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    Summary
    EudraCT Number:2016-004661-23
    Sponsor's Protocol Code Number:C38072-AS-30066
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-02-14
    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 number2016-004661-23
    A.3Full title of the trial
    An Open-Label Extension Study of Reslizumab 110-mg Fixed, Subcutaneous Dosing in Patients 12 Years of Age and Older with Severe Eosinophilic Asthma
    A rögzített 110 mg adagban, szubkután alkalmazott reslizumab nyílt, kiterjesztett vizsgálata legalább 12 éves, súlyos eozinofil asztmában szenvedő betegeknél
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Reslizumab Subcutaneous Dosing in Patients 12 Years of Age and Older with Severe Eosinophilic Asthma
    A.4.1Sponsor's protocol code numberC38072-AS-30066
    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 pointVanessa Miranda
    B.5.3 Address:
    B.5.3.1Street Address929 N.Front Street
    B.5.3.2Town/ cityWilmington, NC
    B.5.3.3Post code28401
    B.5.3.4CountryUnited States
    B.5.4Telephone number+19105587522
    B.5.5Fax number+19196542400
    B.5.6E-mailVanessa.Miranda@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
    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 support the long-term safety of reslizumab 110 mg administered sc once every 4 weeks in patients 12 years of age and older with severe eosinophilic asthma whose asthma is inadequately controlled on standard-of-care treatment.
    E.2.2Secondary objectives of the trial
    The secondary objective of this study is to evaluate the efficacy of reslizumab 110 mg administered sc once every 4 weeks in patients 12 years of age and older with severe eosinophilic asthma that is inadequately controlled on standard-of-care treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients may only be included in the study 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. Male or female patient 12 years or older with eosinophilic asthma who was previously randomized and completed the treatment period in either of the double-blind, placebocontrolled studies (Study 30025 or 30027) for sc reslizumab and who by the assessment of the Principal Investigator can safely participate in this study.

    Adolescents from Study 30025 must also complete the early follow-up visit before being eligible for this study.

    c. Unless surgically sterile or postmenopausal, female patients must have a negative urine pregnancy test at baseline. Definitions of sterile and postmenopausal are given in Protocol Appendix E.

    d. Females of childbearing potential (not surgically sterile or postmenopausal) must have an exclusively same-sex partner or use a medically acceptable method of contraception and must agree to continue the use of this method for the duration of the study and for 5 months after discontinuation of the study drug. Acceptable methods of contraception include intrauterine device, steroidal contraceptive (oral, implanted, transdermal, or injected), barrier method with spermicide, abstinence, bilateral tubal occlusion, and partner vasectomy.

    e. The patient must be willing and able to comply with study restrictions and willing to return to the investigational center for the follow-up procedures and assessments as specified in this protocol.
    E.4Principal exclusion criteria
    Patients will be excluded from participating in this study if they meet any of the following criteria:

    a. Patient has received any intravenous or sc reslizumab administration in any previous clinical trial other than Studies 30025 and 30027.

    b. Patient withdrew early (discontinued from treatment) from either of the placebocontrolled reslizumab studies, Studies 30025 and 30027, for any reason.

    c. 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.

    d. 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).

    e. The patient has a known/diagnosed hypereosinophilic syndrome.

    f. The patient has a diagnosis of malignancy within 5 years of the screening visit, except for treated and cured non-melanoma skin cancers.

    g. 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. Administration of IMP will be discontinued for any female patient who becomes pregnant during the study.

    h. The patient required treatment for an asthma exacerbation within 4 weeks of screening or during the screening. (Note: This is required only in patients who did not rollover seamlessly from Study 30025 or 30027, ie, had a gap between placebo-controlled study
    EOT and screening for Study 30066 [including adolescents from Study 30025 who must also complete the early follow-up visit].)

    Patients who did not rollover seamlessly from Study 30025 or 30027 may be considered for rescreening if they are excluded from study participation for not satisfying this criterion. A patient may be rescreened for this reason 1 time only. The duration between
    the first visit during the screening period and the rescreening must be >30 days.

    i. The patient is a current smoker (ie, has smoked within the last 6 months before screening) or has a smoking history ≥10 pack-years.

    j. The patient is currently using any systemic immunosuppressive or immunomodulatory biologic (eg, anti-immunoglobulin E monoclonal antibody [mAb] or other mAb [eg, mepolizumab, benralizumab, dupilumab] or soluble receptors) or non-biologic (eg, methotrexate or cyclosporine), except maintenance oral corticosteroids for the treatment of asthma (up to and including 40 mg of prednisone daily or equivalent every-other-day dosing). Note: Previous use of such agents that occurred >5 half-lives from the initial screening visit may be allowed.

    k. The patient participated in a clinical study other than approved Teva reslizumab studies within 30 days or 5 half-lives of the investigational drug before screening, whichever is longer.

    l. The patient has a history of an immunodeficiency disorder including human immunodeficiency virus (HIV).

    m. The patient has current or suspected drug and/or 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 is expected to be poorly compliant with study procedures or visits.

    q. The patient is a vulnerable patient (eg, a patient who is or may be for any reason unable to take care of himself or herself, unable to protect himself or herself against significant harm or exploitation, or kept in detention).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the frequency of adverse events including serious adverse events.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Patient counts and percentages will be provided for the frequency of patients with at least 1 adverse event.
    E.5.2Secondary end point(s)
    The secondary safety endpoints for this study include the following:
    - clinical laboratory test results
     - hematology and chemistry results at baseline and at weeks 4 (chemistry only), 8, 24, and 36 or early withdrawal visit
    - local tolerability at the injection site at approximately 1 hour after study drug administration every 4 weeks throughout the study
    - vital signs measurements every 4 weeks throughout the study
    - concomitant medication usage every 4 weeks throughout the study

    The secondary efficacy endpoints for this study include the following:
    - clinical asthma exacerbation (CAE) and healthcare utilization (HCU)-related endpoints
     - frequency of CAEs
     - frequency of asthma-specific hospital admissions
     - length of hospital stay and number of ICU days
     - frequency of asthma-specific emergency department visits
     - frequency of school/work days missed due to asthma
    - change from baseline in pre-bronchodilator FEV1 measured using spirometry at weeks 0, 8, 24, and 36 or early withdrawal visit
    - change in daily morning ambulatory FEV1 from baseline at each week through week 36 or early withdrawal, as measured by the handheld spirometry device
    - absolute and percent reduction in the daily OCS dose at weeks 20 and 36 or early withdrawal visit as compared with the dose at baseline (for patients on daily OCS at baseline)
    - change from baseline in total inhalations of reliever bronchodilator medication (eg, short-acting beta-agonist) measured using weekly averages until week 36 or early withdrawal visit
    - change from baseline in ACQ-6 score performed at weeks 0, 8, 24, and 36 or early withdrawal visit
    - change from baseline in AQLQ12+ score performed at weeks 0, 8, 24, and 36 or early withdrawal visit
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary safety endpoints include clinical laboratory tests, local site reactions, vital signs measurements, and concomitant medication usage. Secondary efficacy endpoints include CAE and HCU-related events, change from baseline in pulmonary function tests, absolute and percent reduction in the daily OCS dose (for patients on daily OCS at baseline), change from baseline in total inhalations of reliever bronchodilator medication (eg, SABA), and change from baseline in patient-reported outcome questionnaires (ACQ-6 and AQLQ12+).
    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 No
    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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA91
    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
    Belgium
    Canada
    Czech Republic
    France
    Germany
    Hungary
    Israel
    Poland
    Romania
    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 Patient Last Visit (LPLV) of the treatment period is defined as the EOT. The EOS visit for immunogenicity testing only will be performed 19 weeks (±2 weeks) after the final dose of study drug (approximately week 51). 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 days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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: 25
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 320
    F.1.3Elderly (>=65 years) Yes
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 276
    F.4.2.2In the whole clinical trial 360
    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 should be treated with standard-of-care treatment after withdrawal from or withdrawal of the study, as appropriate.

    Patients will return to the care of their primary physician and/or asthma specialist after the end of this 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 Decision2017-04-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-29
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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