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    Summary
    EudraCT Number:2021-000144-21
    Sponsor's Protocol Code Number:DIUR-016-AI
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-08-27
    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 ConcernedGermany - BfArM
    A.2EudraCT number2021-000144-21
    A.3Full title of the trial
    A Double-Blind, Double-Dummy, Two-Way Cross-Over, Randomised, Phase II Study of Efficacy, Safety and Tolerability of Modified-Release Hydrocortisones: Chronocort® Versus Plenadren®, in Adrenal Insufficiency
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Chronocort versus Plenadren replacement therapy in adults with adrenal
    insufficiency
    A.3.2Name or abbreviated title of the trial where available
    Chronocort versus Plenadren replacement therapy in adults with adrenal insufficiency
    A.4.1Sponsor's protocol code numberDIUR-016-AI
    A.5.4Other Identifiers
    Name: The CHAMPAIN StudyNumber:/
    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 SponsorDiurnal Limited
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportDiurnal Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDiurnal Limited
    B.5.2Functional name of contact pointRegulatory Department
    B.5.3 Address:
    B.5.3.1Street AddressCardiff Medicentre, Heath Park
    B.5.3.2Town/ cityCardiff
    B.5.3.3Post codeCF14 4UJ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+4478 87 522498
    B.5.6E-mailregulatory@diurnal.co.uk
    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 Chronocort® (Efmody) 5 mg modified-release hard capsules
    D.2.1.1.2Name of the Marketing Authorisation holderDiurnal Europe B.V.
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/07/441
    D.3 Description of the IMP
    D.3.1Product nameChronocort®
    D.3.4Pharmaceutical form Modified-release capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHydrocortisone
    D.3.9.1CAS number 50-23-7
    D.3.9.3Other descriptive nameHYDROCORTISONE MICRONIZED
    D.3.9.4EV Substance CodeSUB194422
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 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 Chronocort® (Efmody) 10 mg modified-release hard capsules
    D.2.1.1.2Name of the Marketing Authorisation holderDiurnal Europe B.V.
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/05/296
    D.3 Description of the IMP
    D.3.1Product nameChronocort®
    D.3.4Pharmaceutical form Modified-release capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHydrocortisone
    D.3.9.1CAS number 50-23-7
    D.3.9.3Other descriptive nameHYDROCORTISONE MICRONIZED
    D.3.9.4EV Substance CodeSUB194422
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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: 3
    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 Plenadren® 5 mg modified-release tablets
    D.2.1.1.2Name of the Marketing Authorisation holderShire Services BVBA
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/06/372
    D.3 Description of the IMP
    D.3.1Product namePlenadren 5 mg modified-release tablets
    D.3.4Pharmaceutical form Modified-release tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNhydrocortisone
    D.3.9.3Other descriptive nameHYDROCORTISONE
    D.3.9.4EV Substance CodeSUB08065MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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: 4
    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 Plenadren® 20 mg modified-release tablets
    D.2.1.1.2Name of the Marketing Authorisation holderShire Services BVBA
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/06/372
    D.3 Description of the IMP
    D.3.1Product namePlenadren® 20 mg modified-release tablets
    D.3.4Pharmaceutical form Modified-release tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNhydrocortisone
    D.3.9.3Other descriptive nameHYDROCORTISONE
    D.3.9.4EV Substance CodeSUB08065MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboModified-release capsule, hard
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboModified-release capsule, hard
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboModified-release tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 4
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboModified-release tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Adrenal Insufficiency (AI)
    E.1.1.1Medical condition in easily understood language
    adults with adrenal 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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Efficacy - To compare Chronocort to Plenadren in terms of morning serum cortisol levels.

    Safety - To compare Chronocort to Plenadren in terms of safety and tolerability; in terms of blood pressure; in terms of glycated haemoglobin (HbA1c) levels; in terms of stress dosing (use of participant administered emergency treatment pack); in terms of lipid profile.
    E.2.2Secondary objectives of the trial
    Efficacy - To compare Chronocort to Plenadren in terms of:
    - morning fatigue using the Multidimensional Assessment of Fatigue (MAF) questionnaire within 1 hour of waking
    - achieving physiological morning cortisol levels.
    - closeness of overall salivary cortisone levels during the day to a normal physiological profile
    - adrenocorticotropic hormone (ACTH) control in the morning
    - the impact on the bone marker of osteocalcin.
    - morning fatigue using the Patient-Reported Outcomes Measurement Information System (PROMIS® 7b) questionnaire within 1 hour of waking
    - QoL using the EuroQol 5-level Standardised Health Questionnaire (EQ-5D-5L™)
    - QoL using the Health-related Quality of Life in Addison’s disease (AddiQoL) questionnaire
    - QoL using the 36-Item Short Form Health Survey (SF-36®) questionnaire.
    Exploratory Efficacy - activity; Sleep; preference for treatment; QoL using the Diurnal Alertness visual analogue scale (VAS); QoL using the General Anxiety Disorder-7 (GAD-7)

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female participants aged ≥18 years.
    2. Participants with known (documented) primary AI, defined as early morning pre-dose cortisol <50 nmol/L and currently treated with glucocorticoid as replacement therapy. Primary AI includes any cause of acquired or congenital primary adrenal failure including autoimmune Addison’s disease and bilateral adrenalectomy (except when performed for Cushing’s syndrome).
    3. Participants on stable glucocorticoid treatment for ≥3 months prior to the Screening Visit
    4. Participants on a stable dose of fludrocortisone (if applicable) for ≥3 months prior to the Screening Visit.
    5. Male participants must agree to use contraception as detailed in Appendix 4 during the Screening, Treatment, and Follow-up Periods and refrain from donating sperm during these periods and for 7 days after the last dose of study treatment.
    6. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and for whom at least one of the following conditions applies: not a woman of childbearing potential (WOCBP) as defined in Appendix 4, or a WOCBP with a negative urine pregnancy test at entry into the study who agrees to follow the contraceptive guidance described in Appendix 4 during the Screening, Treatment and Follow-up Periods and for 7 days after the last dose of study treatment. Note: Females presenting with oligomenorrhea or amenorrhea who are ≤55 years should be considered potentially fertile (unless permanently sterile) and therefore, as well as undergoing pregnancy testing like all other female participants, will be expected to use an acceptable method of contraception as described in Appendix 4 during the Screening, Treatment and Follow-up Periods and for 7 days after the last dose of study treatment.
    7. Capable of giving signed informed consent (as described in Appendix 1), which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
    E.4Principal exclusion criteria
    1. Participants with CAH.
    2. Participants with secondary and tertiary AI.
    3. Past or current history of Cushing’s syndrome.
    4. Adrenal suppression and/or AI induced by exogenous steroids.
    5. Drug-induced AI.
    6. Clinical or biochemical evidence of hepatic disease: elevated liver function tests (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] >3 times the upper limit of normal [ULN]).
    7. Clinical or biochemical evidence of renal disease: serum creatinine level of >221 µmol/L (2.5 mg/dL) or calculated creatinine clearance of <25 mL/min.
    8. History of malignant brain tumours or traumatic brain injury.
    9. History of malignancy within the last 5 years or treated basal cell carcinoma within the past year.
    10. Participants who have type 1 diabetes or type 2 diabetes receiving regular insulin.
    11. Participants with type 2 diabetes whose screening HbA1c exceeds 9%.
    12. Participants who have elective surgical procedures scheduled during the study.
    13. Participants with significant medical or psychiatric conditions that in the opinion of the Investigator would preclude participation in the study.
    14. Participants who have had bariatric surgery within the past 6 months and participants who plan to undertake a major weight loss and/or exercise program during the same time period as anticipated study involvement.
    15. Restless legs syndrome/Willis-Ekbom disease.
    16. Participants who have increased gastrointestinal motility e.g., chronic diarrhoea, that may be at risk of impaired cortisol exposure. There are no data in patients with confirmed slow gastric emptying or decreased motility disease/disorder so the clinical response should be monitored in patients with these conditions.
    17. Participants anticipating regular prophylactic use of additional steroids e.g., for strenuous exercise.
    18. Participants with co-morbidities requiring daily administration of a medication (or consumption of any material) that interferes with the metabolism of glucocorticoids.
    19. Participants on regular daily inhaled, topical, nasal, or oral steroids for any indication other than AI.
    20. Participants who have received intra-articular steroid injections within 1 year prior to the Screening Visit or for whom such injections are planned during the study.
    21. Participants who are receiving <10 mg hydrocortisone dose at the Screening Visit or the hydrocortisone dose equivalent.
    22. Participants taking sleeping medication.
    23. Participants treated at screening with either Chronocort or Plenadren.
    24. Participation in another clinical study of an investigational or licensed drug or device within 12 weeks or 5 half-lives prior to the Screening Visit or at any time during study participation.
    25. Active alcohol or drug abuse within 1 year prior to the Screening Visit.
    26. Participants who routinely work night shifts and do not sleep during the usual night-time hours.
    27. Participants who intend to travel and cross a time zone of greater than ±3 hours within 1 week of the scheduled visit dates.
    28. Participants unable to comply with the requirements of the protocol in the opinion of the Investigator.
    29. Participants with a known hypersensitivity to any of the components of the Chronocort capsules, the Plenadren tablets, the Chronocort placebo, or the Plenadren placebo
    E.5 End points
    E.5.1Primary end point(s)
    1. To compare Chronocort to Plenadren in terms of morning serum cortisol levels.
    The treatment effect (Chronocort minus Plenadren, after logarithmic transformation) will be estimated in the efficacy evaluable analysis set (EEAS) (defined as participants with morning serum cortisol assessed at baseline and after each treatment period, with no "major significant" protocol deviations) using a linear mixed model. Superiority of Chronocort to Plenadren will be declared if the 95% confidence interval (CI) for the treatment effect is wholly above zero
    2. To compare Chronocort to Plenadren in terms of morning fatigue using the Multidimensional Assessment of Fatigue (MAF) questionnaire within 1 hour of waking.
    The treatment effect (Chronocort minus Plenadren) will be estimated in the EEAS using a linear mixed model. Superiority of Chronocort to Plenadren will be declared if the 95% CI for the treatment effect is wholly above zero, provided superiority of Chronocort to Plenadren
    has been declared in the primary analysis. Analyses of fatigue at other timepoints are supplementary analyses.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. The primary efficacy outcome variable is the 07:00 hour serum cortisol level after 4 weeks of treatment.
    2. The key secondary efficacy outcome variable is the MAF morning fatigue score after 4 weeks of treatment.
    E.5.2Secondary end point(s)
    The secondary outcomes are focused on whether this reduces fatigue and improves QoL in patients with AI. Therefore, the same total daily dose of Plenadren and Chronocort will be used.
    1. To compare Chronocort to Plenadren in terms of achieving physiological morning cortisol levels.
    2. To compare Chronocort to Plenadren in terms of closeness of overall salivary cortisone levels during the day to a normal physiological profile.
    3. To compare Chronocort to Plenadren in terms of ACTH control in the morning.
    4. To compare Chronocort to Plenadren in terms of the impact on the bone marker of osteocalcin.
    5. To compare Chronocort to Plenadren in terms of morning fatigue using the Patient-Reported Outcomes Measurement Information System (PROMIS® 7b) questionnaire within 1 hour of waking.
    6. To compare Chronocort to Plenadren in terms of QoL using the EuroQol 5-level Standardised Health Questionnaire (EQ-5D-5L™).
    7. To compare Chronocort to Plenadren in terms of QoL using the Health-related Quality of Life in Addison’s disease (AddiQoL) questionnaire
    8. To compare Chronocort to Plenadren in terms of QoL using the 36-Item Short Form Health Survey (SF-36®) questionnaire
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. 07:00 hour serum cortisol before the morning dose of >140 nmol/L after 4 weeks of treatment
    2. A salivary cortisone profile score will be derived at the end of 4 weeks of treatment.
    3. The 07:00 hour plasma ACTH level after 4 weeks of treatment
    4. Osteocalcin levels after 4 weeks of treatment
    5. Morning fatigue, using the PROMIS 7b questionnaire, within 1 hour of waking after 4 weeks of treatment
    6. QoL, using the EQ-5D-5L after 4 weeks of treatment
    7. QoL, using the AddiQoL questionnaire after 4 weeks of
    treatment
    8. QoL, using SF-36 questionnaire after 4 weeks of treatment
    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 Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    A Double-Blind, Double-Dummy, Two-Way Cross-Over, Randomized, Phase II Study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Plenadren®
    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 concerned3
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United Kingdom
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months7
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 28
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 22
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 50
    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)
    All participants completing the study or discontinuing early will return to SoC, as determined by the Investigator.
    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 Decision2021-12-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-14
    P. End of Trial
    P.End of Trial StatusOngoing
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