ToleroMune Ragweed Follow up Study - Full Text View

Purpose

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.

Condition	Intervention
Ragweed Allergy Rhinoconjunctivitis	Biological: Placebo Biological: ToleroMune Ragweed

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	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.

Resource links provided by NLM:

MedlinePlus related topics: Allergy

U.S. FDA Resources

Further study details as provided by Circassia Limited:

Primary Outcome Measures:

Total Rhinoconjunctivitis Symptom Score [ Time Frame: 48-54 weeks after the start of treatment in TR002 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Total nasal and non-nasal symptom scores [ Time Frame: 48-54 weeks after the start of treatment in TR002 ] [ Designated as safety issue: No ]
Change in Immunoglobulin A (IgA) [ Time Frame: 50-56 weeks after the start of treatment in Tr002 ] [ Designated as safety issue: No ]
Change in Immunoglobulin E (IgE) [ Time Frame: 50-56 weeks after the start of treatment in Tr002 ] [ Designated as safety issue: No ]
Change in Immunoglobulin G4 (IgG4) [ Time Frame: 50-56 weeks after the start of treatment in Tr002 ] [ Designated as safety issue: No ]
Adverse Events [ Time Frame: 50-56 weeks after the start of treatment in TR002 ] [ Designated as safety issue: Yes ]

Enrollment:	109
Study Start Date:	October 2011
Study Completion Date:	March 2012
Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Placebo Subjects previously randomised to placebo in TR002	Biological: Placebo No further medication to be administered in this study. Intervention refers to treatment received in Study TR002.
ToleroMune Ragweed Regimen 1 Subjects previously randomised to receive ToleroMune Ragweed regimen 1 in study TR002	Biological: ToleroMune Ragweed No further medication to be administered in this study. Intervention refers to treatment received in Study TR002.
ToleroMune Ragweed Regimen 2 Subject previously randomised to receive ToleroMune Ragweed regimen 2 in study TR002	Biological: ToleroMune Ragweed No further medication to be administered in this study. Intervention refers to treatment received in Study TR002.
ToleroMune Ragweed regimen 3 Subject previously randomised to receive ToleroMune Ragweed regimen 3 in study TR002	Biological: ToleroMune Ragweed No further medication to be administered in this study. Intervention refers to treatment received in Study TR002.
ToleroMune Ragweed regimen 4 Subjects previously randomised to receive ToleroMune Ragweed regimen 4 in study TR002	Biological: ToleroMune Ragweed No further medication to be administered in this study. Intervention refers to treatment received in Study TR002.

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Subjects previously randomised in study TR002 and completed all dosing visits and the Post Treatment Challenge (PTC).

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01448603

Locations

Canada, Ontario
Cetero Research
Mississauga, Ontario, Canada, L4W 1N2

Sponsors and Collaborators

Circassia Limited

Adiga Life Sciences

Cetero Research, San Antonio

Investigators

Principal Investigator:

Peter Couroux, MD

Cetero Research, San Antonio

More Information

No publications provided

Responsible Party:	Circassia Limited
ClinicalTrials.gov Identifier:	NCT01448603 History of Changes
Other Study ID Numbers:	TR002B
Study First Received:	October 6, 2011
Last Updated:	May 16, 2012
Health Authority:	Canada: Health Canada

Keywords provided by Circassia Limited:

Ragweed allergy
ToleroMune ragweed
immunotherapy

Additional relevant MeSH terms:

Hypersensitivity
Conjunctivitis
Rhinitis, Allergic, Seasonal
Immune System Diseases
Conjunctival Diseases
Eye Diseases

Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on May 23, 2013