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    Summary
    EudraCT Number:2012-003349-13
    Sponsor's Protocol Code Number:NOG112264
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-12-18
    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 ConcernedUK - MHRA
    A.2EudraCT number2012-003349-13
    A.3Full title of the trial
    Study NOG112264, a Phase II Study of Ozanezumab
    (GSK1223249) versus Placebo in the Treatment of Amyotrophic
    Lateral Sclerosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Ozanezumab (GSK1223249) versus Placebo in the Treatment of Amyotrophic Lateral Sclerosis (ALS)
    A.3.2Name or abbreviated title of the trial where available
    Ozanezumab Phase II study in patients with ALS
    A.4.1Sponsor's protocol code numberNOG112264
    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 and Development Limited
    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
    B.4.2CountryChina
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline
    B.5.2Functional name of contact pointGSK Clinical Support Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressGlaxoSmithKline, Iron 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(0)2089904466
    B.5.5Fax number+44(0)2089901234
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/10/797 - EMA/OD/060/10
    D.3 Description of the IMP
    D.3.1Product nameOzanezumab
    D.3.2Product code GSK1223249
    D.3.4Pharmaceutical form 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 INNOzanezumab
    D.3.9.1CAS number 1310680-64-8
    D.3.9.2Current sponsor codeGSK1223249
    D.3.9.3Other descriptive nameImmunoglobulin G1, anti (protein Nogo A) (human Mus musculus monoclonal heavy chain), disulfide with human Mus musculus monoclonal light chain, dimer
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Amyotrophic Lateral Sclerosis (ALS)
    E.1.1.1Medical condition in easily understood language
    Amyotrophic Lateral Sclerosis is a progressive, neurodegenerative disorder characterised by degeneration/death of motor neurones in the brain and spinal cord, resuting in severe disability and death.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10002026
    E.1.2Term Amyotrophic lateral sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to assess the effect of ozanezumab on the physical function and survival of ALS subjects over a treatment period of 48 weeks. Function will be measured
    using the Amyotrophic Lateral Sclerosis Functional Rating Scale – Revised (ALSFRS-R).
    E.2.2Secondary objectives of the trial
    Secondary objectives include the evaluation of other clinical outcomes associated with ALS (respiratory function, muscle strength, progression free survival and overall survival) in support of the primary objective. Quality of life, safety, tolerability, immunogenicity and pharmacokinetics (ozanezumab and riluzole) will also be assessed.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Deviations from inclusion criteria are not allowed because they can potentially jeopardise the scientific integrity of the study, regulatory acceptability or subject safety. Therefore,
    adherence to the criteria as specified in the protocol is essential.
    Subjects eligible for enrolment in the study must meet all of the following criteria:
    1. Patients with diagnosis of familial or sporadic ALS, defined as meeting the possible, laboratory-supported probable, probable, or definite criteria for a diagnosis of ALS according to the revised World Federation of Neurology El Escorial criteria [Rix Brooks, 2000].
    2. Onset of muscle weakness no more than 30 months before screening visit.
    3. SVC of at least 65% predicted for gender, age, ethnicity and height at Screening.
    4. If on riluzole, the dose must have been stable for at least 28 days prior to Baseline visit.
    5. Age 18 – 80 years inclusive.
    6. Female subjects may participate if they are of non-child-bearing potential or if they are of child-bearing potential and agree to satisfy one of the requirements for contraception listed in Appendix 4 (Section 11.4) during the study and 4 months
    after the last dose to avoid pregnancy. Women of childbearing potential must have a negative pregnancy test and be non-lactating.
    7. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2x upper limit of normal (ULN); alkaline phosphatase and bilirubin ≤ 1.5xULN.
    8. QTc (both QTcB and QTcF) <450 milliseconds (msec) or <480 msec for subjects with Bundle Branch Block at Screening and Baseline (average from triplicate ECGs).
    9. 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
    Deviations from exclusion criteria are not allowed because they can potentially jeopardise the scientific integrity of the study, regulatory acceptability or subject safety. Therefore, adherence to the criteria as specified in the protocol is essential.
    Subjects meeting any of the following criteria must not be enrolled in the study:
    1. Patients with other neuromuscular disorders (including a history of polio), which in the opinion of the investigator could have contributed to the muscular atrophy or weakness caused by ALS or could have any other effect on the study efficacy or
    safety assessments that in the opinion of the investigator would impact participation in the study.
    2. Patients with primary lateral sclerosis, monomelic ALS, ALS Parkinsonism dementia complex.
    3. Patients requiring non-invasive or mechanical ventilation (non-invasive ventilation for sleep apnoea is allowed subject to discussion with Medical Monitor).
    4. Patients on diaphragmatic pacing.
    5. Presence of any of the following clinical conditions:
    a. Drug abuse or alcoholism (according to Diagnostic and Statistical Manual of Mental Disorders –Fourth Edition [DSM-IV] criteria).
    b. Uncontrolled hypertension despite optimal antihypertensive treatment; unstable cardiovascular, pulmonary, renal, endocrine or hematologic condition; current malignancy.
    c. Active major infectious disease e.g. systemic infections with visceral involvement (pneumonia, pyelonephritis, endocarditis) and/or septicaemia.
    d. Unstable psychiatric illness, such as psychosis or untreated major depression, within 90 days of the Screening visit.
    6. Subjects, who in the investigator's judgement, pose a significant suicide risk.
    7. Current or chronic history of liver disease, known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones), positive Hepatitis B surface antigen or Hepatitis C antibody test.
    8. Subjects who have participated in a clinical trial involving receipt of a biopharmaceutical product (recombinant proteins, monoclonal antibodies, blood products, sera, allergens, and gene and cell therapy products) within 6 months prior to the first dosing day.
    9. Patients who have received any type of vaccination within 2 weeks prior to study drug administration.
    10. Chronic (>3 months) use of systemic immunosuppressants including systemic steroids.
    11. Exposure to non-biological experimental agents (including investigational products and marketed medications used off-label) 1 month or 5 half-lives prior to Baseline visit (whichever is longer).
    12. History of sensitivity to ozanezumab, or components thereof, or a history of other allergies that, in the opinion of the investigator, contraindicates participation in the study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the joint rank scores for combined analysis of function and survival (also called joint rank analysis). Function is measured using the amyotrophic lateral sclerosis functional rating scale – revised (ALSFRS-R)

    E.5.1.1Timepoint(s) of evaluation of this end point
    ALSFRS-R will be assessed every 4 weeks for 48 weeks. Primary endpoint evaluated at Week 48.
    E.5.2Secondary end point(s)
    Secondary endpoints include: Change from Baseline in ALSFRS-R, Slow Vital Capacity (SVC), Muscle Strength (HHD), Amyotrophic lateral sclerosis assessment questionnaire-40 (ALSAQ-40), EuroQoL – Short form EQ-5D-L, ; Proportion of clinical global impression - improvement (CGI-I) responders; Overall survival and progression free survival.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Endpoints evaluation at Week 48 (and week 60 for overall survival). Actual assessments administered every 4 weeks or 3 months depending on assessment.
    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 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 EEA19
    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
    Canada
    Japan
    Korea, Republic of
    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 years
    E.8.9.1In the Member State concerned months30
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months30
    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: 279
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 162
    F.4.2.2In the whole clinical trial 294
    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)
    Following study completion, investigators should continue treatment of the subject’s condition according to best accepted clinical practices with consideration to available licensed products for the treatment of ALS. Post-study treatment with ozanezumab will not be provided by GSK as sufficient efficacy and safety data is not yet available to confirm a positive benefit/risk profile of ozanezumab in ALS patients.
    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 Decision2012-12-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-01-22
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