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NCT Number: NCT02292875

ToleroMune Grass Follow on Study

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.

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Key information

Conditions

Rhinoconjunctivitis Grass Allergy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kanata, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Total Rhinoconjunctivitis Symptom Scores

    Time frame: 32 months post first dose in TG002

Secondary outcomes

  1. Grass Specific Immunoglobulin A (IgA)

    Time frame: 32 months post first dose in TG002

  2. Grass Specific Immunoglobulin E (IgE)

    Time frame: 32 months post first dose in TG002

  3. Grass Specific Immunoglobulin G Isotype 4 (IgG4)

    Time frame: 32 months post first dose in TG002

  4. Skin Prick Weal Diameter

    Time frame: 32 months post first dose in TG002

  5. Adverse Events

    Time frame: 32 months post first dose in TG002

Sponsors and collaborators

Lead sponsor

Circassia Limited

Industry

Collaborators

  • Adiga Life Sciences, Inc.

Registry information

Official study 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.

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Nov 17, 2014
Registry last updated
Nov 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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