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    Summary
    EudraCT Number:2013-000211-24
    Sponsor's Protocol Code Number:IMAT-PV
    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:2013-07-08
    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 number2013-000211-24
    A.3Full title of the trial
    A multicenter, randomized, placebo-controlled, double-blind proof of concept study to evaluate the efficacy and safety of the human normal immunoglobulin Intratect® 5% for intravenous use as adjuvant therapy in patients with Pemphigus Vulgaris
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    immunoglobulin infusion as adjuvant therapy in patients with Pemphigus Vulgaris
    A.3.2Name or abbreviated title of the trial where available
    IMAT-PV
    A.4.1Sponsor's protocol code numberIMAT-PV
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorRuprecht-Karls-University Heidelberg
    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 supportBiotest AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Heidelberg
    B.5.2Functional name of contact pointDepartment of Dermatology
    B.5.3 Address:
    B.5.3.1Street AddressVoßstr. 2
    B.5.3.2Town/ cityHeidelberg
    B.5.3.3Post code69115
    B.5.3.4CountryGermany
    B.5.4Telephone number+49 6221 563714
    B.5.5Fax number+49 6221 568083
    B.5.6E-mailEva.Hadaschik@med.uni-heidelberg.de
    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 Intratect 5%
    D.2.1.1.2Name of the Marketing Authorisation holderBiotest Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameIntratect
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameWATER FOR INJECTION
    D.3.9.4EV Substance CodeSUB12398MIG
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number1
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameGLYCINE
    D.3.9.4EV Substance CodeSUB12000MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µmol micromole(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 placeboInfusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    patients with Pemphigus vulgaris
    E.1.1.1Medical condition in easily understood language
    patients with Pemphigus vulgaris
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10052802
    E.1.2Term Pemphigus vulgaris
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The proportion of patients suffering relapse (Relapse rate) during IVIG or placebo treatment within 12 months
    Relapse: The appearance of ≥ 3 new lesions a month that do not heal spontaneously within 1 week, or by the extension of established lesions in a patient who has achieved disease control.
    E.2.2Secondary objectives of the trial
    Efficacy parameters
    a. Time to achieve control of disease activity (beginning of consolidation phase)
    b. The proportion of patients in remission on therapy (2 months no new lesions), (minimal therapy ≤ 10mg/d prednisolone ± minimal adjuvant therapy ≥ 2 months)
    c. The proportion of patients with premature discontinuation of the study due to relapse
    d. Change in ‘Pemphigus Disease Area Index’ (PDAI), Baseline to month 12
    e. Change in ‘Autoimmune Bullous Skin Disorder Intensity Score’ (ABSIS), Baseline to month 12
    f. Change in ‘Dermatology Life Quality Index’ (DLQI)
    g. Cumulative doses of steroid and azathioprine or mycophenolate mofetil
    h. Reduction of serum anti-Dsg1 and Dsg3 antibody titers
    Safety
    a. Number of adverse events including safety laboratory parameters and immunological parameters
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients with clinical signs of Pemphigus vulgaris
    2. Patients with Pemphigus vulgaris proven by direct immunofluorescence (deposition of IgG intraepidermally on the keratinocyte membrane)
    3. Patients with relapse of Pemphigus vulgaris < 2 months before inclusion. (Relapse is defined by the appearance of 3 or more new lesions a month that do not heal spontaneously within 1 week, or by the extension of established lesions in a person who has achieved disease control).
    4. Prednisone doses (or the equivalent) ≥ 10 mg per day
    5. Indication for or therapy with additional immunosuppressive therapy (e.g. Azathioprine or Mycophenolatemofetil)
    6. Age ≥ 18years
    7. Written informed consent, signed and dated
    8. Sufficient knowledge of languages (German)
    E.4Principal exclusion criteria
    1. Patients with drug-induced forms of Pemphigus Vulgaris are excluded
    2. Patients relapsing at a dose under 10 mg Prednisone (or the equivalent) per day
    3. Clinically significant heart disease (NYHA Class III or IV)
    4. Clinically significant renal insufficiency (CDC III or IV)
    5. Patients with a history of thromboembolic episodes such as deep vein thromboses, myocardial infarction or stroke
    6. HIV, HCV or HBV infections
    7. Bleeding disorders
    8. Patients with serious intercurrent illness, requiring hospitalization
    9. Patients taking or requiring immunosuppressive drugs such as systemic corticosteroids other than study medication for a distinct medical disorder (e.g. rheumatoid arthritis). Topical or inhalational steroids are permitted
    10. Patients treated with steroid pulse therapy, plasma exchange therapy within 30 days, other biotherapeutics (e.g. TNF-α inhibitors, interferons, rituximab) or HD-IVIg within 60 days before the start of study treatment.
    11. Active malignancy within 1 year prior to entry into the study, except for cured non-melanoma skin cancer and cervical carcinoma in situ.
    12. Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
    13. Participation in chemotherapy or irradiation therapy within 4 weeks prior to enrolment.
    14. Participation in any other clinical trial within 4 weeks prior to enrolment and treatment with another investigational agent within 5 elimination half-lives prior to enrolment.
    15. Pregnancy or breastfeeding woman, or women of childbearing potential refusing or unable to use effective means of contraception (i.e. oral or injectable contraceptives, intrauterine devices, double-barrier method, contraceptive patch, female sterilisation or condoms).
    16. History of severe allergic reactions to study drugs, vaccines or unknown allergens
    17. Patients with known absolute IgA deficiency
    18. Patients who are unable to be treated due to obesity
    19. Patients who are unable to receive concomitant immunosuppressive therapy
    20. Suspicion of drug and / or alcohol abuse
    The patient planned to be enrolled is an employee of any involved investigator or any involved institution including the sponsor of the trial
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of this study is the clinical efficacy as measured by the proportion of patients suffering relapse during IVIG or placebo treatment within 12 months (relapse rate on therapy).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Relapses will be analysed individually within first 12 months after start of treatment (relapse on therapy).
    E.5.2Secondary end point(s)
    The time to achieve control of disease activity, the time to the beginning of the consolidation phase and the time to the end of the consolidation phase will be listed in a single list by treatment group and patient. Each single patient’s remission will be listed with time along with start and end time of therapy. The PDAI, DLQI and ABSIS will be plotted over time as connected plots for all patients of each group, as one diagram for each group. The corticosteroid/azathioprine/mycophenolate daily dose will be plotted as over time as connected plots for all patients of each group, as one diagram for each group. The cumulative dose of corticosteroid/azathioprine/mycophenolate will be listed by treatment group and patient. Levels of IgG autoantibodies will be plotted over time as connected plots for all patients of each group, as one diagram for each group. All analyses will be performed on the full analysis set.
    E.5.2.1Timepoint(s) of evaluation of this end point
    see above (Point 5.2)
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    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.8.2.4Number of treatment arms in the trial2
    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 concerned3
    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 No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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)
    For patients who have finished the trial and for all patients who drop out prematurely it is the responsibility of the investigator to choose adequate therapeutic measurements.
    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 Decision2013-07-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-01
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2014-12-10
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