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    Summary
    EudraCT Number:2017-003634-93
    Sponsor's Protocol Code Number:NLG2107
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2017-11-29
    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 ConcernedUK - MHRA
    A.2EudraCT number2017-003634-93
    A.3Full title of the trial
    A Phase 2/3 (Adaptive Design) Study of the Concomitant Administration of Indoximod or Placebo plus Pembrolizumab or Nivolumab in Adult Patients with Unresectable Stage III or Stage IV Malignant Melanoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2/3 (Adaptive Design) Study of the Concomitant Administration of Indoximod or Placebo plus Pembrolizumab or Nivolumab in Adult Patients with Unresectable Stage III or Stage IV Malignant Melanoma
    A.4.1Sponsor's protocol code numberNLG2107
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03301636
    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 SponsorNewLink Genetics Corporation
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNewLink Genetics Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNewLink Genetics Corporation
    B.5.2Functional name of contact pointLisa DeLuca
    B.5.3 Address:
    B.5.3.1Street Address2503 South Loop Drive, Suite 5100
    B.5.3.2Town/ cityAmes, Iowa
    B.5.3.3Post code50010
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1515708 6505
    B.5.6E-mailLDeLuca@linkp.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 nameIndoximod
    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 INNINDOXIMOD
    D.3.9.3Other descriptive nameindoximod, Indoximod Hydrochloride (HCl); 1-methyl-Dtryptophan
    D.3.9.4EV Substance CodeSUB187195
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    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 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 KEYTRUDA 50 mg powder for concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp &Dohme Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 namePembrolizumab
    D.3.4Pharmaceutical form Powder for concentrate for solution for injection/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.3.9.3Other descriptive namePEMBROLIZUMAB
    D.3.9.4EV Substance CodeSUB167136
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 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 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 OPDIVO 10 mg/mL concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharma EEIG
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameNivolumab
    D.3.4Pharmaceutical form Concentrate for solution for injection/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 INNNIVOLUMAB
    D.3.9.3Other descriptive nameNIVOLUMAB
    D.3.9.4EV Substance CodeSUB122750
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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 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 placeboFilm-coated tablet
    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
    Adult Patients with Unresectable Stage III or Stage IV Malignant Melanoma
    E.1.1.1Medical condition in easily understood language
    Advanced melanoma (stage 3 or 4)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase 2
    To establish the Phase 3 dose of indoximod in combination with immune checkpoint inhibitor pembrolizumab or nivolumab in adult patients with unresectable stage III or stage IV malignant melanoma – an open label evaluation of PK, safety and tolerability of the combined treatment.

    Phase 3
    To evaluate progression-free-survival (PFS) and/or overall survival (OS) in adult patients with unresectable stage III or stage IV malignant melanoma receiving either indoximod plus pembrolizumab or nivolumab versus placebo plus pembrolizumab or nivolumab.
    E.2.2Secondary objectives of the trial
    Phase 3
    To evaluate the objective response rate (ORR) in adult patients with unresectable stage III or stage IV malignant melanoma receiving either indoximod plus pembrolizumab or nivolumab versus placebo plus pembrolizumab or nivolumab To evaluate safety, tolerability and adverse experience profile of a combination of indoximod and pembrolizumab or nivolumab versus placebo plus pembrolizumab or nivolumab.

    To evaluate safety, tolerability and adverse experience profile of a combination of indoximod and pembrolizumab or nivolumab versus placebo plus pembrolizumab or nivolumab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participant must be 18 years and older (adults and seniors) at the time of signing the
    informed consent.
    1. Have histologically- or cytologically-confirmed unresectable stage III or stage IV melanoma, as per AJCC (8th Edition) staging system not amenable to local therapy
    2. Subject must have at least one radiologically measurable lesion as per RECIST 1.1 (Appendix 7: RECIST 1.1 Guideline of the protocol) defined as a lesion that is 10mm in longest diameter or lymph node that is 15mm in short axis imaged by computed tomography (CT) scan or magnetic resonance imaging (MRI).
    3. Have been untreated for advanced or metastatic disease except as follows
    a) BRAF V600 mutant melanoma may have received standard of care targeted therapy (e.g. BRAF/MEK inhibitor, alone or in combination)
    b) Prior adjuvant or neoadjuvant melanoma therapy is permitted if it was completed at least 4 weeks before randomization and all related adverse events have either returned to baseline or stabilized for non-immune therapy based regimens.
    c) Prior adjuvant therapy containing immunotherapy such as interferon or anti-CTLA-4 therapy will only be permitted if relapse did not occur during treatment or within 6 months of treatment discontinuation.
    d) Prior anti-PD-1, anti-PD-L1, or IDO1 inhibitors are excluded.
    4. Have documentation of V600-activating BRAF mutation status or consent to BRAF V600 mutation testing during the screening period.
    5. Must collect and submit available archival tumor tissue. If no archival tumor tissue is available, subject will not be excluded.
    6. ECOG performance status 0 or 1
    7. Patient has adequate bone marrow and organ function as defined by the following laboratory values: Absolute Neutrophil Count (ANC) ≥ 1,500 cells/μL (1.5 x109/L), without growth factor support; Platelets ≥ 100,000 cells/μL (100 x109 cells/L), without growth factor support; Hemoglobin ≥ 9.0 g/dL (90g/L); INR ≤ 2 x ULN
    8. Any hyperkalemia, hypokalemia, hypermagnesemia, hypomagnesemia, hypercalcemia, hypocalcemia must be ≤ Grade 1 per CTCAE Version 4.03
    9. Serum Creatinine ≤ 1.5 x ULN, or creatinine clearance (Ccr) > 60 mL/min based on the Cockcroft-Gault equation.
    10. Total bilirubin, amylase and lipase ≤ 1.5 x ULN (in patients with known Gilbert Syndrome, total bilirubin ≤ 3 x ULN, with direct bilirubin ≤ 1.5 x ULN)
    11. Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) ≤ 3 x ULN, (in subjects with liver metastases, < 5 x ULN)
    12. Serum Albumin ≥ 3 g/dL
    13. Patients must have normal pituitary function as determined by investigator clinical judgment.
    14. HIV positive patients who are stable on antiretroviral medication (ART). Patients stable on ART are defined as those who have received ART for at least 1 year with no adverse drug reactions requiring regular monitoring, no current illnesses or pregnancy, a good understanding of lifelong adherence, and evidence of treatment success. Treatment success is defined as two consecutive undetectable viral load measures or, in the absence of viral load monitoring, rising CD4 counts or CD4 counts above 200 cells/mm3 and an objective
    adherence measure.
    15. Patients with known brain metastases will only be eligible after definitive treatment of brain metastases with SBRT or surgery provided that the brain lesions are stable (without evidence of progression by imaging for at least 4 weeks before the first dose of study treatment), subject is neurologically stable and has had no persistent side effects / complications from the treatment, have no evidence of new or enlarging brain metastases confirmed by repeat imaging, and have not required steroids for at least 14 days before
    study treatment.
    16. If female of childbearing potential, must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. If female of childbearing potential, must be willing to use an adequate method of contraception as outlined in Appendix 4, for the course of the study through minimum of 4 months (for those who receive pembrolizumab) and a minimum of 5 months (for those
    who receive nivolumab) after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
    17. If male of childbearing potential, must agree to use an adequate method of contraception as outlined in Appendix 4, and not to donate sperm starting with the first dose of study therapy through minimum of 4 months (for those who receive pembrolizumab) and a minimum of 5 months (for those who receive nivolumab) after the last dose of study therapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
    18. Ability to ingest oral medications
    19. Ability to understand and the willingness to sign a written informed consent document
    E.4Principal exclusion criteria
    1. Has Ocular Melanoma
    2. Has received prior systemic treatment for unresectable or metastatic melanoma (except
    BRAF directed therapy as noted in inclusion criteria #3).
    3. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or
    IDO1 inhibitor or any other antibody or drug specifically targeting checkpoint pathways
    other than anti-CTLA-4 which is permitted in the adjuvant setting.
    4. Has received prior adjuvant therapy, monoclonal antibody or an investigational agent or
    device within 4 weeks or 5 half-lives (whichever is longer) before study Day 1 or not
    recovered (Grade 1 or at baseline) from AEs due to previously administered agents.
    Exception to this rule would be use of bisphosphonates, which is not excluded.
    5. Has received prior radiotherapy within 2 weeks of therapy. Subjects must have recovered
    from all radiation-related toxicities, not require corticosteroids, and not have had radiation
    pneumonitis. A 1-week washout is permitted for palliative radiation (2 weeks of RT) to
    non-CNS disease.
    6. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in
    dosing exceeding 10 mg daily of prednisone equivalent) or any other form of
    immunosuppressive therapy within 7 days before the first dose of study treatment.
    7. Has known active, uncontrolled brain or CNS metastases and/or carcinomatous meningitis.
    8. History or presence of an abnormal electrocardiogram (ECG) that, in the investigator’s
    opinion, is clinically meaningful. Screening QTc interval > 480 msec is excluded
    (corrected by Fredericia or Bazett formula). In the event that a single QTc is > 480 msecs,
    the subject may enroll if the average QTc for the 3 ECGs is < 480 msecs.
    9. Has clinically significant cardiac disease, including unstable angina, acute myocardial
    infarction within 6 months from first dose of study drug administration, New York Heart
    Association Class III or IV congestion heart failure (see Appendix 6), and arrhythmia
    requiring therapy. Medically controlled arrhythmia would be permitted.
    10. Has history of allergic reactions attributed to compounds of similar chemical or biologic
    composition to pembrolizumab, nivolumab or tryptophan-containing substances.
    11. Is pregnant or breast-feeding or expecting to conceive or father children within the
    projected duration of the study, starting with the screening visit through minimum of
    4 months (for those who receive pembrolizumab) and a minimum of 5 months (for those
    who receive nivolumab) after the last dose of study treatment.
    12. Patients who have active, chronic, or on active treatment for Hep B or Hep C are excluded.
    13. Any other cancer, unless the patient has been disease-free for ≥ 5 years (except treated and
    cured basal-cell or squamous-cell skin cancer, superficial bladder cancer, or treated
    carcinoma in situ of the cervix, breast, or bladder and treated localized prostate cancer with
    undetectable PSA for 2 years).
    14. Patients with laboratory evidence of pancreatitis are excluded.
    15. Has presence of a gastrointestinal condition that may affect drug absorption.
    16. Patients with an active autoimmune disease that has required systemic treatment in past 2
    years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive
    drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid
    replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of
    systemic treatment.
    17. Chronic use of immune-suppressive drugs (i.e., systemic corticosteroids used in the
    management of cancer or non-cancer related illnesses, e.g., COPD in dosing exceeding 10
    mg daily of prednisone equivalent). Inhaled steroids are allowed.
    18. Patients who are receiving or have received any other investigational agent within 30 days
    prior to enrollment into the study (or 5 half-lives of agent, whichever is longer).
    19. Patients taking L- tryptophan or 5-hydroxy-tryptophan supplements.
    20. Patients with untreated or uncontrolled HIV
    E.5 End points
    E.5.1Primary end point(s)
    The co-primary efficacy endpoints below will be analyzed using ITT and the PPS:
    1. Progression-free survival (PFS) time which is defined as time from date of randomization until the earliest date of disease progression per RECIST 1.1, or death from any cause, whichever comes first. Patients who have neither progressed nor died will be censored at the last tumor assessment date for the endpoint PFS and will be assessed per RECIST 1.1.
    2. OS is defined as the time from the date of randomization until death from any cause. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Disease progression and survival
    E.5.2Secondary end point(s)
    The following secondary efficacy endpoint will be analyzed using ITT and the
    PPS:
    - Objective response rate (ORR): The first tumor assessment test will be conducted at 9 weeks followed by assessments every 9 weeks for duration of study participation. Defined as patients who have a best response as complete or partial response based on RECIST 1.1.
    An overall false-positive rate of 5% level for the above key secondary efficacy endpoint will be maintained, in that no significance of the key secondary endpoint will be claimed unless either of the co-primary statistical analyses is significant at the 2.5% level. We will compare response rates in the study groups using the
    stratified Miettinen and Nurminen method (1985).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Disease progression
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA52
    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
    Belgium
    Canada
    France
    Germany
    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
    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 months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months9
    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: 500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 state74
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 370
    F.4.2.2In the whole clinical trial 650
    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 Decision2018-01-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-28
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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