ToleroMune Grass Exposure Unit Study

Rhinoconjunctivitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01385800
• Other study ID #: TG002
• Status: Completed
• Phase: Phase 2
• First received: June 29, 2011
• Last updated: August 14, 2013
• Start date: August 2011
• Est. completion date: August 2013

Study information

• Verified date: August 2013
• Source: Circassia Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: August 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Conjunctivitis
• Grass Allergy
• Rhinoconjunctivitis

Intervention

Biological:
• ToleroMune Grass
Intradermal injection 1 x 8 administrations 2 weeks apart
• Placebo
Intradermal injection 1 x 8 administrations 2 weeks apart

Locations

Country	Name	City	State
Canada	Kingston General Hospital	Kingston	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Circassia Limited	Adiga Life Sciences, Inc., Pharm-Olam International

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Rhinoconjunctivitis Symptom Score		Upto 25 weeks	No
Secondary	Symptom scores for nasal and non nasal symptoms		Upto 25 weeks	No
Secondary	Skin prick testing		Upto 25 weeks	No
Secondary	Peak Nasal Inspiratory Flow		Up to 25 weeks	No
Secondary	Grass specific IgA		Upto 26 weeks	No
Secondary	Grass specific IgE		Upto 26 weeks	No
Secondary	Grass specific IgG4		Up to 26 weeks	No
Secondary	Adverse Events		Up tp 26 weeks	Yes