ToleroMune Ragweed Exposure Chamber Study

Phase 2

Completed

• Conditions: Ragweed Allergy
• Interventions: Biological: ToleroMune Ragweed; Biological: Placebo

• Registration Number: NCT01198613
• Lead Sponsor: Circassia Limited

Brief 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.

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 Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-06
• Study First Submitted QC: 2010-09-09
• Study First Posted: 2010-09-10
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-06
• Last Update Posted: 2011-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 275

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ToleroMune Ragweed Regimen 4	ToleroMune Ragweed	-
Placebo	Placebo	-
ToleroMune Ragweed Regimen 1	ToleroMune Ragweed	-
ToleroMune Ragweed Regimen 2	ToleroMune Ragweed	-
ToleroMune Ragweed Regimen 3	ToleroMune Ragweed	-

Primary Outcome Measures

Name	Time	Method
Total Rhinoconjunctivitis Symptom Score	Upto 22 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

KGK Synergize Inc.; 🇨🇦 London, Ontario, Canada

Cetero Research; 🇨🇦 Mississauga, Ontario, Canada