NCT00901914

Study of rBet v1 Tablets

A Multi-national, Randomised, DBPC, Phase II Study to Assess the Efficacy and Safety of Three Doses of SLIT Administered as rBet v 1 Tablets Once Daily to Patients Suffering From Birch Pollen Rhinoconjunctivitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 483 (actual)
• Sponsor: Stallergenes Greer · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the efficacy and safety of three doses of r Bet v1 administered as sublingual tablets in birch pollen allergic subjects.

Conditions

• Birch Pollen-related Rhinoconjunctivitis
• Rhinitis, Allergic, Seasonal

Interventions

Type	Name	Description
BIOLOGICAL	Placebo	One sublingual tablet of matching placebo daily during approximately 5.5 months
BIOLOGICAL	rBet v 1	One sublingual tablet containing rBet v 1 at a dosage of 12.5 µg daily during approximately 5.5 months
BIOLOGICAL	rBet v 1	One sublingual tablet containing rBet v 1 at a dosage of 25 µg daily during approximately 5.5 months
BIOLOGICAL	rBet v 1	One sublingual tablet containing rBet v 1 at a dosage of 50 µg daily during approximately 5.5 months

Timeline

• Start date: 2008-10-01
• Primary completion: 2009-06-01
• Completion: 2009-08-01
• First posted: 2009-05-14
• Last updated: 2013-06-27

Locations

8 sites across 8 countries: Denmark, Finland, France, Germany, Lithuania, Poland, Russia, Sweden