Cat Allergy Clinical Trial
Official title:
Identification of Potential Biomarkers of Peptide Immunotherapy. Part 1 - Proteomics Analysis
Verified date | January 2014 |
Source | Circassia Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
Cat allergy is an increasingly prevalent condition, affecting 10-15% of patients with
allergic rhinoconjunctivitis. Cat-PAD is a novel synthetic, allergen derived peptide
desensitizing vaccine currently being developed for the treatment of cat allergy.
At present, the efficacy of immunotherapy (peptide or otherwise) can only be established at
the conclusion of therapy. The aim of this study is to identify changes in potential
biomarkers after peptide immunotherapy that may be subsequently developed as biomarkers that
equate with clinical efficacy.
Status | Completed |
Enrollment | 10 |
Est. completion date | December 2013 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Male or Female, aged 18-65 years - A minimum 1-year documented history of rhinoconjunctivitis on exposure to cats. - Positive skin prick test to cat allergen with a wheal diameter at least 3mm larger than that produced by the negative control. - Regular exposure to a cat in their normal living or working circumstances throughout the course of the study. - Minimum qualifying rhinoconjunctivitis symptom scores Exclusion Criteria: - History of asthma - A history of anaphylaxis to cat allergen - A history of allergen immunotherapy in the previous 10 years, or in the previous 3 years for pre-seasonal immunotherapy treatments - A history of any significant disease or disorder (e.g. autoimmune, cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, neoplastic/malignant, psychiatric, major physical impairment, severe atopic dermatitis) |
Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Kingston General Hospital | Kingston | Ontario |
Lead Sponsor | Collaborator |
---|---|
Circassia Limited | Adiga Life Sciences, Inc. |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Identification of potential plasma biomarkers of response to peptide immunotherapy | Blood samples derived from the study will be submitted for proteomics analyses aimed at the identification of one or more plasma proteins whose concentration over the course of the study varies in relation to the treatment administered. The outcome will be determined on the basis of measurements from samples collected over a period commencing prior to treatment and ending 6 months following treatment. | 6 months following last treatment | No |
Secondary | Symptom scores for ocular and nasal symptoms | 4 weeks following treatment | No | |
Secondary | Interleukin production and eosinophil level changes | 4 weeks following treatment | No | |
Secondary | Functional genomic changes | 4 weeks following treatment | No | |
Secondary | Changes in urine metabolomic profiles | 4 weeks following treatment | No |
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