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    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2006-006601-83
    Sponsor's Protocol Code Number:P04481
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-03-20
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2006-006601-83
    A.3Full title of the trial
    A Study to Assess the Clinical Effects of SCH 527123 in Psoriasis.
    A.4.1Sponsor's protocol code numberP04481
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    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 Corp.
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameSCH 527123
    D.3.2Product code SCH 527123
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 862464-58-2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 placeboCapsule*
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Psoriasis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10037153
    E.1.2Term Psoriasis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the clinical effect of SCH 527123 on the Psoriasis Activity and Severity Index (PASI) in patients with psoriasis.
    E.2.2Secondary objectives of the trial
    (1) To investigate the effects of SCH 527123 on the Physician's Global Assessment (PGA) of psoriasis activity;
    (2) To investigate the safety and tolerability of SCH 527123 in psoriatic patients;
    (3) To determine the multiple-dose pharmacokinetics of SCH 527123 in patients with psoriasis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ● Subjects must have a diagnosis of psoriasis vulgaris (PASI >8) which must be established and must have been present for at least 1 year. Subjects with an on-therapy PASI ≤8 at Screening may be considered for inclusion. These subjects must be discussed with the Sponsor prior to enrollment and the subject must have indicated that they are not satisfied and are considering changing their current therapy. To be included, subjects must have a PASI >8 following washout of their current psoriasis therapy.
    ● The target lesion selected must be located on the head, trunk, arms or legs and be at least 10 cm^2 in size.
    ● The selected target lesion’s total numerical ratings for erythema, infiltration, and desquamation must be at least 6 out of the possible 12 using the following definitions for each sign: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe. The severity score for desquamation must be at least 2.
    ● Vital sign measurements (taken after ~3 minutes in a supine position) must be within the following ranges:
    a. oral body temperature between 35.0 C to 37.5 C
    b. systolic blood pressure, 90 to 160 mm Hg
    c. diastolic blood pressure, 45 to 90 mm Hg
    d. pulse rate, 40 to 100 bpm
    ● Subjects must have stable disease (ie, the off treatment PASI during Screening period and Baseline PASI should not differ by more than 40%).
    ● Subjects’ clinical laboratory tests (CBC, blood chemistries, and urinalysis) must be within normal limits or clinically acceptable to the investigator/sponsor. Subjects must have a neutrophil count of at least 2 x 10^9/L to be included.
    ● Subjects must be free of any clinically significant disease (other than psoriasis) that would interfere with the study evaluations and/or study safety.
    ● Subjects must be willing to give written informed consent and able to adhere to dose and visit schedules.
    ● For females subjects:

    Female subjects of childbearing potential must have a negative serum pregnancy test (beta-hCG) at Screening and have a negative urine pregnancy test throughout the study.

    a. Women of childbearing potential must agree to use medically accepted methods of contraception during and for an appropriate pre-study period (hormonal contraceptives or IUD), while receiving protocol-specified medication, and for 1 month after stopping the medication.

    Acceptable methods of contraception include 2 of the following:
    oral/transdermal/injectable hormonal contraceptives, intrauterine device with spermicide, or hormonal estrogen/progesterone oral contraceptives.

    A stable oral contraceptives regimen must have been used without uterine bleeding for 2 months prior to Screening. An intrauterine device must have been inserted at least 2 months prior to Screening. Females of childbearing potential should be counseled in the appropriate use of birth control while in this study and one additional method listed must also be used.

    condoms (male or female) with spermicide,
    diaphragm or cervical cap with spermicide,

    Vasectomy of the partner should be considered a single barrier contraceptive and one additional contraceptive method listed above must be used.

    Females who are not currently sexually active must agree and consent to use 2 of the above-mentioned methods should they become sexually active while participating in the study,

    OR

    b. Female subjects of non childbearing potential must be surgically sterilized (eg, documented hysterectomy or tubal ligation) or be postmenopausal (defined as 12 months with no menses and with an estradiol level of <30 pg/mL).

    ● Male subjects must agree to use an adequate form of contraception for the duration of the study and agree to have sexual relations only with women using medically acceptable forms of contraception
    E.4Principal exclusion criteria
    ● Female subjects who are pregnant, intend to become pregnant (within 3 months of ending the study), or are breastfeeding.
    ● Subjects who, in the opinion of the investigator, will not be able to participate optimally in the study.
    ● Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug. The investigator should be guided by evidence of any of the following and be discussed with the sponsor prior to enrollment into the trial:
    a. history or presence of inflammatory bowel disease, ulcers, gastrointestinal or rectal bleeding
    b. history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection;
    c. history of pancreatic injury or pancreatitis;
    d. history or presence of liver disease or liver injury;
    e. history or presence of impaired renal function as indicated by abnormal creatinine, urinary albumin, BUN/urea or clinically significant urinary cellular constituents (eg, cast); or
    f. history of urinary obstruction or difficulty in voiding.
    ● Subject who has a history of any infectious disease within 4 weeks prior to drug administration.
    ● Subjects who are positive for hepatitis B surface antigen, hepatitis C antibodies or HIV.
    ● Immunocompromised subjects.
    ● Subjects who have a positive screen for drugs with a high potential for abuse (eg. opiates, cocaine, THC, etc).
    ● Subjects with a history of mental instability or who have been treated for mood disorders.
    ● Subjects with a history of alcohol or drug abuse in the past 2 years.
    ● Subjects who have previously received this compound.
    ● Subjects who are currently participating in another clinical study or have participated in a clinical study within 30 days.
    ● Subjects who are part of the study staff personnel or family members of the study staff personnel.
    ● Subjects who have demonstrated clinically significant (requiring intervention - eg, emergency room visit, epinephrine administration, etc) allergic reactions (eg, food, drug, atopic reactions or asthmatic episodes) or who are known to be allergic to components of local anesthetics, such as lidocaine.
    ● Subjects who have received any treatment listed below more recently than the indicated washout period prior to Randomization. All prescription medications should be discussed with the sponsor to determine if they can be continued throughout the study.

    Prohibited Medications

    methotrexate, cyclosporine or systemic retinoids (washout prior to randomization – 4 weeks)
    Biologics (washout prior to randomization – 3 months)
    Topical anti-psoriasis therapy (washout prior to randomization – 2 weeks)
    Phototherapy (washout prior to randomization – 4 weeks)
    All other OTC medications (excluding paracetamol) including vitamins, herbal supplements, homeopathic or over the counter medications (washout prior to randomization – 2 weeks)

    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study will be the percent change from baseline to Day 29 PASI score. Mean percent change from Baseline in Day 29 PASI score for each treatment will be compared using a one-way ANOVA model extracting the effect due to treatment. The mean and 95% confidence intervals will be provided for each treatment group as well as the difference between SCH 527123 and placebo. The last post-baseline observation will be carried forward for subjects who withdraw from the study.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    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.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months4
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2007-03-20. Yes
    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 30
    F.4.2.2In the whole clinical trial 30
    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 Decision2007-04-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-05-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-10-31
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