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    Summary
    EudraCT Number:2012-004916-79
    Sponsor's Protocol Code Number:SMART_10
    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:2012-11-19
    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 number2012-004916-79
    A.3Full title of the trial
    Efficacy and Safety of sublingual immunotherapy with Allergoid LAIS® Grass tablets for patients with grass pollen-induced allergic rhinoconjunctivitis, a phase III study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study which aims at evaluating the efficacy and safety of LAIS® Grass tablets in patients suffering from g from allergic inflammation of the conjunctiva and rhinitis which are caused by grass pollen
    A.4.1Sponsor's protocol code numberSMART_10
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/143/2011
    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 number+492214783456
    B.5.5Fax number+492214783465
    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 AgU antigen unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSublingual tablet
    D.8.4Route of administration of the placeboSublingual use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients suffering from allergic rhinoconjunctivitis
    E.1.1.1Medical condition in easily understood language
    Patients suffering from allergic inflammation of the conjunctiva and rhinitis
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10001728
    E.1.2Term Allergic rhinoconjunctivitis
    E.1.2System Organ Class 100000004853
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to assess the efficacy of sublingual immunotherapy with the allergoid LAIS®Grass tablets by the total combined score (TCS) taking in account the rhinoconjunctivitis total symptom score (RTSS) of the six rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes and the total rescue medication score (TRMS) for the peak of the grass pollen season.
    E.2.2Secondary objectives of the trial
    -Total Combined Score (TCS) (entire pollen season)
    - 6 individual symptom scores of the Rhinoconjunctivitis Symptom Score (peak month and entire pollen season)
    - Total Rhinoconjunctivitis Symptom Score (entire pollen season)
    - Total Rescue Medication Score (entire pollen season)
    - Asthma symptoms + use of asthma rescue medication (entire pollen season)
    - clinical benefit of SLIT (reduction of rhinoconjunctivitis symptoms and rhinitis symptom control)
    - Mean improvement in allergic severity S in CPT (baseline and visit V4)
    - changes of the threshold allergen concentration for a positive response within CPT (baseline and V4)
    -The redness of the eye in CPT (assessed by a central observer)
    - The “well days”(entire pollen season, maximum symptom score of 2, no rescue medication)
    - Assessment of grass specific IgG4
    - A global evaluation (entire pollen season)
    - Safety (physical examinations, adverse Events, safety laboratory data)
    - Rhinoconjunctivitis Quality of Life (RQLQ)
    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 seasonal controlled allergic asthma [From the Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma (GINA) 2012. Available from: http://www.ginasthma.org].
    • Clinical sensitization to grass pollen. Patients with sensitization to perennial allergens like mites, cats and dogs may be included, in the case that these sensitizations are not clinically relevant during the evaluation season.
    • Positive clinical history of grass pollen, proven by:
    - the majority of clinical symptoms appearing during the appropriate season for grass,
    - specific IgE reactivity to grass pollen: CAP-RAST results to Phl p1 or Phl p5b ≥ class 2 (0.70 kU/L) AND CAP-RAST results to Phl p1 or Phl p5b > CAP-RAST results Phl p7 or Phl p12
    - positive screening skin prick test (wheal diameter > 3 mm, negative control < 2 mm),
    - positive response to conjunctival provocation testing (CPT) with at least 10.000 SQ-E/ml of allergenes at both visits V0 and V1.
    - planned antiallergic or antiasthmatic treatment with the following drugs: local Levocabastine (eye), Loratadine (oral), Budesonide (nasal) or inhaled corticosteroids with long-acting beta2-agonists.
    • Retrospective Total Symptom Score (RRTSS) during the previous grass pollen season greater than or equal to 8
    • Compliance and ability of the patient to complete a diary card for self-evaluation of the symptoms and antisymptomatic medication,
    • Signed and dated patient´s Informed Consent

    Special criteria for patients with co-sensitizations: for all patients with co-sensitizations all of the following inclusion criteria must be fulfilled:
    • Patients do not suffer from typical symptoms caused by co-allergens during the grass-pollen season e.g. patients with sensitization to animal dander are not exposed to the specific allergen
    • Specific IgE to perennially prevalent co-allergens (animal dander, house dust mites) or the co-seasonally prevalent co-allergen alternaria are less (the difference has to be at least 1 CAP RAST class less (≥ 1) than sIgE to grass pollen (Phl p1 or Phl p5b)
    • The result of the skin prick test to perennially prevalent co-allergens allergens (animal dander, house dust mites) or to the seasonally prevalent co-allergen alternaria is less than the result to grass pollen
    E.4Principal exclusion criteria
    • Simultaneous participation in other clinical trials
    • Previous immunotherapy with grass allergens or cross-reacting allergens within the last 5 years,
    • Ongoing immunotherapy with any allergen
    • Patients being in any relationship or dependence with the sponsor and/or investigator
    • Other reasons contraindicating 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 (see Annex XX.3)
    • Predominant perennial allergic rhinitis
    • Partly controlled or uncontrolled asthma
    • Chronic asthma or emphysema, particularly with a FEV <70% of the predicted value and/or PEF <70% of the individual optimum value
    • Infections of the oral cavity with severe symptoms
    • Patients with Galactose-intolerance, Lactase-deficiency, Glucose-Galactose-malabsorption
    • Patients with nasal abnormalities and/or polyps
    • Active tuberculosis
    • Generally inflammatory as well severe acute and chronic inflammatory diseases
    • Immune deficiency (for example induced by immunosuppressive drugs)
    • Auto-immune disorders
    • Physician diagnosed diseases of the liver, spleen, nervous system, thyroidal gland as well as rheumatic diseases, based on an autoimmune mechanism
    • Malignancy
    • Alcohol abuse as well as drug and/or medication abuse
    • 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
    • Patients treated with contra-indicated drugs.
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective is to assess the efficacy of sublingual immunotherapy with the allergoid LAIS® Grass tablets by the total combined score (TCS) regarding the rhinoconjunctivitis total symptom score (RTSS) of the six rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes and the total rescue medication score (TRMS).
    E.5.1.1Timepoint(s) of evaluation of this end point
    The peak of the grass pollen season, defined by those 30 consecutive days per centre with the highest local grass pollen counts, starting with at least “moderate” pollen concentrations (stage 2 according to Deutscher Wetterdienst Medizin-Meteorologie, http://www.dwd.de) in the nearest pollen count station in that region
    E.5.2Secondary end point(s)
    -Total Combined Score (TCS) (entire pollen season)
    - 6 individual symptom scores of the Rhinoconjunctivitis Symptom Score (peak month and entire pollen season)
    - Total Rhinoconjunctivitis Symptom Score (entire pollen season)
    - Total Rescue Medication Score (entire pollen season)
    - Asthma symptoms + use of asthma rescue medication (entire pollen season)
    - clinical benefit of SLIT (reduction of rhinoconjunctivitis symptoms and rhinitis symptom control)
    - Mean improvement in allergic severity S in CPT (baseline and visit V4)
    - changes of the threshold allergen concentration for a positive response within CPT (baseline and V4)
    -The redness of the eye in CPT (assessed by a central observer)
    - The “well days”(entire pollen season, maximum symptom score of 2, no rescue medication)
    - Assessment of grass specific IgG4
    - A global evaluation (entire pollen season)
    - Safety (physical examinations, adverse Events, safety laboratory data)
    - Rhinoconjunctivitis Quality of Life (RQLQ)
    E.5.2.1Timepoint(s) of evaluation of this end point
    The peak of the grass pollen season, defined by those 30 consecutive days per centre with the highest local grass pollen counts, starting with at least “moderate” pollen concentrations (stage 2 according to Deutscher Wetterdienst Medizin-Meteorologie, http://www.dwd.de) in the nearest pollen count station in that region
    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) 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.8.2.4Number 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 concerned15
    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 months11
    E.8.9.1In the Member State concerned 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: 160
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state200
    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 Decision2013-02-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-09-26
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