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    Summary
    EudraCT Number:2010-024006-35
    Sponsor's Protocol Code Number:C38072/3083
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-05-10
    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 ConcernedGreece - EOF
    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 SponsorCephalon 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 supportCephalon 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 pointMariah Walter
    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+1 910 319 7847
    B.5.5Fax number1 919 654 9300
    B.5.6E-mailMariah.Walter@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.3.10 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 13.1
    E.1.2Level LLT
    E.1.2Classification code 10068462
    E.1.2Term Eosinophilic asthma
    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
    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.
    A CAE is defined by one of the following:
    1) a hospitalization because of asthma,
    2) emergency treatment because of asthma,
    3) a decrease in forced expiratory volume in 1 second (FEV1) by 20% or more, or
    4) a decrease in peak expiratory flow rate (PEFR) of 30% or more in 2 consecutive measurements.
    Emergency treatment includes unscheduled visits to the physician’s office for nebulizer treatment or other urgent treatment to prevent worsening of asthma symptoms, or a visit to the emergency room for treatment, regardless of subsequent admission.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are the following:
    • to evaluate the efficacy of reslizumab:
    ― lung function [FEV1], [%FEV1], [FVC], [FEF25-75%]
    ― time to first CAE
    ― oral corticosteroids prescribed for asthma worsening
    ― use of short-acting beta-agonists
    ― blood eosinophil count
    ― Asthma Symptom Utility Index (ASUI)
    ― Asthma Control Questionnaire (ACQ)
    ― Asthma Quality of Life (AQLQ)
    • to evaluate the safety and tolerability of reslizumab:
    ― occurrence of adverse events
    ― clinical laboratory test results
    ― vital signs
    ― ECG findings
    ― physical examination findings
    ― concomitant medication usage throughout the study
    ― measurement of anti-drug antibodies
    • as exploratory objectives, to evaluate PEFR, and to characterize potential biomarkers in sputum that may more effectively identify patients who have this phenotype of asthma
    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) The patient is male or female, 12 through 75 years of age, with a previous diagnosis of asthma.
    (b) The patient has had at least 1 asthma exacerbation requiring oral 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/L.
    (d) The patient has airway reversibility of at least 12% to beta-agonist administration.
    (e) The patient has an ACQ score of at least 1.5.
    (f) Inclusion criterion (f) is replaced by (f1). 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. Patients’ baseline asthma therapy regimen (including but not limited to inhaled corticosteroids, leukotriene antagonists, 5-lipooxegnase inhibitors, cromolyn) must be stable for 30 days prior to screening, and continue without dosage changes throughout 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) 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) in conjunction with a barrier method.
    (i) Written informed consent is obtained. Patients 12 through 17 years old must provide assent.
    (j) 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, serum chemistry, hematology, and urinalysis.
    (k) The patient must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period, and willing to return to the clinic for the follow-up evaluation as specified in this protocol.
    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) The patient is using systemic immunosuppressive or immunomodulating drugs eg, systemic corticosteroids greater than 10 mg/day daily dose, methotrexate, cyclosporine, antibody 6 months prior to study entry (randomization).
    (f) The patient has participated in an anti-interleukin-5 (IL-5) study for asthma.
    (g) The patient has any aggravating medical factors that are inadequately controlled (eg, rhinitis, gastroesophageal reflux disease).
    (h) The patient has participated in any investigative drug or device study within 30 days prior to study enrollment (randomization).
    (i) The patient has participated in any investigative biologics study within 3 months prior to study enrollment (randomization).
    (j) 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] in conjunction with a barrier method) are excluded from this study.
    (k) The patient has concurrent infection or disease that may preclude assessment of active asthma.
    (l) The patient has a history of concurrent immunodeficiency (human immunodeficiency or acquired immunodeficiency syndrome or congenital immunodeficiency).
    (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) Presence of or suspected parasitic infestation /infection.
    (o) Patients may not have received any live attenuated vaccine within the 12-week period prior to screening.
    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 double-blind treatment period and within 2 weeks after the last visit.

    A CAE is defined by 1 of the following:
    1) a hospitalization because of asthma,
    2) emergency treatment because of asthma,
    3) a decrease in FEV1 by 20% or more, or
    4) a PEFR of 30% or more in 2 consecutive measurements.

    Patients who experience a CAE will be instructed to come to the study center for pulmonary function tests and asthma symptom score assessment.
    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 and within 2 weeks after the last visit.

    A CAE is defined by 1 of the following:
    1) A hospitalization because of asthma,
    2) Emergency treatment because of asthma,
    3) A decrease in FEV1 by 20% or more, or
    4) A PEFR of 30% or more in 2 consecutive measurements.

    Patients who experience a CAE will be instructed to come to the study center for pulmonary function tests and asthma symptom score assessment.
    E.5.2Secondary end point(s)
    The secondary efficacy variables and endpoints for this study are as follows:

    • Change in lung function as measured by FEV1, %FEV1, FVC, FEF25-75% from baseline to weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52, and endpoint, or at time of first CAE
    • Time to first CAE
    • Change in the number of courses of oral corticosteroids prescribed for asthma worsening (3 or more days of administration or doubling of current dose) from baseline to weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52, and endpoint, or at time of first CAE
    • Change in short-acting beta-agonist use from baseline to weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52, and endpoint, or at time of first CAE
    • Change in blood eosinophil count from baseline to weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52, and endpoint, or at time of first CAE
    • Change in ASUI score at weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52, and endpoint, or at time of first CAE
    • Change in ACQ score from baseline to weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52, and endpoint, or at time of first CAE
    • Change in AQLQ score from baseline to weeks 16, 32, and 52, and endpoint, or at time of first CAE
    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 concerned4
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 105
    F.4.2.2In the whole clinical trial 400
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-05-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-04-03
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