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    Summary
    EudraCT Number:2010-021170-11
    Sponsor's Protocol Code Number:MOP4843g
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-11-12
    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 ConcernedSweden - MPA
    A.2EudraCT number2010-021170-11
    A.3Full title of the trial
    A PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,
    PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF
    INTRAVENOUS MEMP1972A IN THE PREVENTION OF ALLERGEN-INDUCED AIRWAY OBSTRUCTION IN PATIENTS WITH MILD ASTHMA
    A.4.1Sponsor's protocol code numberMOP4843g
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGENENTECH, Inc.
    B.1.3.4CountryUnited States
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameAnti−M1 prime
    D.3.2Product code MEMP1972A (RO5541079)
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeMEMP1972A (RO5541079)
    D.3.9.3Other descriptive nameAnti−M1 prime
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 typehumanized afucosylated monoclonal immunoglobulin G1 (IgG1) antibody
    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
    asthma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10003553
    E.1.2Term Asthma
    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 of this study is to evaluate whether MEMP1972A decreases the allergen-induced late airway response (LAR) after 12 weeks of exposure.
    E.2.2Secondary objectives of the trial
    • To assess the safety and tolerability of MEMP1972A
    • To evaluate whether MEMP1972A decreases allergen-induced early airway response (EAR) after 12 weeks of exposure
    • To evaluate whether MEMP1972A decreases bronchial hyper-responsiveness in response to methacholine challenge 24 hours after the airway allergen challenge
    • To characterize the pharmacokinetics of MEMP1972A
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    SUBSTUDY IN ASSOCIATION WITH MEMP1972A STUDY MOP4843g
    E.3Principal inclusion criteria
    • Signed informed consent
    • Men and women between 18 and 65 years old
    • Weight between 50 and 125 kg
    • Mild, stable allergic asthma
    • History of episodic wheeze and shortness of breath
    • FEV1 at baseline ≥ 70% of the predicted value
    • Males or females who are surgically sterilized, post-menopausal for the past year, or are using two acceptable methods of contraception (excluding abstinence) against pregnancy through at least 5 months (predicted 5 half -lives of the study drug) following the last administration of study drug (see Appendix B for definitions of highly effective contraception)
    • ECG at screening within normal limits as assessed by the study investigator
    • Ability to comprehend and willingness to follow all required study procedures
    • Methacholine challenge at screening must be documented to confirm a
    diagnosis of asthma and provide a PC20 value for prediction of the starting
    allergen concentration for inhalation in the screening test for responsiveness
    to allergen.
    • Positive skin prick test to common standard aeroallergens extracts
    (e.g., ragweed, tree mix, grass mix, dog, cat, horse, feathers, dust mites)
    • Positive allergen-induced early and late airway response
    E.4Principal exclusion criteria
    • A worsening of asthma within 6 weeks preceding Visit 1
    • Acute respiratory infection (including viral infection) within 6 weeks preceding
    Visit 2 or any ongoing chronic infection
    • History of recurrent bacterial infection as an adult or history or presence of any
    chronic infectious condition, including (but not limited to) parasitic infection
    • Risk of exposure, as determined by the investigator, to water-borne parasites
    or clinical diagnosis of parasitic infection that is untreated within 3 months
    prior to Visit 5
    • Lung disease other than mild allergic asthma
    • History of clinically significant hypotensive episodes or symptoms of fainting,
    dizziness, or lightheadedness
    • History or symptoms of cardiovascular disease, particularly coronary artery
    disease, arrhythmias, hypertension, or congestive heart failure
    • History or symptoms of significant neurologic disease, including transient
    ischemic attack, stroke, seizure disorder, or behavioral disturbances
    • History of significant hepatic or renal impairment
    • Evidence of an active or suspected cancer or history of treatment for cancer
    • History or symptoms of clinically significant autoimmune disease
    • Any acquired or congenital immune deficiency
    • Confirmed positive test for HIV or hepatitis B or C
    • Concomitant disease or condition, which could interfere with the conduct
    of the study, or for which the treatment might interfere with the conduct
    of the study, or which would, in the opinion of the investigator, poses an
    unacceptable risk to the patients in this study, including, but not limited to
    cancer, alcoholism, drug dependency or abuse, or psychiatric disease
    • History of serious adverse reaction or hypersensitivity to any drug
    • Clinically significant abnormal chest radiograph within the last 12 months
    • Clinically significant abnormalities in laboratory test results (including complete
    blood count, coagulation, serum chemistry panel, and urinalysis)
    • Pregnancy or lactation or positive serum pregnancy test at screening
    • Use of corticosteroids (oral, systemic or inhaled), immunosuppressives,
    anticoagulants (warfarin or heparin), or any medications that may interact
    with study drug within 4 weeks prior to Visit 2
    • Chronic use of any other medication for treatment of allergic lung disease
    other than short-acting β2-agonists or ipratropium bromide
    • Use of cromoglycate, nedocromil, leukotriene receptor antagonists
    (zafirlukast, pranlukast, montelukast), and inhibitors of 5-lipoxygenase
    (zileuton) are not permitted within 4 weeks prior to Visit 2
    • Allergen or peptide immunotherapy within 6 months prior to Visit 1
    • Participation in any other investigational drug study within the preceding
    30 days or 5 half-lives of that drug, whichever is longer at the time of Visit 2
    • Current (or history of) treatment with a monoclonal antibody or
    chimeric biomolecule within the past 5 months (5 half-lives of the drug),
    including omalizumab, at the time of Visit 2
    • Use of statins are not permitted within 4 weeks prior to Visit 2
    • Received live or attenuated vaccine (including but not limited to FluMist-brand influenza vaccine, MMR (measles, mumps, rubella), VZV (varicella zoster/chickenpox), oral polio, etc. within 30 days prior to Visit 5
    • Regular use of tobacco products of any kind or within the previous 6 months,
    or smoking history > 10 pack-years
    • History of drug or alcohol abuse, which, in the judgment of the investigator,
    may put the patient at risk for being unable to participate fully in the study for
    the duration of the study
    • Donation of blood over 500 mL within 3 months prior to Visit 5
    • Unwillingness or inability to comply with the study protocol for any other reason
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure is the LAR AUC (percent decline in FEV1 over time)
    between 3 and 7 hours after allergen challenge at 12 weeks (Day 86) after the
    first dose.

    The safety and tolerability of MEMP1972A will be assessed using the following measures:
    • Incidence and nature of treatment-emergent adverse events as well as incidence, nature, relatedness, and severity of adverse events
    • Incidence and nature of infusion reactions
    • Incidence of infectious complications
    • Clinically significant changes in vital signs, ECG, FEV1, and safety laboratory measures
    • Incidence of anti-therapeutic antibodies (ATA)
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.6.13.1Other scope of the trial description
    Tolerability
    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.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    The end of the study is defined as the last patient’s last visit or the last key
    data point received.
    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 months0
    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 months0
    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.1.3Elderly (>=65 years) No
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 36
    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)
    See Protocol Section 4.8
    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 Decision2011-01-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-01-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-01-05
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