ToleroMune Ragweed Exposure Chamber Study

Ragweed Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01198613
• Other study ID #: TR002
• Status: Completed
• Phase: Phase 2
• First received: September 6, 2010
• Last updated: October 6, 2011
• Start date: September 2010
• Est. completion date: August 2011

Study information

• Verified date: October 2011
• Source: Circassia Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 275
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• 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 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 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

• Ragweed Allergy

Intervention

Biological:
• ToleroMune Ragweed
Intradermal injection 1 x8 administrations 2 weeks apart
• Placebo
Intradermal injection, 1x8 administrations 2 weeks apart

Locations

Country	Name	City	State
Canada	KGK Synergize Inc.	London	Ontario
Canada	Cetero Research	Mississauga	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Circassia Limited	Adiga Life Sciences, Inc., Cetero Research, San Antonio

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Rhinoconjunctivitis Symptom Score		Upto 22 weeks	No
Secondary	Symptom scores for ocular and nasal symptoms		Upto 22 weeks	No
Secondary	Acoustic Rhinometry		Upto 22 weeks	No
Secondary	Skin prick testing		Baseline and final follow up	No
Secondary	Ragweed specific IgE		At baseline and at follow up	No
Secondary	Ragweed specific IgA		At baseline and follow up	No
Secondary	Ragweed specific IgG4		At baseline and at follow up	No
Secondary	Adverse Events		Upto 23 weeks	Yes