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

NCT05299554

CompletedPhase 3

Sponsor: Immedica Pharma AB

Conditions: Congenital Adrenal Hyperplasia

Interventions: Chronocort

Countries: United States, France, Japan

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 overview

Sex: ALL

Age: 16 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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).
Locations (21)
  • Los Angeles, California, United States
  • Orange, California, United States
  • Jacksonville, Florida, United States
  • Iowa City, Iowa, United States
  • Bethesda, Maryland, United States
  • Ann Arbor, Michigan, United States
  • Rochester, Minnesota, United States
  • Las Vegas, Nevada, United States
  • Dallas, Texas, United States
  • Seattle, Washington, United States
  • Milwaukee, Wisconsin, United States
  • Caen, France
  • Lyon, France
  • Paris, France
  • Pessac, France
  • Toulouse, France
  • Toulouse, France
  • Yokohama, Kanagawa, Japan
  • Bunkyō-Ku, Tokyo, Japan
  • Setagaya-Ku, Tokyo, Japan
  • Shinjuku-Ku, Tokyo, Japan