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    Summary
    EudraCT Number:2011-002174-23
    Sponsor's Protocol Code Number:SMART_5
    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:2011-06-22
    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 number2011-002174-23
    A.3Full title of the trial
    A dose Finding Study of the Efficacy of LAIS Grass tablets in patients suffering from grass pollen-induced allergic rhinoconjunctivitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study which aims at finding an optimal dose and at evaluating the efficacy of LAIS Grass tablets in patients suffering from allergic inflammation of the conjunctiva and rhinitis which are caused by grass pollen
    A.4.1Sponsor's protocol code numberSMART_5
    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 SponsorLofarma S.p.A.
    B.1.3.4CountryItaly
    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 supportLofarma S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut für Med. Statistik, Informatik u. Epidemiologie
    B.5.2Functional name of contact pointCoordinating investigator
    B.5.3 Address:
    B.5.3.1Street AddressLindenburger Allee 42
    B.5.3.2Town/ cityKöln
    B.5.3.3Post code50931
    B.5.3.4CountryGermany
    B.5.4Telephone number00492214783456
    B.5.6E-mailinformatik@imsie.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 No
    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 nameLAIS Grass Tablets
    D.3.2Product code LAIS Grass Tablets
    D.3.4Pharmaceutical form Sublingual tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSublingual use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLAIS Grass tablets
    D.3.9.3Other descriptive nameChemically modified extract (monomeric allergoid) from grass pollen extracts (Holcus lanatus 33%, Phleum pratense 33%, Poa pratensis 33%)
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number300 to 2000
    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) Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    allergic rhinoconjunctivitis
    E.1.1.1Medical condition in easily understood language
    allergic inflammation of the conjunctiva and rhinitis which are caused by allergens
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10001728
    E.1.2Term Allergic rhinoconjunctivitis
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The efficacy of sublingual immunotherapy with the allergoid LAIS® Grass tablets will be assessed by the number of patients per treatment group with a change of the response threshold to induce a positive conjunctival provocation test (CPT), according to the evaluation defined by Riechelmann between the visits V1 and V4.
    The titrated conjunctival allergen challenge will be conducted with solutions containing 100, 1,000 and 10,000 AU/ml grass allergens.

    Change of the response threshold:
    For each of the four treatment groups the changes of the threshold allergen concentration for a positive CPT response will be compared.
    It is the aim of this trial to document that a large proportion of patients can be protected from reacting to their allergen by a 12 week course of SLIT.
    The protection is documented by an improved response threshold for a positive CPT.
    E.2.2Secondary objectives of the trial
    Physical examinations and the description of the adverse events (frequency, intensity, severity and duration of adverse events) during the treatment with LAIS® Grass tablets
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Female or male patients aged 18–75 years with a history of at least two years of grass pollen-induced allergic rhinitis and/or allergic rhinoconjunctivitis with or without controlled seasonal allergic asthma [From the Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma (GINA) 2007.]
    • Clinically relevant sensitization to grass pollen. Patients with clinically relevant sensitization to other seasonal aero-allergens, for example ragweed, trees or rye may be included. However, patients with clinically relevant sensitization to perennial allergens like house dust mites, cats and dogs dander may not be included.
    • Positive clinical history of grass pollen induced allergic rhinitis, proven by
    o the majority of clinical symptoms appearing during the appropriate season for grass pollen,
    and
    o positive skin prick test,
    and
    o positive response to conjunctival provocation testing (CPT) with one of the three solutions.
    The conjunctival allergen challenge will be conducted with solutions containing 100, 1,000
    and 10,000 AU/ml grass allergens
    CPT is considered positive if the response is stage II or higher.

    Stage Findings
    0 no subjective or visible reaction
    I itching, reddening, foreign body sensation
    II stage I and in addition tearing, vasodilation of conjunctiva, bulbi
    III stage II and in addition vasodilation and erythema of conjunctiva tarsi, blepharospasm
    IV stage III and in addition chemosis, lid swelling

    • Signed and dated patient’s Informed Consent.
    E.4Principal exclusion criteria
    • Simultaneous participation in other clinical trials
    • Previous immunotherapy with grass allergens within the last 5 years
    • Ongoing immunotherapy
    • Patients being in any relationship or dependence with the sponsor and/or investigator
    Other reasons contra-indicating an inclusion into the trial according to the investigator’s estimation (e.g. poor compliance, inability of the patient to understand study documents and instructions)
    Existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection
    • Predominant perennial allergic rhinitis
    • Partly controlled or uncontrolled asthma
    • Chronic asthma or emphysema, particularly with a FEV <70% of the predicted value
    • Chronic asthma or emphysema, particularly with a PEF <70% of the individual optimum value
    • Patients with Galactose-intolerance, Lactase-deficiency, Glucose-Galactose-malabsorption
    • Active tuberculosis
    • Generally inflammatory as well as severe acute and chronic inflammatory diseases
    • Irreversible secondary disorders at the target organ (e.g. emphysema, bronchoectasis)
    • Immune deficiency (for example induced by immunosuppressive drugs)
    • Physician diagnosed diseases of the liver, spleen, nervous system, thyroidal gland as well as rheumatic diseases, based on an autoimmune mechanism
    • Malignancy
    • Alcohol abuse
    • Patients treated with β-blockers and/or other contra-indicated drugs
    • Locally applied ß-blockers (eye drops) are not allowed
    • Contra-indication for adrenalin (for example, acute or chronic symptomatic coronary heart disease, severe hypertension, hyperthyroidism)
    • Completed or ongoing long-term treatment with tranquilizer or psycho active drugs
    • Completed or ongoing treatment with anti-IgE-antibody
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective is to assess the efficacy of a sublingual immunotherapy with the allergoid LAIS® Grass tablets by the number of patients per treatment group with a change of the response threshold to induce a positive conjunctival provocation test (CPT), according to the evaluation defined by Riechelmann between the visits V1 and V4.
    The primary outcome parameter is the reaction to the conjunctival allergen challenge as documented in the CRF. In line with national and international guidelines the test will be considered positive, if the patient reacts with distinctive clinical symptoms to the application of the allergen.
    E.5.1.1Timepoint(s) of evaluation of this end point
    day 0 and day 84 of the study
    E.5.2Secondary end point(s)
    physical examinations and the description of the adverse events
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visit 1, Visit 2, Visit 3 and Visit 4 of the study
    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 Yes
    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 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    different doses of IMP
    E.8.2.4Number of treatment arms in the trial4
    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 concerned8
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months4
    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) 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: 110
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state140
    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)
    Patients will be treated during the grass pollen season following this clinical trial by their physician according to the guidelines.
    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 Decision2011-11-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-19
    P. End of Trial
    P.End of Trial StatusCompleted
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