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    Summary
    EudraCT Number:2016-002125-11
    Sponsor's Protocol Code Number:CT-P13-3.5
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-07-11
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2016-002125-11
    A.3Full title of the trial
    A Randomized, Parallel-Group, Phase I/III Study to Evaluate Efficacy, Pharmacokinetics and Safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis
    I/III. fázisú, randomizált, párhuzamos csoportos
    vizsgálat a CT-P13 szubkután és a CT-P13 intravénás alkalmazás
    farmakokinetikájának, hatékonyságának és biztonságosságának
    összehasonlítására aktív rheumatoid arthritisben szenvedő betegeknél
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluating efficacy, pharmacokinetics and safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis
    A.4.1Sponsor's protocol code numberCT-P13-3.5
    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 SponsorCelltrion, Inc
    B.1.3.4CountryKorea, Republic of
    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 supportCelltrion, Inc
    B.4.2CountryKorea, Republic of
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCelltrion, Inc
    B.5.2Functional name of contact pointSung Young Lee
    B.5.3 Address:
    B.5.3.1Street Address23, Academy-ro
    B.5.3.2Town/ cityYeonsu-gu, Incheon
    B.5.3.3Post code22014
    B.5.3.4CountryKorea, Republic of
    B.5.4Telephone number+82328506532
    B.5.5Fax number+82328506543
    B.5.6E-mailSungYoung.Lee@celltrion.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code CT-P13
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINFLIXIMAB
    D.3.9.1CAS number 170277-31-3
    D.3.9.2Current sponsor codeCT-P13
    D.3.9.4EV Substance CodeSUB02681MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 No
    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.3.2Product code CT-P13
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINFLIXIMAB
    D.3.9.1CAS number 170277-31-3
    D.3.9.2Current sponsor codeCT-P13
    D.3.9.4EV Substance CodeSUB02681MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 REMSIMA
    D.2.1.1.2Name of the Marketing Authorisation holderCELLTION HEALTHCARE HUNGARY KFT.
    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.3.2Product code CT-P13
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINFLIXIMAB
    D.3.9.1CAS number 170277-31-3
    D.3.9.2Current sponsor codeCT-P13
    D.3.9.4EV Substance CodeSUB02681MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder for concentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Active Rheumatoid Arthritis
    E.1.1.1Medical condition in easily understood language
    Rheumatoid Arthritis
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part 1
    • To find the optimal dose of CT-P13 SC over the first 30 weeks as determined by the area under the concentration-time curve (AUCτ) at steady state between Week 22 and Week 30
    Part 2
    • To demonstrate that CT P13 SC is noninferior to CT-P13 IV at Week 22, in terms of efficacy, as determined by clinical response according to change from baseline in disease activity measured by Disease Activity Score using 28 joint counts (DAS28) (CRP)
    E.2.2Secondary objectives of the trial
    Part 1
    • To evaluate efficacy, pharmacokinetics (PK), pharmacodynamics (PD) and overall safety of CT P13 SC in comparison with CT-P13 IV up to Week 54
    Part 2
    • To evaluate efficacy, PK, PD and overall safety of CT-P13 SC in comparison with CT-P13 IV (over the first 30 weeks)
    • To evaluate efficacy, PK, PD and overall safety of CT-P13 SC up to Week 54
    Tertiary Objective for Part 2
    • To evaluate biomarkers (optional)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient is male or female aged 18 to 75 years old, inclusive.
    2. Patient has a diagnosis of RA according to the 2010 ACR/EULAR classification criteria [Aletaha et al. 2010] for at least 6 months prior to the first administration of the study drug (Day 0).
    3. Patient has active disease as defined by the presence of 6 or more swollen joints (of 28 assessed), 6 or more tender joints (of 28 assessed), and a serum CRP concentration > 0.6 mg/dL at Screening. Unexplained or unexpected Screening CRP value that does not match the clinical activity of RA according to the investigator’s assessment or recent test can be retested once within the Screening period.
    4. Patient who has completed at least 3 months of treatment of oral or parenteral dosing with methotrexate between 12.5 to 25 mg/week and on stable dosing with methotrexate between 12.5 to 25 mg/week for at least 4 weeks prior to the first administration of the study drug (Day 0).
    5. Patient has adequate renal and hepatic function at Screening as defined by the following clinical chemistry results:
    • Serum creatinine <1.5 × upper limit of normal (ULN) or an estimated creatinine clearance level >50 mL/min (by Cockcroft-Gault formula)
    • Serum alanine aminotransferase <2.5 × ULN
    • Serum aspartate aminotransferase <2.5 × ULN
    • Serum total bilirubin <2 × ULN
    6. Patient has the following hematology laboratory test results at Screening:
    • Hemoglobin ≥8.5 g/dL (SI [Système International d'Unités] units: ≥85 g/L or 5.28 mmol/L)
    • White blood cell count ≥3.5 × 103 cells/µL (SI units: ≥3.5 × 109 cells/L)
    • Neutrophil count ≥1.5 × 103 cells/µL (SI units: ≥1.5 × 109 cells/L)
    • Platelet count ≥100 × 103 cells/µL (SI units: ≥100 × 109 cells/L)
    7. Patient has the ability to comprehend the full nature and purpose of the study, including possible risks and side effects, to cooperate with the investigator, to understand verbal and/or written instructions, and to comply with the requirements of the entire study.
    8. Patient (or legal guardian, if applicable) is informed of the full nature and purpose of the study, including possible risks and side effects, and given ample time and opportunity to read or understand this information, signed and dated the written informed consent before inclusion in the study.
    9. For both male and female patients, the patient and their partners of childbearing potential agree to use one of the following medically acceptable methods of contraception during the course of the study and for 6 months following discontinuation of study drug (excluding women who are not of childbearing potential and men who have been sterilized):
    • Barrier contraceptives (male condom, female condom, or diaphragm with a spermicidal gel)
    • Hormonal contraceptives (implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings)
    • Intrauterine device
    Male and female patients and their partners who have been surgically sterilized for less than 6 months prior to the date of informed consent must agree to use any medically acceptable methods of contraception.
    Menopausal females must have experienced their last period more than 12 months prior to the date of informed consent to be classified as not of childbearing potential.
    E.4Principal exclusion criteria
    1.Patient who has previously received a biological agent for the treatment of RA
    2.Patient who has allergies to any of the excipients of infliximab or any other murine and/or human proteins or patient with a hypersensitivity to immunoglobulin product.
    3.Patient who has a current or past history of following infection:
    •Current or past history of chronic infection with hepatitis C or HIV-1 or-2 or current infection with hepatitis B
    •Acute infection requiring oral antibiotics within 2 weeks or parenteral injection of antibiotics within 4 weeks prior to the first administration of the study drug (Day 0)
    •Other serious infection within 6 months prior to the first administration of the study drug (Day 0)
    •Recurrent herpes zoster or other chronic or recurrent infection within 6 weeks prior to the first administration of the study drug (Day 0)
    •Past or current granulomatous infections or other severe or chronic infection
    4.Patient who has a medical condition including one or more of the following:
    •Classified as obese (body mass index ≥35 kg/m2)
    •Uncontrolled diabetes mellitus, even after insulin treatment
    •Uncontrolled hypertension (as defined by systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg)
    •Any other inflammatory or rheumatic diseases
    •History of any malignancy within the 5 years prior to the first administration of the study drug (Day 0)except completely excised and cured squamous carcinoma of the uterine cervix in situ, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma
    •History of lymphoma or lymphoproliferative disease or bone marrow hyperplasia
    •NYHA class III or IV heart failure, severe uncontrolled cardiac disease (unstable angina or clinically significant electrocardiogram [ECG] abnormalities), or myocardial infarction within the 6 months prior to the first administration of the study drug (Day 0)
    •History of organ transplantation, including corneal graft/transplantation
    •Any uncontrolled, clinically significant respiratory disease, including but not limited to chronic obstructive pulmonary disease, asthma, bronchiectasis, or pleural effusion.
    •Previous diagnosis or symptoms suggestive of demyelinating disorders, including multiple sclerosis and Guillain-Barré syndrome
    •Severe physical incapacitation (unable to perform routine self-care, has RA ACR functional status class 4 or who cannot benefit from medication
    •Any conditions significantly affecting the nervous system if it may interfere with the investigator’s assessment on disease activity scores including joint counts
    •Any other serious acute or chronic medical or psychiatric condition that may increase the risk associated with study participation or investigational product administration or that may interfere with the interpretation of study results.
    5.Patient who has received or has plan to receive any of following prohibited medications or treatment:
    •Any biological agents for the treatment of RA
    •Intra-articular corticosteroids within 4 weeks prior to the first administration of the study drug (Day 0). Patient is permitted to receive either oral or parenteral glucocorticoids (≤10 mg daily of prednisone/prednisolone or equivalent), and nonsteroidal anti-inflammatory drug, if they have received a stable dose for at least 4 weeks prior to the first administration of the study drug (Day 0). In addition, patients are permitted to receive low potency topical, otic, and ophthalmic glucocorticoid preparations provided the preparations are administered per the instructions on the product label.
    •DMARDs, other than methotrexate, including hydroxychloroquine, chloroquine, or sulfasalazine, within 4 weeks prior to the first administration of the study drug (Day 0)
    •Alkylating agents within 12 months prior to the first administration of the study drug (Day 0)
    •Live or live-attenuated vaccine within 4 weeks the first administration of the study drug (Day 0)
    •Any planned live or live-attenuated vaccination at the time of the first administration of the study drug (Day 0)
    •Any surgical procedure, including bone or joint surgery or synovectomy (including joint fusion or replacement) within 12 weeks prior to the first administration of the study drug (Day 0) or planned within 6 months after the first administration of the study drug (Day 0)
    6.Patient who has a current or past history of drug or alcohol abuse.
    7.Patient who has had treatment with any other investigational device or medical product within 4 weeks prior to the first administration of the study drug (Day 0) or 5 half-lives, whichever is longer.
    8.Female patient who is currently pregnant, breastfeeding, or planning to become pregnant or breastfeed within 6 months of the last dose of study drug.
    9.Patient who, in the opinion of his or her GP or investigator, should not participate in the study.
    TB exclusion criteria revised as per protcol amendment version 2.1 dated 13Jan2017
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy Assessments: Primary Endpoint for Part 2
    • Change from baseline in disease activity measured by DAS28 (CRP) at Week 22

    Pharmacokinetic Assessments: Primary Endpoint for Part 1
    The following primary PK endpoint will be assessed at steady state between Week 22 and 30:
    • AUCτ Area under the concentration-time curve at steady state between Week 22 and Week 30
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary efficacy will be assessed by change from baseline in disease activity measured by DAS28 (CRP) at Week 22.
    E.5.2Secondary end point(s)
    Efficacy Assessments: Secondary Endpoints for both Part 1 and Part 2
    The following secondary efficacy endpoints will be assessed:
    • Individual components of the DAS28
    • DAS28 (CRP) and DAS28 (ESR)
    • Individual components of the ACR
    • ACR 20, 50 and 70
    • Hybrid ACR response
    • Proportion of patients with a good response, defined according to the EULAR response criteria
    • SDAI and CDAI
    • Health assessment questionnaire (HAQ)
    36-item short form health survey (SF-36) (Part 2 only)

    Pharmacokinetic Assessments: Secondary Endpoints for Part 1
    The following secondary PK endpoints will be assessed between Week 22 and Week 30:
    • Cmax Observed maximum serum concentration
    • MRT Mean residence time
    • CL Clearance after IV dosing
    • CL/F Apparent clearance after SC dosing
    • BA Bioavailability (absolute and/or relative)

    The following secondary PK endpoint will be assessed up to Week 54:
    • Ctrough Trough concentration

    Secondary Endpoints for Part 2
    The following secondary PK endpoints will be assessed between Week 22 and Week 30:
    • AUCτ Area under the concentration-time curve at steady state between Week 22 and Week 30
    • Cmax Observed maximum serum concentration

    The following secondary PK endpoint will be assessed up to Week 54:
    Ctrough Trough concentration

    Pharmacodynamic Assessments:
    Secondary Endpoints for both Part 1 and Part 2
    The following PD parameters for CT-P13 SC and CT-P13 IV will be determined as secondary PD endpoints (up to Week 54):
    • Rheumatoid Factor (RF)
    • Anti-cyclic citrullinated peptide (anti-CCP)
    • CRP
    • ESR

    Biomarker Assessment (Optional for Part 2): For patients who sign a separate informed consent form for the biomarker assessment, a blood sample for evaluation of any necessary genotypes will be collected before dosing on Day 0 of Week 0. These genes will include, but are not limited to FcγRIIIa.

    Safety assessments will be performed on immunogenicity, hypersensitivity monitoring (including delayed hypersensitivity monitoring), vital sign measurements (including blood pressure, heart and respiratory rates and body temperature), weight, interferon-γ release assay, chest x-ray, hepatitis B and C and HIV-1 and -2 status, physical examination findings, ECGs, AEs (including serious AEs), adverse events of special interest (infusion related reactions/hypersensitivity/anaphylactic reactions, delayed hypersensitivity, injection site reactions, infection and malignancies), clinical laboratory analyses, pregnancy testing, local site pain using 100 mm Visual Analogue Scale (VAS), signs and symptoms of TB and previous and concomitant medications.
    In case of delayed hypersensitivity occurred after 24 hours of study drug administration, including serum sickness-like reactions (myalgia with fever or rash, arthralgia, lymphadenopathy, skin eruption or edema), following assessments will be additionally performed to determine Serum Sickness during the study period;
    • Immunogenicity
    • Clinical Laboratory Analyses
    • Complement (C3, C4) and Total Haemolytic Complement
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary efficacy will be assessed at the time points specified in the schedule of events
    The secondary PK endpoint evaluations will be conducted during the Treatment Period up to Week 54, with blood samples for analysis obtained at the time points specified in the schedule of events.
    Efficacy, pharmacodynamics, safety and biomarkers assessments will be performed at the time points specified in the schedule of events.
    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 Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Phase I/III to evaluate efficacy, pharmacokinetics and safety in patients with active RA
    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 Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Part 1 is open; placebo double blind, double dummy design is introduced in Part 2 only
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    Belgium
    Bosnia and Herzegovina
    Bulgaria
    Chile
    Czech Republic
    Estonia
    Hungary
    Italy
    Korea, Republic of
    Latvia
    Lithuania
    Mexico
    Peru
    Poland
    Russian Federation
    Slovakia
    South Africa
    Spain
    Ukraine
    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 years3
    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 years3
    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: 208
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state29
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 258
    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)
    Patients will transition to local standard of care treatment if required in
    the opinion of 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 Decision2016-09-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-08-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-04-15
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