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.
1 other identifier
observational
109
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2011
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 6, 2011
CompletedFirst Posted
Study publicly available on registry
October 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedMay 17, 2012
May 1, 2012
5 months
October 6, 2011
May 16, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total Rhinoconjunctivitis Symptom Score
48-54 weeks after the start of treatment in TR002
Secondary Outcomes (5)
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
Study Arms (5)
Placebo
Subjects previously randomised to placebo in TR002
ToleroMune Ragweed Regimen 1
Subjects previously randomised to receive ToleroMune Ragweed regimen 1 in study TR002
ToleroMune Ragweed Regimen 2
Subject previously randomised to receive ToleroMune Ragweed regimen 2 in study TR002
ToleroMune Ragweed regimen 3
Subject previously randomised to receive ToleroMune Ragweed regimen 3 in study TR002
ToleroMune Ragweed regimen 4
Subjects previously randomised to receive ToleroMune Ragweed regimen 4 in study TR002
Interventions
No further medication to be administered in this study. Intervention refers to treatment received in Study TR002.
No further medication to be administered in this study. Intervention refers to treatment received in Study TR002.
Eligibility Criteria
Subjects previously randomised in study TR002 and completed all dosing visits and the Post Treatment Challenge (PTC).
You may qualify if:
- Previously randomised into study TR002 and completed all treatment visits and the PTC.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Circassia Limitedlead
- Adiga Life Sciences, Inc.collaborator
- Cetero Research, San Antoniocollaborator
Study Sites (1)
Cetero Research
Mississauga, Ontario, L4W 1N2, Canada
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Couroux, MD
Cetero Research, San Antonio
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2011
First Posted
October 7, 2011
Study Start
October 1, 2011
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
May 17, 2012
Record last verified: 2012-05