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    The EU Clinical Trials Register currently displays   44237   clinical trials with a EudraCT protocol, of which   7338   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:2004-000530-37
    Sponsor's Protocol Code Number:24978
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2004-10-11
    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
    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 ConcernedLithuania - SMCA
    A.2EudraCT number2004-000530-37
    A.3Full title of the trial
    A multicentre, randomised, double blind, placebo controlled phase III study of subcutaneously administered onercept in the initial treatment and continued treatment after extended therapy in subjects with moderate to severe plaque psoriasis.
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code number24978
    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 SponsorSerono International S.A.
    B.1.3.4CountrySwitzerland
    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 Information not present in EudraCT
    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 nameonercept
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNonercept
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive namer-hTBP-1 (recombinant human tumour necrosis factor-binding protein-1)
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150 mg / 1.05 ml
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 placeboSolution 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 is an inflammatory skin disorder that affects between 1 and 2% of the population. It is characterised by an increased proliferation of the epidermis, and presents as well-defined thickened erythematous patches typically covered with a silver scale.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.0
    E.1.2Level PT
    E.1.2Classification code 10037153
    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 is to assess the safety and efficacy of an initial 12-week treatment course with onercept 150 mg TIW for the induction of remission in patients with moderate to severe psoriasis, compared to matching placebo.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to assess the safety of continued therapy with onercept for 28 weeks in patients having received an initial 12-week treatment course with onercept 150 mg TIW or placebo and to assess the safety and efficacy of withdrawal of therapy after 28-40 weeks continuous treatment by comparing onercept 150 mg TIW with matching placebo during a 12-week placebo controlled randomised withdrawal period.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Written informed consent, given before any study-related procedure not part of the subject’s normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his or her future medical care.

    2. At least 18 years of age.

    3. Female subjects must be neither pregnant nor breast-feeding, and must lack childbearing potential, as defined by either:·

    Being post-menopausal (i.e. at least 12 months past last menses) or surgically sterile, or
    Using an effective form of contraception (i.e. condoms, oral contraceptives or IUD).
    Confirmation that the subject is not pregnant must be established by a negative urinary hCG test within 7 days before Study Day 1 (SD1). A pregnancy test is not required if the subject is post-menopausal or surgically sterile.

    4. Outpatient status at the time of enrolment.

    5. Plaque psoriasis for at least 12 months.

    6. Plaque psoriasis covering at least 10% of total body surface area and a PASI score of 12.0 or more.

    7. Candidacy for phototherapy or systemic therapy.

    8. Static PGA of 3 or more.
    E.4Principal exclusion criteria
    1. Use of more than one NSAID to treat psoriatic arthritis or having a change in chronic NSAID regimen during the 28 days before SD1. Note for guidance: subjects with psoriatic arthritis who are not expected to be controlled by one stable NSAID regimen throughout the entire duration of the study should not be included.
    Clarification: see amendment 2

    2. Previous systemic treatment with biologics, including interferon and other cytokines/anti?cytokines (e.g. anti-TNF-alpha, anti-CD4, IL-10, IL-1ra, anti-CD11a) within 3 months before SD1

    3. Participation in any other investigational study or experimental therapeutic procedure that is considered to interfere with the study within 3 months before SD1.
    Clarification: see amendment 2

    4. Treated with any systemic corticosteroids or intra-articular corticosteroid injection during the 28 days prior to SD1

    5. Experimental or off-label treatments for psoriasis and/or psoriatic arthritis, such as azathioprine, hydroxyurea/hydroxycarbamide, mycophenolate, chlorambucil, leflunomide or cyclophosphamide, within 1 year prior to SD1

    6. Treatment with cyclosporin, methotrexate, oral retinoids retinoids (i.e acetretin), or fumaric acid esters within 28 days (3 months for acetretin) before SD1

    7. Treatment with any topical therapies, such as vitamin D derivatives, corticosteroids, tars and tar oils, dithranol for chronic or short contact therapy, salicylic acid and topical retinoids, within 14 days before SD1

    8. Phototherapy within 28 days prior to SD1

    9. Use of tanning booths within 14 days before SD1

    10. Abnormal liver function, defined by a total bilirubin ≥ 1.2 times the upper limit of normal values (except in case of Gilbert’s syndrome), or aspartate aminotransferase, alanine aminotransferase or total alkaline phosphatase levels ≥ 2.5 times the upper limit of normal values

    11. Inadequate bone marrow reserve, defined by Leucocytes ≤3.5 x 109/L, thrombocytes ≤100 x 109/L, or Haemoglobin ≤5.5 mmol/L (8.9 g/dL)

    12. Abnormal renal function, defined by serum creatinine >150 micromol/L

    13. Seropositivity for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)
    Clarification: see amendment 2

    14. Planned major surgery within the treatment period of the study

    15. History of cancer in the preceding 5 years (except adequately treated basal cell carcinoma of the skin or squamous cell carcinoma in situ of the skin). Any history of hematopoietic cancer

    16. History of active tuberculosis, current active tuberculosis or candidacy for prophylactic therapy for tuberculosis (see Appendix I for guidance on PPD testing, chest X-ray screening and evaluation of patients at high risk for tuberculosis)

    17. Active severe infection (or non-severe infection at the discretion of the Investigator)

    18. History of any opportunistic infection (e.g., viral, fungal, protozoal, or bacterial) in the 6 months preceding SD1 related to any clinical condition of immunodeficiency

    19. Clinically significant and serious abnormalities on electrocardiography or chest X-ray (at the investigator’s discretion)

    20. Other serious concomitant disorders incompatible with the study. In particular, subjects with congestive heart failure, prior or current history of blood dyscrasia or central nervous system demyelinating disorders should not be included in the study

    21. History of drug (including narcotics) abuse, or current active problems with alcohol abuse

    22. Requirement for immunisation, allergy desensitisation or vaccination during the entire study period (it is recommended that these procedures be scheduled at least 14 days prior to SD 1 or >3 months after the last injection of study drug), with the exception of killed influenza vaccines which are allowed at any time during the study

    23. Guttate, erythrodermic or pustular psoriasis as sole or predominant form of psoriasis

    24. Evidence of skin conditions other than psoriasis (e.g. eczema) that would interfere with psoriasis disease assessments

    25. Clinically significant psoriasis flare during screening or at the time of enrolment necessitating immediate relief (at the Investigator’s discretion)

    26. Live or killed virus or bacteria vaccines within 14 days before SD1, with the exception of killed influenza vaccines which are allowed prior to SD1 and at any time during the study

    27. Bedridden status

    28. Previous use of onercept
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the proportion of subjects with at least a 75% improvement in the Psoriatic Area and Severity Index (PASI) score between baseline (Study Day 1) and week 12 of the First Treatment period (PT).
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    See protocol
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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 Information not present in EudraCT
    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 2004-10-11. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 90
    F.4.2.2In the whole clinical trial 460
    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)
    See protocol
    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 Decision2004-09-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-09-01
    P. End of Trial
    P.End of Trial StatusCompleted
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