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    Summary
    EudraCT Number:2021-006487-24
    Sponsor's Protocol Code Number:ADNorGC
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-10-12
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNorway - NOMA
    A.2EudraCT number2021-006487-24
    A.3Full title of the trial
    A registry-based, open-label, randomized study to investigate quality-of-life with Plenadren compared with Cortison in participants aged 16-80 with newly diagnosed primary adrenal insufficiency
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of Plenadren and Cortsone in newly diagnosed primary adrenal insufficiency
    A.3.2Name or abbreviated title of the trial where available
    CORTAD
    A.4.1Sponsor's protocol code numberADNorGC
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorHelse Bergen HF
    B.1.3.4CountryNorway
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHelse Bergen HF
    B.5.2Functional name of contact pointClinical Trial Unit
    B.5.3 Address:
    B.5.3.1Street AddressJonas Liesvei 65
    B.5.3.2Town/ cityBergen
    B.5.3.4CountryNorway
    B.5.6E-mailforskningsstotte@helse-bergen.no
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Plenadren
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda Pharmaceuticals International AG Ireland Branch
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePlenadren
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Cortison
    D.2.1.1.2Name of the Marketing Authorisation holderOrifarm Healthcare A/S
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCortison
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Primary adrenal insufficiency
    E.1.1.1Medical condition in easily understood language
    Renal insufficiency
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10052381
    E.1.2Term Primary adrenal insufficiency
    E.1.2System Organ Class 10014698 - Endocrine disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine superiority of Plenadren compared to thrice daily Cortisone for improving overall patient outcome in newly-diagnosed patients with Primary Adrenal Insufficiency.

    This will be determined by investigating differences in health-related quality of life (HRQoL) scores in patients receiving Plenadren and conventional Cortisone at time of diagnosis and 1, 6, and 12 months after treatment initiation.
    E.2.2Secondary objectives of the trial
    Secondary objctives:
    1) Differences in clinical markers of cardio-metabolic health in patients receiving Plenadren and conventional thrice daily Cortisone at time of diagnosis and 6 and 12 months after treatment initiation.
    2) Differences in hair cortisol concentrations time of diagnosis and in patients receiving Plenadren and conventional Cortisone at 6 and 12 months after treatment initiation.
    3) Differences in salivary cortisol day curves in patients receiving Pleandren and conventional Cortisone at 6 and 12 months after treatment initiation.
    4) Differences in the urinary cortisol metabolome in patients receiving Pleandren and conventional Cortisone at 6 and 12 months after treatment initiation.
    5) Differences in sleep quality in patients receiving Plenadren and conventional Cortisone at 6 and 12 months after treatment initiation.
    6) Differences in cognitive function in patients receiving Plenadren and conventional Cortisone at 1, 6 and 12 months after treatment initiation
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Age between 16-80 years.

    2) Established PAI according to the diagnostic criteria as specified above.

    3) Participants must be recently diagnosed, specifically treated with glucocorticoid replacement therapy for less than 21 days prior to inclusion to secure treatment naivety.

    4) Participants must be capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
    E.4Principal exclusion criteria
    Medical conditions
    1) Ongoing treatment for active malignant disease
    2) Severe hepatic or renal disease
    3) Sever psychiatric disease
    4) Chronic abuse of alcohol or drug abuse

    Prior/Concomitant Therapy
    5) High dose glucocorticoid therapy for other disease during last three months prior to screening. This includes steroid injections for allergic disease and injections into joints. Local glucocorticoid treatment (inhalations, nasal spray or creams for use on skin) is allowed.
    6) Prior/Concurrent Clinical Study Experience
    7) Participation in another blinded clinical study involving an investigational medicinal product within 1 month prior to study inclusion

    Diagnostic Assessments
    8) Participants not fulfilling the diagnostic criteria for PAI, as specified above in 5.1.
    E.5 End points
    E.5.1Primary end point(s)
    Differences in health-related quality of life (HRQoL) scores in patients receiving Plenadren and conventional Cortisone at time of diagnosis and 1, 6, and 12 months after treatment-initiation in newly diagnosed patients with PAI, using two validated questionnaires: one specific for PAI (AddiQoL-30) and one generic (RAND-36).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation will be made at time of diagnosis and at 1, 6, and 12 months after treatment-initiation
    E.5.2Secondary end point(s)
    Evaluation of cardio-metabolic health:
    • Differences in clinical markers of cardio-metabolic health in patients receiving Plenadren and conventional thrice daily Cortisone at time of diagnosis and 6 and 12 months after treatment initiation.
    * Blood pressure: systolic blood pressure and diastolic blood pressure
    * Body weight, waist circumference, and body mass index
    * Body composition, fat distribution
    * Levels of total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides
    * Levels of glucose, insulin, and HOMA index

    Evaluation of bone health:
    • Differences in markers of bone health in patients receiving Plenadren and conventional Cortisone at time of diagnosis and 12 months after treatment initiation.
    * C-terminal telopeptide of type 1 collagen (CTx1)
    * N-terminal propeptide of type 1 procollagen (P1NP)
    * Osteocalcin
    * Bone mineral density and body composition

    Evaluation of cortisol exposure:
    • Differences in hair cortisol concentrations at time of diagnosis and 12 months after treatment initiation in patients receiving Plenadren and conventional Cortisone.
    • Differences in salivary cortisol day curves in patients receiving Plenadren and conventional Cortisone at 6 and 12 months after treatment initiation.
    • Differences in the urinary cortisol metabolome in patients receiving Plenadren and conventional Cortisone at 6 and 12 months after treatment initiation.

    Evaluation of sleep:
    • Differences in sleep quality in patients receiving Plenadren and conventional Cortisone at 6 and 12 months after treatment initiation, using the following instruments:
    * Epworth sleep questionnaire and sleep diary (https://helse-bergen.no/nasjonal-kompetansetjeneste-for-sovnsykdommer-sovno/sovndagbok-sovno)
    * Sleep radar

    Evaluation of cognitive function:
    • Difference in reaction time and working memory in patients receiving Plenadren and conventional Cortisone at 6 and 12 months after treatment initiation, specifically targeting:
    - Reaction time
    - Working memory
    E.5.2.1Timepoint(s) of evaluation of this end point
    Evaluation will be made at time of diagnosis and at 6 and 12 months after treatment-initiation
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    End of study is defined as Last Patient Last Visit (LPLV).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 8
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 8
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 32
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Ppost trial treatment according to standard of care.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-12-05
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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