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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01448603

Enrollment

109

Registered

2011-10-07

Start date

2011-10-31

Completion date

2012-03-31

Last updated

2012-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ragweed Allergy, Rhinoconjunctivitis

Keywords

Ragweed allergy, ToleroMune ragweed, immunotherapy

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.

Interventions

BIOLOGICALPlacebo

No further medication to be administered in this study. Intervention refers to treatment received in Study TR002.

BIOLOGICALToleroMune Ragweed

No further medication to be administered in this study. Intervention refers to treatment received in Study TR002.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026