ToleroMune Ragweed Follow up Study

Circassia Pharmaceuticals

Status: Completed

Conditions: Rhinoconjunctivitis; Ragweed Allergy

Treatments: Biological: ToleroMune Ragweed; Biological: Placebo

Study type: Observational

Funder types: NETWORK; Industry

Identifiers

NCT01448603

TR002B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 109 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

109 participants in 5 patient groups

Placebo

Description:

Subjects previously randomised to placebo in TR002

Treatment:

Biological: Placebo

ToleroMune Ragweed Regimen 1

Description:

Subjects previously randomised to receive ToleroMune Ragweed regimen 1 in study TR002

Treatment:

Biological: ToleroMune Ragweed

ToleroMune Ragweed Regimen 2

Description:

Subject previously randomised to receive ToleroMune Ragweed regimen 2 in study TR002

Treatment:

Biological: ToleroMune Ragweed

ToleroMune Ragweed regimen 3

Description:

Subject previously randomised to receive ToleroMune Ragweed regimen 3 in study TR002

Treatment:

Biological: ToleroMune Ragweed

ToleroMune Ragweed regimen 4

Description:

Subjects previously randomised to receive ToleroMune Ragweed regimen 4 in study TR002

Treatment:

Biological: ToleroMune Ragweed