ToleroMune Grass Follow on Study

Rhinoconjunctivitis Clinical Trial

Official title: An Optional Follow-Up Study to Evaluate the Continued Efficacy of ToleroMune Grass in Grass Allergic Subjects Following Challenge With Grass Allergen in an Environmental Exposure Unit.

Status Completed

Clinical Trial Summary

Grass pollen allergens are recognised as a major cause of allergic diseases in humans and animals. Worldwide, at least 40% of allergic patients are sensitised to grass pollen allergens and between 50-90% of hayfever or seasonal allergy sufferers are allergic to grass pollen. ToleroMune Grass is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of grass allergy.

The purpose of this optional observational follow-on study is to further evaluate rhinoconjunctivitis symptoms on exposure to Grass in the EEU among subjects who completed all dosing visits in study TG002 approximately two years after the start of treatment.

Clinical Trial Description

This is a follow-up study to a multi-centre, randomised, double-blind, placebo controlled, parallel group clinical study (TG002) which evaluated the efficacy, safety and tolerability of three doses of ToleroMune Grass versus placebo in grass allergic subjects. Subjects who completed TG002 in calendar year 2012 will undergo a further single exposure to grass allergens in an EEU. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Conjunctivitis
• Grass Allergy
• Rhinoconjunctivitis

• NCT number: NCT02292875
• Study type: Observational
• Source: Circassia Limited
• Status: Completed
• Phase: Phase 2
• Start date: April 2014
• Completion date: September 2014