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    Summary
    EudraCT Number:2004-000535-29
    Sponsor's Protocol Code Number:24981
    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:2005-05-23
    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 number2004-000535-29
    A.3Full title of the trial
    A multicentre, open label and subsequent randomised, double blind, placebo controlled phase III study to assess the safety and efficacy of maintenance and extended therapy with subcutaneously administered onercept of subjects with moderate to severe plaque psoriasis who have either responded or partially responded to an initial 12-week induction treatment with onercept.
    A.3.2Name or abbreviated title of the trial where available
    Not Applicable
    A.4.1Sponsor's protocol code number24981
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberNot Applicable
    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 tumor 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 number150mg/1.05ml
    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 Yes
    D.3.11.13.1Other medicinal product typebinding protein
    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 of the study is to assess the safety and efficacy of maintenance therapy with onercept 150 mg TIW compared to matching placebo in subjects having achieved a PASI 75 response at the end of an initial 12-week induction treatment with onercept 150 mg TIW.
    E.2.2Secondary objectives of the trial
    The secondary objective of the study is to assess the safety and efficacy of extended therapy with onercept 150 mg TIW compared to matching placebo in subjects that have only achieved a partial response (PASI 50 to 74) after initial 12-week induction course with onercept 150 mg TIW.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Inclusion criteria:

    1. Written informed consent, given prior to 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. Age between 18 and 75 years, inclusive.

    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 contraception (i.e. oral contraceptive, condoms or IUD).Confirmation that the subject is not pregnant must be established by a negative urinary hCG test within 7 days prior to 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
    Exclusion criteria:

    1. Use of more than one NSAID or having a change in 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.

    2. Previous systemic treatment with biologics, including interferon and/or 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 any experimental therapeutic procedure considered to interfere with the study within 3 months before SD1 (exceptions to be discussed with Serono).

    4. Treatment with any systemic corticosteroids or intra-articular corticosteroid injection during the 28 days before SD1.

    5. Any previous treatment with chlorambucil or cyclophosphamide.

    6. Treated with cyclosporine or methotrexate or oral retinoids within 28 days prior to SD1.

    7. Treatment with topical therapies (vitamin D derivatives, corticosteroids) within 14 days before SD1.

    8. Phototherapy within 28 days before 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 valuses, aspartate aminotransferase, alanine aminotransferase or alkaline phosphatase level ≥1.5 times the upper limit of normal values.

    11. Inadequate bone marrow reserve, defined by:
    · Leucocytes ≤ 3.5 x 109/L, or
    · 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 virus (HBV) or hepatitis C virus (HCV).

    14. Planned major surgery during 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).

    16. History of active tuberculosis, current active tuberculosis or current treatment or prophylactic therapy for tuberculosis.

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

    18. Opportunistic infection in the 3 months preceding SD1.

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

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

    21. History of or current 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 are scheduled at least 14 days prior to SD1 or more than 3 months after the last injection of study drug).

    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).

    27. Wheelchair-bound or bedridden status.

    28. Previous use of onercept.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is the time to relapse, defined for subjects achieving PASI 75 at Week 12 of the Open Label First Treatment (OLFT) period, to be the loss of at least 50% of the improvement in PASI achieved at Week 12 (OLFT period) with respect to baseline (Study Day 1).
    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 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 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) 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
    Provided in the 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 2005-05-23. 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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 511
    F.4.2.2In the whole clinical trial 900
    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 Decision2004-09-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-08-12
    P. End of Trial
    P.End of Trial StatusCompleted
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