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    The EU Clinical Trials Register currently displays   43850   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2015-001580-39
    Sponsor's Protocol Code Number:C38072-AS-30027
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-10-28
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2015-001580-39
    A.3Full title of the trial
    A Phase 3, 24-Week Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study of Reslizumab Subcutaneous Dosing (110 mg Every 4 weeks) in Patients with Oral Corticosteroid Dependent Asthma and Elevated Blood Eosinophils
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 24-Week Efficacy and Safety Study of Reslizumab Subcutaneous Dosing in Patients with Oral Corticosteroid Dependent Asthma and Elevated Blood Eosinophils
    A.4.1Sponsor's protocol code numberC38072-AS-30027
    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 Global
    B.5.2Functional name of contact pointMichele Vaughn
    B.5.3 Address:
    B.5.3.1Street Address3900 Paramount Parkway
    B.5.3.2Town/ cityMorrisville
    B.5.3.3Post codeNC 27560
    B.5.3.4CountryUnited States
    B.5.4Telephone number0019193802000
    B.5.5Fax number001919 3792678
    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 injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNReslizumab
    D.3.9.1CAS number 241473-69-8
    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 number110
    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 No
    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 injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Asthma & elevated blood Eosinophils
    E.1.1.1Medical condition in easily understood language
    Asthma
    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 19.0
    E.1.2Level PT
    E.1.2Classification code 10003553
    E.1.2Term 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 the ability of reslizumab (110 mg) administered subcutaneously (sc) once every 4 weeks to produce a corticosteroid-sparing effect (as demonstrated by percent reduction in daily OCS use) in patients with OCS-dependent asthma and elevated blood eosinophils, without loss of asthma control.
    E.2.2Secondary objectives of the trial
    The secondary objective of this study is to evaluate the clinical benefits of reslizumab in the context of OCS reduction.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients may be included in the study only if they meet all of the
    following criteria:
    a. The patient is male or female, 12 years of age and older, with a previous diagnosis of asthma. Patients 12 to <18 years of age are excluded from participating in South Korea, the Netherlands, and Argentina, and patients 66 years of age and older are excluded from participating in South Korea.
    b. Written informed consent is obtained. A patient 12 through <18 years of age must provide assent and his/her parent(s) or legal guardian(s) must provide consent.
    c. The patient continues to require an average daily maintenance dose of OCS or equivalent for asthma of between 5 and 40 mg during the 3 months before screening. Patients on an OCS dose of >40 mg at screening who the investigator believes may be able to decrease OCS dose to ≤40 mg during the optimization period may also be enrolled. Note: every-other-day dosing that is within this daily average (ie, 10 to 80 mg) is allowed.
    d. The patient has a documented blood eosinophil level of at least 300/μL during the previous 12 months while on at least medium total daily dose of ICS based on Global Initiative for Asthma 2015 clinical comparability table (Appendix A), or ≥300/μL at screening while on chronic OCS or that becomes manifest during the OCS optimization period or at the week -2 visit (end of optimization period/beginning of run-in period).
    e. The patient has required at least 880 μg of inhaled fluticasone propionate or equivalent daily PLUS another controller(s) (eg, longacting beta-agonist [LABA], long-acting anti-muscarinic antagonist, leukotriene inhibitor, or theophylline), or documented intolerance to another controller, for at least 6 months before the screening visit. For a fixed-dose ICS/LABA preparation, the highest labeled dose in that region will satisfy this criterion. For patients 12 through <18 years of age, the ICS
    dose must correspond to at least a medium total daily ICS dose.
    Note: the dose and regimen of asthma controllers and any allergen immunotherapy
    should have been stable during the 30 days before signing the Informed Assent Form/Informed Consent Form (ICF).
    f. The patient has FEV1 reversibility of at least 12% after administration of inhaled reliever medication according to the standard American Thoracic Society (ATS) or European Respiratory Society (ERS) protocol. Given the refractory nature of the disease in this population and the influence of high background controller medications on reversibility testing, documented FEV1 reversibility of 12% or a provocation concentration producing a 20% fall in FEV1 for methacholine of ≤8 mg/mL within 24 months of the screening visit, and performed accordingto the standard ATS/ERS procedures, would fulfill this criterion.
    g.Females of childbearing potential (not surgically sterile or 2 years postmenopausal) must have exclusively same-sex partners or use medically acceptable methods of birth control and must agree to continue use of this method for the duration of the study and for 5 months after the last study drug dose. Acceptable methods of birth
    control include intrauterine device, systemic hormonal contraceptive (oral, implanted, transdermal, or injected), barrier method with spermicide, abstinence, and partner vasectomy.
    h. The patient must be willing and able to comply with study restrictions, willing and able to perform requisite procedures 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.
    i. Except for the OCS, which will be adjusted per protocol, the patient must maintain his/her usual asthma controller regimen without change throughout the screening, optimization, run-in, and treatment periods.
    E.4Principal exclusion criteria
    Patients will be excluded from participating in this study if they meet any of the following criteria:
    a. The patient has any clinically significant, uncontrolled medical condition (treated or untreated) that would interfere with the study schedule or procedures and interpretation of efficacy results or would compromise the patient’s safety.
    b. The patient has another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease, interstitial lung disease, bronchiectasis eosinophilic granulomatosis with polyangiitis [also known as Churg-Strauss syndrome], or allergic bronchopulmonary aspergillosis).
    c. The patient has a known hypereosinophilic syndrome.
    d. The patient has a history of any malignancy within 5 years of the screening visit, except for treated and cured non-melanoma skin cancers.
    e. The patient is pregnant or intends to become pregnant during the study or within 5 months from last dose of study drug or is lactating. Any woman becoming pregnant will be withdrawn from the study.
    f. The patient required treatment for an asthma exacerbation within 4 weeks of screening.
    g. The patient is a current smoker (ie, has smoked within the last 6 months before screening) or has a smoking history ≥10 pack-years.
    h. The patient is currently using any systemic immunosuppressive or immunomodulatory biologic (eg, anti immunoglobulin E monoclonal antibody [mAb] or other mAb [eg, mepolizumab] or soluble receptor) or non-biologic (eg, methotrexate, cyclosporine), except maintenance OCS for the treatment of asthma. Previous use of such agents that occurred >5 half-lives from the screening visit may be allowed, if approved by the medical monitor.
    i. The patient participated in a clinical study within 30 days or 5 half-lives of the investigational drug before screening, whichever is longer.
    j. The patient was previously exposed to benralizumab within 12 months of screening.
    k. The patient was previously exposed to reslizumab
    l. The patient has a history of immunodeficiency disorder including human immunodeficiency virus.
    m. The patient has current suspected drug and/or alcohol abuse.
    n. The patient has had an active helminthic parasitic infection or was treated for one within 6 months of screening.
    o. The patient has a history of allergic reactions or hypersensitivity to any component of the study drug.
    p. The patient has a history of latex allergy. (The current prefilled syringe device has a natural rubber component to the needle shield.)
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable and endpoint for this study is the categorized percent reduction in the daily OCS dose during weeks 20 to 24 as compared with the dose at the end of the optimization phase. Percent reduction will be categorized as follows:
    • 90% to 100%
    • 75% to <90%
    • 50% to <75%
    • >0% to <50%
    • No decrease in OCS, or loss of baseline asthma control during weeks 20 through 24, or discontinuation from study drug
    Loss of baseline asthma control will be defined as FEV1 value of less than 80% of baseline at the week 24 visit, or clinically significant worsening in ACQ-6 score (change in score of 0.5) at the week 24 visit compared with baseline, and/or clinical asthma exacerbation (CAE) during weeks 20 through 24.
    E.5.1.1Timepoint(s) of evaluation of this end point
    during the 20-24-week treatment period
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints are as follows:
    • Proportion of patients achieving ≥50% reduction in OCS dose at weeks 20 to 24 relative to the OCS dose at DoR/baseline, while maintaining asthma control
    • Proportion of patients achieving dose reduction to ≤5 mg daily dose at weeks 20 to 24, while maintaining asthma control
    • Percent change from DoR/baseline in OCS dose at weeks 20 to 24
    • Proportion of patients achieving less than 5 mg decrement in OCS dose (ie, the minimal and non-responders) at weeks 20 to 24 compared with the OCS dose at DoR/baseline, while maintaining asthma control
    • Clinical asthma exacerbation related:
    - Annualized rate of CAEs requiring a burst of systemic corticosteroid (injection, or if oral, at least a doubling from the current OCS dose for at least 3 days); an asthma-specific hospital admission; or an asthma-specific emergency department visit during the treatment period (weeks 0 to 24)
    • Proportion of patients discontinuing OCS at weeks 20 to 24, while maintaining asthma control
    E.5.2.1Timepoint(s) of evaluation of this end point
    during the 24-week treatment period.
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA43
    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
    Czech Republic
    France
    Germany
    Hungary
    Israel
    Italy
    Korea, Democratic People's Republic of
    Mexico
    Netherlands
    Poland
    Russian Federation
    Spain
    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 Subject Last Visit (LSLV) treatment period is defined as end of treatment (approximately week 24). LSLV late follow up, for immunogenicity testing only, will be performed after the treatment period (approximately week 48). This will be considered the end of the trial for the purposes of end of trial notification.
    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 months0
    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 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 Yes
    F.1.1Number of subjects for this age range: 8
    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: 8
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 129
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 15
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 58
    F.4.2.2In the whole clinical trial 152
    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)
    Standard of Care
    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 Decision2015-10-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-12-04
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