ToleroMune Grass Exposure Unit Study
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Grass Allergy Rhinoconjunctivitis |
Biological: ToleroMune Grass Biological: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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 |
- Total Rhinoconjunctivitis Symptom Score [ Time Frame: Upto 25 weeks ] [ Designated as safety issue: No ]
- Symptom scores for nasal and non nasal symptoms [ Time Frame: Upto 25 weeks ] [ Designated as safety issue: No ]
- Skin prick testing [ Time Frame: Upto 25 weeks ] [ Designated as safety issue: No ]
- Peak Nasal Inspiratory Flow [ Time Frame: Up to 25 weeks ] [ Designated as safety issue: No ]
- Grass specific IgA [ Time Frame: Upto 26 weeks ] [ Designated as safety issue: No ]
- Grass specific IgE [ Time Frame: Upto 26 weeks ] [ Designated as safety issue: No ]
- Grass specific IgG4 [ Time Frame: Up to 26 weeks ] [ Designated as safety issue: No ]
- Adverse Events [ Time Frame: Up tp 26 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 280 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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).
Contacts and Locations| Canada, Ontario | |
| Kingston General Hospital | Recruiting |
| Kingston, Ontario, Canada, K7L 2V7 | |
| Contact: Lisa Steacy 613 549 6666 ext 3941 steacyl@kgh.kari.net | |
| Principal Investigator: Anne K Ellis, MD MSC FRCPC | |
| Principal Investigator: | Anne K Ellis, MD MSC FRCPC | Queen's University, Kingston, Ontario |
More Information
No publications provided
| Responsible Party: | Circassia Limited |
| ClinicalTrials.gov Identifier: | NCT01385800 History of Changes |
| Other Study ID Numbers: | TG002 |
| Study First Received: | June 29, 2011 |
| Last Updated: | October 25, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Circassia Limited:
|
Grass allergy Rhinoconjunctivitis Environmental Exposure Unit Immunotherapy ToleroMune Grass |
Additional relevant MeSH terms:
|
Hypersensitivity Conjunctivitis Rhinitis, Allergic, Seasonal Immune System Diseases Conjunctival Diseases Eye Diseases |
Rhinitis Nose Diseases Respiratory Tract Diseases Respiratory Hypersensitivity Otorhinolaryngologic Diseases Hypersensitivity, Immediate |
ClinicalTrials.gov processed this record on May 21, 2013