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    Summary
    EudraCT Number:2015-000865-29
    Sponsor's Protocol Code Number:C38072-AS-30025
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-07-24
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2015-000865-29
    A.3Full title of the trial
    A 52-Week Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Study of Reslizumab 110 mg Fixed, Subcutaneous Dosing in Patients with Uncontrolled Asthma and Elevated Blood Eosinophils
    Dvojitě zaslepené, placebem kontrolované klinické hodnocení s paralelními skupinami v délce 52 týdnů ke stanovení účinnosti a bezpečnosti fixní dávky 110 mg přípravku reslizumab podávaného subkutánně u pacientů s nekontrolovaným astmatem a zvýšeným počtem eozinofilů v krvi
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 52-Week Efficacy and Safety Study of Reslizumab Subcutaneous Dosing in Patients with Uncontrolled Asthma and Elevated Blood Eosinophils
    A.4.1Sponsor's protocol code numberC38072-AS-30025
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/256/2016
    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 pointSean Egan
    B.5.3 Address:
    B.5.3.1Street Address980 Harvest Drive, Suite 210
    B.5.3.2Town/ cityBlue Bell, PA
    B.5.3.3Post code19422-1955
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1910558 4676
    B.5.5Fax number+1919654 8901
    B.5.6E-mailSean.Egan@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 in pre-filled syringe
    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
    Uncontrolled 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 19.1
    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 effect of reslizumab (110 mg) administered subcutaneously every 4 weeks on clinical asthma exacerbations (CAEs) in adults and adolescents with asthma and elevated blood eosinophils who are inadequately controlled on standard-of-care asthma therapy.
    E.2.2Secondary objectives of the trial
    Secondary efficacy objectives are to evaluate the effects of reslizumab compared with placebo on a range of clinical markers of asthma control including pulmonary function (forced expiratory volume in 1 second [FEV1]).
    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. Written informed consent is obtained. A patient 12 through <18 years
    of age must provide assent, and their parent(s) or legal guardian(s)
    must provide consent.
    b. The patient is male or female, 12 years of age and older, with a
    diagnosis of asthma. (Patients 12 to <18 years of age are excluded from
    participating in South Korea and Argentina, and patients 66 years of age
    and older are excluded from participating in South Korea.)
    c. The patient has had at least 2 documented asthma exacerbations
    requiring the use of systemic (oral, intramuscular, or intravenous)
    corticosteroids within 12 months of signing the Informed Assent
    Form/Informed Consent Form.
    d. The patient has an ACQ-6 score of at least 1.5 at screening (visit 1).
    e. The patient has a blood eosinophil level of at least 300/µL during the
    screening period (ie, before visit 2).(A maximum of 30% of the patients
    with blood eosinophil levels of 300/μL to <400/μL will be enrolled.
    When this 30% threshold has been reached, only patients with blood
    eosinophil levels of ≥400/μL will then be enrolled).
    f. The patient has an FEV1 reversibility of at least 12% after
    administration of inhaled SABA according to standard American Thoracic
    Society (ATS) or European Respiratory Society (ERS) protocol.
    Documented historical reversibility within 12 months of signing the
    Informed Assent Form/Informed Consent Form is acceptable.
    g. The patient has required at least a medium total daily inhaled
    corticosteroid (ICS) dose based on Global Initiative for Asthma 2016
    clinical comparability table (Appendix A) for at least 3 months. For
    ICS/LABA combination preparations, the mid-strength approved
    maintenance dose in the local country will meet this ICS criterion.
    h. The patient has required an additional asthma controller medication
    (eg, long-acting beta-2-agonist[LABA], long-acting muscarinic
    antagonist [LAMA], leukotriene receptor antagonist [LTRA], or
    theophylline preparations), besides inhaled corticosteroids, for at least 3
    months or a documented failure in the past 12 months of an additional
    asthma controller medication for at least 3 successive months.
    i. Females of childbearing potential (not surgically sterile by
    hysterectomy, bilateral salpingectomy, bilateral oophorectomy, 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, bilateral fallopian tube occlusion, and partner
    vasectomy. Contraception is further clarified in an administrative letter
    in Section 1.1.1.
    j. The patient must be willing and able to comply with study restrictions,
    perform requisite procedures and remain at the clinic for the required
    duration during the study period, and be willing to return to the clinic for
    the follow-up evaluation as specified in this protocol.
    k. The patient must maintain their usual asthma controller regimen
    without change throughout the screening and run-in periods. A patient
    who experiences an asthma exacerbation during this time that requires
    additional medication, beyond increased SABA use, will be considered to
    have failed screening/run-in and cannot undergo randomization. A
    patient may be rescreened for this reason 1 time only. The duration
    between the date of Screen Failure and the re-screening must be >30
    days. Patients may be screened again if they did not meet
    spirometry/reversibility criteria initially.
    I. In order to be randomized, a patient must demonstrate the following:
    -- inadequate asthma control at baseline/DoR as evidenced by:
    ○ daytime asthma symptom score >0 on >2 of the previous 7 days
    based on the asthma control diary received at run-in OR
    i) need for reliever SABA use on >2 of the previous 7 days OR
    ii) ≥1 nighttime awakening due to asthma over the previous 7 days OR
    ○ pre-bronchodilator FEV1 <80% predicted at baseline/DoR
    AND
    -- completion of at least 4 days of diary entries or equivalent during the
    last 7 days of run-in. A patient may be rescreened for this reason 1 time
    only.
    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, interpretation of efficacy results, or 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 [EGPA, also known as Churg-Strauss syndrome], or allergic bronchopulmonary aspergillosis [ABPA]).
    c. The patient has a known hypereosinophilic syndrome.
    d. The patient has a diagnosis of malignancy within 5 years of the screening visit, except for treated and cured non-melanoma skin cancers.
    e. The patient is a pregnant or lactating woman, or intends to become pregnant during the study or within 5 months after the last dose of study drug. Any woman becoming pregnant during the study will be withdrawn from the study.
    f. The patient required treatment for an asthma exacerbation within 4 weeks of screening or during the screening/run-in period.
    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 or other monoclonal antibody [eg, mepolizumab] or soluble receptors) or non-biologic (eg, methotrexate or cyclosporine), except maintenance oral corticosteroids for the treatment of asthma (up to and including 10 mg of prednisone daily or equivalent). Note: Previous use of such agents that occurred >5 half-lives from the initial screening visit may be allowed, if approved by the medical monitor.
    i. The patient participated in a clinical trial 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 an immunodeficiency disorder including HIV.
    m. The patient has current or suspected drug and alcohol abuse.
    n. The patient has an active helminthic parasitic infection or was treated for one within 6 months of screening.
    o. The patient has a history of allergic reaction 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 endpoint is the frequency of CAEs per patient during the 52-week treatment period.
    For this study, a CAE is defined as a clinically judged deterioration in asthma control as determined by the
    investigator and as evidenced by new or worsening asthma signs or symptoms based on the patient history, asthma control diary, physical examination, and/or ambulatory or clinic visit assessment of lung function and that results in a medical intervention, including at least 1 of the following:
    -- use of systemic corticosteroids (oral or injection) or at least a doubling from a stable maintenance oral
    corticosteroid dose for at least 3 days
    -- asthma-specific hospital admission
    -- asthma-specific emergency department visit
    Additional medication and/or medical intervention that would satisfy the CAE definition occurring within 7 days of the last day of a prior CAE event will be considered as part of the same event for analysis purposes.
    E.5.1.1Timepoint(s) of evaluation of this end point
    during the 52-week treatment period
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints are as follows:
    1. change in pre-bronchodilator FEV1 from baseline/the day of randomization (DoR) at week 52
    2. change in Asthma Quality of Life Questionnaire for patients 12 years and older (AQLQ +12) score from baseline/DoR at week 52
    3. change in 6-item Asthma Control Questionnaire (ACQ-6) score from baseline/DoR at week 52
    4. change in total asthma symptom scores (day and night) from baseline at week 52
    5. percentage of asthma control days from baseline/DoR to week 52
    6. change in St. George's Respiratory Questionnaire (SGRQ) score from baseline/DoR at week 32
    7. time to first CAE during the 52-week treatment period
    8. frequency of exacerbations requiring hospitalization or emergency
    department visits per patient during the 52-week treatment period
    9. frequency of moderate exacerbations defined as exacerbations requiring additional asthma controller medication that was not a systemic corticosteroid and that did not result
    in an asthma-specific hospitalization or emergency department visit
    during the 52-week treatment period
    E.5.2.1Timepoint(s) of evaluation of this end point
    during the 52-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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA47
    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
    Colombia
    Czech Republic
    Denmark
    France
    Germany
    Greece
    Hungary
    Israel
    Italy
    Japan
    Korea, Republic of
    Mexico
    Netherlands
    New Zealand
    Poland
    Romania
    Russian Federation
    South Africa
    Spain
    Sweden
    Turkey
    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 (week 52). LSLV late follow up for immunogenicity testing only, will be performed 28 weeks (±2 weeks) after the last dose of study drug(approximately week 76). 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 years3
    E.8.9.1In the Member State concerned months9
    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 months9
    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: 60
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 378
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 143
    F.4.2.2In the whole clinical trial 468
    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)
    Following termination of the study, patients should be treated according to the standard of care, and as guided by the Principal Investigator.
    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 Decision2015-10-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-08-05
    P. End of Trial
    P.End of Trial StatusCompleted
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