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

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: Anergis

Criteria

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