ToleroMune Ragweed Exposure Chamber Study

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

It is believe that ragweed is the primary cause of autumn allergies and 87% of patients with ragweed allergy suffer rhinoconjunctivitis. ToleroMune Ragweed is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of ragweed allergy.

This study will look at the efficacy, safety and tolerability of two doses of ToleroMune Ragweed in ragweed allergic subjects following challenge with ragweed in an EEC.

Study Overview

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

Detailed Description

This study is designed as a randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety and tolerability of ToleroMune Ragweed in ragweed allergic subjects with allergic rhinoconjunctivitis,subjects may also have controlled asthma. The efficacy of ToleroMune Ragweed will be explored in subjects using an(Environmental Exposure Chamber)EEC.

The study will consist of 3 study periods. In Period 1, Screening will be performed up to a maximum of 12 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 EEC 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 five 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 EEC 18-22 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): 275
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, ON N6A 5R8
      • KGK Synergize Inc.
    • Mississauga, Ontario, Canada, L4W 1N2
      • Cetero Research

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 ragweed. [Subjects may also have controlled asthma
• Positive skin prick test to ragweed allergen.
• Minimum qualifying rhinoconjunctivitis symptom scores

Exclusion criteria

• History of asthma.
• A history of anaphylaxis to ragweed allergen.
• Subjects with an FEV1 <70% of predicted.
• Subjects who cannot tolerate baseline challenge in the EEC.
• 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

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Biological: Placebo; Intradermal injection, 1x8 administrations 2 weeks apart
Experimental: ToleroMune Ragweed Regimen 3	Biological: ToleroMune Ragweed; Intradermal injection 1 x8 administrations 2 weeks apart
Experimental: ToleroMune Ragweed Regimen 2	Biological: ToleroMune Ragweed; Intradermal injection 1 x8 administrations 2 weeks apart
Experimental: ToleroMune Ragweed Regimen 1	Biological: ToleroMune Ragweed; Intradermal injection 1 x8 administrations 2 weeks apart
Experimental: ToleroMune Ragweed Regimen 4	Biological: ToleroMune Ragweed; Intradermal injection 1 x8 administrations 2 weeks apart

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total Rhinoconjunctivitis Symptom Score	Upto 22 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Symptom scores for ocular and nasal symptoms	Upto 22 weeks
Acoustic Rhinometry	Upto 22 weeks
Skin prick testing	Baseline and final follow up
Ragweed specific IgE	At baseline and at follow up
Ragweed specific IgA	At baseline and follow up
Ragweed specific IgG4	At baseline and at follow up
Adverse Events	Upto 23 weeks

Collaborators and Investigators

• Sponsor: Circassia Limited
• Collaborators: Cetero Research, San Antonio; Adiga Life Sciences, Inc.
• Investigators: Principal Investigator: Deepen Patel, MD, CCFP, Cetero Research, San Antonio

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: September 6, 2010
• First Submitted That Met QC Criteria: September 9, 2010
• First Posted (Estimate): September 10, 2010

Study Record Updates

• Last Update Posted (Estimate): October 7, 2011
• Last Update Submitted That Met QC Criteria: October 6, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: Immunotherapy; Rhinoconjunctivitis; Exposure chamber; Ragweed allergy; ToleroMune Ragweed
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: TR002