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

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

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

Sponsors & Collaborators

• BioTech Tools S.A.

  lead INDUSTRY

Principal Investigators

• Claus Bachert, MD · UZ Ghent

• Jan Ceuppens, MD · UZ Leuven

• Didier Ebo, MD · UZ Antwerpen

• Jean-Luc Halloy, MD · CHR Warquignies

• Stijn Hallewyck, MD · Universitair Ziekenhuis Brussel

• Peter Hellings, MD · UZ Leuven

• Renaud Louis, MD · Centre Hospitalier Universitaire de Liege

• Catherine Mbasoa, MD · Clinique du Parc Léopold Bruxelles

• Charles Pilette, MD · UCL Saint Luc Bruxelles

• Hélène Simonis, MD · CHR Citadelle Liège

• Olivier Vandenplas, MD · UCL Mont Godinne Yvoir

• Christoph Verhoye, MD · AZ Sint-Lucas Brugge

• Patricia Wackenier, MD · CHU Ambroise-Paré - Mons

• Frédéric De Blay, MD · CHRU Strasbourg

• Marie-Christine Castelain, MD · Hôpital Saint Vincent de Paul, Lille

• François Lavaud, MD · CHRU Reims

• Benoît Wallaert, MD · CHU Lille

• François Wessel, MD · Private Practice Nantes

• Bruno Lebeaupin, MD · Private Practice Nantes

• François Hentges, MD · CHL Luxembourg

• François Durand Perdriel, MD · Private Practice Nantes

• François Spirlet, MD · CH de Dinant

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-12-31

Primary Completion

2011-10-31

Completion

2011-12-31

Countries

• Belgium
• France
• Luxembourg

Study Locations