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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02292875
• Other study ID #: TG002B
• Status: Completed
• Phase: Phase 2
• First received: November 13, 2014
• Last updated: November 14, 2014
• Start date: April 2014
• Est. completion date: September 2014

Study information

• Verified date: November 2014
• Source: Circassia Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Conjunctivitis
• Grass Allergy
• Rhinoconjunctivitis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Circassia Limited	Adiga Life Sciences, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Rhinoconjunctivitis Symptom Scores		32 months post first dose in TG002	No
Secondary	Grass Specific Immunoglobulin A (IgA)		32 months post first dose in TG002	No
Secondary	Grass Specific Immunoglobulin E (IgE)		32 months post first dose in TG002	No
Secondary	Grass Specific Immunoglobulin G Isotype 4 (IgG4)		32 months post first dose in TG002	No
Secondary	Skin Prick Weal Diameter		32 months post first dose in TG002	No
Secondary	Adverse Events		32 months post first dose in TG002	Yes