ToleroMune Ragweed Follow up Study

Completed

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

• Registration Number: NCT01448603
• Lead Sponsor: Circassia Limited

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.

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 Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-06
• Study First Submitted QC: 2011-10-06
• Study First Posted: 2011-10-07
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-16
• Last Update Posted: 2012-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Subjects previously randomised to placebo in TR002
ToleroMune Ragweed Regimen 1	ToleroMune Ragweed	Subjects previously randomised to receive ToleroMune Ragweed regimen 1 in study TR002
ToleroMune Ragweed Regimen 2	ToleroMune Ragweed	Subject previously randomised to receive ToleroMune Ragweed regimen 2 in study TR002
ToleroMune Ragweed regimen 3	ToleroMune Ragweed	Subject previously randomised to receive ToleroMune Ragweed regimen 3 in study TR002
ToleroMune Ragweed regimen 4	ToleroMune Ragweed	Subjects previously randomised to receive ToleroMune Ragweed regimen 4 in study TR002

Primary Outcome Measures

Name	Time	Method
Total Rhinoconjunctivitis Symptom Score	48-54 weeks after the start of treatment in TR002

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Cetero Research; 🇨🇦 Mississauga, Ontario, Canada