ToleroMune Grass Follow on Study

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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02292875

Enrollment

Registered

2014-11-17

Start date

2014-04-30

Completion date

2014-09-30

Last updated

2014-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Grass Allergy, Rhinoconjunctivitis

Keywords

Grass Allergy, Rhinoconjunctivitis, Environmental Exposure Unit, Immunotherapy, ToleroMune Grass

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Total Rhinoconjunctivitis Symptom Scores	32 months post first dose in TG002

Secondary

Measure	Time frame
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

Countries

Canada

Outcome results