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    Summary
    EudraCT Number:2010-024006-35
    Sponsor's Protocol Code Number:C38072/3083
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-05-03
    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 - PEI
    A.2EudraCT number2010-024006-35
    A.3Full title of the trial
    A 12-Month, Double-Blind, Placebo-Controlled, Parallel-Group Study to evaluate the Efficacy and Safety of Reslizumab (3.0 mg/kg) in the reduction of Clinical Asthma Exacerbations in Patients (12-75 years of age) with Eosinophilic Asthma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate the efficacy, as measured by the reduction of exacerbations, and safety of a drug called reslizumab performed by comparing simultaneously 2 groups of patients aged from 12 to 75 years suffering from eosinophilic asthma and receiving during 12 months, either reslizumab (at a dose of 3mg/kg) or a placebo (inactive substance). Treatment given to each patient will be drawn at random, without both the patient and the physician knowing which one has been attributed.
    A.4.1Sponsor's protocol code numberC38072/3083
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01285323
    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 SponsorTeva Branded Pharmaceutical Products R&D, 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 supportTeva Branded Pharmaceutical Products R&D, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPPD
    B.5.2Functional name of contact pointMichele Vaughn
    B.5.3 Address:
    B.5.3.1Street Address929 North Front Street
    B.5.3.2Town/ cityWilmington
    B.5.3.3Post codeNC 28401
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1 314-258-0817
    B.5.5Fax number+1 919-379-2678
    B.5.6E-mailMichele.Vaughn@ppdi.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 nameReslizumab
    D.3.2Product code CEP-38072
    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 INNReslizumab
    D.3.9.1CAS number Pending
    D.3.9.2Current sponsor codeCEP-38072
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Yes
    D.3.11.13.1Other medicinal product typeHumanised monoclonal antibody of the immunoglobulin (Ig) IgG4 isotype derived from a rat monoclonal antibody to human Interleukin-5 (IL-5)
    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
    Treatment for patients with eosinophilic asthma
    E.1.1.1Medical condition in easily understood language
    A particular form of asthma characterized by the presence of a high number in the lungs of a certain type of white blood cells, called eosinophils, which lead to airways inflammation and symptoms.
    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 LLT
    E.1.2Classification code 10068462
    E.1.2Term Eosinophilic asthma
    E.1.2System Organ Class 100000004855
    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 determine whether reslizumab,
    at a dose of 3 mg/kg administered intravenously (iv) every 4 weeks over
    12 months, is more effective than placebo in reducing the number of
    clinical asthma exacerbations (CAEs) in patients with eosinophilic
    asthma as assessed by the frequency of CAEs.
    An exacerbation event will be considered a CAE if the patient meets
    either or both of the 2 criteria listed below and this is corroborated with
    at least 1 other measurement to indicate the worsening of clinical signs
    and symptoms of asthma:
    • use of systemic, or an increase in the use of inhaled, corticosteroid
    treatment for 3 or more days
    • asthma-related emergency treatment
    Above criteria must be corroborated with at least 1 other measurement
    to indicate worsening in the clinical signs and symptoms of asthma.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of reslizumab treatment compared with placebo
    treatment in patients with eosinophilic asthma, as assessed by the effect
    of reslizumab on the following:
    • overall change from baseline in FEV1 over 16 weeks
    • change from baseline in Asthma Quality of Life Questionnaire (AQLQ)
    score to week 16
    • overall change from baseline in Asthma Control Questionnaire (ACQ)
    score over 16 weeks
    • time to 1st CAE
    • overall change from baseline in Asthma Symptom Utility Index (ASUI)
    score over 16 weeks
    • overall change from baseline in short-acting beta-agonist use over 16
    weeks
    • overall change from baseline in blood eosinophil count over 16 weeks
    and 52 weeks
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients are included in the study if all of the following criteria are met:
    (a) Inclusion criterion (a2) is replaced by (a3).
    (a2) The patient is male or female, 12 through 75 years of age, with a
    previous diagnosis of asthma. Patients 12 through 17 years of age are
    excluded from participating in Germany, India, Argentina, and Korea; patients 66
    through 75 years of age are excluded from participating in India and
    Korea.
    (b) Inclusion criterion (b) is replaced by (b1).
    (b1) The patient has had at least 1 asthma exacerbation requiring oral,
    intramuscular, or iv corticosteroid use for at least 3 days over the past
    12 months before screening.
    (c) The patient has a current blood eosinophil level of at least 400/µL.
    (d) The patient has airway reversibility of at least 12% to beta-agonist
    administration.
    (e) Inclusion criterion (e) is replaced by (e1).
    (e1) The patient has an ACQ score of at least 1.5 at the screening and baseline (before the 1st dose of study drug) visits.
    (f) Inclusion criterion (f2) is replaced by (f3).
    (f3) The patient is taking inhaled fluticasone at a dosage of at least 440
    μg, or equivalent, daily. Chronic oral corticosteroid use (no more than 10
    mg/day prednisone or equivalent) is allowed. If a patient is on a stable
    dose, eg, 2 weeks or more of oral corticosteroid treatment at the time of
    study enrollment, the patient must remain on this dose throughout the
    study. The patients' baseline asthma therapy regimen (including but not
    limited to inhaled corticosteroids, oral corticosteroids up to a maximum
    dose of 10 mg prednisone daily or equivalent, leukotriene antagonists,
    5 lipoxygenase inhibitors, cromolyn) must be stable for 30 days prior to
    screening and baseline and must continue without dosage changes throughout the study.
    (g) All female patients must be surgically sterile, 2 years
    postmenopausal, or must have a negative pregnancy test (ß-human
    chorionic gonadotropin [ß-HCG]) at screening (serum) and baseline
    (urine).
    (h) Inclusion criterion (h1) is replaced by (h2).
    (h2) Female patients of childbearing potential (not surgically sterile or 2
    years postmenopausal), must use a medically accepted method of
    contraception and must agree to continue use of this method for the
    duration of the study and for 30 days after participation in the study.
    Acceptable methods of contraception include barrier method with
    spermicide, abstinence, intrauterine device (IUD), or steroidal
    contraceptive (oral, transdermal, implanted, and injected). NOTE: Partner sterility alone is not acceptable for inclusion in the study.
    (i) Inclusion criteria (i) is replaced by (i1).
    (i1) Written informed consent is obtained. Patients 12 through 17 years
    old, where participating, must provide assent.
    (j) Inclusion criterion (j) is replaced by (j1).
    (j1) The patient is in reasonable health (except for diagnosis of asthma)
    as judged by the investigator, and as determined by a medical history,
    medical examination, ECG evaluation (at screening), serum chemistry, hematology, and
    urinalysis.
    (k) Inclusion criterion (k) is replaced by (k1).
    (k1) The patient must be willing and able to understand and comply with
    study restrictions, requirements, and procedures, as specified by the
    study center, and to remain at the study center for the required duration during the study period, and willing to return to the study center for the
    follow-up evaluation as specified in this protocol.
    (l) Patients who experience an asthma exacerbation during the
    screening period will be considered to have failed screening and cannot
    be randomly assigned to study drug. Patients may be rescreened 1 time
    only.
    E.4Principal exclusion criteria
    Patients are excluded from participating in this study if 1 or more of the
    following criteria are met:
    (a) The patient has a clinically meaningful comorbidity that would
    interfere with the study schedule or procedures, or compromise the
    patient's safety.
    (b) The patient has known hypereosinophilic syndrome.
    (c) Exclusion criterion (c) is replaced by (c1). The patient has another
    confounding underlying lung disorder (eg, chronic obstructive pulmonary
    disease, pulmonary fibrosis, or lung cancer). Patients with pulmonary
    conditions with symptoms of asthma and blood eosinophilia (eg, Churg-
    Strauss syndrome, allergic bronchopulmonary aspergillosis) will also be
    excluded.
    (d) The patient is a current smoker (ie, has smoked within the last 6
    months prior to screening).
    (e) Exclusion criterion (e2) is replaced by (e3).
    (e3) The patient is using systemic immunosuppressive, immunomodulating, or other biologic agents (including, but not limited to, anti-IgE mAb, methotrexate, cyclosporin,
    interferon-α, or anti-tumor necrosis factor [anti TNF] mAb) within 6
    months prior to screening.
    (f) Exclusion criterion (f1) is replaced by (f2).
    (f2) The patient has previously received an anti-hIL-5 monoclonal
    antibody (eg, reslizumab, mepolizumab, or benralizumab).
    (g) Exclusion criterion (g) is replaced by (g1).
    (g1) The patient has any aggravating medical factors that are
    inadequately controlled (eg, rhinitis, gastroesophageal reflux disease, and uncontrolled diabetes).
    (h) Exclusion criterion (h) is replaced by (h1).
    (h1) The patient has participated in any investigative drug or device
    study within 30 days prior to screening.
    (i) Exclusion criterion (i1) is replaced by (i2).
    (i2) The patient has participated in any investigative biologics study within 6 months prior to screening.
    (j) Exclusion criterion (j1) is replaced by (j2).
    (j2) Female patients who are pregnant, nursing, or, if of childbearing
    potential, and not using a medically accepted, effective method of birth
    control (eg, barrier method with spermicide, abstinence, IUD, or
    steroidal contraceptive [oral, transdermal, implanted, and injected]) are
    excluded from this study. NOTE: Partner sterility alone is not considered an acceptable form of birth control.
    (k) The patient has concurrent infection or disease that may preclude
    assessment of active asthma.
    (l) Exclusion criterion (l) is replaced by (l1).
    (l1) The patient has a history of concurrent immunodeficiency (human
    immunodeficiency virus [HIV] or acquired immunodeficiency syndrome
    or congenital immunodeficiency). Patients in Argentina must have
    documented serology testing for HIV performed during screening.
    (m) The patient has current suspected drug and alcohol abuse as
    specified in the Diagnostic and Statistical Manual of Mental Disorders,
    Fourth Edition, Text Revision (DSM-IV-TR) criteria.
    (n) Exclusion criterion (n) is replaced by (n1).
    (n1) The patient has had an active parasitic infection within 6 months prior to screening.
    (o) Patients may not have received any live attenuated vaccine within
    the 12-week period prior to screening.
    (p) The patient has a history of allergic reactions to or hypersensitivity
    to any component of the study drug.
    (q) The patient has had an infection requiring the following:
    ― an admission to the hospital for at least 24 hours within 4 weeks
    prior to screening or during the screening period
    ― treatment with iv antibiotics within 4 weeks prior to screening or
    during the screening period
    ― treatment with oral antibiotics within 4 weeks prior to screening or
    during the screening period
    (r) The patient has a history of exposure to water borne parasites
    within 6 weeks prior to screening or during the screening period or a
    history of diarrheal illness of undetermined etiology within 3 months
    prior to screening or during the screening period.
    (s) The patient requires treatment for an asthma exacerbation within 4
    weeks of screening or during the screening period.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy measure for this study is the frequency of CAEs per
    patient during the 52 week treatment period.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The frequency of CAEs per patient will be measured during the 52 week
    double-blind treatment period.
    E.5.2Secondary end point(s)
    The secondary efficacy variables and endpoints for this study are as
    follows:
    • overall change from baseline in FEV1 over 16 weeks
    • change from baseline in AQLQ score to week 16
    • overall change from baseline in ACQ score over 16 weeks
    • time to 1st CAE
    • overall change from baseline in ASUI score over 16 weeks
    • overall change from baseline in short-acting beta-agonist use over 16
    weeks
    • overall change from baseline in blood eosinophil count over 16 weeks
    and 52 weeks
    E.5.2.1Timepoint(s) of evaluation of this end point
    See E.5.2
    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 No
    E.6.7Pharmacodynamic No
    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.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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA37
    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
    Canada
    France
    Germany
    Greece
    India
    Korea, Republic of
    Mexico
    Peru
    Romania
    Russian Federation
    Slovakia
    Taiwan
    Ukraine
    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
    The last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    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 Yes
    F.1.1Number of subjects for this age range: 40
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 40
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 360
    F.4.2.2In the whole clinical trial 460
    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)
    Patients from Study C38072/3083 may be eligible to enter the extension study C38072/3085 if the investigator believes they would benefit from ongoing treatment. C38072/3085 (EudraCT number 2010-024540-15) is a long term open label extension study.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-05-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-04-03
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