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    Summary
    EudraCT Number:2006-004547-35
    Sponsor's Protocol Code Number:IMP27330.1
    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:2006-11-16
    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 number2006-004547-35
    A.3Full title of the trial
    Phase IV study to investigate neutrophil downregulation of Thy-1 by Raptiva® (Efalizumab) as a potential responder predictor in patients with moderate to severe plaque psoriasis
    A.3.2Name or abbreviated title of the trial where available
    Responder Prediction Study
    A.4.1Sponsor's protocol code numberIMP27330.1
    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 GmbH
    B.1.3.4CountryGermany
    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 Yes
    D.2.1.1.1Trade name Raptiva
    D.2.1.1.2Name of the Marketing Authorisation holderSerono Europe Ltd., 56 Marsh Wall, London E14 9TP, UK
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.11 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 Yes
    D.3.11.13.1Other medicinal product typeRecombinant humanised monoclonal antibody (IgG1 kappa Immunglobulin)
    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
    Moderate to severe chronic plaque psoriasis (PASI ≥ 12) failing to respond to, or with a contraindication to, or intolerant to other systemic therapies including cyclosporine, methotrexate and Psoralen ultraviolet light A (PUVA)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10050576
    E.1.2Term Psoriasis vulgaris
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate

    - whether the decrease in the adhesion of psoriatic neutrophils to Thy-1 is a first sign of a successful treatment before the clinical improvement can be observed, and

    - whether the failure of a significant decrease in the Thy-1-mediated adhesion during anti-psoriatic therapy is a predictor for patients who will not efficiently respond to the treatment
    E.2.2Secondary objectives of the trial
    To show efficacy of Raptiva in patients with moderate to severe plaque psoriasis

    To collect safety data for Raptiva in patients with moderate to severe plaque psoriasis
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The local extension study
    “Extension-Studie an Blut- und Haut-Proben im Rahmen bzw. als Ergänzung zur Multizenter-Studie IMP27330.1 (Phase IV study to investigate neutrophil downregulation of Thy-1 by Raptiva® (Efalizumab) as a potential responder predictor in patients with moderate to severe plaque psoriasis)“
    (Version 1.05 vom 19.03.2007)
    is planned at the University Clinic of Magdeburg.

    In this study, which will be conducted and analysed only at the trial site of Prof. Gollnick and Prof. Bonnekoh, additional blood samples and biopsies will be used to evaluate whether
    1) the Efalizumab-Therapy-Responder Prediction-Toponome (CD4, CD7, CD36, CD45,
    CD45R0, CD247, HLA-DQ and SNA Single-Epitop-Cluster) found in peripheral blood lymphocytes can be confirmed
    2) an Efalizumab-Therapy-Responder Prediction-Toponome can be characterised in skin samples
    3) intercurrent aggravation and exacerbation phenomena possibly occurring during Efalizumab therapy can be correlated to distinct toponome effects a) in peripheral blood and/or b) in skin tissue.

    For this extension study, a separate study protocol, patient information sheet and patient informed consent have been created which will be used at the University Clinic of Magdeburg only.
    E.3Principal inclusion criteria
    1. Adult patient with moderate to severe chronic plaque psoriasis (PASI ≥ 12) who has failed to respond to, or who has a contraindication to, or is intolerant to other systemic therapies including cyclosporine, methotrexate and Psoralen ultraviolet light A (PUVA) according to SmPC

    2. 18 to 75 years old

    3. Body weight max. 120 kg

    4. Discontinuation of any systemic psoriasis treatment prior to commencement of the study treatment. An appropriate washout period is required for these agents (e.g. for cyclosporin, corticosteroids, methotrexate, retinoids, MMF, thioguanine, hydroxyurea, sirolimus, azathioprine, and 6-MP); and for any systemic immunosuppressive treatment applied for psoriasis. The specific wash out requirements must be followed for each systemic therapy and a wash out period of at least one month prior to receiving the first dose of study drug (SD 0) is required, if not indicated otherwise.
    Application of PUVA treatment must have been discontinued one month prior to receiving the first dose of study drug (SD 0); biologic agents must not have been applied within three months prior to receiving the first dose of study drug (SD 0)

    5. Discontinuation of all high potency topical corticosteroid treatments for psoriasis at least 14 days prior to receiving the first dose of study drug (SD 0)

    6. Discontinuation of any investigational drug or treatment prior to commencement of the study treatment. A washout period of two months is required for these agents prior to receiving the first dose of study drug (SD 0)

    7. Treatment regimens of ß-blockers, ACE inhibitors, antimalarial drugs, quinidine, interferon, or lithium stable for at least 28 days prior to receiving the first dose of study drug (SD 0)

    8. No required vaccination (e.g. tetanus, booster, influenza vaccine) at least 14 days prior to receiving the first dose of study drug (SD 0).

    9. Willingness to hold sun exposure reasonably constant and to avoid use of tanning booths or other UV light sources during the study
    E.4Principal exclusion criteria
    1. Guttate, erythrodermic or pustular psoriasis as sole or predominant form of psoriasis

    2. History of severe allergic or anaphylactic reactions to humanised monoclonal antibodies

    3. History of or ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection

    4. History of opportunistic infections (e.g., systemic fungal infections, parasites)

    5. History of or ongoing active tuberculosis (TB) or other serious infections

    6. History of clinically significant thrombocytopenia, bleeding disorders or a platelet count < 50,000

    7. Application of any biologic agent within 3 months prior to receiving the first dose of study drug (SD 0)

    8. Application of systemic treatments (see inclusion criteria) within 1month prior to receiving the first dose of study drug (SD 0)

    9. Application of any systemic immunosuppressive treatment applied for any condition other than psoriasis within 1 month prior to receiving the first dose of study drug (SD 0)

    10. UV/PUVA treatment within 1month prior to receiving the first dose of study drug (SD 0)

    11. Application of any investigational drug or treatment less than 2 months ago prior to receiving the first dose of study drug (SD 0)

    12. Application of live or killed virus or bacteria vaccines within 14 days prior to receiving the first dose of study drug (SD 0)

    13. Presence of malignancy within the past 5 years, including lymphoproliferative disorders. Patients with a history of fully resolved basal cell or squamous cell skin cancer may be enrolled

    14. Diagnosis of hepatic cirrhosis, regardless of cause or severity

    15. Hospital admission for cardiac disease, stroke, or pulmonary disease within the last year

    16. History of drug abuse within the last 5 years

    17. History of seropositivity for human immunodeficiency virus (HIV)

    18. History of seropositivity for hepatitis B or C virus

    19. WBC count <4,000/L or >14,000/L

    20. Hepatic enzymes 3 times the upper limit of normal

    21. Serum creatinine 2 times the upper limit of normal
    E.5 End points
    E.5.1Primary end point(s)
    PASI 75 at week 12

    Sensitivity and specificity of inhibition of Thy-1- mediated adhesion of neutrophils as a biomarker to identify PASI 75 responders
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarker for response prediction
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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.8.4.1Number of sites anticipated in Member State concerned5
    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
    For administrative and safety reporting purposes the end of the study will be defined as the date of the final clinical database lock. This provides for a single and conservative definition across all study sites.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    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 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 state35
    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)
    If continuation of treatment with Raptiva is considered appropriate for a patient beyond his/her participation in the trial, treatment with Raptiva can be continued upon prescription. Therapy for patients who drop out prematurely follows the standard treatment of the condition.
    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 Decision2006-12-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-01-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-07-25
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