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    Summary
    EudraCT Number:2014-002992-27
    Sponsor's Protocol Code Number:201496
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-10-01
    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 ConcernedGermany - BfArM
    A.2EudraCT number2014-002992-27
    A.3Full title of the trial
    201496: A Study to Evaluate the Efficacy and Safety of 15mg BID Losmapimod (GW856553) Compared to Placebo in Frequently Exacerbating Subjects with Chronic Obstructive Pulmonary Disease (COPD).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy and Safety of Losmapimod in Subjects with COPD who Frequently Exacerbate.
    A.3.2Name or abbreviated title of the trial where available
    GW856553, Ph2a, COPD Patients, exacerbation study
    A.4.1Sponsor's protocol code number201496
    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 number+44 208 990 4466
    B.5.5Fax number+44 208 990 4466
    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 nameGW856553X
    D.3.9.4EV Substance CodeSUB31868
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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
    Chronic Obstructive Pulmonary Disease
    E.1.1.1Medical condition in easily understood language
    Chronic Obstructive Pulmonary Disease
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10009033
    E.1.2Term Chronic obstructive pulmonary disease
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the rate of COPD exacerbations in losmapimod compared to placebo treated subjects.
    E.2.2Secondary objectives of the trial
    1. To evaluate the time to first COPD exacerbation in subjects treated with losmapimod compared to placebo treated subjects.
    2. To evaluate the effect of losmapimod treatment compared to placebo on additional parameters of lung function, in subjects with COPD.
    3. To evaluate the safety and tolerability of losmapimod treatment compared to placebo, in subjects with COPD.
    4. To evaluate the plasma PK of losmapimod in subjects with COPD.
    5. To evaluate the use of rescue medication in subjects with COPD who are treated with losmapimod compared to placebo treated subjects.
    6. To evaluate the health status of subjects with COPD who are treated with losmapimod compared to placebo treated subjects.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A subject will be eligible for inclusion in this study only if all of the following criteria apply:
    1. COPD diagnosis and severity:
    -Subjects with a clinical history of COPD (established by a physician) in accordance with the following definition by the American Thoracic Society/European Respiratory Society [Celli, 2004], for at least 6 months prior to enrolment.
    -Subjects must have evidence of airflow obstruction, defined as postbronchodilator FEV1 equal to or less than 80% of predicted normal value calculated using NHANES III reference equation at Visit 1 [Hankinson, 1999; Hankinson, 2010] and a FEV1 / FVC ratio <=70% at Screening (Visit 1).
    Note: Post-bronchodilator spirometry will be performed approximately 10-15 minutes after the subject has self-administered 4 inhalations (i.e., total 400/360mcg) of salbutamol/albuterol via a Metered Dose Inhaler (MDI) (use of spacer optional). The study-provided central spirometry equipment will calculate the FEV1/FVC ratio and FEV1 percent predicted values.
    2. Exacerbation History: A documented history (e.g., medical record verification) in the 12 months prior to Visit 1 of ≥ 2 COPD exacerbations resulting in prescription for antibiotics and/or oral corticosteroids or hospitalisation or extended observation in a hospital emergency room or outpatient centre.
    Note: Prior use of antibiotics alone does not qualify as a moderate exacerbation unless the use was specifically for the treatment of worsening symptoms of COPD.
    3. Existing COPD maintenance treatment: Subject must be receiving daily maintenance treatment for their COPD for at least 3 months prior to Screening.
    Notes: Subjects receiving only PRN COPD medications are not eligible for inclusion in the study. All subjects will continue on their current SoC COPD medications throughout the entire duration of the study.
    4. Tobacco use: Subjects with a current or prior history of ≥10 pack-years of cigarette smoking at Screening (Visit 1). Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. One pack year = 20 cigarettes smoked per day for 1 year or the equivalent. Number of pack years = (number of cigarettes per day/20) x number of years smoked.
    5. Sex: Male or female subjects aged ≥40 years at Screening (Visit 1).
    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 [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<140 pmol/L) is confirmatory] or if of child-bearing potential is using a highly effective method for avoidance of pregnancy (refer to Section 4.3.1) from 30 days before the first dose, for the duration of dosing and until 2 weeks post last-dose.
    6. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
    7. QTc <450msec or QTc <480msec for subjects with bundle branch block
    The QTc is the QT interval corrected for heart rate according to either Bazett’s formula (QTcB), Fridericia’s formula (QTcF), or another method, machine or manual overread.
    -For eligibility and withdrawal, ideally the same QT correction formula will be used for all subjects. However, because this is not always possible, the same QT correction formula must be used for each individual subject to determine eligibility for and withdrawal from the study.
    - The QTc should be based on single or averaged QTc values of triplicate electrocardiograms (ECGs) obtained over a brief recording period.
    E.4Principal exclusion criteria
    A subject will not be eligible for inclusion in this study if any of the following criteria apply:
    8. Eosinophils: > 2.0% blood eosinophils at Screening (Visit 1)
    9. Concomitant medication:
    - COPD Medication: Subjects currently on chronic treatment with macrolides or Roflumilast; Long term oxygen therapy (LTOT) or nocturnal oxygentherapy required for greater than 12 hours a day. Oxygen PRN use (i.e. <=12 hours per day) is not exclusionary.
    - MATE1 inhibitors: cimetidine, pyrimethamine, trimethoprim (short course treatment with trimethoprim is allowed).
    - Other medications: Chronic maintenance therapy with anti-Tumor Necrosis Factor (anti-TNF), anti-Interleukin-1 (anti-IL1), PDE4 inhibitors, or any other
    immunosuppressive therapy (not including steroids) within 60 days prior to dosing.
    - Any other investigational drug within 30 days or 5 half lives, whichever is longer prior to Screening Visit.
    10. Other respiratory disorders: Subjects with asthma (as primary diagnosis) lung cancer, bronchiectasis, active sarcoidosis, active lung fibrosis, cystic fibrosis, idiopathic pulmonary hypertension, active interstitial lung diseases or other active pulmonary diseases. Subjects with alpha1-antitrypsin deficiency as the underlying cause of COPD.
    11. Subjects with clinically significant sleep apnea who require use of continuous positive airway pressure (CPAP) device.
    12. Subjects who require a non-invasive positive pressure ventilation (NIPPV) device (Note: Use of NIV in hospital as part of the medical management of an acute exacerbation is permitted.)
    13. Lung resection: Subjects who have undergone previous lung reduction surgery (e.g. lobectomy, pneumonectomy, or lung volume reduction).
    14. COPD stability: Less than 30 days prior to Visit 1 have elapsed from completion of a course of antibiotics or oral corticosteroids for a recent COPD exacerbation.
    15. Evidence of pneumonia or a clinically significant abnormality not believed to be due to the presence of COPD on chest X-ray (posteroanterior with lateral) or CT scan (historic data up to 1 year may be used).
    16. Pulmonary rehabilitation program: Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1. Subjects who are in the maintenance phase of a pulmonary rehabilitation program are not excluded.
    17. ALT >2xULN and bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
    18. Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
    19. Malignancy: A current malignancy or previous history of cancer in remission for less than 12 months prior to Visit 1 (Subjects that had localized carcinoma of the skin or cervix which was resected for cure will not be excluded).
    20. Other diseases/abnormalities: History or current evidence of clinically significant or uncontrolled cardiovascular, pulmonary, metabolic, neurological, endocrine (including uncontrolled diabetes or thyroid disease), renal, hepatic, haematological (including agranulocytosis) or gastrointestinal conditions that are uncontrolled on permitted therapy and in the opinion of the investigator and/or GSK Medical Monitor, places the subject at an unacceptable risk as participant in this trial or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study
    21. Viral infections: Presence of hepatitis B surface antigen (HBsAg), Hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment. Note: Subjects with positive Hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C RNA PCR test is obtained.
    22. A positive test for HIV antibody
    23. TB: Subject with active tuberculosis or who have previously tested positive for latent TB and not received treatment or prophylaxis following the positive test.
    24. Vaccination: Subjects who have received live attenuated vaccines in the 6 weeks prior to randomization. The use of live attenuated vaccines during the treatment period and in the 4 weeks post-discontinuation of investigational product is prohibited.
    25. Drug/food allergy: Subjects with a history of hypersensitivity to any of the study medications (e.g., lactose, magnesium stearate).
    26. Lactating females
    27. Pregnant females (as determined by positive urine hCG test prior to dosing).
    28. Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years.
    29. Prior use of study medication/other investigational drugs: Subjects who have received an investigational drug within 30 days of entry into this study or within 5 drug half-lives of the investigational drug, whichever is longer. (Please refer to the Protocol for Further Exclusion Criteria's POINTS 30 - 33 P 26)
    E.5 End points
    E.5.1Primary end point(s)
    Yearly rate of moderate and severe exacerbations in both placebo and losmapimod treated groups.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of study
    E.5.2Secondary end point(s)
    1. Time to first moderate-severe exacerbation.
    2. Change from baseline in spirometry parameters over time including, but not limited to FEV1, FVC and FEV6.
    3. Safety and tolerability parameters include: adverse events, clinical laboratory tests, electrocardiograms (ECGs), liver safety testing and vital signs.
    4. AUC(0-t) [t=12h], Cmax, Ctrough
    5. Frequency of short acting beta-agonist or anticholinergic use.
    6. Change from baseline in SGRQ-C total and domain scores over time.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. End of study (Week 53)
    2. End of study (Week 53)
    3. End of study (Week 53)
    4. Weeks 2, 12 and 26
    5. End of study (Week 53)
    6. Weeks 12, 26, 39 and 52.
    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 No
    E.6.10Pharmacogenetic Yes
    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 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    Brazil
    Bulgaria
    Chile
    Germany
    Italy
    Korea, Republic of
    Slovakia
    Spain
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 years1
    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: 200
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 110
    F.4.2.2In the whole clinical trial 220
    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)
    No extension to the study is planned and no post study treatment will be available.
    The investigator is responsible for ensuring that consideration has been given to the poststudy care of the patient’s medical condition i.e. at the end of the double-blind treatment period, the investigator should prescribe appropriate alternative COPD therapy for the subject. There will be no provision to supply losmapimod after the end of the treatment period.
    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 Decision2014-10-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-06-30
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