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    Summary
    EudraCT Number:2012-001186-33
    Sponsor's Protocol Code Number:20050111
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2012-03-07
    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 number2012-001186-33
    A.3Full title of the trial
    An Open-Label Extension Study to Evaluate the Safety of Etanercept in Pediatric Subjects With Plaque Psoriasis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study evaluating safety in children with childhood plaque psoriasis
    A.4.1Sponsor's protocol code number20050111
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00141921
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/236/2010
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAmgen, Inc. One Amgen Center Drive Thousand Oaks, California 91320
    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 supportAmgen, Inc.
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportPfizer, Inc.
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportAmgen, Inc.
    B.4.2CountryCanada
    B.4.1Name of organisation providing supportPfizer, Inc.
    B.4.2CountryCanada
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen
    B.5.2Functional name of contact pointAmgen Medical Information
    B.5.3 Address:
    B.5.3.1Street AddressNot answered
    B.5.3.2Town/ cityThousand Oaks, California
    B.5.3.3Post code91320
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018007726436
    B.5.5Fax number0018662926436
    B.5.6E-mailmedinfo@amgen.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 Yes
    D.2.1.1.1Trade name Enbrel
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameEnbrel (Etanercept)
    D.3.4Pharmaceutical form Powder and solvent for 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 INNETANERCEPT
    D.3.9.1CAS number 185243-69-0
    D.3.9.4EV Substance CodeSUB01984MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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.IMP: 2
    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 Yes
    D.2.1.1.1Trade name Enbrel
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameEnbrel (Etanercept)
    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 INNETANERCEPT
    D.3.9.1CAS number 185243-69-0
    D.3.9.4EV Substance CodeSUB01984MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    Pediatric plaque psoriasis
    E.1.1.1Medical condition in easily understood language
    Plaques psoriasis in children
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10037153
    E.1.2Term Psoriasis
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue 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 was to evaluate the safety of long-term administration of etanercept in pediatric subjects with moderate to severe plaque psoriasis.
    E.2.2Secondary objectives of the trial

    The secondary objective was to evaluate the long-term efficacy of etanercept administration in pediatric subjects with moderate to severe plaque psoriasis
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Subjects must have met one of the following conditions on the original study 20030211
    o Complete the week 48 visit on the original study 20030211
    o Complete at least the week 12 visit on the original study 20030211 and have received benefit from the investigational product therapy as demonstrated by achieving ≥PASI 50 on or after week 12.
    • Heterosexual active male and female subjects must practice a method of birth control (considered effective and medically acceptable by the investigator) during the study, including screening.
    • An adult must be available to assist with administering SC injections of etanercept and/or subjects must be capable of performing self-injection technique, in the judgement of the investigator.
    • Before any study-specific procedure, the appropriate written informed consent and asset must be obtained
    • Subjects entering the study following an interruption of investigational product administration > 4 weeks between the last dose on the original study 20030211 and the first dose on this exension study 20050111, must meet the following additional criteria
    o No active guttate, erythrodermic, or pustular psoriasis during the screening period
    o No presence of a grade 3 or 4 infection≤ 30 days before the first screening visit or during the screening period
    o ALT or AST ≤ 2.0 times the upper limit of normal for the age range
    o Creatinine ≤ 1.5 times the upper limit of normal for the age range
    o White blood cell count ≥2.0 x 109/L.
    o Hemoglobin ≥ 8.5 g/dL
    o Platelet count≥ 150 x 109/L.
    o Female subjects of childbearing potential must have negative serum pregnancy test at screening and a urine pregnancy test at day 1. A female subject of childbearing potential is defined as a female who has had at least one menstrual period, regardless of age.
    E.4Principal exclusion criteria
    • Any serous adverse event reported during the original study 20030211 and considered to be related to investigational product
    • Any grade 3 or 4 adverse event reported during the original study 20030211 and considered related to study drug must be discussed between Amgen and the investigator
    • Receipt of PUVA, UVB, UVA, systemic psoriasis therapy other than etanercept (eg: methotrexate, cyclosporine), parenteral corticosteroids, oral corticosteroids, or potent topical steroids ≤ 14 days before the first dose on this extension study 20050111. Poteent topical steroids are defined as greater than moderate strength according to the package insert.
    • Receipt of systemic biologics or investigational product(s) other than etanercept (eg: Raptiva, Amevive) ≤ 30 days before the first dose on this extension study 20050111.
    • Receipt of live attenuated vaccines ≤12 weeks prior to the first dose on this extension study 20050111 (eg: MMR, Varicella, or intranasal influenza vaccine [Flumist®]).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint was the occurrence of adverse events, including infectious episodes, serious adverse events, and serious infectious episodes.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every three months
    E.5.2Secondary end point(s)
    Secondary endpoints included:
    • Psoriasis Area and Severity Index (PASI) 50, PASI 75, PASI 90 response, percent improvement from Study 20030211 baseline in PASI score, Static Physician Global Assessment (sPGA), clear and clear/almost clear status of sPGA, percent improvement fro Study 20030211 baseline in Children’s Dermatology Life Quality Index (CDLQI), percent improvement from Study 20030211 baseline in CDLQI subscales, improvement from Study 20030211 baseline in joint pain.
    • Secondary safety endpoints included injections site reactions, exposure-adjusted event rates for adverse events, infections, and injection site reactions, physical examination including height and weight, vital signs, and laboratory toxicity based on the common toxicity criteria (CDC). Antinuclear antibody and anti-etanercept antibody formation.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Every three months except for urinanalysis (every 6 months) and antinuclear/anti-etanercept antibody (completed at weeks 48, 96, 144 and 168)
    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 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 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
    Canada
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days7
    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: 152
    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: 49
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 103
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Less than 18 years old. Parent/Guardian signature required
    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 182
    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)
    Please refer to protocol
    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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