drugset / Trial / NCT01490411

Dose Range Finding Study With rBet v1-FV - in Adult Patients With Birch Pollen-Allergic Seasonal Rhinoconjunctivitis

NCT01490411 ↗

Phase 2 Completed 37 enrolled Allergopharma GmbH & Co. KG
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to find out if rBet v1-FV works to relieve Seasonal Allergic Rhinitis symptoms compared to Placebo (an inactive substance that looks like rBet v1-FV and also contains Aluminum Hydroxide but does not contain the experimental drug). rBet v1-FV is a vaccine that works by exposing your immune system to something that resembles birch. This vaccine may help to lessen your allergy symptoms during the natural birch season.

Timeline

Start
2010-10
Primary completion
2011-04
Completion
2011-09

Drugs

EvaluationDrugModalityDoseRoute
Subject rBet v1-FV Protein / enzyme biologic 20 ug Subcutaneous
Subject rBet v1-FV Protein / enzyme biologic 80 ug Subcutaneous
Subject rBet v1-FV Protein / enzyme biologic 160 ug Subcutaneous
Subject rBet v1-FV Protein / enzyme biologic 320 ug Subcutaneous

Indications