NCT02143583

Follow-up of Study AN004T to Assess the Persistence of AllerT Efficacy During the 2nd to 4th Season After Treatment

Long-term Follow-up of a Multicentre, Randomized, Double-blind, Placebo-controlled Trial (AN004T) Assessing the Efficacy and Tolerability of 2 Dosing Regimens of AllerT in Adult Subjects Allergic to Birch Pollen

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 196 (actual)
• Sponsor: Anergis · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

Study aiming to evaluate the efficacy of a 2-month pre-seasonal treatment with an AllerT 50 µg or 100 µg maintenance dose administered in previous study AN004T in reducing symptoms of allergic rhinoconjunctivitis during the 2nd following birch pollen season.

Detailed description

Multicenter, international, parallel-group follow-up study of subjects randomized and treated in Study AN004T (AllerT 100 µg, AllerT 50 µg, placebo) and followed over the 2nd, and if appropriate, the 3rd and 4th birch pollen seasons in this study (still double-blind during the 1st year, open-label in the 2nd and 3rd years).

Conditions

• Birch Pollen Allergy

Timeline

• Start date: 2014-02-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2014-05-21
• Last updated: 2015-06-24
• Results posted: 2015-06-24

Locations

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