Efficacy and safety of the SQ tree SLIT-tablet in subjects with moderate to severe allergic rhinitis and/or conjunctivitis induced by pollen from the birch group

INTERVENTION: Product Name: Desloratadine Pharmaceutical Form: Tablet INN or Proposed INN: DESLORATADINE Other descriptive name: DESLORATADINE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5‐ Product Name: SQ tree SLIT‐tablet Pharmaceutical Form: Tablet INN or Proposed INN: BETULA VERRUCOSA POLLEN ALLERGEN EXTRACT Other descriptive name: BETULA VERRUCOSA POLLEN Concentration unit: IU international unit(s) Concentration type: equal Concentration number: 12‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Sublingual use Product Name: Olopatadine Pharmaceutical Form: Ear/eye drops, solution INN or Proposed INN: OLOPATADINE Other descriptive name: OLOPATADINE HYDROCHLORIDE Concentration unit: % percent Concentration type: equal Concentration number: 0.1‐ Product Name: Mometasone Pharmaceutical Form: Nasal drops INN or Proposed INN: mometasone Other descriptive name: MOMETASONE FUROATE MONOHYDRATE Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 50‐ CONDITION: Allergic Rhinoconjunctivitis induced by birch pollen ; MedDRA version: 19.0 Level: LLT Classification code 10066093 Term: Birch pollen allergy System Organ Class: 100000004870 Therapeutic area: Diseases [C] ‐ Ear, nose and throat diseases [C09] PRIMARY OUTCOME: Main Objective: The primary objective is to demonstrate superiority of the SQ tree SLIT‐tablet given once daily compared to placebo in the treatment of allergic rhinoconjunctivitis induced by birch pollen. Primary end point(s): The primary endpoint of the trial is combined rhinoconjunctivitis symptom and deciation score.; Secondary Objective: Key‐secondary objectives are to demonstrate superiority of the SQ tree SLIT‐tablet versus placebo on the rhinoconjunctivitis symptoms induced by birch pollen and pollen from the birch group and in the treatment of allergic rhinoconjunctivitis induced by pollen from the birch group.; Secondary objectives are to demonstrate superiority of the SQ tree SLIT‐tablet versus placebo on the use symptom‐relieving medication in the birch pollen season and tree pollen season on immunological parameters (including Immunoglobulin Eand Immunoglobulin G, subtype 4) to Betula verrucosa, on rhinoconjunctivitis quality of life, mild and severe days induced by birch pollen and by pollen from birch group, global evaluation and on a rhinoconjunctivitis visual analogue scale. Further the safety profile versus placebo will be evaluated. Timepoint(s) of evaluation of this end point: During the birch pollen season. SECONDARY OUTCOME: Secondary end point(s): ‐ The average allergic rhinoconjunctivitis symptom score ; ‐ The average allergic rhinoconjunctivitis daily medication score ; ‐ Average number of mild and severe days ; ‐ Average changes during treatment in immunological parameters ; ‐ Average RQLQ(S) score ; ‐ Average rhinoconjunctivitis symptom VAS ; ‐ Patient‐rated global evaluation ; ‐ Treatment‐emergent AEs ; ‐ Investigational medicinal product related AEs ; ‐ Time from start to resolution of recurrent AEs ; ‐ Daily duration of recurrent AEs ; ‐ Proportion of subjects with local administration site reactions ; ‐ Clinical laboratory values before and after treatment ; ‐ Changes in vital signs ; ‐ Forced expiratory volume in 1 second ; ‐ Physical examination before and after treatment Timepoint(s) of evaluation of this end point: During the tree pollen seasons. ‐ An appropriate minimum level of allergic rhinoconjunctivitis symptoms induced by birch pollen during the BPS of 2016. ‐ Presence of one or more of the following ARIA quality of life items due to allergic rhinitis and/or conjunctivitis during the previous BPS. INCLUSION CRITERIA: ‐ Moderate‐to‐severe allergic rhinitis and/or conjunctivitis induced by birch pollen with or without asthma (controlled/partly‐controlled) despite having received treatment with symptom‐relieving medication during the 2 previous TPS ‐ Positive SPT response (wheal diameter = 3 mm) to Betula verrucosa at screening ‐ Positive specific IgE against species Bet v1 (= IgE Class 2; 0.7 kU/L) at screening Are the trial subjects under 18? yes Number of subjects for this age range: 60 F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 540 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range