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A pivotal Phase 3 randomised, double-blind, active-controlled, clinical evaluating the efficacy, safety and tolerability of modified-release hydrocortisone compared with immediate-release hydrocortisone replacement therapy in participants aged 16-years and over with Congenital-adrenal-hyperplasia

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Trial Profile

A pivotal Phase 3 randomised, double-blind, active-controlled, clinical evaluating the efficacy, safety and tolerability of modified-release hydrocortisone compared with immediate-release hydrocortisone replacement therapy in participants aged 16-years and over with Congenital-adrenal-hyperplasia

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 06 Jun 2022

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At a glance

  • Drugs Hydrocortisone (Primary) ; Hydrocortisone
  • Indications Congenital adrenal hyperplasia
  • Focus Registrational; Therapeutic Use
  • Acronyms CONnECT
  • Sponsors Diurnal

    • Most Recent Events

    • 01 Jun 2022 According to the Diurnal media release, this study is being conducted under a Special Protocol Assessment (SPA) that has been agreed with the US FDA. The SPA provides agreement that the Phase 3 trial design adequately addresses objectives that would support the regulatory submission for drug approval.
    • 01 Jun 2022 According to the Diurnal media release, this pivotal study for key US and Japan markets worth together in excess of $100m per annum will recruit up to 150 subjects with CAH who will be treated for a period of 52 weeks, The study is anticipated to take up to one year to recruit all patients, with subsequent data readout anticipated in 2024.
    • 01 Jun 2022 According to the Diurnal media release, first patient has been dosed in this trial
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