ToleroMune Ragweed Follow up Study

An Optional One Year Follow-up Study to Evaluate the Continued Efficacy of ToleroMune Ragweed in Ragweed Allergic Subjects Following Challenge With Ragweed Allergen in an Environmental Exposure Chamber.

Ragweed is the primary cause of autumn allergies. The ragweed season begins in mid-August. In the third National Health and Nutrition Examination Surveys54.3% of the population had positive test responses to one or more allergens, with the prevalence for short ragweed being 26.2%

The purpose of this observational follow-on study is to further evaluate rhinoconjunctivitis symptoms on exposure to ragweed allergen in the EEC among subjects who completed all dosing visits and the post treatment challenge (PTC) visit in study TR002 approximately one year after the start of treatment.

Study Overview

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

Detailed Description

Subjects who were randomised in study TR002 and who completed all dosing visits and the PTC will be invited to attend the Screening Visit for TR002B. Subjects will attend the EEC for 4 visits on successive days. Following the final EEC visit a follow-up visit will be performed 3-10 days later.

• Study Type: Observational
• Enrollment (Actual): 109

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • 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

• Sampling Method: Non-Probability Sample

Study Population

Subjects previously randomised in study TR002 and completed all dosing visits and the Post Treatment Challenge (PTC).

Description

Inclusion Criteria

• Previously randomised into study TR002 and completed all treatment visits and the PTC.

Exclusion Criteria

• History of asthma (a diagnosis of asthma in childhood may be allowed).
• Subjects with an FEV1 <70% of predicted.
• Subjects being treated with beta-blockers.
• Developed a significant disease, disorder or inability to communicate, since completing study TR002 which, in the opinion of the Sponsor's medical representative, may either put the subject at risk because of participation in the study, or influence the results of the study, or the subject's ability to participate in the study.

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Placebo; Subjects previously randomised to placebo in TR002	Biological: Placebo; No further medication to be administered in this study. Intervention refers to treatment received in Study TR002.
ToleroMune Ragweed Regimen 1; Subjects previously randomised to receive ToleroMune Ragweed regimen 1 in study TR002	Biological: ToleroMune Ragweed; No further medication to be administered in this study. Intervention refers to treatment received in Study TR002.
ToleroMune Ragweed Regimen 2; Subject previously randomised to receive ToleroMune Ragweed regimen 2 in study TR002	Biological: ToleroMune Ragweed; No further medication to be administered in this study. Intervention refers to treatment received in Study TR002.
ToleroMune Ragweed regimen 3; Subject previously randomised to receive ToleroMune Ragweed regimen 3 in study TR002	Biological: ToleroMune Ragweed; No further medication to be administered in this study. Intervention refers to treatment received in Study TR002.
ToleroMune Ragweed regimen 4; Subjects previously randomised to receive ToleroMune Ragweed regimen 4 in study TR002	Biological: ToleroMune Ragweed; No further medication to be administered in this study. Intervention refers to treatment received in Study TR002.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total Rhinoconjunctivitis Symptom Score	48-54 weeks after the start of treatment in TR002

Secondary Outcome Measures

Outcome Measure	Time Frame
Total nasal and non-nasal symptom scores	48-54 weeks after the start of treatment in TR002
Change in Immunoglobulin A (IgA)	50-56 weeks after the start of treatment in Tr002
Change in Immunoglobulin E (IgE)	50-56 weeks after the start of treatment in Tr002
Change in Immunoglobulin G4 (IgG4)	50-56 weeks after the start of treatment in Tr002
Adverse Events	50-56 weeks after the start of treatment in TR002

Collaborators and Investigators

• Sponsor: Circassia Limited
• Collaborators: Cetero Research, San Antonio; Adiga Life Sciences, Inc.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: October 6, 2011
• First Submitted That Met QC Criteria: October 6, 2011
• First Posted (Estimate): October 7, 2011

Study Record Updates

• Last Update Posted (Estimate): May 17, 2012
• Last Update Submitted That Met QC Criteria: May 16, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: immunotherapy; Ragweed allergy; ToleroMune ragweed
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: TR002B