NCT03724240

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 624 (estimated)
• Sponsor: ASIT Biotech S.A. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

This is a randomised, double-blind, placebo-controlled, international, multicentre, confirmatory Phase III study in patients with grass pollen-related allergic rhinoconjunctivitis. After having given written informed consent, the patients will be examined to establish eligibility according to inclusion/exclusion criteria. The eligible patients will be randomised to Placebo or gpASIT+™ treatment according to a 1:1 ratio. Study treatment will be administered before the start of the pollen season in 2019

Conditions

• Hay Fever

Interventions

Type	Name	Description
BIOLOGICAL	Placebo solution	4 x 2 injection over 21 days the dosage is100 µg/ml
BIOLOGICAL	gpASIT+TM	4 x 2 injection over 21 days the dosage is100 µg/ml

Timeline

• Start date: 2019-01-02
• Primary completion: 2019-09-01
• Completion: 2019-12-01
• First posted: 2018-10-30
• Last updated: 2018-10-30