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    Summary
    EudraCT Number:2008-003833-25
    Sponsor's Protocol Code Number:EFACLE2008
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-10-16
    Trial 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 number2008-003833-25
    A.3Full title of the trial
    Efficacy ans safety of subcutaneous Efalizumab in the treatment of patients with cutaneous lupus erythematosus: A mono-centre, open-label, prospective pilot study
    A.3.2Name or abbreviated title of the trial where available
    EFALUPUS
    A.4.1Sponsor's protocol code numberEFACLE2008
    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 SponsorUniversitätskrankenhaus Schleswig-Holstein
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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.
    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 Powder and solvent 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 humanized IgG1 kappa isotype monoclonal antibody that binds to human CD11a
    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
    Cutaneous lupus erythematosus (discoid LE or subacute cutaneous LE) or systemic lupus erythematosus with cutaneous DLE or SCLE lesions without major organ involvment.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10013071
    E.1.2Term Discoid lupus erythematosis
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10057903
    E.1.2Term Subacute cutaneous lupus erythematosus
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10056509
    E.1.2Term Cutaneous lupus erythematosus
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of Efalizumab 1 mg/kg in the treatment of CLE lesions with respect to the percentages of responders based on the investigators global assessment (IGA) score at baseline and after 12 weeks of treatment.
    E.2.2Secondary objectives of the trial
    •the percentages of responders after 2, 4, 6, 8 and 10 weeks of treatment
    •the treatment effect of Efalizumab with respect to change from baseline for the local RCLASI score after 2, 4, 6, 8, 10 and 12 weeks of treatment
    •the treatment effect of Efalizumab with respect to changes from baseline in total RCLASI for the assessment of the overall disease activity and damage score in the patients after 12 weeks of treatment and at week 16 (Follow up Visit).
    •the percentages of failures to treatment
    •the Patient Assessment of Global Improvement (PAGI) and subject’s assessment of itching and pain assessed by a VAS after 2, 4, 6, 8, 10 and 12 weeks of treatment.
    •the impact of the disease on QoL as determined by DLQI at Baseline and after 4, 8 and 12 weeks of treatment.
    •the safety and tolerability aspects of Efalizumab in patients with CLE for the body as a whole.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Additional Investigation of the mechanism of action of efalizumab in patients with CLE (blood investigation)
    ZUSATZUNTERSUCHUNGEN ZUM WIRKMECHANISMUS VON EFALIZUMAB BEI PATIENTEN MIT CLE IM RAHMEN DER STUDIE:
    Untersuchung zur Wirksamkeit und Sicherheit von Efalizumab
    (Raptiva®) bei Patienten mit kutanem Lupus erythematodes: Eine
    monozentrische, offene, prospektive Pilot-Studie.
    Objectives:

    -Change of T-lympfocytes-sub-population under treatment with efalizumab
    (Veränderungen von T Lymphozyten-(Sub-) Populationen unter
    Efalizumab)
    effect of efalizumab on the B-lymphocytes
    (Wirkung von Efalizumab auf B Lymphozyten)
    -Expression of CD11a and CD18 on Lymphocytes in the peripheral blood of CLE patients
    (Expression von CD11a und CD18 auf Lymphozyten im Blut der CLE
    Patienten)
    -Role of TREG under therapy with Efalizumab
    (Rolle der regulatorischen T Zellen (TREG) unter Therapie mit
    Efalizumab)
    -Impact of skin-homing of the mechanism of action of efalizumab
    (Bedeutung des Skin-Homings in der Wirkung von Efalizumab)
    -Chane of the composition of proinflammatory cytokines in the peripheral blood under therapy with efalizumab
    (Veränderung der Zusammensetzung proinflammatorischer Zytokine im
    peripheren Blut unter Therapie mit Efalizumab)
    Impact of efalizumab on apoptosis in CLE patients
    (Einfluß von Efalizumab auf Apoptose bei Patienten mit kutanem LE)
    -Role of skin-homing of CCR4+ lymphocytes
    (Rolle des Skin-Homings durch CCR4+ T Lymphozyten)
    E.3Principal inclusion criteria
    •Patients of any gender aged from 18 to 65 years;
    •A clinical and histological diagnosis of CLE (DLE, SCLE or SLE with DLE or SCLE lesions) who failed to response to topical corticosteroids;
    •One to 5 target lesions scoring at least “moderate disease” on the IGA scale;
    •One to 5 target lesions with disease activity defined as having a local RCLASI sum scoring of at least 4 per lesion based on an assessment of erythema, scale/hyperkeratosis, edema/infiltration and subcutaneous nodule/plaque of the lesion;
    •Willing and able to self-inject Efalizumab or has a carer (voluntary care giver) who is willing and able to perform the injections or willing and able to come weekly to the site to get the injection;
    •Sexually active females of childbearing potential should either be surgically sterile (hysterectomy or tubal ligation), or should use a medically accepted contraceptive regimen for at least 12 weeks prior to the study, during the study and one month after the end of the study
    E.4Principal exclusion criteria
    •Only scarring target lesions
    •SLE with major organ involvement, requiring systemic medical treatment for the SLE;
    •Active skin disease other than CLE or another progressive or serious disease that interferes with the study outcome
    •Symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks before and during the study
    •Active tuberculosis or other severe infection diseases, including chronic or localized
    •Known malignancies other than effective treated non melanoma skin cancer
    •Known thrombocytemia or anemia
    •Concomitant, or within six weeks prior to dosing, systemic treatment with anti-malarials and/or concomitant or within four weeks prior to dosing, systemic treatment with corticosteroids, retinoids, thalidomide, immunosuppressive or other systemic drugs for CLE and SLE
    •Treatment with immunosuppressive drugs for other reasons 4 weeks prior and within the study
    •Topical corticosteroids within 14 days prior to dosing
    •Concomitant treatment with drugs with a known photosensitizing potential, e.g. tetracyclines, griseofulvin, thiazides, furosemide, sulfonamides or tolebutamide;
    •Known hypersensitivity to RAPTIVA® or any of its components
    •Participation in another clinical trial including the four week period preceding the study or having received a non-licensed drug within the last 3 months prior to the study.
    •Vaccination within 2 weeks prior dosing or planned vaccination during the study;
    E.5 End points
    E.5.1Primary end point(s)
    The percentage of responders to treatment, based on the mean IGA at baseline and Visit 6. The IGA will be applied to the selected active lesions (target lesion) and each chosen target lesion will be assessed separately. The IGA will be scored at a 6-point scale where 0 is “Cleared of symptoms” and 5 “The worst state of disease symptoms” for each chosen target lesion. An improvement from baseline to Visit 6 by at least 1 point in the mean IGA score will be defined as response. No change or an increase will be defined as no response.
    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 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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 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
    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 days0
    E.8.9.2In all countries concerned by the trial years1
    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) 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) Information not present in EudraCT
    F.1.3Elderly (>=65 years) Information not present in EudraCT
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state17
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 17
    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 Decision2009-02-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-11-27
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2009-05-13
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