NCT01308021

Clinical Efficacy and Safety of gpASIT+TM to Treat Seasonal Allergic Rhinoconjunctivitis

Clinical Efficacy, Immunogenicity, Clinical Tolerability and Assessment of Safety of gpASIT+TM Administered Orally, According to Two Administration Schedules, for the Prophylaxis of Seasonal Grass Pollen Rhinoconjunctivitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: BioTech Tools S.A. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the efficacy and safety of grass pollen-derived peptides administrated orally to treat seasonal allergic rhinoconjunctivitis.

Conditions

• Grass Pollen Allergy
• Hay Fever

Interventions

Type	Name	Description
BIOLOGICAL	gpASIT+TM	entero-coated capsules containing 400µg of gpASIT+TM, daily , 28 days
BIOLOGICAL	gpASIT+TM	entero-coated capsules containing 800 µg of gpASIT+TM, daily, 28 days
BIOLOGICAL	Placebo	Placebo entero-coated capsules

Timeline

• Start date: 2010-12-01
• Primary completion: 2011-10-01
• Completion: 2011-12-01
• First posted: 2011-03-03
• Last updated: 2014-05-26

Locations

19 sites across 3 countries: Belgium, France, Luxembourg