CompletedPhase 3

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

United States, France, Japan76 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 range

16 Years

Sex

ALL

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Trial details

NCT IDNCT05299554

SponsorImmedica Pharma AB

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-01-15

View on ClinicalTrials.gov More Congenital Adrenal Hyperplasia trials

Plain-language summary

Who can participate

Age range

16 Years

Sex

ALL

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