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    Summary
    EudraCT Number:2017-001219-35
    Sponsor's Protocol Code Number:COR-2017-01
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-12-19
    Trial results View 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 ConcernedDenmark - DHMA
    A.2EudraCT number2017-001219-35
    A.3Full title of the trial
    A Double-blind, Placebo-Controlled, Randomized Withdrawal Following Open-label Therapy Study to Assess the Safety and Efficacy of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing’s Syndrome
    A.4.1Sponsor's protocol code numberCOR-2017-01
    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 SponsorCortendo AB
    B.1.3.4CountrySweden
    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 supportCortendo AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCortendo AB
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Addressc/o TMF Sweden AB. Sergels Torg 12
    B.5.3.2Town/ cityStockholm
    B.5.3.3Post code111 57
    B.5.3.4CountrySweden
    B.5.6E-mailinfo@cortendo.com
    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 No
    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/3/12/1012
    D.3 Description of the IMP
    D.3.1Product namelevoketoconazole
    D.3.2Product code COR-003
    D.3.4Pharmaceutical form 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 INNlevoketozonazole
    D.3.9.1CAS number 142128-57-2
    D.3.9.2Current sponsor codeCOR-003
    D.3.9.4EV Substance CodeSUB178316
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 placeboTablet
    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
    Endogenous Cushing´s syndrome (CS)
    E.1.1.1Medical condition in easily understood language
    In this condition patients produce an excessive level of a steroid hormone known as cortisol
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10011657
    E.1.2Term Cushings syndrome
    E.1.2System Organ Class 100000004860
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the effect of withdrawing to placebo versus continuing treatment with levoketoconazole on the cortisol therapeutic response previously established during open-label levoketoconazole therapy.
    E.2.2Secondary objectives of the trial
    To compare the effects of levoketoconazole with placebo on:
    - cortisol status during Randomized Withdrawal and Restoration Phases;
    - changes in clinical signs & symptoms of Cushing’s syndrome (CS);
    - changes in biomarkers of CS comorbidities;
    - To assess the safety and tolerability of levoketoconazole;
    - To evaluate the population pharmacokinetics of levoketoconazole in
    subjects with CS
    NOTE: Secondary Objectives 4 & 5 are not subjects of hypothesis tests
    Exploratory Objectives:
    1. To assess changes in anti-diabetic, anti-cholesterol, anti-hypertensive, and chronic anti-inflammatory therapies;
    2. To describe the effects & durations of levoketoconazole action with respect to cortisol status, health-related quality of life, and symptoms of depression
    3. To describe the dose-response relationship of levoketoconazole with respect to safety and tolerability
    4. To describe the effects of levoketoconazole on glucose tolerance among subjects with impaired fasting glucose (IFG).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria for Specified SONICS-Completers:
    Subjects who have completed the SONICS study, within 6 months of the screening visit, including those receiving open-label treatment after SONICS as part of an Expanded Access Program (EAP) may be eligible for the study if the following two inclusion criteria are met:
    1. Completed the final SONICS visit (M12) and have demonstrated maintenance of clinical response (partial or complete) on a stable Therapeutic Dose of levoketoconazole for at least 12 weeks prior to study entry (Visit RW0)
    2. Able and willing to provide written informed consent prior to any study procedures being performed; eligible subjects must be able to understand the informed consent form prior to inclusion into the study
    Inclusion Criteria for All Others:
    The following categories of potential subjects, categorized by prior use of levoketoconazole, may be eligible if the following 11 inclusion criteria are all met:
    • Naïve to levoketoconazole (defined as having never participated in SONICS);
    • Completers of SONICS visit M12 more than 6 months of the screening visit of the current study;
    • Completers of SONICS visit M12 within 6 months of the screening visit who have not been receiving a stable Therapeutic Dose of levoketoconazole for at least 12 weeks prior to the start of screening.

    1. Male or female and at least 18 years of age.
    2. Able and willing to provide written informed consent
    3. Confirmed newly diagnosed, persistent or recurrent endogenous Cushing’s syndrome of any etiology, except secondary to malignancy (including pituitary or adrenal carcinoma). Persistence will not be considered confirmed until 6 weeks or more post-surgery
    4. Elevated mean 24 hour UFC levels at least 1.5X ULN of the normative range of the study’s central laboratory assay and from a minimum of three measurements from adequately collected urine; the study’s central laboratory must be used for all qualifying measurements.
    NOTE: This criterion does not apply to subjects currently on levoketoconazole.
    5. Presence of abnormal values from at least one of these two diagnostic tests (discrepancies between test findings will not be investigated nor considered exclusionary):
    • Abnormal Dexamethasone Suppression Test (DST): Elevated 8 AM blood cortisol at least 1.8 mcg/dL (50 nmol/L) after 1 mg dexamethasone orally at 11 PM the evening prior with concurrent dexamethasone blood concentration greater than 5.6 nmol/liter (220 ng/dL) (results from within the 2 months prior to start of Screening or newly tested with results available by the Baseline Visit [TM0]) OR
    • Elevated LNSC concentrations (at least two measurements) each greater than the ULN of the study’s central laboratory normative range; the study’s test kit and lab must be used for all qualifying measurements.
    NOTE: Abnormal LNSC is required among eligible subjects with estimated glomerular filtration rate (eGFR as determined by Modified Diet in Renal Disease MDRD equation) above 40 and below 60 mL/min/1.73 m2 .
    NOTE: This criterion does not apply to subjects currently on levoketoconazole.
    6. Non-candidates for CS-specific surgery, refuse surgery or surgery will be delayed until after study completion and agree to complete this study prior to surgery.
    7. If post-surgical for CS-specific surgery, then no significant post operative sequelae remain and the risk of such sequelae is considered negligible.
    8. Agree to the following minimum washout periods prior to the Baseline Visit (TM0) (as applicable):
    • Ketoconazole or metyrapone: 2 weeks;
    • Dopamine agonists: bromocriptine (2 weeks), cabergoline (8 weeks);
    • Octreotide acetate LAR, lanreotide Autogel®, pasireotide LAR: 12 weeks;
    • Lanreotide SR: 8 weeks;
    • Octreotide acetate (immediate release) or short-acting pasireotide: 1 week;
    • Mifepristone (RU 486, KORLYM®): 4 weeks;
    • Megestrol acetate or medroxyprogesterone acetate (and selected other synthetic progestins): 6 weeks.
    9. Females who are either of non-child bearing potential (i.e. incapable of becoming pregnant):
    • Post-menopausal, defined as age 50 or older with amenorrhea for more than 1 year or any age with serum follicle stimulating hormone (FSH) at least 23 mIU/mL and estradiol no more than 40 pg/mL (140 pmol/L) OR
    • Surgically sterile—documented hysterectomy and/or bilateral oophorectomy or tubal ligation.
    OR
    • Females of child-bearing potential who agree to use highly effective methods of birth control while participating and for 2 weeks after participation has completed (abstinence is considered acceptable if routinely practiced).
    10. Men who, if fertile, agree to use an acceptable form of birth control, including abstinence if routinely practiced, while enrolled and for 2 weeks after participation has completed.
    11. Able to comprehend and comply with all procedures.
    E.4Principal exclusion criteria
    Subjects will be excluded from the study if ANY of the following criteria are met (NOTE: exclusion criteria apply to and must be assessed in both cohorts):
    1.Enrolled in SONICS but have not completed SONICS through Visit M12
    2.Pseudo-Cushing’s syndrome based on assessment of the Investigator
    3.Cyclic Cushing’s syndrome with multi-week periods of apparent spontaneous CS remission
    4.Non-endogenous source of hypercortisolism, including pharmacological
    corticosteroids or ACTH
    5.Radiotherapy of any modality directed against the source of hypercortisolism within the last 5 years
    6.Treatment with mitotane within 6 months of enrollment
    7.History of malignancy, including adrenal or pituitary carcinomas (other than low risk, well-differentiated carcinomas of thyroid, breast or prostate that are very unlikely to require further treatment in the opinion of the treating physician, or squamous cell or basal cell carcinoma of the skin)
    8.Clinical or radiological signs of compression of the optic chiasm
    9.Major surgery within 1 month of Screening (or within 6 weeks for pituitary surgery)
    10.Clinically significant abnormality in 12-lead ECG during the Screening Phase requiring medical intervention
    11.QTc interval above 470 msec during the Screening Phase via central reader interpretation.
    12.History of Torsades des Pointes, ventricular tachycardia, ventricular fibrillation, history of prolonged QT syndrome
    13.Use of medications associated with possible, probable, or definite QT/QTc prolongation
    14.Pre-existing hepatic disease
    15.Hepatitis B surface antigen (HbsAg) or hepatitis C-positive
    16.Human immunodeficiency virus (HIV)-positive.
    17.History of symptomatic cholelithiasis with intact gallbladder
    18.History of pancreatitis
    19.Liver safety tests during the Screening Phase as follows:
    -ALT and/or AST above 3X ULN
    -Alkaline phosphatase or TBN above 2X ULN Subjects with isolated indirect TBN up to 3X ULN are presumed to have Gilbert’s syndrome and may be enrolled if all other liver safety tests are within normal levels
    20.History of documented or suspected drug-induced liver injury to ketoconazole or any other azole drug
    21.Serum potassium below 4.0 mEq/L
    22.Abnormal free thyroxine (FT4), unless subsequently corrected and stable for at least 4 weeks. Subjects with thyroid-stimulating hormone (TSH) less than the lower limit of normal (LLN) and normal FT4 are potentially eligible without intervention
    23.History of persistent uncontrolled hypertension
    24.Hypercholesterolemia currently treated with atorvastatin, lovastatin or simvastatin and unwilling or unable to change to alternative therapy with: pravastatin, fluvastatin, pitavastatin or rosuvastatin (must switch statin at least 2 weeks prior to dosing) or another allowed therapy
    25.More than one hospitalization for hyperglycemia or complication of diabetes during the last 12 months
    26.Decreased renal function as defined by eGFR below 40 mL/min/1.73 m2, using MDRD equation for eGFR
    27.Pregnant or lactating
    28.Body habitus preventing repeated venipuncture as required by protocol
    29.Any other clinically significant medical condition, as determined by the
    Investigator that precludes enrollment and participation in the study through completion, including conditions that would preclude the subject from being able to follow instructions or perform necessary procedures
    30.History of alcohol or drug abuse in the 6-month period prior to Screening
    31.Currently participating in another study or has received any investigational treatment (drug, biological agent or device) other than levoketoconazole, within prior 30 days or five half-lives of treatment, whichever is longer
    32.Current use of any H2-receptor antagonists, proton-pump inhibitors, or sucralfate (all inhibit absorption of levoketoconazole; subjects may be allowed to enroll after washout). A list of acceptable oral antacids will be provided; if used, antacids must be ingested at least 2 hours after dosing of levoketoconazole
    33.Current use of any prohibited concomitant medication that cannot be discontinued safely and washed out completely prior to the Baseline Visit (TM0 or RW0, for the levoketoconazole-naïve and SONICS-completers cohorts, respectively), including but not limited to the following:
    -Weight loss medications;
    -Acetaminophen (paracetamol) above 2 g total daily dose;
    -Strong inducers or inhibitors of CYP3A4 enzyme system that cannot be discontinued prior to first dose;
    -Herbal preparations: St John’s Wort, echinacea, gingko, goldenseal, yohimbe, red rice yeast, danshen, silybum marianum, Asian ginseng, schissandra sphenanther, shankhapushi, and Asian herb mixture (Xiao chai hu tang and Salboku-to);
    -Topical or inhaled corticosteroids;
    -Carbamazepine, fenofibrate, carbenoxolone;
    -Drugs that pose unacceptable risk due to overlapping or exaggerated toxicities or pharmacological action due to presumed PK or PD interactions with levoketoconazole;
    -Genuine licorice
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects with loss of therapeutic response to levoketoconazole upon withdrawing to placebo compared with the proportion of subjects with loss of therapeutic response upon continuing treatment with levoketoconazole. Loss of therapeutic response (i.e. relapse) is inferred based on mUFC from three 24-hour urinary free cortisol (UFC) measurements obtained at any visit from second through final Randomized Withdrawal Phase visits (RW1 through RW5 inclusive) when:
    (1) mUFC is above 1.5X the ULN of the central laboratory’s reference range, OR
    (2) mUFC is more than 40% above the baseline (RW0) value, if the RW0 value is above the ULN (i.e. >1.0X ULN) , OR
    (3) an early rescue criterion is met
    E.5.1.1Timepoint(s) of evaluation of this end point
    Loss of therapeutic response is inferred based on the mean of three 24-hour UFC measurements (mUFC) obtained at any visit from second through final Randomized Withdrawal Phase visits (RW1 through RW5 inclusive)
    E.5.2Secondary end point(s)
    1. Changes from Baseline (RW0) in mUFC and LNSC at all post-Baseline visits
    with these assessments through the final study visit (RES2)—applies to
    Secondary Objective 1;
    2. Proportion of subjects with normalization of mUFC at RES2—applies to
    Secondary Objective 1;
    3. Changes from Baseline (RW0) in clinical signs and symptoms of CS at all post Baseline visits with these assessments through the final study visit (RES2)—applies to Secondary Objective 2;
    4. Changes from Baseline (RW0) in biomarkers of CS comorbidities (fasting
    glucose, fasting insulin, homeostatic model assessment-insulin resistance [HOMA-IR], hemoglobin A1c (HbA1c), blood pressure, total cholesterol, high-density lipoprotein-cholesterol (HDL-C), low-density
    lipoprotein-cholesterol (LDL-C), high-sensitivity C-reactive protein (hsCRP) at all post-Baseline visits with these measurements through the final study visit (RES2)—applies to Secondary Objective 3;
    5. Incidence and severity of adverse events (AEs), particularly adverse events of special interest (AESI) during
    levoketoconazole open-label therapy in the Dose Titration and Maintenance Phase (levoketoconazole-naïve cohort) and during blinded therapy in the Randomized Withdrawal and Restoration Phases (both cohorts)—applies to Secondary Objective 4.
    Pharmacokinetic Endpoints and Pharmacokinetic/Pharmacodynamic modeling:
    6. Estimates of the following PK parameters: clearance (CL/F), volume of
    distribution (V/F), absorption rate constant (Ka), with associated between subject variability where feasible. These parameters will be used to calculate half-life (t½), area under the concentration time curve (AUC) and peak concentration (Cmax), if feasible—applies to Secondary Objective 5;
    7. Estimates of the following pharmacodynamic (PD) parameters: levoketoconazole concentration producing half maximal UFC suppression (IC50), maximal suppression of UFC (Imax) and associated estimates of between-subject variability, if feasible. UFC concentrations in relation to dose and plasma exposure will be explored—applies to Secondary Objective 5.
    Exploratory Endpoints:
    8. Frequency of usage and changes from Baseline (RW0) in frequency of usage of anti-diabetic, anti-cholesterol, anti-hypertensive, and chronic anti-inflammatory therapies at all post-Baseline visits; changes in corresponding biomarkers accounting for changes in medication usage will also be explored—applies to Exploratory Objective 1;
    9. Time from RW0 to first time of loss of response —applies to Exploratory Objective 2;
    10. Time to first normalization of mUFC beginning from RW5 (subset with mUFC above 1.5X ULN at RW5)—applies to Exploratory Objective 2;
    11. Time to first normalization of LNSC beginning from RW5 (subset with LNSC above ULN at RW5)—applies to Exploratory Objective 2;
    12. Proportion of subjects with normalization of LNSC at RES2—applies to Exploratory Objective 2;
    13. Changes from Baseline (RW0) in health-related QoL, and symptoms of depression at all post-Baseline visits with these assessments through the final study visit (RES2)—applies to Exploratory Objective 2;
    14. Changes from Baseline (RW0) in serum cortisol and adrenocorticotrophic hormone (ACTH) at all post-Baseline visits with these assessments through the final study visit (RES2)—applies to Exploratory Objective 2;
    15. Frequency and severity of common AEs and laboratory abnormalities in relation to dose of study drug administered at the time of the reported AE or laboratory abnormality—applies to Exploratory Objective 3;
    16. Shifts from normality and concentration changes from Baseline (RW0) in serum transaminases, alkaline phosphatase, and total bilirubin at all post-Baseline visits in relation to dose of study drug administered at the time of the shift or change—applies to Exploratory Objective 3;
    17. Durations and changes in durations from Baseline (RW0) of the QT interval corrected for heart rate (QTc) in relation to dose of study drug administered proximal to the measurement—applies to Exploratory Objective 3.
    18. Change from Baseline in observed and derived glucose and insulin parameters during oral glucose tolerance test (OGTT) in the subset of subjects with IFG—applies to Exploratory Objective 4.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1: at all post-Baseline visits through the final study visit (RES2)
    2: at RES2
    3: at all post-Baseline visits through the final study visit (RES2)
    4: at all post-Baseline visits through the final study visit (RES2)
    5, 6 and 7: along the study
    8: all post-Baseline visits
    9: from baseline till first time of loss of response
    10: from RW5 till first normalization of mUFC
    11: from RW5 till first normalization of LNSC
    12: at RES2
    13: at all post-Baseline visits through the final study visit (RES2)
    14: at all post-Baseline visits through the final study visit (RES2)
    15: along the study
    16: at all post-Baseline visits through the final study visit (RES2)
    17: along the study
    18 along the study
    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 Yes
    E.6.7Pharmacodynamic Yes
    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) Yes
    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 No
    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) No
    E.8.2.2Placebo Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    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
    Bulgaria
    Denmark
    France
    Greece
    Hungary
    Israel
    Italy
    Netherlands
    Poland
    Romania
    Spain
    United States
    E.8.7Trial has a data monitoring committee Yes
    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 years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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 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: 8
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 27
    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 state1
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 17
    F.4.2.2In the whole clinical trial 35
    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 subjects completing COR-2017-01 will be invited to participate in an open-label long-term extension study, during which detailed safety assessments will be made at 3-month intervals. The extension has no fixed duration, and we anticipate it remaining open for at least three years after it enrolls its first subject.
    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 Decision2018-02-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-02
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-08-31
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