Clinical Trials

Inclusion Criteria:

- Participants with Congenital adrenal hyperplasia (CAH), in eligible countries who have
successfully completed one of the specified previous Chronocort studies (DIUR-006 or
DIUR-014).

- Participants who are capable of giving signed informed consent/assent.

Exclusion Criteria:

- 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: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 5/1/23. Questions regarding updates should be directed to the study team contact.