ToleroMune Grass Follow on Study

Completed

• Conditions: Grass Allergy; Rhinoconjunctivitis

• Registration Number: NCT02292875
• Lead Sponsor: Circassia Limited

Brief 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.

Detailed 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 Timeline

• Study Start: 2014-04
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2014-11
• Study First Submitted: 2014-11-13
• Study First Submitted QC: 2014-11-14
• Last Update Submitted: 2014-11-14
• Study First Posted: 2014-11-17
• Last Update Posted: 2014-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• Previously randomised into study TG002, and completed all treatment visits and PTC during calendar year 2012

Exclusion Criteria

• "Partly controlled" and "uncontrolled" asthama
• History of anaphylaxis to grass allergen
• FEV1 <80% of predicted
• Treatment with beta-blockers, alpha-adrenoreceptor blockers, tranquilizers or psychoactuve drugs
• Symptoms of a clinically relevant illness
• Subjects who cannot tolerate allergen challenge in the EEU

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total Rhinoconjunctivitis Symptom Scores	32 months post first dose in TG002

Secondary Outcome Measures

Name	Time	Method
Grass Specific Immunoglobulin A (IgA)	32 months post first dose in TG002
Grass Specific Immunoglobulin E (IgE)	32 months post first dose in TG002
Grass Specific Immunoglobulin G Isotype 4 (IgG4)	32 months post first dose in TG002
Skin Prick Weal Diameter	32 months post first dose in TG002
Adverse Events	32 months post first dose in TG002