ToleroMune Grass Exposure Unit Study

A Double-blind, Randomised, Placebo-controlled Study to Evaluate Three Doses of ToleroMune Grass in Grass Allergic Subjects Following Challenge With Grass Allergen in an Environmental Exposure Unit

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.

This study will look at the efficacy, safety and tolerability of three doses of ToleroMune Grass in grass allergic subjects following challenge with with grass in an Environmental Exposure Unit (EEU).

Study Overview

• Status: Completed
• Conditions: Grass Allergy; Rhinoconjunctivitis
• Intervention / Treatment: Biological: Placebo; Biological: ToleroMune Grass

Detailed Description

This study is designed as a randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety and tolerability of ToleroMune Grass in grass allergic subjects with allergic rhinoconjunctivitis. The efficacy of ToleroMune Grass will be explored in subjects using an EEU (Environmental Exposure Unit).

The study will consist of 3 study periods. In Period 1, Screening will be performed up to a maximum of 16 weeks before randomisation and may consist of one or two visits to the clinic, at the Investigator's discretion. Baseline Challenge will consist of 4 visits to the EEU at least 3 days before randomisation.

In Period 2, subjects in each cohort complying with the inclusion/exclusion criteria will be randomised to one of four groups and will receive treatment every 2 weeks (±2 days) for 14 weeks.

In Period 3, Post Treatment Challenge will consist of 4 visits to the EEU about 25 weeks after the first administration in the treatment period and assessments will be performed identical to those at the baseline challenge. Follow-up will be conducted 3-10 days after PTC.

• Study Type: Interventional
• Enrollment (Anticipated): 280
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 2V7
      • Kingston General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria

• Male or female, aged 18-65 years.
• Minimum 2-year documented history of rhinoconjunctivitis on exposure to grass.
• Positive skin prick test to grass allergen.
• Minimum qualifying rhinoconjunctivitis symptom scores

Exclusion criteria

• History of asthma.
• A history of anaphylaxis to grassallergen.
• Subjects with an FEV1 <80% of predicted.
• Subjects who cannot tolerate baseline challenge in the EEU.
• Subjects for whom administration of epinephrine is contra-indicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension).
• A history of severe drug allergy, severe angioedema or anaphylactic reaction to food.
• A history of any significant disease or disorder (e.g. cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, neoplastic/malignant, psychiatric, major physical impairment).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Intradermal injection, 1 x 8 administrations 2 weeks apart	Biological: Placebo; Intradermal injection 1 x 8 administrations 2 weeks apart
Experimental: ToleroMune Grass Dose 1; Intradermal injection 1 x 8 administrations 2 weeks apart	Biological: ToleroMune Grass; Intradermal injection 1 x 8 administrations 2 weeks apart
Experimental: ToleroMune Grass Dose 2; Intradermal injection 1 x 8 administrations 2 weeks apart	Biological: ToleroMune Grass; Intradermal injection 1 x 8 administrations 2 weeks apart
Experimental: ToleroMune Grass Dose 3; Intradermal injection 1 x 8 administrations 2 weeks apart	Biological: ToleroMune Grass; Intradermal injection 1 x 8 administrations 2 weeks apart

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total Rhinoconjunctivitis Symptom Score	Upto 25 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Symptom scores for nasal and non nasal symptoms	Upto 25 weeks
Skin prick testing	Upto 25 weeks
Peak Nasal Inspiratory Flow	Up to 25 weeks
Grass specific IgA	Upto 26 weeks
Grass specific IgE	Upto 26 weeks
Grass specific IgG4	Up to 26 weeks
Adverse Events	Up tp 26 weeks

Collaborators and Investigators

• Sponsor: Circassia Limited
• Collaborators: Adiga Life Sciences, Inc.; Pharm-Olam International
• Investigators: Principal Investigator: Anne K Ellis, MD MSC FRCPC, Queen's University, Kingston, Ontario

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: June 29, 2011
• First Submitted That Met QC Criteria: June 29, 2011
• First Posted (Estimate): June 30, 2011

Study Record Updates

• Last Update Posted (Estimate): August 15, 2013
• Last Update Submitted That Met QC Criteria: August 14, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Immunotherapy; Rhinoconjunctivitis; Grass allergy; Environmental Exposure Unit; ToleroMune Grass
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: TG002