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    Summary
    EudraCT Number:2006-001791-20
    Sponsor's Protocol Code Number:MEPOCHUSS (protocol version 1.2)
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2008-01-02
    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 number2006-001791-20
    A.3Full title of the trial
    A Phase II, single center open label, prospective trial to evaluate the efficacy and safety of mepolizumab for patients with refractory or relapsing Churg Strauss Syndrome
    A.3.2Name or abbreviated title of the trial where available
    MEPOCHUSS
    A.4.1Sponsor's protocol code numberMEPOCHUSS (protocol version 1.2)
    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 SponsorUniversity Hospital of Schleswig-Holstein (UKSH), Campus Lübeck
    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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/04/213
    D.3 Description of the IMP
    D.3.1Product nameMepolizumab
    D.3.2Product code SB-240563
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 196078-29-2
    D.3.9.2Current sponsor codeSB-240563
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 specific for human IL-5
    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
    Churg-Strauss-Syndrome
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10009164
    E.1.2Term Churg Strauss syndrome
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Induction of remission, defined as BVAS = 0 and a daily prednisolone dose of -< 7.5 mg.
    E.2.2Secondary objectives of the trial
    - Change in BVAS score
    - Change in Disease Extent Index (DEI) score
    - Permanent End organ damage assessed by the Vasculitis Damage Index (VDI)
    - Time to remission
    - Response, defined* as a 50 % reduction of the BVAS score
    - Time to response
    - The frequency of relapses, defined* as as a BVAS score of >- 1 in patients who had previously attained remission
    - Blood eosinophil count
    - Frequency of all AEs and SAEs

    *according to consensus definitions of the EUVAS/EULAR Working group on recommendations for conducting clinical trials in systemic vasculitis
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. informed consent

    2. documented history of Churg Strauss Syndrome:
    a. previous or currently active vasculitis either on biopsy or based on the following surrogate parameters proposed by the EMEA group on the classification of primary systemic vasculitides for epidemiological studies [33]: dysmorphic red cells or erythrocyte casts indicative of glomerulonephritis, rapidly progressive neuropathy, alveolar hemorrhage demonstrated on bronchoalveolar lavage, episcleritis.
    b. In agreement with recommendations of the EMEA working group on the classification of primary systemic vasculitides for epidemiological studies the criteria of the American College of Rheumatology are used for classification of Churg Strauss Syndrome, as in contrast to other criteria (Lanham, CHCC) the ACR criteria are data-driven and not based on expert opinion alone. Four or more of the seven (ACR) for classification of Churg-Strauss syndrome need to be fulfilled (see [34] for definitions) in order to yield a sensitivity of 85% and specificity of 99.7 %:
    i. Asthma
    ii. Eosinophilia > 10 % on peripheral blood white cell count
    iii. History of allergy
    iv. Mononeuropathy or Polyneuropathy
    v. Pulmonary infiltrates, non-fixed
    vi. Paranasal sinus abnormality
    vii. Extravascular eosinophils on tissue biopsy

    3. active disease defined as either
    a. active vasculitis (BVAS > 3) and/or
    b. symptomatic tissue eosinophilia and
    c. a prednisolone demand of >- 12.5 mg/day to control disease

    4. Subjects must complete screening and baseline assessment as outlined below

    5. stable corticosteroid dose of > 12.5 mg prednisolone for at least one week

    6. treatment with cyclophosphamide (pulse or daily oral) or methotrexate in a stable dose for at least 4 weeks

    7. Male or female, 18-80 years of age. A female patient may be included only if
    i. She is not pregnant or nursing
    ii. Of non-childbearing potential
    iii. Are of child-bearing potential but have a negative pregnancy test and agree to practice birth control
    E.4Principal exclusion criteria
    1. Life threatening disease or other critical illness deemed inappropriate for inclusion in the study by the principal investigator. Among others, the following manifestations of CSS are considered potentially life-threatening:
    a. severe alveolar hemorrhage requiring blood transfusions or mechanical respiratory support
    b. rapid progressive glomerulonephritis requiring dialysis
    c. severe gastrointestinal involvement (i.e. gangrene, GI-bleeding requiring transfusions)
    d. severe CNS involvement (i.e. ischemic stroke)
    e. severe cardiac involvement (i.e. life-threatening arrhythmias or cardiac failure as outlined below)

    2. Treatment with other immunosuppressive agents within 4 weeks prior to randomisation. Leflunomide must have been washed out according to current guidelines (cholestyramine for 11 days) before entry of the study. MTX or CYC are allowed if their dosage has not been changed within the last 4 weeks.

    3. Corticosteroid pulse of > 60 mg within the last three weeks prior to randomisation.

    4. known secondary cause of eosinophilia: drug eruption, parasitic infection, HIV infection, history of graft versus host disease, acute/chronic eosinophilic leukemia,

    5. no history or clinical features of vasculitis, suggesting a diagnosis of hypereosinophilic syndrome rather than Churg Strauss Syndrome

    6. Diagnosis of other primary systemic vasculitis: Wegener’s granulomatosis, microscopic polyangiitis etc.

    7. currently active malignant disease

    8. abnormal laboratory values:
    a. serum creatinine >- 3 times institutional upper normal limit (UNL)
    b. AST or ALT > UNL
    c. Platelet count < 50.000/µL

    9. Impaired cardiac function defined as:
    a. Left ventricular ejection fraction < 20 %
    b. NYHA class IIIb or IV
    c. Myocardial infarction

    10. history of allergic reaction due to monoclonal antibodies

    11. prior treatment with anti-hIL-5 monoclonal antibody

    12. exposure to investigational drug within 30 days prior to randomisation

    13. positive pregnancy test
    E.5 End points
    E.5.1Primary end point(s)
    Attaining remission (BVAS Score = 0 and prednisolone dose of -< 7.5 mg/d).
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    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) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Yes
    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) No
    E.8.2.2Placebo No
    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
    Last visit of the last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    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 state10
    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)
    Normal standard of care.
    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 Decision2008-06-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-16
    P. End of Trial
    P.End of Trial StatusOngoing
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