CompletedPhase 3

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

United States76 participantsStarted 2022-04-01

Plain-language 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).

Who can participate

Age range16 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 lic…

What they're measuring

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

Timeframe: Up to 32 months

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

Timeframe: 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.

Timeframe: 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.

Timeframe: Up to 32 months

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

Timeframe: Up to 32 months

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

Timeframe: Up to 32 months

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

Timeframe: Up to 32 months

Trial details

NCT IDNCT05299554

SponsorNeurocrine UK Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-01-15

View on ClinicalTrials.gov More Congenital Adrenal Hyperplasia trials

Plain-language summary

Who can participate

Age range16 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: Up to 32 months

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

Timeframe: 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.

Timeframe: 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.

Timeframe: Up to 32 months

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

Timeframe: Up to 32 months

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

Timeframe: Up to 32 months

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

Timeframe: Up to 32 months