ATIBAR - Efficacy and Safety of Two Doses of AllerT in Patients Allergic to Birch Pollen

A Multicentre, Double-blind, Placebo-Controlled, Randomized Trial to Assess the Efficacy and Tolerability of Two Dosing Regimens of AllerT in Adults With Birch Pollen Allergic Rhinitis

A multicentre, Double-blind, Placebo-Controlled, Randomized Trial to Assess the Efficacy and Tolerability of Two Dosing Regimens of AllerT, a Combination of Contiguous Overlapping Peptides Derived from Bet v 1, in Adults with Birch Pollen Allergic Rhinitis/Rhinoconjunctivitis

Inclusion Criteria:

• Adult subjects 18 to 65 yrs old, male or female
• moderate to severe allergic Rhinitis/Rhinoconjunctivitis to birch pollen during the two preceding birch pollen seasons
• positive Skin Prick Test (SPT) to birch pollen extract
• positive specific IgE CAP to Bet v1.

Exclusion Criteria:

• persistent non-controlled asthma (Forced Expiratory Volume, FEV1 < 85% of predicted),
• previous specific immunotherapy (SIT) to tree pollens,
• previous SIT to any allergen within 5 years,
• previous history of severe anaphylactic reaction,
• perennial allergic Rhinitis/Rhinoconjunctivitis,
• other disorder possibly influencing the trial outcomes,
• pregnancy,
• any severely debilitating disease,
• primary or secondary immunodeficiency or treatment with immunosuppressor drugs within one month prior to randomization (oral steroids, other immunosuppressors).