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    Summary
    EudraCT Number:2013-000657-50
    Sponsor's Protocol Code Number:PM1116197
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-05-21
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2013-000657-50
    A.3Full title of the trial
    A Clinical Outcomes Study to Compare the Incidence of Major Adverse Cardiovascular Events in Subjects Presenting with Acute Coronary Syndrome Treated with Losmapimod Compared to Placebo (PM1116197)

    Short title: LosmApimod To Inhibit p38 MAP kinase as a TherapeUtic target and moDify outcomes after an acute coronary syndromE (LATITUDE)-TIMI 60
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PM1116197 is a Clinical Study to Compare the Incidence of Major Adverse Cardiovascular Events in Subjects Presenting with Acute Coronary Syndrome Treated with Losmapimod Compared to Placebo
    A.4.1Sponsor's protocol code numberPM1116197
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1150-5007
    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 & 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 pointClincial Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressIron Bridge Road, Stockley Park West
    B.5.3.2Town/ cityUxbridge, Middlesex
    B.5.3.3Post codeUB11 - 1BU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number442089904466
    B.5.5Fax number442089904466
    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 nameLosmapimod
    D.3.2Product code GW856553
    D.3.4Pharmaceutical form 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 INNLosmapimod
    D.3.9.1CAS number 585543-15-3
    D.3.9.2Current sponsor codeGW856553
    D.3.9.3Other descriptive nameGW 856553X
    D.3.9.4EV Substance CodeSUB23045
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.5
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    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
    Acute Coronory Syndrome
    E.1.1.1Medical condition in easily understood language
    hospitalized due to a heart attack, usually caused by a blockage in one or more of the arteries (blood vessels) in the heart
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10003723
    E.1.2Term Attack coronary
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10051592
    E.1.2Term Acute coronary syndrome
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10071111
    E.1.2Term Non ST segment elevation acute coronary syndrome
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10041894
    E.1.2Term ST segment elevation
    E.1.2System Organ Class 100000004848
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to evaluate the efficacy of oral losmapimod 7.5 mg BID compared to placebo when added to standard of care in subjects with ACS on the time to first occurrence of adjudicated MACE (defined as CV death, MI, or severe recurrent ischemia [SRI-UR]) through 12 weeks of therapy.
    E.2.2Secondary objectives of the trial
    The principal secondary objective is to evaluate the efficacy of losmapimod on the time to first occurrence of adjudicated CV death or MI. Additional secondary objectives are included in the protocol page 21.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1. Renal and Expanded Laboratory Substudy - The objective of the expanded laboratory analysis is to further characterize the effect of losmapimod on inflammatory and renal biomarkers
    2. Pharmacokinetic Assessments for Subjects (n=3850) Enrolled in a PK Substudy - The objective of the pharmacokinetic analyses is to further develop the population PK model previously developed in Phase 2 in order to predict individual losmapimod exposures
    E.3Principal inclusion criteria
    1.Signed written informed consent prior to beginning study-related procedures.
    The subject must understand the aims, investigational procedures and possible consequences of the study
    2.Male or female aged 35 years or older at randomization.
    A female subject is eligible to participate if she is of non-child bearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea or if of child-bearing potential is using a highly effective method for avoidance of pregnancy (refer to Appendix 1) for the duration of dosing and until 2 weeks post last-dose. The decision to include or exclude women of childbearing potential may be made at the discretion of the investigator and in accordance with local practice in relation to adequate contraception.
    3.Hospitalization for NSTEMI or STEMI (Universal Definition Type 1 MI).
    NSTEMI that is presumed spontaneous (Universal Definition Type 1) and is defined as ischemic chest discomfort (or equivalent) that occurs or persists at rest with at least 1 episode lasting ≥10 minutes and is accompanied by a diagnostic elevation in cardiac troponin above the upper limit of normal (99th percentile decision-limit) according to the local laboratory without persistent ST segment elevation. If cardiac troponin is not available, then creatine-kinase MB isoenzyme (CK-MB) must be above the upper limit of normal. The biomarker should exhibit a rising and/or falling pattern when serial testing is available prior to randomization.
    STEMI is defined as ischemic chest discomfort (or equivalent) that occurs or persists at rest with ST segment elevation of at least 0.1 mV in 2 or more contiguous leads or new (or presumed new) left bundle branch block (LBBB) and a presumed diagnosis of STEMI.
    NOTE: Subjects with clinical or laboratory manifestations of ACS (e.g., ST-elevation or increase in cardiac enzymes) that are believed to be secondary to other apparent illness (e.g., sepsis, profound anemia, hypertensive emergency or decompensated heart failure, coronary embolism or dissection; Universal Type 2 MI) or known to be procedurally related (Type 4 - including stent thrombosis- or Type 5) are not considered to meet these criteria for NSTEMI or STEMI.
    4.With the following timing of symptoms:
    NSTEMI: Presence of ischemic symptoms (5 minutes) at rest within 24 hours prior to randomization (may include qualifying episode).
    STEMI: Onset of qualifying ischemic symptoms within 12 hours of randomization.
    5.All subjects must also have at least one of the following additional predictors of cardiovascular risk:
    a.Age ≥60 years at randomization.
    b.History of documented MI (known or presumed Type 1 MI) prior to qualifying ACS event.
    c.History of CABG prior to qualifying ACS event.
    d.NSTEMI with new ischemic ST-segment depression ≥0.1 mV in ≥2 contiguous leads.
    e.Diabetes mellitus requiring pharmacotherapy.
    f.Coexistent clinically diagnosed arterial disease in at least 1 peripheral arterial territory, defined as:
    •History of non-cardioembolic (known or presumed), ischemic stroke (confirmed by medical records or history) or
    •Current or history of peripheral arterial disease: current intermittent claudication with an ankle-brachial index ≤0.85 or history of peripheral arterial stenting or surgery (including amputation due to vascular causes).

    French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
    E.4Principal exclusion criteria
    Subjects meeting any of the following criteria must not be enrolled in the study:
    1. Unable to be randomized prior to coronary revascularization or fibrinolysis for the qualifying MI.
    2. Current severe heart failure or shock (New York Heart Association [NYHA] class III or IV, or Killip class III or IV).
    3. Ongoing clinical instability (e.g., hypotension requiring vasopressor or inotropic support, new stroke or transient ischemic attack [TIA], or recurrent sustained ventricular tachycardia).
    4. History of chronic liver disease (defined below) or known to have current ALT ≥2x upper limit of normal or total bilirubin >1.5x upper limit of normal or known history of hepatitis B or C.
    Defined as known hepatic or biliary abnormalities (with the exception of Gilbert’s syndrome or asymptomatic gallstones). Such abnormalities include current drug therapy for the treatment of liver disease, unstable liver disease (defined by the presence of any of the following deemed by the investigator to be related to liver disease and not to other disease processes: ascites, encephalopathy, coagulopathy, hypoalbuminemia, oesophageal or gastric varices, or persistent jaundice) or other hepatic abnormalities that in the opinion of the investigator would preclude the subject from participation in the study.
    5.Known severe renal impairment.
    Severe renal impairment is defined as receiving chronic dialysis or known estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 at the time of randomization based on serum creatinine and the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (see SPM).
    6.Any condition, other than vascular disease, with life expectancy <1 year that might prevent the subject from completing the study.
    7.Known active tuberculosis, HIV, active opportunistic or life threatening infections.
    8.Vaccination with a live attenuated vaccine (see SPM) within 6 weeks of randomization.
    9.Concomitant use of cytotoxic chemotherapy for cancer or known ongoing or anticipated use of chronic severe immunosuppressive agents as listed below:
    •Chronic prednisone use >10 mg/day for >14 consecutive days.
    •Currently receiving any systemic immunosuppressive therapy (See SPM for details).
    10.Positive pregnancy test or is known to be pregnant or lactating.
    All female subjects of childbearing potential must have a urine or serum β-human chorionic gonadotropin [hCG] pregnancy test performed prior to randomization.
    11.Known alcohol or drug abuse within the past 6 months.
    12.Any current mental condition (psychiatric disorder, senility or dementia), which may affect study compliance or prevent understanding of the aims, investigational procedures or possible consequences of the study.
    13.Use of another investigational product within 30 days or 5 half-lives (whichever is longer) or according to local regulations, or currently participating in a study of an investigational device. Subjects must be randomized only one time in this investigational study.
    14.Anticipated inability to comply with any study procedures, including participation in study visits according to the visit schedule through 24 weeks.
    15.Any other reason the investigator deems the subject to be unsuitable for the study.

    French subjects: In France, a subject will be excluded if he/she has participated in any study using an investigational drug during the previous 30 days.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the composite measure of adjudicated MACE that includes the time to first occurrence of CV death, MI, or SRI-UR.
    If the effect of losmapimod on MACE shows a statistically significant benefit compared to placebo, then the analysis will proceed to testing the hypothesis for the principal secondary endpoint using a serial gate keeping procedure to account for multiplicity.
    E.5.1.1Timepoint(s) of evaluation of this end point
    the principal analysis will be through 12 weeks, with additional analyses through 4 and 24 weeks
    E.5.2Secondary end point(s)
    •The principal secondary endpoint is the time to first occurrence of the composite of adjudicated CV death or MI.
    Additional Secondary Endpoints:
    •The composite of CV death, MI, or hospitalization for HF.
    •The expanded composite of arterial CV events, defined as CV death, MI, SRI-UR, or stroke.
    •The composite of coronary events (defined as CHD death, MI, SRI-UR, or any unplanned coronary artery revascularization).
    Planned coronary artery revascularizations are those initial or staged interventions performed based on the initial qualifying ACS.
    •The composite of CV death or hospitalization for HF
    •The composite of CV death, MI or stroke.
    •The composite of CV death, MI, SRI-UR, stroke or hospitalisation for HF
    •The primary and principal secondary endpoints will be evaluated replacing CV death separately with CHD death (“Coronary MACE”) and all-cause death.
    •The primary and principal secondary endpoints will be evaluated replacing all MI with Type 1 (spontaneous) MI.
    •Individual components of the composite endpoints (including all-cause mortality).
    •Definite or probable stent thrombosis.
    •Any re-hospitalization within 30 days of discharge.
    E.5.2.1Timepoint(s) of evaluation of this end point
    the principal analysis will be through 12 weeks, with additional analyses through 4 and 24 weeks unless otherwise stated in the endpoint
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarkers of CV risk.
    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) 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 Yes
    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 concerned16
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA371
    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
    Argentina
    Australia
    Belgium
    Brazil
    Bulgaria
    Canada
    Chile
    Czech Republic
    Denmark
    Estonia
    France
    Germany
    Greece
    Hong Kong
    Hungary
    India
    Israel
    Italy
    Korea, Democratic People's Republic of
    Mexico
    Netherlands
    New Zealand
    Norway
    Peru
    Philippines
    Poland
    Romania
    Russian Federation
    Slovakia
    South Africa
    Spain
    Sweden
    Taiwan
    Thailand
    Ukraine
    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
    LSLV
    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 months1
    E.8.9.1In the Member State concerned days10
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days8
    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: 13000
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12500
    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 Yes
    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 state300
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 11370
    F.4.2.2In the whole clinical trial 25500
    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)
    Subjects will be treated as deemed appropriate by the investigator following the end of the Treatment Phase. IP will not be available to subjects after the Treatment Phase (Week 12 visit + 2 weeks).
    The investigator is responsible for ensuring that consideration has been given to the post-study care of the subject’s medical condition whether or not GSK is providing specific post-study 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 Decision2014-07-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-05-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-12-08
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