NCT01720251

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Anergis · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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

Conditions

• Allergic Rhinitis
• Rhinoconjunctivitis

Interventions

Type	Name	Description
DRUG	placebo	SC injections of placebo on days 1, 7, 14, 28 and 56
DRUG	AllerT low dose	SC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56
DRUG	AllerT full dose	SC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2012-11-02
• Last updated: 2015-04-13
• Results posted: 2015-04-13

Locations

24 sites across 7 countries: Denmark, France, Latvia, Lithuania, Poland, Sweden, Switzerland