NCT00567346

Efficacy and Safety of Grass Pollen Sublingual Immunotherapy

A Randomised, DB, Plcb Controlled, Multicentre, Multinational Phase II/III Study to Assess the Efficacy and Safety of Three Different Dose Regimens of Oralgen Grass Pollen in Patients With Grass Pollen Related Allergic Rhinoconjunctivitis

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 605 (actual)
• Sponsor: Artu Biologicals · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The study is assessing efficacy and safety of three different dosage regimens of grass pollen sublingual immunotherapy in adult patients suffering from grass pollen related rhinoconjunctivitis.

Detailed description

Patients with seasonal grass pollen related rhinoconjunctivitis will be randomized to one of four treatment groups at 41 centres in Europe. Each treatment group will consist of approximately 150 patients and 150 patients will be randomized to a placebo group. The study will consist of a screening phase, a treatment phase and a variable maintenance period.

Conditions

• Allergic Rhinoconjunctivitis

Interventions

Type	Name	Description
DRUG	Oralgen	Patients will receive drops of grass pollen immunotherapy sublingually
DRUG	grass pollen extract	Patients will receive matching placebo sublingually

Timeline

• Start date: 2006-12-01
• Primary completion: 2007-10-01
• Completion: 2008-03-01
• First posted: 2007-12-04
• Last updated: 2010-05-05

Locations

40 sites across 7 countries: Bulgaria, Czechia, Germany, Hungary, Lithuania, Netherlands, Slovakia