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

Last updated: November 8, 2024
Sponsor: Diurnal Limited
Overall Status: Active - Enrolling

Phase

3

Condition

Male Hormonal Deficiencies/abnormalities

Congenital Adrenal Hyperplasia

Treatment

Chronocort

Clinical Study ID

NCT05299554
DIUR-015
2021-004467-26
  • Ages > 16
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants with Congenital Adrenal Hyperplasia (CAH) who have successfullycompleted Chronocort study DIUR-006 (sites in France and US only) or study DIUR-014.

  • Participants who are capable of giving signed informed consent/assent, whichincludes compliance with the requirements and restrictions listed in the study'sinformed consent form (ICF) and in the protocol.

Exclusion

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 theULN).

  • Participants with a history of malignancy (other than basal cell carcinomasuccessfully 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 inthe opinion of the Investigator would preclude participation in the study.

  • Participants with a co-morbid condition requiring daily administration of amedication or consumption of any material that interferes with the metabolism ofglucocorticoids.

  • Participants on regular daily inhaled, topical, nasal, or oral steroids for anyindication other than CAH.

  • Participants anticipating regular prophylactic use of additional steroids e.g., forstrenuous exercise.

  • Participation in another clinical study of an investigational or licensed drug ordevice within 3 months prior to inclusion in this study, except for another clinicalstudy 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 withthe requirements of the protocol.

  • Participants who routinely work night shifts and so do not sleep during the usualnight-time hours.

  • Participants with a body weight of 50 kg or less (Note: this exclusion criterion isonly applicable for French sites).

Study Design

Total Participants: 76
Treatment Group(s): 1
Primary Treatment: Chronocort
Phase: 3
Study Start date:
April 01, 2022
Estimated Completion Date:
December 31, 2025

Study Description

Participants in eligible countries completing one of the specified previous Chronocort studies (DIUR-006 and DIUR 014) can either continue Chronocort treatment (if the participant received Chronocort in the feeder study) or switch to Chronocort treatment (if the participant received standard glucocorticoid therapy in the feeder study) in this open-label extension study. All participants choosing to enter this extension study will have the study procedures fully explained and informed consent obtained, prior to, or at the last visit of the feeder study. Participants who agree to take part in this extension study will then undergo the final visit of the feeder study, with the assessments conducted at the final visit also providing the baseline data for this DIUR-015 extension study where relevant (note participants who are withdrawn from treatment due to titration issues in study DIUR-014 are eligible to enter at the discretion of the Investigator, as long as all DIUR-014 safety assessments and the end of study visit are completed). Once all the baseline assessments are completed, participants will be given sufficient Chronocort to use until the next visit (the study pharmacies will be supplied with Chronocort for dispensing to participants according to the Investigators' instructions).

Outcome measures in this study will be assessed versus either the 'initial study baseline' (measurements taken at the start of participation in an interventional Diurnal study, regardless of the treatment assignment in this feeder study) or the protocol-defined 'pre-Chronocort baseline' (measurements taken prior to the first dose of continuous Chronocort).

Connect with a study center

  • Diurnal Investigational Site in Caen

    Caen, 14033
    France

    Site Not Available

  • Diurnal investigational Site in Lyon

    Lyon, 69677
    France

    Site Not Available

  • Diurnal Investigational Site in Paris

    Paris, 75651
    France

    Site Not Available

  • Diurnal Investigational Site in Pessac

    Pessac, 33604
    France

    Site Not Available

  • Diurnal Investigational Site in Toulouse

    Toulouse, 31059
    France

    Site Not Available

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

    Toulouse, 31059
    France

    Site Not Available

  • Diurnal Investigational Site in Asahi-ku

    Yokohama-shi, Kanagawa 241-0811
    Japan

    Site Not Available

  • Diurnal Investigational Site in Yushima

    Bunkyō-Ku, Tokyo 113-8519
    Japan

    Site Not Available

  • Diurnal Investigational Site in Okura

    Setagaya-Ku, Tokyo 157-8535
    Japan

    Site Not Available

  • Diurnal Investigational Site in Toyama

    Shinjuku-Ku, Tokyo 162-8655
    Japan

    Site Not Available

  • Diurnal Investigational Site in California

    Los Angeles, California 90027
    United States

    Site Not Available

  • Diurnal Investigational Site in California

    Orange, California 92868
    United States

    Site Not Available

  • Diurnal Investigational Site in Florida

    Jacksonville, Florida 32207
    United States

    Site Not Available

  • Diurnal Investigational Site in Iowa

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • National Institutes of Health Center

    Bethesda, Maryland 20892-1932
    United States

    Site Not Available

  • Diurnal Investigational Site in Michigan

    Ann Arbor, Michigan 48114
    United States

    Site Not Available

  • Diurnal Investigational Site in Minnesota

    Rochester, Minnesota 55901
    United States

    Site Not Available

  • Diurnal Investigational Site in Nevada

    Las Vegas, Nevada 89148
    United States

    Site Not Available

  • Diurnal Investigational Site in Texas

    Dallas, Texas 75235
    United States

    Site Not Available

  • Diurnal Investigational Site in Washington

    Seattle, Washington 98105
    United States

    Site Not Available

  • Diurnal Investigational Site in Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.