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    Summary
    EudraCT Number:2006-003066-34
    Sponsor's Protocol Code Number:101-PG-PSC-150
    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:2006-11-17
    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 number2006-003066-34
    A.3Full title of the trial
    A randomized, double blinded, placebo controlled multicenter study for the efficacy and safety of Depigoid® House dust mites (HDM) in patients suf-fering from moderate to severe atopic eczema.
    A.4.1Sponsor's protocol code number101-PG-PSC-150
    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 SponsorLETI Pharma 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 Depigoid
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratories LETI, S.L.
    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 nameDepigoid Milben Mix
    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 INNNA
    D.3.9.1CAS number NA
    D.3.9.3Other descriptive nameNA
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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) Yes
    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 Information not present in EudraCT
    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
    Moderate to severe atopic eczema with or without rhinitis and/or rhinoconjunctivitis caused by clinical relevant IgE-mediated sensitization against House dust mites (HDM) leading to aggravation of patient’s skin lesions.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10003641
    E.1.2Term Atopic eczema
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of the study is the comparison of the efficacy and tolerability of Depigoid House dust mites (HDM) extract versus placebo in a subcutaneous immuno-therapy over 18 months in patients with moderate to severe atopic eczema with or without rhinitis and/or rhinoconjunctivitis caused by clinical relevant IgE-mediated sensitization against House dust mites (HDM) leading to aggravation of patient’s skin lesions.

    For the comparison of efficacy between Depigoid House dust mites (HDM) and Pla-cebo a hierarchical test procedure will be applied. The primary objective will be evaluated by assessment of the following criteria:
    1)the AUC (area under the Total SCORAD curve) over the 18 months time of treatment,
    2)the medication consumption/basic medication (cumulative intake) over the 18 months time of treatment.
    E.2.2Secondary objectives of the trial
    ·Onset of efficacy
    · Number of atopic exacerbations
    ·Time to and severity of atopic exacerbations
    ·Quality of life questionnaire using the Dermatology Life Quality Index (DLQI)
    ·Specific IgG1, IgG4 and IgE against Der p and Der f
    ·Adverse events
    ·Laboratory
    ·Vital signs
    ·Global evaluation of safety
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Patients of both gender aged from 18 up to 65 years
    2.Prior to study specific examinations the patient has to give his/her written informed consent
    3.At least 2 exacerbations of eczema or permanent skin lesions during the last 2 months
    4.Patients have to suffer from atopic eczema (with or without rhinitis and/or rhinoconjunctivitis) impaired by clinical sensitization against House dust mites (HDM) leading to an aggravation of skin lesions. The sensitization against House dust mites (HDM) has to be verified by*
    ·Symptom aggravation of skin lesions by exposure to House dust mites (HDM) and during winter season
    ·A positive skin prick test for Dermatophagoides pteronyssinus (Der p) and/or Dermatophagoides farinae (Der f), resulting in a wheal diameter of at least 4 mm > negative control reaction or '++' versus histamine
    ·Specific IgE for Der p or Der f CAP-RAST > 3
    5.The diagnosis atopic eczema has to be verified according to the criteria of Hanifin and Rajka
    6.Duration of atopic eczema > 5 years
    7.Encasings of bedding and mattress for more than 6 months (or stable environmental control)

    *Additionally an atopy patch test with Der p and Der f will be performed in selected study sites but not be used as inclusion criterion
    E.4Principal exclusion criteria
    1.The following therapy is not allowed within the last 5 years prior to screening as well as during the study and will prevent the patient from being included into the study:
    ·Specific Immunotheraphy with House dust mites (HDM)
    2.The following therapy is not allowed within within 3 months prior to screening as well as during the study and will prevent the patient from being included into the study:
    ·Photopheresis
    3.The following medications and therapies are not allowed within the last month prior to screening as well as during the study and will prevent the patient from being included into the study:
    ·Immunosuppressive agents (cyclosporins, mycophenolates)
    ·Systemic corticosteroids
    ·UV-therapy, tanning
    4.The following medications and therapies are not allowed during the entire study and will lead to the patient being withdrawn:
    ·b-blocker
    ·Treatment with substances interfering with the immune system
    5.Total SCORAD < 30, documented by digital photography
    6.Patients with therapeutically uncontrolled atopic eczema or erythrodermia
    7.Patients with 3 consecutive exacerbations within 12-24 hours after immunotherapy

    Patients with other known concomitant diseases / treatments

    8.Active tuberculosis
    9.Acute and chronic inflammatory or infectious diseases at the target organ
    10.Advanced secondary changes at the target organ (e.g. emphysema or bronchiectasis)
    11.Immunopathological diseases (e.g. of the liver, kidney, the nervous system, thyroid gland, rheumatic diseases) in which autoimmune mechanisms play a role
    12.Immune deficiencies
    13.Uncontrolled asthma, defined as FEV1 or PEF ≤ 70% of predicted normal value
    14.Any disease which prohibits the use of adrenaline (e.g. hyperthyroidism)
    15.Cardiovascular insufficiency or any severe or unstable pulmonary, or endocrine disease; clinically significant renal or hepatic disease or dysfunction; hematologic disorder; any other clinically significant medical condition that could increase the risk to the study participant
    16.Malignant disease of any kind during the previous 5 years
    17.Abnormal laboratory parameters and vital signs that could increase the risk to the study participant
    18.Alcohol, drug or medication abuse within the past year
    19.Severe psychiatric or neurologic disorders

    Others

    20.Patients who are expected to be non-compliant and/or not co-operative
    21.Participation in any other clinical study within the last 30 days prior to the start of the study
    22.Patients who have already participated in this study
    23.Patients who are employees at the investigational site, relatives or spouses of the investigator
    24.Any donation of germ cells, blood, organs, or bone marrow during the course of the study
    25.Patients who are not contractually capable

    Special restrictions for female patients

    26.Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation
    27.Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, unless they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy or hysterectomy or are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g. bilateral tubal ligation, vasectomy), hormonal contraception (implantable, patch, oral), and double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap)
    E.5 End points
    E.5.1Primary end point(s)
    For the comparison of efficacy between Depigoid House dust mites (HDM) and Pla-cebo a hierarchical test procedure will be applied. The primary objective will be evaluated by assessment of the following criteria:
    1)the AUC (area under the Total SCORAD curve) over the 18 months time of treatment,
    2)the medication consumption/basic medication (cumulative intake) over the 18 months time of treatment.
    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 No
    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) 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 No
    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.8.4.1Number of sites anticipated in Member State concerned25
    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
    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
    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.1.3Elderly (>=65 years) No
    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 state120
    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)
    After the end of the study the patients will be treated following recommended stan-dards and available treatment options in the respective study center.
    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 Decision2007-01-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-01-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-07-02
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