Long-term, up to 3-year follow-up of a multicentre, randomized, double-blind, placebo-controlled trial (AN004T) assessing the efficacy and tolerability of 2 dosing regimens of AllerT, a combination

INTERVENTION: Product Name: AllerT Pharmaceutical Form: Solution for injection INN or Proposed INN: not established CAS Number: none Other descriptive name: AllerT1 Concentration unit: µg microgram(s) Concentration type: up to Concentration number: 34.31‐ INN or Proposed INN: not established CAS Number: none Other descriptive name: AllerT2 Concentration unit: µg microgram(s) Concentration type: up to Concentration number: 51.09‐ INN or Proposed INN: not established CAS Number: none Other descriptive name: AllerT3 Concentration unit: µg microgram(s) Concentration type: up to Concentration number: 39.60‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Product Name: AllerT Pharmaceutical Form: Solution for injection INN or Proposed INN: not established CAS Number: none Other descriptive name: AllerT1 Concentration unit: µg microgram(s) Concentration type: up to Concentration number: 17.15‐ INN or Proposed INN: not established CAS Number: none Other descriptive name: AllerT2 Concentration unit: µg microgram(s) Concentration type: up to Concentration number: 25.55‐ INN or Proposed INN: not established CAS Number: none Other descriptive name: AllerT3 Concentration unit: µg microgram(s) Concentration type: up to Concentration number: 19.80‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use CONDITION: Long‐term follow‐up of desensitization by Specific ImmunoTherapy (SIT) received during the trial AN004T in subjects allergic to birch pollen ; MedDRA version: 16.1 Level: LLT Classification code 10066093 Term: Birch pollen allergy System Organ Class: 100000004870 Therapeutic area: Diseases [C] ‐ Immune System Diseases [C20] PRIMARY OUTCOME: Main Objective: To evaluate the efficacy of a 2‐month pre‐seasonal treatment with an AllerT 50 µg or 100 µg maintenance dose in reducing symptoms of allergic rhinoconjunctivitis during the 2nd following birch pollen season Primary end point(s): The primary efficacy variable is the average of the combined Rhinoconjunctivitis Symptom and Medication Score (RSMS) obtained daily during the birch pollen season. Secondary Objective: • To evaluate the efficacy of a 2‐month pre‐seasonal treatment with an AllerT 50 µg maintenance dose in reducing symptoms of allergic rhinoconjunctivitis during the 3rd and 4th following birch pollen seasons; • To evaluate the maintained efficacy of a 2‐month pre‐seasonal treatment with an AllerT 100‐µg maintenance dose in reducing symptoms of allergic rhinoconjunctivitis during the 3rd and 4th following birch pollen seasons; • To compare the effects of a 2‐month pre‐seasonal treatment with AllerT at maintenance doses of 50 µg and 100 µg during the 2nd to 4th following birch pollen seasons with the effects during the 1st season assessed in Study AN004T. Timepoint(s) of evaluation of this end point: Start day of each birch pollen season until end day of each birch pollen season SECONDARY OUTCOME: Secondary end point(s): • Average quality‐of‐life total score ; The average of the total score of the validated Mini Rhinoconjunctivitis Quality‐of‐life Questionnaire© (Mini RQLQ) obtained weekly during the birch pollen season. ; • Average of the Night‐time Nasal Symptom Score (NNSS) obtained daily during the birch pollen season. ; • Average of the combined Rhinoconjunctivitis and Night‐time Symptom and Medication Score (RNSMS) obtained daily during the birch pollen season ; • Percentage of well days during the birch pollen season ; The percentage of well days over the number of days of the birch pollen season when the daily questionnaires were completed. ; • Percentage of days with severe symptoms during the birch pollen season ; The percentage of days with severe symptoms over the number of days of the birch pollen season when the daily questionnaires were completed. ; • Subject’s global evaluation of treatment efficacy collected at Visit V3 of each year ; Timepoint(s) of evaluation of this end point: Start day of each birch pollen season until end day of each birch pollen season INCLUSION CRITERIA: Subjects satisfying all the following criteria could be included in the trial. 1. Had been randomized in the AN004T trial and had received at least 1 injection 2. Have been informed and provided signed consent for participating in the trial and willing to follow all planned trial assessments Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 238 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range