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    Summary
    EudraCT Number:2014-002108-25
    Sponsor's Protocol Code Number:CC-10004-BCT-002
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-11-25
    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 ConcernedGermany - BfArM
    A.2EudraCT number2014-002108-25
    A.3Full title of the trial
    A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY, FOLLOWED BY AN ACTIVE-TREATMENT PHASE TO EVALUATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) IN THE TREATMENT OF SUBJECTS WITH ACTIVE BEHÇET’S DISEASE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to test whether apremilast is better than placebo (inactive substance in the same form as the drug) for the treatment of active Behçet’s disease (oral ulcers). This study also tests how well the body tolerates apremilast. The study is conducted in several centers in different countries.
    A.4.1Sponsor's protocol code numberCC-10004-BCT-002
    A.5.4Other Identifiers
    Name:IND NumberNumber:101761
    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 SponsorAmgen Inc.
    B.1.3.4CountryUnited States
    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 supportAmgen Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen (EUROPE) GmbH
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street AddressSuurstoffi 22
    B.5.3.2Town/ cityRotkreuz
    B.5.3.3Post codeCH-6343
    B.5.3.4CountrySwitzerland
    B.5.6E-mailmedinfointernational@amgen.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 Yes
    D.2.1.1.1Trade name Otezla
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen 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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameApremilast
    D.3.2Product code CC-10004
    D.3.4Pharmaceutical form Film-coated 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 INNAPREMILAST
    D.3.9.1CAS number 608141-41-9
    D.3.9.2Current sponsor codeCC-10004
    D.3.9.3Other descriptive nameAPREMILAST
    D.3.9.4EV Substance CodeSUB130837
    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: 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 Otezla
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen 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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameApremilast
    D.3.2Product code CC-10004
    D.3.4Pharmaceutical form Film-coated 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 INNAPREMILAST
    D.3.9.1CAS number 608141-41-9
    D.3.9.2Current sponsor codeCC-10004
    D.3.9.3Other descriptive nameAPREMILAST
    D.3.9.4EV Substance CodeSUB130837
    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.IMP: 3
    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 Otezla
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen 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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameApremilast
    D.3.2Product code CC-10004
    D.3.4Pharmaceutical form Film-coated 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 INNAPREMILAST
    D.3.9.1CAS number 608141-41-9
    D.3.9.2Current sponsor codeCC-10004
    D.3.9.3Other descriptive nameAPREMILAST
    D.3.9.4EV Substance CodeSUB130837
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    SUBJECTS WITH ACTIVE BEHÇET’S DISEASE
    E.1.1.1Medical condition in easily understood language
    Behcet's disease causes inflammation in blood vessels throughout the body and manifests mainly as mouth or genital ulcers with eye and skin lesions. The exact cause is unknown.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10004212
    E.1.2Term Behcet's disease
    E.1.2System Organ Class 100000004866
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of apremilast in the treatment of oral ulcers in active Behçet’s disease
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy of apremilast in subjects with Behçet’s disease
    - To evaluate the effect of apremilast on Patient Reported Outcomes (PROs) in subjects with Behçet’s disease
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted.
    2. Male and female subjects ≥18 years of age at the time of signing the informed consent document.
    3. Able to adhere to the study visit schedule and other protocol requirements.
    4. Diagnosed with Behçet’s disease meeting the International Study Group (ISG) criteria.
    5. Oral ulcers that occurred at least 3 times in the previous 12-month period, including oral ulcers at the Screening Visit.
    6. Subjects must have at least 2 oral ulcers at Visit 1 (Screening Visit), and:
    a) at least 2 oral ulcers at Visit 2 (day of randomization), when Visit 2 occurs at least 14 days after Visit 1,
    OR
    b) at least 3 oral ulcers at Visit 2 (day of randomization), when Visit 2 occurs at any time between 1 day and 42 days after Visit 1.
    7. Have prior treatment with at least 1 non-biologic BD therapy, such as, but not limited to, topical corticosteroids, or systemic treatment.
    8. Candidate for systemic therapy, for the treatment of oral ulcers.
    a. A candidate for systemic therapy is a subject, judged by the study Investigator, as someone whose mucocutaneous ulcers are considered inappropriate for topical therapy based on the severity of disease and extent of the affected area, or whose oral ulcers cannot be adequately controlled by topical therapy.
    9. Laboratory Measures: Must meet the following laboratory measures:
    • Hemoglobin > 9 g/dL
    • White blood cell (WBC) count ≥ 3000 /microL (≥ 3.0 X 109/L) and ≤14,000/microL (≤14 X 109/L)
    • Platelet count ≥ 100,000 /microL (≥ 100 X 109/L)
    • Serum creatinine ≤ 1.5 mg/dL (≤ 132.6 ╬╝mol/L)
    • Total bilirubin ≤ 2.0 mg/dL
    • Aspartate transaminase (AST [serum glutamic oxaloacetic transaminase, SGOT]) and alanine transaminase (ALT [serum glutamate pyruvic transaminase, SGPT]) <1.5 X ULN. Subjects who fail screening due to ≥ 1.5 X ULN AST/SGOT and/or ALT/SGPT will be allowed to repeat AST/SGOT and/or ALT/SGPT tests within the screening period. Repeat test results should be ≤ ULN (within reference range) to be eligible.
    Laboratory tests will be allowed to be repeated 1 time, if in the Investigator’s clinical judgment, there is a reasonable possibility of the repeat tests not meeting the exclusion values, and with concurrence from the Medical Monitor.
    10. Contraception Requirements:
    All FCBP must use one of the approved contraceptive options as described below while taking apremilast and for at least 28 days after administration of the last dose of the apremilast.
    At the time of study entry, and at any time during the study when a FCBP’s contraceptive measures or ability to become pregnant changes, the Investigator will educate the subject regarding contraception options and the correct and consistent use of effective contraceptive methods in order to successfully prevent pregnancy.
    All FCBP must have a negative pregnancy test at Visits 1 and 2. All FCBP subjects who engage in activity in which conception is possible must use one of the approved contraceptive options described below:
    Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner’s vasectomy;
    OR
    Option 2: Male or female condom (latex condom or non latex condom NOT made out of natural [animal] membrane [for example, polyurethane]); PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.
    Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (latex or non-latex condoms NOT made out of natural [animal] membrane [for example, polyurethane]) while on IP and for at least 28 days after the last dose of IP.
    E.4Principal exclusion criteria
    1. Behçet’s disease-related active major organ involvement – pulmonary (eg, pulmonary artery aneurysm), vascular (eg, thrombophlebitis), gastrointestinal (eg, ulcers along the gastrointestinal tract), and central nervous systems (eg, meningoencephalitis) manifestations, and ocular lesions (eg, uveitis) requiring immunosuppressive therapy; however:
    • Previous major organ involvement is allowed if it occurred at least 1 year prior to screening and is not active at time of enrollment.
    • Subjects with mild BD-related ocular lesions not requiring systemic immunosuppressive therapy are allowed.
    • Subjects with BD-related arthritis and BD-skin manifestations are also allowed.
    Previous and Current Medications:
    2. Previous exposure to biologic therapies for the treatment of BD oral ulcers
    * Previous biologic therapy exposure is allowed for other indications, including other manifestations of BD
    3. Prior use of apremilast.
    4. Use of any investigational medication within 4 weeks prior to Visit 2 or
    5 pharmacokinetic/pharmacodynamic half-lives (whichever is longer).
    5. Current use of strong cytochrome P450 enzyme inducers (eg, rifampin, phenobarbital,
    carbamazepine, phenytoin)
    6. Having received concomitant immune modulating therapy (except oral or topical corticosteroids) within:
    - Seven days prior to Visit 2 (Baseline Visit; day of randomization) for colchicine
    - Ten days prior to Visit 2 (Baseline Visit; day of randomization) for azathioprine and mycophenolate mofetil
    - Four weeks (28 days) prior to Visit 2 (Baseline Visit; day of randomization) for cyclosporine, methotrexate, cyclophosphamide, thalidomide, and dapsone
    Note: Oral and topical corticosteroids must have been tapered as appropriate and discontinued prior to the day of Visit 2 (day of randomization).
    - At least 5 terminal half-lives for all biologics, including, but not limited to, those listed below; within:
    - Four weeks prior to Visit 2 (Baseline Visit; day of randomization) for etanercept
    - Eight weeks prior to Visit 2 (Baseline Visit; day of randomization) for infliximab
    - Ten weeks prior to Visit 2 (Baseline Visit; day of randomization) for adalimumab, golimumab, certolizumab, abatacept, and tocilizumab
    - Six months prior to Visit 2 (Baseline Visit; day of randomization) for secukinumab
    7. Having received intra-articular or parenteral corticosteroids within 6 weeks (42 days)
    prior to Visit 2 (Baseline Visit; day of randomization).
    General Health:
    8. Any significant medical condition, laboratory abnormality, or psychiatric illness that
    would prevent the subject from participating in the study.
    9. Any condition, including the presence of laboratory abnormalities, which places the
    subject at unacceptable risk if he/she were to participate in the study.
    10. Inability to provide voluntary consent.
    11. Pregnant women or breast feeding mothers.
    12. Systemic or opportunistic fungal infection.
    13. Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or
    other infections (including but not limited to tuberculosis and atypical mycobacterial
    disease, hepatitis B and C and herpes zoster, histoplasmosis, coccidiomycosis, but
    excluding onychomycosis) or any major episode of infection requiring hospitalization or
    treatment with IV or oral antibiotics within 4 weeks of the Screening Phase.
    14. Clinically significant abnormality on chest radiograph.
    15. Clinically significant abnormality on 12-lead ECG.
    16. History of positive test for, or any clinical suspicion of, human immunodeficiency virus
    (HIV), or congenital or acquired immunodeficiency (eg, common variable
    immunodeficiency disease).
    17. Malignancy or history of malignancy, except for:
    - treated (ie, cured) basal cell or squamous cell in situ skin carcinomas;
    - treated (ie, cured) cervical intraepithelial neoplasia (CIN) or carcinoma in situ of the cervix with no evidence of recurrence within the previous 5 years of Visit 1.
    18. Any condition that confounds the ability to interpret data from the study.
    19. Scheduled surgery or other interventions that would interrupt the subject’s participation
    in the study.
    20. Prior history of suicide attempt at any time in the subject’s lifetime prior to Visit 2
    (Baseline Visit; day of randomization) or major psychiatric illness requiring
    hospitalization within 3 years prior to Visit 2 (Baseline Visit; day of randomization).
    E.5 End points
    E.5.1Primary end point(s)
    Area under the curve (AUC) for the number of oral ulcers from baseline through Week 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks after the start of the double-blind, placebo-controlled phase
    E.5.2Secondary end point(s)
    • Complete response rate for oral ulcers at Week 12
    - A complete response is defined as the proportion of subjects who are oral ulcer free.
    • Change from baseline in the pain of oral ulcers as measured by VAS at Week 12
    • Complete response rate for genital ulcers at Week 12 for subjects who had genital ulcers at Baseline
    - A complete response is defined as the proportion of subjects who are genital ulcer free.
    • Change from Baseline in the pain of genital ulcers, as measured by VAS at Week 12 in subjects who had genital ulcers at baseline
    • Change from baseline in disease activity as measured by Behçet’s Disease Current Activity scores (BD Current Activity Form) at Week 12
    • Change from baseline in the BD QoL score at Week 12
    • Change from Baseline in Behçet’s Syndrome Activity Score (BSAS) at Week 12
    • Time to oral ulcer resolution (complete response), ie, the first instance when a subject has a complete response, during the Placebo-controlled Phase
    • Proportion of subjects with no oral ulcers following complete response, ie, the first time when a subject has a complete response, during the Placebo-controlled Phase
    • Number of oral ulcers following loss of complete response, ie, the first instance when a subject has a reappearance of oral ulcers following a complete response, during the Placebo-controlled Phase
    • Time to recurrence of oral ulcers following loss of complete response, ie, the first instance when a subject has a reappearance of oral ulcers following a complete response, during the Placebo-controlled Phase
    • Change from baseline in the total score of the Static Physician’s Global Assessment (PGA) of skin lesions (acne-like lesions, folliculitis and erythema nodosum) of BD at Week 12 in subjects who had BD skin lesions at baseline
    • Proportion of subjects achieving an oral ulcer complete response (oral ulcer free) by week 6, after start of dosing, and who remain oral ulcer free for at least 6 additional weeks during the 12 week Placebo-controlled Phase

    Safety Endpoints
    Safety and tolerability as defined by the following:
    • Type, frequency, severity, and relationship of the AEs to apremilast
    • Number of subjects who prematurely discontinue IP due to any AE
    • Frequency of clinically significant changes in physical examination, vital signs, and/or laboratory findings
    • Absolute weight and the percentage of weight change at each visit (as indicated in Section 5) compared to baseline

    Exploratory Pharmacokinetic / Pharmacodynamic Endpoints
    • PK parameters from non-compartmental analysis including, but not limited to, maximum observed plasma concentration (Cmax), time to Cmax (tmax), and area under the plasma concentration-time curve from time zero to 12 hours post-dose and/or from time zero to the last quantifiable concentration (AUC0-12 and/or (AUC0-t)
    • Change from baseline in the plasma concentration of inflammatory biomarkers and leukocyte subsets

    Exploratory Pharmacogenetic Endpoint
    • Assessment of genetic markers for BD or pharmacodynamic response to apremilast, including but not limited to, HLA-B51, IL-10, IL-23R and IL-12RB2 SNPs at baseline (See Section 6.7.13 for additional markers)

    Exploratory Endpoint(s)
    • The AUC for the combined number of oral and genital ulcers from baseline through Week 12
    • Proportion of subjects with new (ie, in subjects with no history of) or worsening (ie, in subjects with history of) uveitis, arthritis, skin lesions; vascular, gastrointestinal and central nervous system BD manifestations by visit
    • Change from baseline in number of tender and/or swollen joints associated with BD at Week 12 in subjects who had BD-related tender and/or swollen joints at baseline
    • Time to genital ulcer complete response, ie, the first instance when a subject has a complete response, during the Placebo-controlled Phase
    • Proportion of subjects with no genital ulcers following complete response, ie, the first time when a subject has a complete response, during the Placebo-controlled Phase
    • Number of genital ulcers following loss of complete response, ie, the first instance when a subject has a reappearance of genital ulcers following a complete response, during the Placebo-controlled Phase
    • Time to recurrence of genital ulcers following loss of complete response, ie, the first instance when a subject has a reappearance of genital ulcers following a complete response, during the Placebo-controlled Phase
    • Cumulative number of oral ulcers per patient for the entire placebo-controlled period
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 weeks after the start of the double-blind, placebo-controlled phase followed by 52 weeks after the active treatment phase
    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 Yes
    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 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) 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 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 Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    France
    Germany
    Israel
    Italy
    Japan
    Korea, Republic of
    Turkey
    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
    The End of Trial is defined as either the date of the last visit of the last subject to complete the study, or the date of receipt of the last data point from the last subject that is required for primary, secondary and/or exploratory analysis, as pre-specified in the protocol and/or the Statistical Analysis Plan, whichever is the later date.
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 204
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 state19
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 204
    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)
    Once the participation of a subject in the trial has ended, the long term care of the participant will remain the responsibility of the primary treating physician.
    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 Decision2015-02-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-07-17
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