NCT01448603

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.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 109 (actual)
• Sponsor: Circassia Limited · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Ragweed Allergy
• Rhinoconjunctivitis

Interventions

Type	Name	Description
BIOLOGICAL	Placebo	No further medication to be administered in this study. Intervention refers to treatment received in Study TR002.
BIOLOGICAL	ToleroMune Ragweed	No further medication to be administered in this study. Intervention refers to treatment received in Study TR002.

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2011-10-07
• Last updated: 2012-05-17

Locations

1 site across 1 country: Canada