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    Summary
    EudraCT Number:2014-004223-46
    Sponsor's Protocol Code Number:SL75.14
    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:2015-07-17
    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 number2014-004223-46
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, multi-center study of the efficacy and safety of STG320 sublingual tablets of house dust mite (HDM) allergen extracts in adults and adolescents with HDM-associated allergic rhinitis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety study evaluating a new sublingual treatment in HDM allergic rhinitis
    A.4.1Sponsor's protocol code numberSL75.14
    A.5.4Other Identifiers
    Name:16252Number:IND Number
    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 SponsorSTALLERGENES
    B.1.3.4CountryFrance
    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 supportSTALLERGENES
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSTALLERGENES
    B.5.2Functional name of contact pointSenior Medical Director
    B.5.3 Address:
    B.5.3.1Street Address6 rue Alexis de Tocqueville
    B.5.3.2Town/ cityAntony
    B.5.3.3Post code92160
    B.5.3.4CountryFrance
    B.5.4Telephone number+33155592556
    B.5.5Fax number+33155592068
    B.5.6E-mailmartine.legall@stallergenesgreer.com
    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.2.1.1.2Name of the Marketing Authorisation holderShionogi Co., Ltd
    D.2.1.2Country which granted the Marketing AuthorisationJapan
    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 nameHouse dust mite allergen extracts
    D.3.2Product code STG320
    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 INNDermatophagoides pteronyssinus allergen extract
    D.3.9.3Other descriptive nameDERMATOPHAGOIDES PTERONYSSINUS EXTRACT
    D.3.9.4EV Substance CodeSUB84531
    D.3.10 Strength
    D.3.10.1Concentration unit BAU Bioequivalent Allergy Unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDermatophagoides farinae allergen extract
    D.3.9.3Other descriptive nameDERMATOPHAGOIDES FARINAE EXTRACT
    D.3.9.4EV Substance CodeSUB84530
    D.3.10 Strength
    D.3.10.1Concentration unit BAU Bioequivalent Allergy Unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.IMP: 2
    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.2.1.1.2Name of the Marketing Authorisation holderShionogi Co., Ltd
    D.2.1.2Country which granted the Marketing AuthorisationJapan
    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 nameHouse dust mite allergen extracts
    D.3.2Product code STG320
    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 INNDermatophagoides pteronyssinus allergen extract
    D.3.9.3Other descriptive nameDERMATOPHAGOIDES PTERONYSSINUS EXTRACT
    D.3.9.4EV Substance CodeSUB84531
    D.3.10 Strength
    D.3.10.1Concentration unit BAU Bioequivalent Allergy Unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDermatophagoides farinae allergen extract
    D.3.9.3Other descriptive nameDERMATOPHAGOIDES FARINAE EXTRACT
    D.3.9.4EV Substance CodeSUB84530
    D.3.10 Strength
    D.3.10.1Concentration unit BAU Bioequivalent Allergy Unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    D.8 Placebo: 2
    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
    House dust mite allergic rhinitis
    E.1.1.1Medical condition in easily understood language
    Allergic rhinitis due to house dust mite
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10001725
    E.1.2Term Allergic rhinitis due to other allergen
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of STG320 sublingual tablets at a daily dosage of 300 IR when administered for 12 months to adults and adolescents with HDM-associated allergic rhinitis.
    E.2.2Secondary objectives of the trial
    - To assess the efficacy of STG320 sublingual tablets at dosage of 300 IR
    - Rhinoconjunctivitis symptom evaluation and rescue medication use will also be evaluated during the 2-week secondary evalutation period
    - To assess the effect of STG320 on other variables at the end of treatment (work productivity and activity impairment, immunological markers)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Have house dust mite (HDM)-associated allergic rhinitis (AR) (with or without asthma) for at least 1 year based on the presence of:
    • Symptoms for 4 or more consecutive weeks in the previous year and for at least 4 days per week during those weeks.
    • Symptoms requiring regular intake of symptomatic treatment(s).
    • Symptoms evaluated as “troublesome” by the patients or impairing their daily activities, leisure or sport, school or work or involving sleep disturbance.
    2. Have given signed informed consent to participate, after having been informed of the nature and aims of the study, in accordance with local regulation and requirements.
    3. Male or female outpatients 12 to 65 years of age.
    4. Sensitized to D. pteronyssinus (D. pte) and/or D. farinae (D. far) defined as skin prick test wheal diameter at least 5 mm greater than the negative control and HDM-specific serum IgE ≥3.5 kU/L.
    5. Willing to and capable of completing the e-diary, study questionnaires and scales.
    E.4Principal exclusion criteria
    1. A history of rhinitis, rhino-conjunctivitis or asthma to allergens other than HDM, likely to result in rhinitis symptoms during the baseline and primary evaluation periods.
    Specifically, when the following are present:
    • documented sensitization (positive Skin Prick Test or allergen specific serum IgE >3.5kU/L) and history of clinically relevant symptoms to allergen(s) other than HDM,
    • anticipated exposure to such allergen(s) during the baseline and primary evaluation periods.
    For example, the following patients are to be excluded:
    - patients sensitized to cat or dog allergens and regularly exposed to these animals
    - patients sensitized to perennial allergens, such as aspergillus, cladosporium, alternaria, cockroach
    - patients sensitized to seasonal allergens such as parietaria, ragweed or mugwort, if these allergens are endemic in the region during the baseline and primary evaluation periods.
    2. Any diagnosed nasal (other than HDM allergic rhinitis) or oral disease that could interfere with the efficacy or safety assessments, such as nasal polyposis, recurrent chronic rhino-sinusitis (at least 2 isolated episodes per year in the 2 previous years, each episode lasting more than 8 weeks) or a history of chronic oral inflammation or current active oral inflammation from any etiology (e.g., oral lichen planus, oral ulceration or oral mycosis) and/or oral wounds.
    3. Recent nasal surgery (i.e., within the previous 6 months).
    4. Partially controlled or uncontrolled asthma defined in the Global Initiative for Asthma 2014 guidelines (GINA 2014) as the presence of daytime asthma symptoms more than twice/week or nocturnal symptoms/awakening or need for reliever/rescue treatment more than twice/week or FEV1 <80% of predicted or personal best value.
    5. Asthma therapies consistent with GINA treatment Step 3, Step 4 and Step 5 i.e., the preferred controller medication consists of inhaled corticosteroid (ICS) combined with long-acting beta (β)-2 agonist (LABA) according to GINA classification 2014 (refer to Appendix II for the full details of other controller options).
    6. Experienced a life-threatening asthma attack or an asthma exacerbation that resulted in Intensive Care Unit (ICU) hospitalization.
    7. Requiring continuous treatment with systemic corticosteroids for any indication.
    8. Requiring continuous treatment with β-blockers or with Monoamine Oxidase Inhibitors (MAOIs).
    9. Received an immunosuppressive treatment within 3 months prior to screening.
    10. Received allergen specific immunotherapy (AIT) by any route:
    - for house dust mites: AIT for more than 1 month within the 5 years before screening
    - for other allergen(s): ongoing or recently stopped (within 6 months) AIT.
    11. Any history of anaphylaxis after previous allergen immunotherapy, exposure to allergen(s) or of unknown cause.
    12. Any history of hypersensitivity to STG320 or its excipients or contraindication to the use of rescue medications
    13. Female with positive urine pregnancy test or lactating or expecting to conceive within the duration of the study.
    14. Sexually active female of child-bearing potential without medically accepted contraceptive method
    15. Unable or unwilling to comply with the study protocol requirements, including those who anticipate significant changes in their daily environment in relation to HDM exposure or who are likely to travel for extended periods of time during the main efficacy assessment period.
    16. Patients with past or current disease(s) which, as judged by the Investigator, may affect the patient’s participation in or the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematologic disease, neurologic disease, immunodeficiency or immunologic disease and endocrine disease.
    17. Patients with a history of eosinophilic esophagitis or with current severe or persistent gastroesophageal symptoms including dysphagia or chest pain.
    18. Contraindications to allergen specific immunotherapy.
    19. Patients with history of drug or alcohol abuse.
    20. Participation in any clinical study within 30 days prior to the selection visit.
    21. Possible dependency of the patient on sponsor or investigators/subinvestigators or study personnel.
    E.5 End points
    E.5.1Primary end point(s)
    Total Combined Score (TCS). The average TCS is calculated for each patient as the average of the non-missing daily TCSs.
    The daily TCS (scale 0-15) is the sum of the patient’s daily Rhinitis Total Symptom Score (RTSS, scale 0-12) and daily Rescue Medication Score (RMS, scale 0-3).
    E.5.1.1Timepoint(s) of evaluation of this end point
    All along the study
    E.5.2Secondary end point(s)
    Rhinitis Total Symptom Score (RTSS)
    Rescue Medication Score (RMS)
    Adjusted Symptom Score (ASS, scale 0-12)
    Combined Symptom and Medication Score (CSMS, scale 0-6)
    Total Ocular Symptom Score (TOSS, scale 0-6)
    Six Individual Rhinoconjunctivitis Symptom Scores (RSSs)
    Rhinoconjunctivitis rescue medication usage
    Visual Analogue Scale (VAS)
    Proportion of Symptom-Controlled Days (PSCD)
    Controlled patients (CP)
    Overall Standardized Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ(S)≥12) scores
    EQ-5D-5L Generic health-related quality of life questionnaire
    Global Rating of Change Score (GRCS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    All along 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 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.8.2.4Number 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 concerned68
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA125
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Bulgaria
    Canada
    Czech Republic
    France
    Germany
    Israel
    Italy
    Poland
    Russian Federation
    Slovakia
    Spain
    United States
    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 Patient
    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 months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 200
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 200
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1540
    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 state280
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1100
    F.4.2.2In the whole clinical trial 1740
    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)
    None
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-07-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-16
    P. End of Trial
    P.End of Trial StatusCompleted
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