrials.gov

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