Efficacy and safety of the SQ tree sublingual immunotherapy tablet in children and adolescents (5 through 17 years of age) with moderate to severe allergic rhinitis and/or conjunctivitis induced by pollen from birch and trees belonging to the birch homologous group.

INTERVENTION: Trade Name: ITULAZAX Product Name: SQ tree SLIT‐tablet Pharmaceutical Form: Oral lyophilisate INN or Proposed INN: BETULA VERRUCOSA (108) POLLEN EXTRACT Other descriptive name: BETULA VERRUCOSA (108) Concentration unit: SQU Standardised Quality Unit(s) (Deprecated) Concentration type: equal Concentration number: 12‐ Pharmaceutical form of the placebo: Oral lyophilisate Route of administration of the placebo: Sublingual use CONDITION: Therapeutic area: Diseases [C] ‐ Immune System Diseases [C20] Tree pollen induced allergic rhinitis and/or conjuctivitis. ; MedDRA version: 20.0 Level: LLT Classification code 10001726 Term: Allergic rhinitis due to pollen System Organ Class: 100000004870 ; MedDRA version: 20.0 Level: LLT Classification code 10001709 Term: Allergic conjunctivitis System Organ Class: 100000004853 PRIMARY OUTCOME: Main Objective: To compare the efficacy of the SQ tree SLIT‐tablet to placebo in the treatment of moderate to severe allergic rhinitis and/or conjunctivitis induced by pollen from birch and trees belonging to the birch homologous group in children and adolescents (5 through 17 years of age) based on the average allergic rhinoconjunctivitis daily total combined score (average TCS) during the birch pollen season (BPS) Primary end point(s): Average TCS during the BPS Secondary Objective: Key secondary objectives:; To compare the efficacy of the SQ tree SLIT‐tablet to placebo based on:; •The average TCS during the tree pollen season (TPS); •The average allergic rhinoconjunctivitis daily symptom score (average DSS) during the BPS and TPS; •The average allergic rhinoconjunctivitis daily medication score (average DMS) during the BPS and TPS; Secondary objectives:; •To compare the safety and tolerability of the SQ tree SLIT‐tablet to placebo; •To compare the efficacy of the SQ tree SLIT‐tablet to placebo using additional endpoints based on daily allergic rhinoconjunctivitis symptoms and rescue medication use; •To compare the efficacy of the SQ tree SLIT‐tablet to placebo based on assessments of quality of life; •To compare the efficacy of the SQ tree SLIT‐tablet to placebo based on patient treatment satisfaction; •To compare the effect of the SQ tree SLIT‐tablet to placebo on immunological parameters to birch, alder, hazel and oak pollen ; Timepoint(s) of evaluation of this end point: During the Birch Pollen Season (BPS) SECONDARY OUTCOME: Secondary end point(s): •Average TCS during the TPS; •Average DSS during the BPS; •Average DSS during the TPS; •Average DMS during the BPS; •Average DMS during the TPS; Timepoint(s) of evaluation of this end point: During either Birch Pollen Season (BPS) or Tree Pollen Season (TPS), respectively. INCLUSION CRITERIA: Subjects are eligible to be included in the trial only if all the following criteria apply: •Male or female of any race/ethnicity aged =4 to <18 years on the day informed consent is obtained from the parent/caregiver; the subject must be =5 to <18 years old at the randomisation visit •A documented, physician diagnosed, clinically relevant history of moderate to severe AR/C induced by birch pollen (with or without asthma) despite having received treatment with symptom‐relieving medication during at least 1 previous tree pollen season for ages 4 through 6 years at screening or at least 2 previous tree pollen seasons for ages 7 through 17 years at screening •Positive skin prick test (SPT) to Betula verrucosa at screening •Positive specific IgE to Bet v at screening •Presence of 1 or more of the following Allergic Rhinitis Impact on Asthma (ARIA) quality of life items due to AR/C during the previous BPS: a.Sleep disturbance b.Impairment of dail