Efficacy Study of a Preseasonal Treatment With AllerT in Subjects With Birch Pollen Allergy

Phase IIb Study to Assess the Efficacy, Safety and Tolerability of Two Dosing Regimens of AllerT in Comparison to Placebo in Adult Subjects Allergic to Birch Pollen

The main objective of the trial is to demonstrate the efficacy of a two months pre-seasonal treatment with AllerT 100 µg maintenance dose in reducing symptoms of allergic rhinoconjunctivitis during the following birch pollen season

Inclusion Criteria:

• moderate to severe allergic rhinoconjunctivitis to birch pollen:

  1. Score of symptoms of the Rhinoconjunctivitis Symptom Score (RSS) ≥ 12 during the two preceding birch pollen seasons
  2. Previous use of anti-allergy medications during the two preceding birch pollen seasons
  3. Positive SPT to birch pollen extract
  4. Positive specific IgE CAP test for Bet v 1

Exclusion Criteria:

• uncontrolled asthma, FEV1 < 80% of predicted
• previous SIT (specific immunotherapy) to birch pollen or any other SIT within 5 years
• clinical symptoms due to allergens other than birch pollen during the whole trial period
• history of anaphylaxis
• positive skin prick test to AllerT
• any other treatment or conditions which may increase the risk of the study for the subject or affect the efficacy assessments during the birch pollen season