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    The EU Clinical Trials Register currently displays   39795   clinical trials with a EudraCT protocol, of which   6532   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2009-017272-24
    Sponsor's Protocol Code Number:P05495
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-08-16
    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 ConcernedGermany - PEI
    A.2EudraCT number2009-017272-24
    A.3Full title of the trial
    Randomized, Double-Blinded, Placebo-Controlled, Parallel-Design,
    Dose-Range Finding Study of Subcutaneous SCH 900222 in Subjects
    with Moderate-to-Severe Chronic Plaque Psoriasis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dose Range Finding Study of Subcutaneous SCH900222
    in Subjects with Moderate to Severe Chronic Psoriasis
    A.4.1Sponsor's protocol code numberP05495
    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 SponsorSchering-Plough Research Institute, a Division of Schering Corporation
    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 supportSchering-Plough Research Institute, a Division of Schering Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSchering-Plough Research Institute, a Division of Schering Corporation
    B.5.2Functional name of contact pointRichard S. Shames, MD
    B.5.3 Address:
    B.5.3.1Street Address901 California Avenue
    B.5.3.2Town/ cityPalo Alto, CA
    B.5.3.3Post code94306
    B.5.3.4CountryUnited States
    B.5.4Telephone number0016504961191
    B.5.5Fax number0016504966808
    B.5.6E-mailrichard.shames@merck.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 nameAnti IL-23 Monoclonal Anitbody
    D.3.2Product code SCH 900222
    D.3.4Pharmaceutical form Powder 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 INNAnti-Human Interleukin-23 Monoclonal Antibody
    D.3.9.2Current sponsor codeSCH 900222
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboPowder for solution 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
    Psoriasis
    E.1.1.1Medical condition in easily understood language
    Psoriasis
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    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 of Part 1 (Weeks 0 to 16) is to evaluate the optimal dose regimen of SCH 900222 to induce PASI 75 response at Week 16 in subjects with moderate-to-severe psoriasis.The primary objective of Part 2 (Weeks 16-52) is to evaluate the optimal dose regimen to maintain PASI 75 response at Week 52. The primary objective of Part 3 (Weeks 52-72) is to assess the duration of effect of SCH 900222 as determined by the time at which the Week 52 improvement from baseline is reduced by > 50% (ie, disease relapse). The primary safety objective is to assess the safety/tolerability of multiple-dose administration of SCH 900222.
    E.2.2Secondary objectives of the trial
    Assess efficacy as defined by PASI 75 at Week 12. Assess efficacy as defined by PGA at Week 16.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A subject must meet all the criteria listed below to participate in the trial.
    1. Ability to understand the purpose and risks of the trial, willingness and ability
    to comply with the protocol, provide written informed consent in accordance
    with institutional and regulatory guidelines, and, for subjects at US sites,
    authorization to use protected health information (Health Insurance Portability
    and Accountability Act [HIPAA]).
    2. Subject must be ≥18 years of age. A subject may be of either sex and of any
    race/ethnicity.
    3. Diagnosis of predominantly plaque psoriasis for ≥6 months (as determined by
    subject interview and confirmation of diagnosis through physical examination
    by investigator).
    4. Subject is considered to be a candidate for phototherapy or systemic therapy.
    5. PASI score ≥12 at Baseline.
    6. Psoriasis BSA involvement ≥10% at Baseline.
    7. PGA of at least moderate disease (moderate, marked, or severe) at Baseline.
    8. Subject is considered to be eligible according to the following tuberculosis
    (TB) Screening criteria:
    a. Has no history of untreated latent or active TB prior to Screening.
    Prophylactic treatment for latent TB (as per local guidelines) must be
    initiated at least 4 weeks prior to first administration of study medication.
    b. Has no signs or symptoms suggestive of active TB upon medical
    history and/or physical examination.
    c. Has had no recent close contact with a person with active TB or, if
    there has been such contact, will be referred to a physician
    specializing in TB to undergo additional evaluation and, if warranted,
    receive appropriate treatment for latent TB prior to or simultaneously
    with the first administration of study medication.
    d. Within 4 weeks prior to the first administration of study medication,
    either has negative diagnostic TB test results (defined as a negative
    tuberculin skin test or a negative QuantiFERON-TB Gold test.
    e. A subject who has a positive intradermal skin test or positive
    QuantiFERON gold TB test, or who has had recent close contact with
    a person with active TB, or has signs or symptoms suggestive of active
    TB upon medical history and/or physical examination, must have a
    negative chest CT scan taken within 4 weeks of the first administration
    of study medication. The scan must be read by a qualified radiologist,
    and must have no evidence of current active TB or old inactive TB.
    9. Subject is unlikely to conceive, as indicated by at least one “yes” answer to
    the following questions:
    a. Subject is a male.
    b. Subject is a surgically sterilized female.
    c. Subject is a postmenopausal female ≥45 years of age with >1year
    since last menses.
    d. Subject is a non-sterilized, premenopausal female and agrees to
    abstain from heterosexual activity OR use double barrier contraception
    (ie, condom with spermicide or has a vasectomized partner PLUS oral,
    intramuscular or implanted contraceptives, diaphragm with spermicide,
    contraceptive sponge, intrauterine device [IUD]) OR use appropriate
    double barrier contraception as per local regulations or guidelines.
    10. For women of childbearing potential, a negative serum pregnancy test at
    Screening and a negative urine pregnancy test within 24 hours prior to the
    first dose of study medication.
    11. Subject must have results of clinical laboratory tests (complete blood count
    [CBC], blood chemistries, and urinalysis) within normal limits or clinically
    acceptable to the investigator and medical monitor (or appropriate designee)
    prior to the first dose of study medication.
    12. Subject must have results of a physical examination, including blood
    pressure, within normal limits or clinically acceptable limits to the investigator
    and medical monitor (or appropriate designee) prior to the first dose of study
    medication.
    13. To participate in the pharmacogenomics analysis, skin biopsies, or whole
    body photography, the subject must be willing to give written informed
    consent for these procedures and be able to adhere to dose and visit
    schedules. Note: A subject unwilling to consent to these procedures may be
    included in the trial; however, pharmacogenomic samples, skin biopsies
    and/or whole body photography must not be obtained.
    E.4Principal exclusion criteria
    A subject meeting any of the exclusion criteria listed below must be excluded
    from participating in the trial:
    1. Presence of nonplaque forms of psoriasis specifically erythrodermic psoriasis,
    predominantly pustular psoriasis, medication-induced or medicationexacerbated
    psoriasis, or new onset guttate psoriasis.
    2. Subject who will require oral or injectable corticosteroids during the trial.
    3. Presence of any infection requiring treatment with systemic antibiotics within 2 weeks
    prior to Screening, or serious infection (eg, pneumonia, cellulitis, bone or joint
    infections) requiring hospitalization or treatment with IV antibiotics within
    8 weeks prior to Screening.
    4. Women of childbearing potential who are pregnant, intend to become
    pregnant (within 6 months of completing the trial), or are lactating.
    5. Positive human immunodeficiency virus (HIV) test result, hepatitis B surface
    antigen, or hepatitis C test result.
    6. Prior malignancy or concurrent malignancy (excluding successfully treated
    basal cell carcinoma, squamous call carcinomaof the skin in situ, squamous call carcinoma with no evidence of recurrence within 5 years, or carcinoma in situ of the cervix that has been
    adequately treated).
    7. Subject who has received live virus vaccination within 4 weeks prior to
    Baseline or who intends to receive live virus vaccination during the trial.
    8. Previous exposure to any agents targeting IL-12 and/or IL-23.
    9. Subject with prior exposure to two or more TNF antagonists with
    discontinuation due to lack of efficacy.
    10. Subject who is currently participating in another interventional clinical trial or
    have participated in an interventional clinical trial within 4 weeks prior to
    Screening. Note: Subjects participating in observational studies or noninterventional
    registry studies may be included in the study.
    11. The subject or a family member is among the personnel of the investigational
    or sponsor staff directly involved with this trial.
    12. Within 6 months prior to Screening, any significant organ dysfunction,
    including cardiac (see below), renal, liver, central nervous system, pulmonary,
    vascular, gastrointestinal, endocrine, psychiatric, ophthalmologic, or
    metabolic conditions or clinically significant laboratory abnormalities that
    place the subject at unacceptable risk for participation in a trial of an
    immunomodulatory therapy in the judgment of the investigator and sponsor.
    However, if the subject has significant organ dysfunction or exceeds the
    ranges below, the investigator should confer with the medical monitor (or
    appropriate designee) regarding study enrollment:
    a. absolute neutrophil count <1500/mm3
    b. platelet count <100,000/mm3
    c. hemoglobin <11 g/dL
    d. creatinine ≥1.5 x the upper limit of normal (ie, ≥133 ╬╝mol/L)
    e. alanine transaminase (ALT [SGPT]) or aspartate transaminase (AST
    [SGOT]) ≥2.5 x the upper limit of normal
    13. History of myocardial infarction, congestive heart failure (New York Heart
    Association [NYHA] Class 3 or 4), uncontrolled arrhythmias, cardiac
    revascularization, stroke, uncontrolled hypertension, or uncontrolled diabetes
    within 6 months of Screening.
    14. Subject who, in the opinion of the investigator, will not be able to participate
    optimally in the trial.
    15. Subject with a history of alcohol or drug abuse in the previous 2 years.

    16. Subject who has received any of the medications listed below within the
    indicated washout period prior to randomization:
    Prohibited Medications, Supplements, and Other Substances for Entry Into the Trial
    Prohibited Medications, Supplements, and Other Substances
    a) Topical psoriasis treatment (excluding class VI or VII low-potency topical
    corticosteroids such as prednicarbate 0.05%, triamcinolone acetonide
    0.025%, fluocinolone acetonide 0.01%, desonide 0.05%, hydrocortisone
    2.5% or hydrocortisone 1%)--2 weeks washout period prior to randomization
    b) Conventional systemic psoriasis therapy (eg, cyclosporine, methotrexate,
    acitretin, fumaric acid esters) or phototherapy (eg, UV-B light
    phototherapy, Psoralen-UV therapy, tanning salon or home-administered
    UVB) --4 weeks washout period prior to randomization
    c) Treatment with a biological agent (including monoclonal antibodies,
    etanercept, alefacept) --12 weeks washout period prior to randomization
    d) Treatment with a non-biological investigational agent--4 weeks washout period prior to randomization
    e) Treatment with a biological investigational agent--12 weeks (or 5 half-lives,
    whichever is greater) washout period prior to randomization
    Note: Subjects with current or history of severe psoriatic arthritis who are well-controlled on their current therapy should not be included in the study.
    E.5 End points
    E.5.1Primary end point(s)
    1) Primary Efficacy Endpoint for Part 1: PASI 75 response (ie, proportion of subjects with greater than or equal to 75 % improvement in PASI from Baseline) at week 16.
    2) Primary Efficacy Endpoint for Part 2: PASI 75 response at week 52.
    3) Primary Efficacy Endpoint for Part 3: the time at which the Week 52 improvement from baseline in PASI score is reduced by greater than 50% in subjects who attain PASI 75 at endpoint of Week 52.

    Primary Safety Endpoints:
    1) Percent of subjects with serious infections, defined as any infection meeting the regulatory definition of a serious adverse event, or any infection requiring IV antibiotics whether or not reported as a serious event, as per the regulatory definition.
    2) Percent of subjects with malignancies
    3) Percent of subjects with major cardiovascular adverse events including nonfatal stroke, non-fatal myocardial infarction or cardiovascular death
    4) Percent of subjects with injection site reactions.
    5) Percent of subjects with drug-related hypersensitivity reactions
    -Adjudication of major cardiovascular events will be conducted by external panels. Additional CRFs will be used to record more detailed data following
    occurrence of malignancies and serious infections.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) Baseline and Week 16
    2) Week 16 and Week 52
    3) Baseline and Week 52

    Safety endpoints
    Baseline through Week 52
    E.5.2Secondary end point(s)
    1) PASI 75 response at Week 12.
    2) Proportion of subjects with PGA "cleared" or "minimal" at Week 16
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Baseline and Week 12
    2) Baseline and Week 16
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.7.1Other trial design description
    Third party blind - open to IMP preparer, blinded to physician, patient and sponsor
    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 trial5
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA31
    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
    Austria
    Belgium
    Canada
    Denmark
    Finland
    France
    Germany
    Hungary
    Japan
    Norway
    United Kingdom
    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
    The overall trial ends when the last remaining subject has ended participation in the trial, by completing the trial, being discontinued from the trial, or being lost to follow-up.
    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 months6
    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 months6
    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 No
    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) No
    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: 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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 280
    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)
    The dosing period for this study is 52-weeks followed by discontinuation of study drug with a 20-week observational period where no study medication is administered. There are no current plans to extend treatment for subjects beyond 1 year in the 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 Decision2011-01-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-10-24
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