Comparison of Chronocort Versus Standard Hydrocortisone Replacement Therapy in Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia (CONnECT)

  • STATUS
    Recruiting
  • End date
    Dec 27, 2023
  • participants needed
    150
  • sponsor
    Diurnal Limited
Updated on 4 October 2022
prednisone
deficiency
glucocorticoids
prednisolone
dexamethasone
replacement therapy
fludrocortisone
glucocorticoid therapy

Summary

This study is a randomized, double-blind, active-controlled, phase III study of Chronocort® compared with immediate-release hydrocortisone replacement therapy in participants aged 16 years and over with Congenital Adrenal Hyperplasia.

Description

The study will compare the efficacy, safety and tolerability of twice daily Chronocort with twice daily immediate release hydrocortisone replacement therapy (IRHC) (Cortef®) over a randomized treatment period of up to 52 weeks in participants aged 16 years and over with known classic Congenital Adrenal Hyperplasia (CAH) due to 21 hydroxylase deficiency. The primary efficacy assessment of biochemical responder rate and the key secondary assessment of dose responder rate will be assessed after 52 weeks of randomized treatment.

Details
Condition Congenital Adrenal Hyperplasia
Treatment Cortef, Chronocort
Clinical Study IdentifierNCT05063994
SponsorDiurnal Limited
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female participants must be aged 16 years or older at the time of signing the informed consent/assent
In participants aged <18 years, height velocity must be less than 2 cm/year in the last year and puberty must be completed (Tanner stage V)
Participants with known classic CAH due to 21 hydroxylase deficiency diagnosed in childhood with documented (at any time) elevated 17-OHP and with or without elevated A4 and currently treated with hydrocortisone, prednisone, prednisolone or dexamethasone (or a combination of the aforementioned glucocorticoids) and on stable glucocorticoid therapy for a minimum of 3 months
Participants who are receiving fludrocortisone must be on a documented stable dose for a minimum of 3 months prior to enrollment and must have stable renin levels at screening
Female participants of childbearing potential and all male participants must agree to the use of an accepted method of contraception during the study
A female participant is eligible to participate if she is not pregnant, not breastfeeding, and she is either not a woman of childbearing potential (WOCBP) or has a negative pregnancy test at entry into the study. Note: females presenting with oligomenorrhea or amenorrhea who are aged ≤55 years should be considered potentially fertile and therefore should undergo pregnancy testing like all other female participants
Capable of giving signed informed consent/assent which includes compliance with requirements and restrictions listed in the informed consent form (ICF) and in this protocol

Exclusion Criteria

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)
History of bilateral adrenalectomy
History of malignancy (other than basal cell carcinoma successfully treated >26 weeks prior to entry into the study)
Participants who have type 1 diabetes or receive regular insulin, have uncontrolled diabetes, or have a screening HbA1c greater than 8%
Persistent signs of adrenal insufficiency or the participant does not tolerate treatment at the end of the 4-week run-in period
Participants with any other significant medical or psychiatric conditions that in the opinion of the Investigator would preclude participation in the study
Participants on regular daily inhaled, topical, nasal or oral steroids for any indication other than CAH
Co-morbid condition requiring daily administration of a medication or consumption of any material that interferes with the metabolism of glucocorticoids
Participants who are receiving <10 mg hydrocortisone dose at screening or the hydrocortisone dose equivalent
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 the 12 weeks prior to screening
Inclusion in any natural history or translational research study that would require evaluation of androgen levels during the study period outside of this protocol's assessments
Participants who have previously been exposed to Chronocort in any Diurnal study
Participants who routinely work night shifts and so do not sleep during the usual night-time hours
Participants, who in the opinion of the Investigator, will be unable to comply with the requirements of the protocol
Participants with a known hypersensitivity to any of the components of the Chronocort capsules, the Cortef tablets, or the placebo capsules
Participants with congenital galactosemia, malabsorption of glucose and galactose, or who are lactase deficient
Participants with a body weight of 45 kg or less
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