NCT02271009

Compare Dose Regimens of AllerT, in Adults With Allergic Rhino-Conjunctivitis to Birch Pollen Studied in EEC

A Double-Blind, Placebo-Controlled, Randomized Trial to Compare the Efficacy and Tolerability of Three Dose Regimens of AllerT, in Adults With Allergic Rhino-Conjunctivitis to Birch Pollen Studied in Environmental Exposure Chamber

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 213 (actual)
• Sponsor: Anergis · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find the optimal dose of AllerT that should be used to treat moderate to severe allergies due to birch tree pollen. There are 4 treatment groups in this study; 3 treatment groups will receive AllerT at different doses and 1 treatment group will receive placebo. This study will also assess the effectiveness and safety of AllerT compared to placebo in relieving allergy symptoms.

Detailed description

Primary Objective: To evaluate the dose-response trend of three doses of adjuvanted AllerT and of placebo in reducing symptoms of allergic rhino-conjunctivitis in subjects exposed to birch tree pollen in an environmental exposure chamber (EEC). Secondary Objectives: * To evaluate three dose regimens of AllerT , versus a placebo in reducing symptoms of allergic rhino-conjunctivitis in subjects exposed to birch tree pollen in an EEC. * To assess the safety and tolerability of a two month treatment with three dose regiments of AllerT (10 µg, 25 µg and 50 µg with Al(OH)3). * To explore the immunological response to AllerT.

Conditions

• Allergic Rhino-Conjunctivitis

Interventions

Type	Name	Description
DRUG	AllerT	Ultrafast immunotherapy
DRUG	Placebo	placebo control

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2014-10-22
• Last updated: 2015-12-03

Locations

1 site across 1 country: Canada