Clinical trial

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

Name

DIUR-015

Description

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).

Trial arms

Trial start

2022-04-01

Estimated PCD

2024-12-31

Trial end

2024-12-31

Phase

Early phase I

Treatment

Chronocort

Hydrocortisone modified-release capsule 5 mg and 10 mg

Arms:

Chronocort (hydrocortisone modified-release capsule)

Other names:

Hydrocortisone modified-release hard capsule

Size

Primary endpoint

Signs and symptoms of over-treatment [Safety and Tolerability] throughout the study.

Up to 32 months

Signs and symptoms of under-treatment [Safety and Tolerability] throughout the study.

Up to 32 months.

To measure signs or symptoms of under treatment [Safety and Tolerability] in terms of use of additional glucocorticoid treatment throughout the study.

Up to 32 months

To measure signs or symptoms of under treatment [Safety and Tolerability] in terms of incidence of adrenal crises throughout the study.

Up to 32 months

To measure the incidence of Treatment-Emergent Adverse Events [Safety and Tolerability].

Up to 32 months

To measure the change from pre-Chronocort baseline in terms of hematology safety laboratory assessments [Safety and Tolerability].

Up to 32 months

To measure the change from pre-Chronocort baseline in terms of clinical chemistry safety laboratory assessments [Safety and Tolerability].

Up to 32 months

To measure the change from pre-Chronocort baseline in terms of vital signs assessments.

Up to 32 months

Eligibility criteria

Inclusion Criteria: * 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. 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: this exclusion criterion is only applicable for French sites).

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single arm extension study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 81, 'type': 'ESTIMATED'}}

Updated at

2024-04-01

1 organization

1 product

1 indication

Product

Chronocort

Indication

Congenital Adrenal Hyperplasia

Organization

Diurnal