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    Summary
    EudraCT Number:2017-002060-40
    Sponsor's Protocol Code Number:C38072-AS-10069
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2017-07-11
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2017-002060-40
    A.3Full title of the trial
    A Single-Dose, Open-Label, Parallel Group Study to Characterize the Pharmacokinetics, Pharmacodynamics, Immunogenicity, Safety, and Tolerability of Reslizumab Following Subcutaneous Administration in Children with Asthma (6 to Less Than 12 Years of Age)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Single-Dose, Open-Label, Parallel Group Study to Characterize the Pharmacokinetics, Pharmacodynamics, Immunogenicity, Safety, and Tolerability of Reslizumab Following Subcutaneous Administration in Children with Asthma (6 to Less Than 12 Years of Age)
    A.4.1Sponsor's protocol code numberC38072-AS-10069
    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
    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.5.3.4CountryUruguay
    B.5.4Telephone number34911910626
    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.3.9.3Other descriptive nameRESLIZUMAB
    D.3.9.4EV Substance CodeSUB96120
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number33 to 110
    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
    Asthma
    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 20.0
    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 evaluate the pharmacokinetics and pharmacodynamics of reslizumab in pediatric patients with asthma 6 to less than 12 years of age following administration of a single subcutaneous (sc) dose.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to evaluate the immunogenicity, safety, and tolerability of reslizumab in pediatric patients with asthma 6 to less than 12 years of age following administration of a single sc dose.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a. Written informed consent (signed and dated) is provided by parent(s)/guardian(s) (in accordance with local regulations) before conducting any study-related procedure. Written informed assent is to be provided by children.
    b. The patient has a body weight within 2 standard deviations (SDs) from the mean for their age and sex.
    c. The patient is 6 to less than 12 years old with a current diagnosis of asthma.
    d. The patient has been taking an inhaled corticosteroid or leukotriene inhibitor (eg, montelukast) for at least 30 days prior to screening. Patients are allowed to be on additional asthma controllers (eg, long acting β-agonist).
    e. The patient is in otherwise good health (except for the diagnosis of asthma).
    f. The patient has a blood eosinophil level of at least 150 x 106/L at screening.
    g. Female patients who are postmenarche or sexually active must have a negative pregnancy test result, must have exclusively same sex partners or be using a highly effective method of birth control, and must agree to continued use of this method for 30 days prior to the study, for the duration of the study, and for 5 months after the dose of study drug. Highly effective methods of birth control are defined as those, alone or in combination, that result in a low failure rate (ie, <1% per year) when used consistently and correctly. Highly effective methods of birth control in this study include: combined (estrogen and progestogen containing) or progestogen only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone releasing system, bilateral tubal occlusion, vasectomized partner, and sexual abstinence.
    h. The patient has negative alcohol test and urine drug screen (UDS) results. A positive UDS result with appropriate medical explanation may be permitted after consultation with the medical monitor.
    I. The patient and parent(s)/guardian(s) are willing and able to comply with all study restrictions, perform required procedures, report to the study center for the required visits and remain at the study center for the required durations.
    E.4Principal exclusion criteria
    a. The patient has any clinically significant medical history or current uncontrolled medical condition (treated or untreated) that would interfere with the study schedule or procedures, interpretation of results, or compromise the patient’s safety. This includes clinically uncontrolled asthma, in the judgment of the investigator.
    b. The patient is anemic (hemoglobin <lower limit of normal–2.0 g/dL).
    c. The patient has known hypereosinophilic syndrome.
    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], allergic bronchopulmonary aspergillosis, or autoimmune disease).
    e. The patient has a history of near-fatal asthma (an episode that required intubation and/or was associated with hypercapnia, respiratory arrest, or hypoxic seizures) at any time in the past.
    f. The patient is currently using any systemic immunosuppressive treatment or immunomodulatory biologic (eg, anti-IgE monoclonal antibody, other monoclonal antibodies or soluble receptors), non biologic (eg, methotrexate, cyclosporine, or maintenance oral corticosteroids), or allergen immunotherapy.
    g. The patient has received an investigational drug within 30 days or 5 half-lives prior to the dose of study drug. For a new chemical entity or biologic product, the patient has received the product within 3 months or 5 half-lives prior to the dose of study drug, whichever is longer.
    h. The patient has a positive test result for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C virus.
    i. The patient has an active helminthic parasitic infection or was treated for one within 6 months prior to screening. Patients who live with anyone that currently has a helminthic parasitic infection or was treated for one within 6 months are also excluded.
    j. The patient has a known or suspected hypersensitivity or idiosyncratic reaction to anti interleukin 5 (anti-IL-5) antibodies, any compound present in the study drug, or monoclonal antibodies.
    k. The patient has previously been exposed to reslizumab or any other anti IL 5 treatment.
    l. The patient is, in the opinion of the investigator or designee, considered unsuitable or unlikely to comply with the study protocol for any other reason.
    E.5 End points
    E.5.1Primary end point(s)
    Blood samples for eosinophil measurement and determination of serum reslizumab concentrations will be collected prior to and over 12 weeks after administration of reslizumab

    E.5.1.1Timepoint(s) of evaluation of this end point
    Days 1, 3, 7, 14, 28, 56, 84
    E.5.2Secondary end point(s)
    Blood samples to test for the presence of ADAs will be collected prior to and over 12 weeks after administration of reslizumab
    E.5.2.1Timepoint(s) of evaluation of this end point
    Days 1, 14, 28, 56, 84
    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 No
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Pharmacokinetics, Pharmacodynamics, Immunogenicity, Safety, and Tolerability Study
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    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.8.2.4Number of treatment arms in the trial3
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years1
    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: 36
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 36
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 36
    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
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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