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

• Status: Completed
• Trial end date: 2017-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anergis

Criteria

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).