Who is sponsoring NCT01490411?

NCT01490411 is sponsored by Allergopharma GmbH & Co. KG.

What condition does NCT01490411 study?

NCT01490411 studies Allergic Rhinoconjunctivitis.

What drugs are being tested in NCT01490411?

Interventions: Placebo, rBet v1-FV, rBet v1-FV, rBet v1-FV, rBet v1-FV.

What is the status of NCT01490411?

NCT01490411 is currently COMPLETED.

Last reviewed 2014-01-23 · How we verify

A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Investigate the Relative Efficacy and Safety of Immunotherapy With rBet v1-FV Compared to Placebo in Birch Pollen-Allergic Patients With IgE-Mediated Seasonal Allergic Rhinoconjunctivitis

NCT01490411 Phase 2 COMPLETED

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.

Details

Lead sponsor	Allergopharma GmbH & Co. KG
Phase	Phase 2
Status	COMPLETED
Enrolment	37
Start date	2010-10
Completion	2011-09

Conditions

Allergic Rhinoconjunctivitis

Interventions

Placebo
rBet v1-FV
rBet v1-FV
rBet v1-FV
rBet v1-FV

Primary outcomes

Relative efficacy of four different doses compared to placebo. — 6 hours
To assess the relative efficacy of four different dose regimes of rBet v1-FV compared to Placebo based on post-treatment intracutaneous testing results. The post-treatment wheal size (length in mm) after intracutaneous injection of a birch pollen solution was determined.

Countries

Germany