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    Summary
    EudraCT Number:2014-000185-22
    Sponsor's Protocol Code Number:20110265
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-08-05
    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 ConcernedSweden - MPA
    A.2EudraCT number2014-000185-22
    A.3Full title of the trial
    A Phase 1b/2, Multicenter, Open-label Trial of Talimogene Laherparepvec in Combination With MK-3475 for Treatment of Previously Untreated, Unresected, Stage IIIB to IVM1c Melanoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    MK 3475 With or Without Talimogene Laherparepvec in Unresected Melanoma
    A.4.1Sponsor's protocol code number20110265
    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 (EUROPE) GmbH
    B.5.2Functional name of contact pointIHQ medical Info-Clinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressDammstrasse 23, P.O. Box 1557
    B.5.3.2Town/ cityZug
    B.5.3.3Post codeCH-6300
    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 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.3.1Product 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.3.9.2Current 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 number1000000
    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 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.3.1Product 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.3.9.2Current 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 number100000000
    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 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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Previously Untreated, Unresected, 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 17.0
    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 MK-3475 in subjects with previously untreated, unresected, stage IIIB to IVM1c melanoma.

    Phase 2, Part 1: To evaluate the efficacy, as assessed by the confirmed objective response rate (ORR) by week 24 of treatment with talimogene laherparepvec in combination with MK-3475, as
    compared to MK-3475 alone.

    Phase 2, Part 2: To evaluate the efficacy, as assessed by the confirmed ORR by week 24 of treatment with talimogene laherparepvec in combination with MK-3475 following progression on
    MK-3475 alone in part 1 of phase 2.
    E.2.2Secondary objectives of the trial
    Dependent on phase of study:
    -efficacy of talimogene laherparepvec in combination with MK-3475; as compared to MK-3475 alone; as compared to MK-3475 alone in subjects who are either PD-L1-negative or -positive prior to initiating therapy; or confirmed PD on MK-3475
    -safety of talimogene laherparepvec in combination with MK-3475; compared to MK-3475 alone; or following confirmed PD on MK-3475 alone
    -incidence of anti-MK-3475 antibodies when MK-3475 is administered in combination with talimogene laherparepvec; alone or in combination with TVEC; or following confirmed PD on MK-3475 alone
    -PK of MK-3475 when administered in combination with TVEC; or in combination with talimogene laherparepvec; or following confirmed PD on MK-3475 alone
    -whether talimogene laherparepvec induces changes in PD-L1 expression by immunohistochemistry in injected and in non-injected lesions
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Phase 1b and Part 1 of Phase 2:
    Male or female age ≥ 18 years with histologically confirmed diagnosis of melanoma and stage IIIB to IVM1c for whom surgery in not recommended. Subject must be treatment naïve (ie, must not
    have received any prior systemic anticancer treatment consisting of chemotherapy, immunotherapy, or targeted therapy for unresected stage IIIB to IVM1c melanoma. Subject who received prior adjuvant therapy for melanoma will not be excluded (including, but not limited to, interferon, limb infusion/perfusion, or use of investigational agents in the adjuvant setting). However, if the subject received adjuvant therapy, the subject must have completed therapy at
    least 6 months prior to enrollment. Subject must have measurable disease and be a candidate for intralesional therapy administration into cutaneous, subcutaneous, or nodal lesions. Subject must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and adequate hematologic, hepatic, renal, and coagulation function.

    Part 2 of Phase 2:
    Subject randomized to arm 2 (MK-3475 monotherapy arm) of part 1 of the phase 2 study must have evidence of PD at week 12 or subsequent tumor assessment visit through month 20
    documented by an independent central review committee and confirmed by the investigator ≥ 4 weeks later using modified irRC. Subject must have ECOG performance status of 0 or 1, and
    adequate hematologic, hepatic, renal, and coagulation function
    E.4Principal exclusion criteria
    Phase 1b and Part 1 of Phase 2:
    Subject must not have clinically active cerebral metastases. Subject with up to 3 cerebral metastases, and neurological performance status of 0 may be enrolled, provided that all lesions have been adequately treated with stereotactic radiation therapy, craniotomy, or gammaknife therapy, with no evidence of progression, and have not required steroids, for at least 2 months prior to enrollment. Subject must not have primary uveal or mucosal melanoma, history or evidence of melanoma associated with immunodeficiency states (eg, hereditary immune deficiency, organ transplant, or leukemia), or history of other malignancy within the past 3 years with the exceptions of the prior malignancies. Subject must not have received prior talimogene laherparepvec, tumor vaccine, MK-3475, other anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, ipilimumab, other cytotoxic T-lymphocyte associated antigen 4 (CTLA-4) inhibitor, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways, even if given in the adjuvant setting. Subject must not have history or evidence of symptomatic autoimmune pneumonitis, glomerulonephritis, vasculitis, other symptomatic autoimmune disease, documented history of autoimmune disease or syndrome requiring systemic steroids or immunosuppressive agents (except vitiligo or resolved childhood asthma/atopy), or evidence of clinically significant immunosuppression. Subject 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.

    Part 2 of Phase 2:
    Subject must not have stopped MK-3475 treatment in part 1 of phase 2 due to intolerance or reasons other than confirmed PD per modified irRC at week 12 or subsequent tumor assessment visit through month 20. Subject must not have history or evidence of symptomatic autoimmune pneumonitis, glomerulonephritis, vasculitis, other symptomatic autoimmune disease, documented history of autoimmune disease or syndrome requiring systemic steroids or immunosuppressive agents (except vitiligo or resolved
    childhood asthma/atopy), or evidence of clinically significant immunosuppression. Subject 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 2, Part 1:
    • Confirmed ORR (CR+PR) by week 24 from the date of the first dose of MK-3475 in phase 2 part 1 (response evaluation by an investigator using modified immune-related Response Criteria [irRC])

    Phase 2, Part 2:
    • Confirmed ORR (CR+PR) by week 24 from the date of the first dose of MK-3475 in combination with talimogene laherparepvec in phase 2 part 2 (response evaluation by an investigator using modified irRC).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase 1b:
    The primary analysis will occur when the last subject enrolled in the phase 1b has had the opportunity to be on treatment for at least 6 weeks from the initial dosing of MK-3475.

    Phase 2:
    The timing of the primary analysis for part 1 of phase 2 will be when
    all subjects have had the opportunity to complete 36 weeks of treatment.

    The timing of the primary analysis for part 2 of phase 2 will be when all subjects who have confirmed progression by month 20 on MK-3475
    alone in part 1 of phase 2 have had the opportunity to cross over to part 2 of phase 2 and complete 36 weeks of treatment.
    E.5.2Secondary end point(s)
    Phase 1b:
    • Confirmed ORR (CR+PR) by 24 weeks from the date of the first dose of MK-3475.
    • BOR, DRR, DOR, PFS, and OS
    • Ordinal categorical response score
    • Incidence of treatment-emergent and treatment-related adverse events (all AEs, grade ≥ 3 AEs, serious adverse events, fatal AEs, and AEs defined as events of interest).
    • Incidence of anti-MK-3475 antibodies
    • Descriptive statistics of trough and peak levels of MK-3475

    Phase 2, Part 1:
    • BOR, DRR, DOR, PFS, and OS
    • Ordinal categorical response score and deep response rate (CR+Very Good Partial Response [VGPR])
    • BOR, ordinal categorical response score, deep response rate, (CR+VGPR), DRR, DOR, PFS, and OS for PD-L1 negative subjects and PD-L1 positive subjects based on pre-treatment biopsy specimen.
    • Incidence of treatment-emergent and treatment-related adverse events (all AEs, grade ≥ 3 AEs, serious adverse events, fatal AEs, and AEs defined as events of interest.
    • Incidence of anti-MK-3475 antibodies.
    • Descriptive statistics of trough and peak levels of MK-3475.

    Phase 2, Part 2:
    • BOR, ordinal categorical response score, deep response rate (CR+VGPR), DRR, DOR, PFS and OS.
    • Incidence of treatment-emergent and treatment-related adverse events (all AEs, grade ≥ 3 AEs, serious adverse events, fatal AEs, and AEs defined as events of interest).
    • Incidence of anti-MK-3475 antibodies.
    • Pharmacokinetic parameters for MK-3475.

    Phase 1b and Phase 2:
    • Changes in PD-L1 expression by immunohistochemistry (eg, negative to positive) that occur in injected lesions after starting talimogene laherparepvec in either subjects who are treatment-naïve (phase 1b) or those who have been receiving MK-3475 (part 2 of phase 2) and are PD-L1-negative prior to receiving talimogene laherparepvec.
    • Changes in PD-L1 expression by immunohistochemistry (eg, negative to positive) that occur in non-injected lesions after starting talimogene laherparepvec in either subjects who are treatment-naïve (phase 1b) or those who have been receiving MK-3475 (part 2 of phase 2) and are PD-L1-negative prior to receiving talimogene laherparepvec.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The clinical study report (CSR) will be written based on the results of the primary analysis of phase 2 (part 1 and part 2) and also include the results from the phase 1b and second-course (retreatment).
    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 safety of talimogene laherparepvec in combination with MK-3475
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    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 EEA11
    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
    Switzerland
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The time when the last subject is assessed or receives an intervention for
    evaluation in the study. The end of study will occur when the last subject discontinues the study treatment and has had the opportunity to complete the safety follow-up visit or the long-term survival follow-up, whichever is later.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    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: 57
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 53
    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 state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 110
    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 Decision2014-11-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-03-11
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