Clinical Trials Directory

Trials / Completed

CompletedNCT02560948

Clinical Efficacy and Safety of a Subcutaneous Immunotherapy With gpASIT+™ in Patients With Grass Pollen-induced Allergic Rhinoconjunctivitis

A Multicenter, International, Randomised, Double-blind, Placebo Controlled Study to Demonstrate the Clinical Efficacy and Safety of a Subcutaneous Immunotherapy With gpASIT+™ in Patients With Grass Pollen-induced Allergic Rhinoconjunctivitis

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
554 (actual)
Sponsor
BioTech Tools S.A. · Industry
Sex
All
Age
18 Years – 64 Years
Healthy volunteers
Not accepted

Summary

gpASIT+TM product is based on highly purified allergen fragments obtained from grass pollen. The purpose of this study is to demonstrate the clinical efficacy and safety of a subcutaneous immunotherapy with gpASIT+™ in patients with grass pollen-induced allergic rhinoconjunctivitis compared to placebo.

Conditions

Interventions

TypeNameDescription
BIOLOGICALPlacebo solution4 x 2 injections over 21 days
BIOLOGICALgpASIT+TM4 x 2 injections over 21 days

Timeline

Start date
2015-12-01
Primary completion
2016-08-01
Completion
2016-08-01
First posted
2015-09-25
Last updated
2018-10-11

Locations

3 sites across 3 countries: Belgium, Italy, Spain

Source: ClinicalTrials.gov record NCT02560948. Inclusion in this directory is not an endorsement.

Clinical Efficacy and Safety of a Subcutaneous Immunotherapy With gpASIT+™ in Patients With Grass Pollen-induced Allergi (NCT02560948) · Clinical Trials Directory