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New hormone treatment shows promise for rare adrenal disorder

NCT ID NCT05299554

Disease control Sponsor: Immedica Pharma AB Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at the long-term safety of a medication called Chronocort in 76 people aged 16 and older with congenital adrenal hyperplasia (CAH), a condition where the body can't make enough cortisol. Researchers monitored for signs of over- or under-treatment, adrenal crises, and side effects over time. The goal was to see if Chronocort is safe for ongoing use to control the disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

76 people

The number who actually took part.

Started

Apr 2022

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

16 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

congenital adrenal hyperplasia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Congenital adrenal hyperplasia

Contacts and locations

Locations

  • National Institutes of Health Center

    Bethesda, Maryland, 20892-1932, United States

  • Neurocrine Investigational Site in Asahi-ku

    Yokohama, Kanagawa, 241-0811, Japan

  • Neurocrine Investigational Site in Caen

    Caen, 14033, France

  • Neurocrine Investigational Site in California

    Los Angeles, California, 90027, United States

  • Neurocrine Investigational Site in California

    Orange, California, 92868, United States

  • Neurocrine Investigational Site in Florida

    Jacksonville, Florida, 32207, United States

  • Neurocrine Investigational Site in Iowa

    Iowa City, Iowa, 52242, United States

  • Neurocrine Investigational Site in Michigan

    Ann Arbor, Michigan, 48114, United States

  • Neurocrine Investigational Site in Minnesota

    Rochester, Minnesota, 55901, United States

  • Neurocrine Investigational Site in Nevada

    Las Vegas, Nevada, 89148, United States

  • Neurocrine Investigational Site in Okura

    Setagaya-Ku, Tokyo, 157-8535, Japan

  • Neurocrine Investigational Site in Paris

    Paris, 75651, France

  • Neurocrine Investigational Site in Pessac

    Pessac, 33604, France

  • Neurocrine Investigational Site in Texas

    Dallas, Texas, 75235, United States

  • Neurocrine Investigational Site in Toulouse

    Toulouse, 31059, France

  • Neurocrine Investigational Site in Toulouse (Children's hospital)

    Toulouse, 31059, France

  • Neurocrine Investigational Site in Toyama

    Shinjuku-Ku, Tokyo, 162-8655, Japan

  • Neurocrine Investigational Site in Washington

    Seattle, Washington, 98105, United States

  • Neurocrine Investigational Site in Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Neurocrine Investigational Site in Yushima

    Bunkyō-Ku, Tokyo, 113-8519, Japan

  • Neurocrine investigational Site in Lyon

    Lyon, 69677, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.