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    Summary
    EudraCT Number:2018-002816-29
    Sponsor's Protocol Code Number:205207
    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:2019-02-25
    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 number2018-002816-29
    A.3Full title of the trial
    A Phase I/II Single Arm Open-Label Study to Explore Safety and Clinical Activity of GSK2857916 Administered in Combination with Pembrolizumab in Subjects with Relapsed/Refractory Multiple Myeloma (DREAMM 4)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open-label single-arm study of GSK2857916 in combination with Pembrolizumab in subjects with relapsed/refractory multiple myeloma
    A.4.1Sponsor's protocol code number205207
    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 SponsorGlaxoSmithKline Research & Development Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportGlaxoSmithKline, Research and Development Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Ltd
    B.5.2Functional name of contact pointClinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street Address980 Great West Road
    B.5.3.2Town/ cityBrentford, Middlesex
    B.5.3.3Post codeTW8 9GS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 0800 783 9733
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 nameGSK2857916
    D.3.2Product code GSK2857916
    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 INNHumanized IgG1 antibody drug conjugate
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeGSK2857916
    D.3.9.3Other descriptive namebelantamab mafodotin
    D.3.9.4EV Substance CodeSUB130430
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) 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 Yes
    D.3.11.13.1Other medicinal product typeGSK2857916 is a Humanized afucosylated, maleimidocaproyl monomethyl auristatin phenylalanine (mcMMAF) conjugated IgG1 antibody.
    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 namePembrolizumab
    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.3.9.3Other descriptive nameMK-3475
    D.3.9.4EV Substance CodeSUB167136
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Relapsed/Refractory Multiple Myeloma
    E.1.1.1Medical condition in easily understood language
    Relapsed/Refractory Multiple Myeloma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10028228
    E.1.2Term Multiple myeloma
    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
    Part 1: To determine safety, tolerability and to establish the
    recommended Phase 2 dose (RP2D) of the combination of belantamab
    mafodotin and pembrolizumab in subjects with RRMM

    Part 2: To assess the clinical activity of the combination treatment with belantamab mafodotin and pembrolizumab in subjects with RRMM
    E.2.2Secondary objectives of the trial
    Part 1:
    - To evaluate clinical activity of the combination of belantamab mafodotin and pembrolizumab in subjects with RRMM
    -To evaluate the pharmacokinetic profile of belantamab mafodotin when administered intravenously in combination with pembrolizumab
    -To assess anti-drug antibodies (ADAs) against belantamab mafodotin

    Part 2:
    -To further evaluate the safety of belantamab mafodotin administered in combination with
    pembrolizumab in subjects with RRMM
    -To further assess the clinical activity of the combination treatment with belantamab mafodotin and pembrolizumab in subjects with RRMM
    -To evaluate the pharmacokinetic profile of belantamab mafodotin when administered intravenously in combination with pembrolizumab
    -To assess ADAs against belantamab mafodotin
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects eligible for enrolment in the study must meet all of the following criteria:
    1. Provide signed written informed consent, which includes compliance with the
    requirements and restrictions listed in the consent form
    2. Male or female, 18 years or older (at the time consent is obtained)
    3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    (Appendix 2 of the protocol)
    4. Subjects must:
    -Has histologically or cytologically confirmed diagnosis of MM, as defined by
    IMWG, 2014 [Rajkumar, 2014], and
    -Has undergone stem cell transplant or is considered transplant ineligible, and
    - Has been treated with at least 3 prior lines of prior anti-myeloma treatments
    including an IMiD (eg. lenalidomide or pomalidomide), a proteasome inhibitor
    (eg. bortezomib, ixazomib or carfilzomib) and an anti-CD38 antibody alone or
    in combination. Line of therapy are defined by consensus panel of the
    International Myeloma Workshop [Rajkumar, 2011].
    -Has measurable disease defined as one the following:
    a) Serum M-protein ≥0.5 g/dL (≥5 g/L)
    b) Urine M-protein ≥200 mg/24h
    c) Serum FLC assay: Involved FLC level ≥10 mg/dL (≥100 mg/L) and an
    abnormal serum free light chain ratio (<0.26 or >1.65)
    5. Subjects with a history of autologous stem cell transplant are eligible for study
    participation provided the following eligibility criteria are met:
    a) transplant was > 100 days prior to study enrolment
    b) no active infection (s)
    c) subject meets the remainder of the eligibility criteria outlined in this
    protocol
    6. Adequate organ system functions as defined in Table 3 of the study protocol
    7. All prior treatment-related toxicities (defined by National Cancer Institute-
    Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 4.03, 2010)
    [NCI, 2010] must be ≤ Grade 1 at the time of enrollment except for alopecia and
    Grade 2 neuropathy.
    8. A female subject is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
    - Is not a woman of childbearing potential (WOCBP)
    OR
    -Is a WOCBP and using a contraceptive method that is highly effective (with a
    failure rate of <1% per year), preferably with low user dependency, as
    described in Appendix 8 during the intervention period and for 9 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The
    investigator should evaluate the effectiveness of the contraceptive method in
    relationship to the first dose of study Intervention. Contraceptive use by women should be consistent with
    local regulations regarding the methods of contraception for those
    participating in clinical studies.
    A WOCBP must have a negative highly sensitive serum pregnancy test (as
    required by local regulations) within 72 hours of dosing on C1D1 and
    agree to use effective contraception during the study and for 9 months
    after the last dose of study medication. Additional requirements for pregnancy testing during and after study intervention are located in Appendix 8 of the protocol.
    The investigator is responsible for review of medical history, menstrual history,
    and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
    9. Male subjects:
    Male subjects are eligible to participate if they agree to the following from the time of first dose of study until 6 months after the last dose of
    study treatment to allow for clearance of any altered sperm :
    -Refrain from donating sperm
    PLUS either:
    -Be abstinent from heterosexual intercourse as their preferred and usual
    lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent
    OR
    •Must agree to use contraception/barrier as detailed below
    •Agree to use a male condom, even if they have undergone a successful
    vasectomy, and female partner to use an additional highly effective
    contraceptive method with a failure rate of <1% per year as described in
    Appendix 8 when having sexual intercourse with a woman of
    childbearing potential who is not currently pregnant.
    •Contraceptive use by men should be consistent with local regulations
    regarding the methods of contraception for those participating in clinical
    studies.
    E.4Principal exclusion criteria
    A subject will not be eligible for inclusion in this study if any of the following criteria apply:
    1. Systemic anti-myeloma therapy or an investigational drug ≤14 days or five half-lives, whichever is shorter, preceding the first dose of study drug
    2. Plasmapheresis within 7 days prior to the first dose of study drug
    3. Prior treatment with a monoclonal antibody within 30 days of receiving the first dose of study drugs
    4. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137) and was discontinued from that treatment due to a Grade 3 or higher immune related adverse event (irAE)
    5. Current corneal epithelial disease except mild punctate keratopathy
    6. Any major surgery within the last four weeks prior to the first dose of study therapy
    7. Presence of active renal condition (infection, requirement for dialysis or any other condition that could affect subject’s safety). Subjects with isolated proteinuria resulting from MM are eligible, provided they fulfill criteria given in Table 3 of the protocol
    8. Any serious and/or unstable pre-existing medical, psychiatric disorder or other
    conditions (including lab abnormalities) that could interfere with subject’s safety,
    obtaining informed consent or compliance to the study procedures.
    9. Has received prior radiotherapy within 2 weeks of start of study therapy. Subjects must have recovered from all radiation-related toxicities, not requite corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
    10. History of (non-infectious) pneumonitis that required steroids, or current pneumonitis
    11. Current active liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. Note: Stable chronic liver disease (including Gilbert’s syndrome or asymptomatic gallstones) or hepatobiliary involvement of malignancy is acceptable if subject otherwise meets entry criteria
    12. Malignancies other than disease under study are excluded, except for any other malignancy from which the subject has been disease-free for more than 2 years and, in the opinion of the principal investigators and GSK Medical Monitor, will not affect the evaluation of the effects of this clinical trial treatment on the currently targeted malignancy (RRMM). Subjects with curatively treated non-melanoma skin cancer are allowed.
    13. Has known active CNS metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study therapy
    14. Evidence of cardiovascular risk including any of the following:
    a. QTcF interval ≥470 msecs.
    NOTE: The QT interval should be corrected for heart rate by Fridericia’s formula (QTcF).
    b. Evidence of current clinically significant uncontrolled arrhythmias;
    i. including clinically significant ECG abnormalities including 2nd degree
    (Type II) or 3rd degree atrioventricular (AV) block.
    c. History of myocardial infarction, acute coronary syndromes (including
    unstable angina), coronary angioplasty, or stenting or bypass grafting within
    six months of Screening.
    d. Class III or IV heart failure as defined by the New York Heart Association
    functional classification system (Appendix 4 of the protocol)
    e. Uncontrolled hypertension
    f. Presence of cardiac pacemaker (or defibrillator) with a predominantly
    ventricular paced rhythm, limiting ECG/QTcF analysis.
    g. Abnormal cardiac valve morphology (≥Grade 2) documented by
    echocardiogram (subjects with grade 1 abnormalities [i.e., mild
    regurgitation/stenosis] can be entered on study). Subjects with moderate
    valvular thickening should not be entered on study.
    15. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to belantamab mafodotin or pembrolizumab, or any of the components of the study treatment.
    16. Pregnant or lactating female.
    17. Known active infection requiring antibiotic, antiviral, or antifungal treatment.
    18. Known HIV infection.
    19. Presence of hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb at screening or within 3 months prior to first dose of study treatment

    Please see the protocol Section 5.2 Exclusion Criteria for a complete list of exclusion criteria


    E.5 End points
    E.5.1Primary end point(s)
    Part 1:
    -Percent of subjects with AEs, changes in clinical signs and laboratory parameters
    -Number of subjects with dose limiting toxicities (DLTs)

    Part 2:
    -Overall Response Rate (ORR), defined as the percentage of subjects with a confirmed PR or better (i.e., PR, VGPR, CR and sCR), according to the IMWG Response Criteria [Kumar, 2016].
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part 1:
    -approximately 6 months to reach end of Part 1 Dose Escalation

    Part 2:
    -at final analysis
    E.5.2Secondary end point(s)
    Part 1:
    -Overall Response Rate (ORR), defined as the percentage of subjects with a confirmed partial response (PR) or better (i.e., PR, very good partial response [VGPR], complete response [CR] and stringent complete response [sCR]), according to the International Myeloma Working Group (IMWG) Response Criteria [Kumar, 2016].
    -Pharmacokinetic parameters following IV administration as data permit (e.g., AUCs, Cmax, time of Cmax [tmax], terminal phase half-life [t½]) after the first dose; concentration at trough (Ctrough), and end of infusion concentration in the subsequent cycles when measured.
    -Incidence and titers of ADAs against belantamab mafodotin

    Part 2:
    -Number (percent) of subjects with AEs, changes in clinical signs and laboratory parameters
    -Ocular finding on ophthalmic exam
    -Clinical benefit rate (CBR), defined as the percentage of participants with a confirmedminimal response (MR) or better per IMWG
    -Duration of response (DoR), defined as: the time from first documented evidence of PR or better, to the time when disease progression (PD) is documented per IMWG; or death due to PD occurs among subjects who achieve an overall response, i.e. confirmed PR or better
    -Time to response (TTR), defined as: the time between the date of first dose and the first documented evidence of response (PR or better) among participants who achieved a confirmed response of PR or better
    -Time to best response, defined as the time between the date of first dose and the first best documented response (PR or better) among subjects who achieved a confirmed response of PR or better
    -Progression-free survival (PFS), defined as: the time from first dose until the earliest date of PD per IMWG, or death due to any cause
    -Time to disease progression (TTP), defined as: the time from first dose until the earliest date of PD per IMWG, or death due to PD
    -Overall Survival (OS), defined as the time from first dose until death due to any cause
    -Pharmacokinetic parameters following IV administration as data permit (e.g., AUCs, Cmax, time of Cmax [tmax], terminal phase half-life [t½]) after the first dose; concentration at trough (Ctrough), and end of infusion concentration in the subsequent cycles when measured.
    -Incidence and titer of ADA to belantamab mafodotin
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints will be evaluated during the dosing schedule under evaluation and at the end of study. For subjects who elect to continue to receive the IMP beyond the dose cohort, all other safety parameters and adverse events are followed until the patient discontinues the study.
    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 No
    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 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) 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.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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
    Canada
    Germany
    Spain
    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
    LSLV
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 14
    F.4.2.2In the whole clinical trial 40
    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)
    The investigator is responsible for ensuring that consideration has been given for the post study
    care of the subject’s medical condition whether or not GSK is providing specific post-study treatment. If a subject remains on treatment at the time end of study is achieved they may be offered an option to extend treatment.
    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 Decision2019-06-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-12
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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