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Completed

NCT Number: NCT01923779

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 one year after the start of treatment.

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Key information

Conditions

Grass Allergy Rhinoconjunctivitis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

About this study

Subjects who completed all dosing visits and the post treatment challenge (PTC) in study TG002 will be invited to attend the Screening Visit for TG002a. Subjects will attend for 4 visits to the EEU on successive days. Following the last EEC visit a follow-up visit will be performed 3-10 days later.

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, completed all treatment visits and PTC during calendar year 2012.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Total Rhinoconjunctivitis Symptom Score

    Time frame: Eighteen months post first dose in TG002

Secondary outcomes

  1. Symptom scores for nasal and non nasal symptoms

    Time frame: Eighteen months post first dose in TG002

  2. Skin prick wheal diameter

    Time frame: Eighteen months post first dose in TG002

  3. Peak Nasal Inspiratory Flow

    Time frame: Eighteen months post first dose in TG002

  4. Grass specific IgA

    Time frame: Eighteen months post first dose in TG002

  5. Grass specific IgE

    Time frame: Eighteen months post first dose in TG002

  6. Grass specific IgG4

    Time frame: Eighteen months post first dose in TG002

  7. Adverse Events

    Time frame: Eighteen months post first dose in TG002

Sponsors and collaborators

Lead sponsor

Circassia Limited

Industry

Collaborators

  • Adiga Life Sciences, Inc.
  • Pharm-Olam International

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
2013
Primary completion
2013
Study completion
2013
First posted
Aug 16, 2013
Registry last updated
Nov 26, 2013

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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