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    Summary
    EudraCT Number:2010-024540-15
    Sponsor's Protocol Code Number:C38072/3085
    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
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2010-024540-15
    A.3Full title of the trial
    An Open-Label Extension Study to evaluate the Long-Term Safety and Efficacy of Reslizumab (3.0 mg/kg) as Treatment for Patients with Eosinophilic Asthma who completed a prior Cephalon-sponsored Study in Eosinophilic Asthma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate over a prolonged period of time, the safety and the efficacy of a treatment with Reslizumab (at a dose of 3mg/kg) for patients suffering from eosinophilic asthma who completed a prior Cephalon-sponsored study in eosinophilic asthma.
    A.4.1Sponsor's protocol code numberC38072/3085
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01290887
    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 Product 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 Product 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+48 22 3070 627
    B.5.5Fax number+48 661 612 428
    B.5.6E-mailPiotr.Chachulski@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
    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 the study is to obtain additional safety data for
    reslizumab at a dosage of 3.0 mg/kg every 4 weeks relative to baseline
    for up to 24 months in pediatric and adult patients with moderate to severe eosinophilic asthma, as assessed by the following:
    • adverse events throughout the study
    • clinical laboratory test (chemistry, hematology, and urinalysis) results at weeks 4, 8, and 24, and every 24 weeks thereafter throughout the study
    • brief physical examination findings at all visits (every 4 weeks) throughout the study
    • vital signs measurements every 4 weeks throughout the study
    • concomitant medication usage every 4 weeks throughout the study
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to evaluate long-term efficacy of reslizumab as assessed by the following:
    • pulmonary function test results, as measured by FEV1, %predicted
    FEV1, FVC, and FEF25-75% every 4 weeks for 16 weeks, at 24 weeks, and every 12 weeks thereafter throughout the study
    • short-acting beta-agonist use every 4 weeks for 16 weeks, at 24 weeks, and every 12 weeks thereafter throughout the study
    • ASUI every 4 weeks for 16 weeks, at 24 weeks, and every 12 weeks thereafter throughout the study
    • ACQ every 4 weeks for 16 weeks, at 24 weeks, and every 12 weeks thereafter throughout the study
    • AQLQ every 24 weeks throughout the study

    Immunogenicity will be assessed by testing for the presence of antireslizumab antibodies every 24 weeks throughout the study and at the end of treatment (4 weeks after the last infusion of study drug) or early withdrawal.
    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. 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) Written informed consent is obtained. Patients 12 through 17 years old, where participating, need to provide assent in accordance with local standards.
    (c) Patient must have completed treatment in a previous double-blind asthma exacerbation study or received at least 2 doses of study drug treatment in a pulmonary function study.
    (d) 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 another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease, pulmonary fibrosis, or lung cancer).
    (c) The patient is a current smoker.
    (d) The patient is expected to be poorly compliant with study drug administration, study procedures, or visits.
    (e) The patient has any aggravating factors that are inadequately controlled (eg, gastroesophageal reflux disease [GERD]).
    (f) 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).
    (g) The patient has a current infection or disease that may preclude assessment of asthma.
    E.5 End points
    E.5.1Primary end point(s)
    The safety of reslizumab will be assessed throughout the study by evaluating adverse events, clinical laboratory test results, vital signs measurements, brief physical examination findings, concomitant medication usage as follows:
    • Adverse events will be evaluated throughout the study
    • Chemistry, hematology, and urinalysis tests (except for urine β-HCG test conducted predose every 4 weeks for women who are not 2 years
    postmenopausal or surgically sterile) will be performed at baseline (endof-treatment visit of the previous Teva-sponsored double-blind study of reslizumab in eosinophilic asthma), at weeks 4, 8, and 24, and every 24 weeks thereafter until end-of-treatment visit, or early termination, and 90 days after the end of treatment visit.
    • Vital signs measurements, brief physical examinations, and concomitant medication usage will be assessed every 4 weeks throughout the study, and 90 days after the end of treatment visit.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Please see E.5.1
    E.5.2Secondary end point(s)
    The efficacy measures and endpoints for this study are as follows:
    • Pulmonary function assessments (FEV1, % predicted FEV1, FVC, FEF25-75%) assessed every 4 weeks for 16 weeks, at 24 weeks, and every 12 weeks thereafter until end-of-treatment visit or last postbaseline observation
    • Use of short-acting beta-agonists assessed every 4 weeks for 16 weeks, at 24 weeks, and every 12 weeks thereafter until end-of-treatment visit or last postbaseline observation
    • ASUI assessed every 4 weeks for 16 weeks, at 24 weeks, and every 12 weeks thereafter until end-of-treatment visit or last postbaseline observation
    • ACQ assessed every 4 weeks for 16 weeks, at 24 weeks, and every 12 weeks thereafter until end-of-treatment visit/early termination or last postbaseline observation
    • AQLQ assessed every 24 weeks until end-of-treatment visit or last postbaseline observation
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please 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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA109
    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
    Australia
    Belgium
    Brazil
    Canada
    Chile
    Colombia
    Czech Republic
    Denmark
    France
    Germany
    Greece
    Hungary
    India
    Israel
    Korea, Republic of
    Malaysia
    Mexico
    Netherlands
    New Zealand
    Peru
    Philippines
    Poland
    Romania
    Russian Federation
    Slovakia
    South Africa
    Sweden
    Taiwan
    Thailand
    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
    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 years3
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months3
    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: 74
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    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: 100
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 750
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 state23
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 298
    F.4.2.2In the whole clinical trial 1000
    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)
    Teva is considering a program to supply reslizumab via compassionate use where permitted by local laws (or any other locally applicable mechanism) for patients enrolled in study 3085 who, in the opinion of the investigator, are benefiting from intravenous reslizumab treatment and have limited or no alternative therapeutic options to manage their asthma.
    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 trial2015-01-16
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