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    Summary
    EudraCT Number:2014-000185-22
    Sponsor's Protocol Code Number:20110265
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-07-09
    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 - PEI
    A.2EudraCT number2014-000185-22
    A.3Full title of the trial
    A Phase 1b/3, Multicenter, Trial of Talimogene Laherparepvec in Combination With Pembrolizumab (MK-3475) for Treatment of Unresectable, Stage IIIB to IVM1c Melanoma (MASTERKEY-265)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pembrolizumab (MK 3475) With Talimogene Laherparepvec or placebo in Unresectable Melanoma
    A.4.1Sponsor's protocol code number20110265
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02263508
    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.4.1Name of organisation providing supportMerck Sharp and Dohme International GmbH
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen GmbH
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street AddressRiesstr. 24
    B.5.3.2Town/ cityMünchen
    B.5.3.3Post code80992
    B.5.3.4CountryGermany
    B.5.4Telephone number+498002643644
    B.5.6E-maileudemedinf@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 IMLYGIC
    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 nameTalimogene Laherparepvec
    D.3.2Product code AMG 678
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralesional use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTalimogene laherparepvec
    D.3.9.1CAS number 1187560-31-1
    D.3.9.2Current sponsor codeAMG 678
    D.3.9.3Other descriptive nameTALIMOGENE LAHERPAREPVEC
    D.3.9.4EV Substance CodeSUB130338
    D.3.10 Strength
    D.3.10.1Concentration unit PFU/ml plaque forming unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10e6
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product Yes
    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 Yes
    D.3.11.3.5.1CAT classification and reference numberClassified as a Gene Therapy Medicinal Product EMA/CAT/451866/2012
    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 Yes
    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 IMLYGIC
    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 nameTalimogene Laherparepvec
    D.3.2Product code AMG 678
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralesional use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTalimogene laherparepvec
    D.3.9.1CAS number 1187560-31-1
    D.3.9.2Current sponsor codeAMG 678
    D.3.9.3Other descriptive nameTALIMOGENE LAHERPAREPVEC
    D.3.9.4EV Substance CodeSUB130338
    D.3.10 Strength
    D.3.10.1Concentration unit PFU/ml plaque forming unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10e8
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product Yes
    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 Yes
    D.3.11.3.5.1CAT classification and reference numberClassified as a Gene Therapy Medicinal Product EMA/CAT/451866/2012
    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 Yes
    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 Keytruda
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Limited
    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 nameKeytruda
    D.3.2Product code MK-3475
    D.3.4Pharmaceutical form 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 INNPembrolizumab
    D.3.9.1CAS number 1374853-91-4
    D.3.9.2Current sponsor codeMK-3475
    D.3.9.3Other descriptive nameMK-3475
    D.3.9.4EV Substance CodeSUB91641
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 placeboIntralesional use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Unresectable Stage IIIB to IVM1c Melanoma
    E.1.1.1Medical condition in easily understood language
    Melanoma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10053571
    E.1.2Term Melanoma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase 1b: To evaluate the safety, as assessed by incidence of dose limiting toxicity (DLT), of talimogene laherparepvec in combination with pembrolizumab in subjects with previously untreated, unresectable, stage IIIB to IVM1c melanoma.

    Phase 3: To evaluate the efficacy of talimogene laherparepvec with pembrolizumab versus placebo with pembrolizumab, as assessed by progression-free survival (PFS) (response evaluation by blinded independent central review using modified Response Evaluation Criteria in Solid Tumors 1.1 [RECIST]) and overall survival (OS).
    E.2.2Secondary objectives of the trial
    Phase 1b:
    • evaluate the efficacy of talimogene laherparepvec in combination with pembrolizumab, as assessed by:
    − ORR,BOR,DRR,DOR,DCR,&PFS
    − OS
    • evaluate the safety of talimogene laherparepvec in combination with pembrolizumab as assessed by incidence of treatment-emergent and -
    related AEs, and abnormal laboratory tests.
    Phase 3:
    • Evaluate efficacy of talimogene laherparepvec with pembrolizumab, versus placebo with pembrolizumab, as assessed by:
    - iCRR by blinded independent central assessed modified irRC-RECIST
    - iPFS by blinded independent central assessed modified irRC-RECIST
    - OS in subjects excluding stage IVM1c per CRF
    - ORR, BOR, DRR, DOR, DCR, iORR, iBOR, iDRR, iDOR, and iDCR
    • Evaluate safety of talimogene laherparepvec with pembrolizumab, versus placebo with pembrolizumab, as assessed by incidence of treatment -emergent and -related AEs and abnormal laboratory tests.
    • Evaluate patient reported outcomes (PRO)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Phase 1b and Phase 3:
    • Male or female age ≥ 18 years with histologically confirmed diagnosis of melanoma and stage IIIB to IVM1c for whom surgery in not recommended.
    • Subjects must have measurable disease and be a candidate for intralesional therapy administration into cutaneous, subcutaneous, or nodal lesions.
    • Subjects must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and adequate hematologic, hepatic, renal, and coagulation function.
    Phase 1b only:
    • Subjects enrolled in phase 1b must be treatment naïve (i.e., must not have received any prior systemic anticancer treatment consisting of
    chemotherapy, immunotherapy, or targeted therapy) given in a nonadjuvant setting for unresectable stage IIIB to IVM1c melanoma.
    • Subjects who received prior adjuvant therapy for melanoma will not be excluded (including, but not limited to, radiotherapy, interferon, limb
    infusion/perfusion, or use of investigational agents in the adjuvant setting) with the exception that prior adjuvant therapy with inhibitors of
    programmed cell death 1 (PD-1) or programmed cell death ligand 1 (PD-L1) is not allowed. However, if the subject received adjuvant therapy, the
    subject must have completed therapy at least 3 months prior to enrolment.

    Phase 3 only:
    • Subjects enrolled in phase 3 with serine/threonine protein kinase B-Raf V600 (BRAFV600) wild-type tumors must not have received any prior systemic anticancer treatment consisting of chemotherapy, immunotherapy, or targeted therapy given in a nonadjuvant setting for unresectable stage IIIB to IVM1c melanoma.
    • Subjects enrolled in phase 3 with BRAFV600 mutated tumors who have received prior BRAF inhibitor therapy either alone or in combination with MEK inhibitor as their only prior systemic therapy are eligible for the phase 3 of this study. Subjects with BRAFV600 mutant melanoma or unknown BRAFV600 mutation status who have not received a BRAF inhibitor are also eligible for the phase 3 of this study as first-line treatment if they meet the following criteria: lactate dehydrogenase (LDH) < upper limit of normal (ULN), no clinically significant tumor related symptoms, and absence of rapidly progressing metastatic melanoma. Subjects (BRAF mutant, wildtype and UNK) who received prior adjuvant therapy for melanoma will not be excluded (including, but not limited to, interferon, ipilimumab, limb infusion/perfusion, or use of investigational agents in the adjuvant setting) with the exception that prior adjuvant therapy with inhibitors of PD-1 OR PD-L1 is not allowed. However, if the subject received adjuvant therapy, the subject must have completed therapy at least 28 days prior to enrolment.
    • Subjects must have a tumor sample (archival sample or newly obtained biopsy) that is adequate for PD-L1 assessment prior to randomization.
    E.4Principal exclusion criteria
    Phase 1b and Phase 3:
    • Subjects must not have clinically active cerebral metastases and/or
    carcinomatous meningitis.
    • Subjects with up to 3 cerebral metastases may be enrolled, provided
    that all lesions have been adequately treated with stereotactic radiation
    therapy, craniotomy, or Gamma Knife therapy, with no evidence of
    progression, and not requiring steroids, for at least 2 months prior
    to enrolment. Carcinomatous meningitis is excluded regardless of clinical
    stability.
    • Subjects must not have primary uveal or mucosal melanoma, history or
    evidence of melanoma associated with immunodeficiency states (e.g.,
    hereditary immune deficiency, organ transplant, or leukemia), or history
    of other malignancy within the past 3 years with the exceptions of the
    prior malignancies noted in Section 4.1.2.
    • Subjects may not have been previously treated with talimogene
    laherparepvec, any other oncolytic virus, pembrolizumab, or any other
    inhibitor of PD-1, PD-L1, or programmed cell death ligand 2 (PD-L2).
    Prior treatment with other immunotherapies ( e.g., anti-CD137, or
    cytotoxic T-lymphocyte associated antigen 4 (CTLA-4) inhibitor, or any
    other antibody or drug specifically targeting T-cell co-stimulation or
    checkpoint pathways), is allowed only in the adjuvant setting.
    • Subjects must not have history or evidence of symptomatic
    autoimmune glomerulonephritis, vasculitis, other symptomatic
    autoimmune disease, documented history of autoimmune disease or
    syndrome requiring systemic treatment in the past 2 years (ie, with use
    of disease modifying agents, steroids or immunosuppressive agents)
    except vitiligo or resolved childhood asthma/atopy, or evidence of
    clinically significant immunosuppression.
    • Subjects must not have active herpetic skin lesions or prior
    complications of herpetic infection (eg, herpetic keratitis or encephalitis)
    and must not require intermittent or chronic treatment with an
    antiherpetic drug (eg, acyclovir), other than intermittent topical use.
    E.5 End points
    E.5.1Primary end point(s)
    Phase 1b:
    • Incidence of DLT
    Phase 3:
    • PFS (response evaluation by blinded independent central review assessed using modified RECIST 1.1) (PFS1) and OS
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary completion: The date when the last subject is assessed or
    receives an intervention for the primary endpoint(s), for the purpose of
    conducting the primary analysis, whether the study concluded as
    planned in the protocol or was terminated early.

    End of Trial: The date when the last subject across all sites is assessed
    or receives an intervention for evaluation in the study (ie, last subject
    last visit), following any additional parts in the study (eg, long-term
    follow-up), as applicable.
    E.5.2Secondary end point(s)
    Phase 1b:
    • Confirmed ORR (CR+PR) (response evaluation by investigator using
    modified irRC).
    • BOR, DRR, DOR, PFS and DCR (response evaluation by investigator
    using modified irRC).
    • OS.
    • Incidence of treatment-emergent and treatment-related adverse
    events (all AEs, grade ≥ 3 AEs, SAEs, fatal AEs, and AEs defined as
    events of interest), and abnormal laboratory tests.
    Phase 3:
    • iCRR by blinded independent central review using modified irRC-RECIST
    • iPFS by blinded independent central review using modified irRC-RECIST
    (PFS2)
    • OS in subjects excluding stage IVM1c per CRF
    • ORR (CR+PR), BOR, DRR, DOR, and DCR (response evaluation by
    blinded independent central review assessed using modified RECIST 1.1
    and iORR (iCR + iPR), iBOR, iDRR, iDOR, and iDCR (response evaluation by blinded independent central review assessed using modified irRC-RECIST)
    • Incidence of treatment-emergent and treatment-related AEs (all AEs,
    grade ≥ 3 AEs, serious adverse events, fatal AEs, and AEs defined as
    events of interest), and abnormal laboratory tests
    • Changes in EORTC QLQ-C30 GHS/QoL subscale.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The clinical study report (CSR) will be written based on the results from
    the OS primary analysis for phase 3, which will also include safety data
    from subjects in phase 1b. However, a CSR will be prepared should there
    be a decision for unblinding the study team based on early stopping for
    safety, efficacy, or futility (Section 10.4.1). Amgen senior management
    will make the decision to unblind the study team based on the DMC's
    recommendations; however, only a subset of the study team will be
    unblinded prior to the OS primary analysis.
    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 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) 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 1b to evaluate the safety, as assessed by incidence of dose limiting toxicity (DLT)
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Keytruda
    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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA75
    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
    Australia
    Austria
    Belgium
    Canada
    Czechia
    Finland
    France
    Germany
    Greece
    Hungary
    Italy
    Netherlands
    Norway
    Poland
    Portugal
    Russian Federation
    South Africa
    Spain
    Switzerland
    United Kingdom
    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 date when the last subject across all sites is assessed or receives
    an intervention for evaluation in the study (ie, last subject last visit),
    following any additional parts in the study (eg, long-term follow-up),
    as applicable.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years8
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 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: 330
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 350
    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 state38
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 330
    F.4.2.2In the whole clinical trial 680
    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)
    None
    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 Decision2016-02-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-08
    P. End of Trial
    P.End of Trial StatusOngoing
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