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    EudraCT Number:2010-023342-67
    Sponsor's Protocol Code Number:C38072/3081
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-05-11
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2010-023342-67
    A.3Full title of the trial
    A 16-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Reslizumab (0.3 or 3.0 mg/kg) as Treatment for 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 and safety of a drug called reslizumab performed by comparing simultaneously 3 groups of patients aged from 12 to 75 years suffering from eosinophilic asthma and receiving during 16 weeks, either reslizumab at a dose of 0.3mg/kg or 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 numberC38072/3081
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01270464
    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 pointProject Management
    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+1 910-558-4676
    B.5.5Fax number+1 919-654-8901
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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. 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 14.1
    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 dosage of 0.3 or 3.0 mg/kg administered once every 4 weeks for a total of 4 doses, is more effective than placebo in improving lung function in patients with eosinophilic asthma as assessed by the overall change from baseline in forced expiratory volume in 1 second (FEV1).
    E.2.2Secondary objectives of the trial
    • to evaluate the efficacy of reslizumab :
    ― lung function as measured by FEV1, % predicted FEV1, FVC and FEF25-75%
    ― short-acting beta-agonist use
    ― blood eosinophil count
    ― asthma symptoms (ASUI)
    ― asthma control (ACQ)
    ― quality of life (AQLQ)
    • to characterize the PK of reslizumab
    • to characterize the relationship between serum concentrations of reslizumab and measures of efficacy and safety
    • to evaluate the safety and tolerability of reslizumab:
    ― occurrence of adverse events
    ― clinical laboratory test results
    ― vital signs measurements
    ― physical examination findings
    ― 12-lead electrocardiography (ECG) findings at week 16 or early withdrawal
    ― concomitant medication usage
    ― to assess immunogenicity by measurement of anti-reslizumab antibodies at weeks 8 and 16 or early withdrawal
    • as exploratory objective, to characterize potential biomarkers in sputum and/or blood 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) Inclusion criterion (a) is replaced by (a1).
    (a1) 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 India and Argentina; patients 66 through 75 years of age are excluded from participating in India.
    (b) The patient has an ACQ score of at least 1.5.
    (c) The patient has airway reversibility of at least 12% to beta-agonist administration at screening.
    (d) Inclusion criteria (d) is replaced by (d1).
    (d1) The patient is currently taking fluticasone at a dosage of at least 440 μg daily (or equivalent). Patients’ baseline asthma therapy regimen (including but not limited to inhaled corticosteroids, leukotriene antagonists, 5-lipooxegnase inhibitors, cromolyn) must be stable for 30 days before screening, and continue without dosage changes throughout the study.
    (e) The patient has a blood eosinophil count of at least 400/L.
    (f) Female patients must be surgically sterile, 2 years postmenopausal, or must have a negative pregnancy test beta-human chorionic gonadotropin (ßHCG) at screening (serum) and baseline (urine).
    (g) Inclusion criterion (g) is replaced by (g1).
    (g1) 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 the end-of-treatment visit. Acceptable methods of contraception include barrier method with spermicide, abstinence, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected).
    (h) Inclusion criterion (h) is replaced by (h1).
    (h1) Written informed consent is obtained. Patients 12 through 17 years old, where participating, need to provide assent in accordance with local standards.
    (i) 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, urinalysis, and serology.
    (j) 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 HES.
    (c) Exclusion criteria (c) is replaced by (c1).
    (c1) The patient has another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease, pulmonary fibrosis, or lung cancer). The patient has other pulmonary conditions with symptoms of asthma and blood eosinophilia
    (eg, Churg-Strauss syndrome, allergic bronchopulmonary aspergilosis).
    (d) The patient is a current smoker (ie, has smoked within the last 6 months prior to screening).
    (e) The patient has a history of use of systemic immunosuppressive or immunomodulating agents (anti-IgE mAb, methotrexate, cyclosporin, interferon-α, or anti-tumor necrosis factor mAb) within 6 months prior to study entry (randomization).
    (f) The patient is currently using systemic corticosteroids (includes use of oral corticosteroids).
    (g) The patient is expected to be poorly compliant with study drug administration, study procedures, or visits.
    (h) The patient has any aggravating factors that are inadequately controlled (eg, gastroesophageal reflux disease).
    (i) The patient has participated in any investigative drug or device study within 30 days prior to screening.
    (j) The patient has participated in any investigative biologics study within 90 days prior to screening.
    (k) The patient has previously received anti-hIL-5 monoclonal antibody (eg, mepolizumab).
    (l) Exclusion criterion (l) is replaced by (l1).
    (l1) Female patients who are pregnant, or nursing, or, if of childbearing potential and not using a medically accepted, effective method of birth control (eg, spermicide, abstinence, IUD, or steroidal contraceptive [oral, transdermal, implanted, and injected]) are excluded from this study.
    (m) The patient has a current infection or disease that may preclude assessment of asthma.
    (n) Exclusion criterion (n) is replaced by (n1).
    (n1) The patient has a history of concurrent immunodeficiency (human immunodeficiency, acquired immunodeficiency syndrome, or congenital immunodeficiency). Patients in Argentina must have documented serology testing for HIV performed during screening.
    (o) The patient has current suspected drug or alcohol abuse as specified in the
    Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text
    Revision (DSM-IV-TR) criteria.
    (p) The patient has presence of or suspected parasitic infestation/infection.
    (q) Patients may not have received any live attenuated vaccine within the 12-week period before screening.
    (r) The patient has a history of allergic reactions to or hypersensitivity to any component of the study drug.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable for this study is the change from baseline in FEV1.
    FEV1 is a standard measurement of air movement in the lungs of patients with asthma. It is the volume of air expired in the first second of a forced expiration. Improvement in FEV1 is a measure of the reduction of bronchospasm, the reduction of airway inflammation, or both. FEV1 will be measured using forced expiratory air spirometry.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 4, 8, 12, 16 or early withdrawal
    E.5.2Secondary end point(s)
    The secondary efficacy measures and endpoints for this study are as follows:
    • lung function as measured by FEV1, % predicted FEV1, FVC, and FEF25-75% at weeks 4, 8, 12, 16, or early withdrawal
    • short-acting beta-agonist use assessed at weeks 4, 8, 12, 16, or early withdrawal
    • blood eosinophil count at weeks 4, 8, 12, 16, and follow-up or early withdrawal
    • ASUI at weeks 4, 8, 12, 16, or early withdrawal
    • ACQ at weeks 4, 8, 12, 16, or early withdrawal
    • AQLQ at week 16, or early withdrawal

    Exploratory variables and endpoints for this study are as follows:
    • sputum eosinophil levels measured at endpoint
    • biomarkers measured at endpoint
    • the presence or absence of nasal polyps
    E.5.2.1Timepoint(s) of evaluation of this end point
    • lung function as measured by % FEV1, % predicted FEV1,FVC, and FEF25-75% at weeks 4, 8, 12, 16, or early withdrawal)
    • short-acting beta-agonist use assessed at weeks 4, 8, 12, 16, or early withdrawal
    • blood eosinophil count at weeks 4, 8, 12, 16, and follow-up or early withdrawal
    • ASUI at weeks 4, 8, 12, 16, or early withdrawal
    • ACQ at weeks 4, 8, 12, 16, or early withdrawal
    • AQLQ at week 16, or early withdrawal

    Exploratory variables and endpoints for this study are as follows:
    • Sputum eosinophil levels measured at endpoint
    • Biomarkers measured at endpoint
    • The presence or absence of nasal polyps
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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. 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 trial3
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    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
    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
    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 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 Yes
    F.1.1Number of subjects for this age range: 18
    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. of subjects for this age range: 18
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 135
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 27
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 168
    F.4.2.2In the whole clinical trial 300
    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 C38072/3081 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 Decision2011-06-30
    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 trial2013-09-12
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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