Cat Allergy
Conditions
Keywords
Cat Allergy, Rhinoconjunctivitis, Immunotherapy, Cat-PAD
Brief summary
Cat allergy is an increasingly prevalent condition, affecting 10-15% of patients with allergic rhinoconjunctivitis. Cat-PAD is a novel, synthetic, allergen derived peptide desensitising vaccine currently being developed for treatment of cat allergy. At present, the efficacy of immunotherapy (peptide or otherwise) can only be established at the conclusion of therapy. No reliable predictive biomarkers of clinical efficacy currently exist. Identification of surrogate biomarkers of clinical efficacy, would facilitate clinical development of peptide immunotherapy vaccines, in addition to providing an improved understanding of the underlying molecular mechanisms of efficacy, thus providing new leads for therapeutic intervention.
Interventions
BIOLOGICALCat-PAD
Intradermal injection 1 x 4 administrations 4 weeks apart
Sponsors
Adiga Life Sciences, Inc.
Circassia Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female, aged 18-65 years. * Weight \>50 kg. * A minimum 1-year documented history of rhinoconjunctivitis on exposure to cats. * Positive skin prick test to cat allergen. * Subjects must have 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 * History of anaphylaxis to cat allergen * History of allergen immunotherapy in the previous 10 years, or in the previous 3 years for pre-seasonal immunotherapy treatments * 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Identification of a change in gene expression over the course of and potentially attributable to Cat-PAD treatment. | 6 months following treatment |
Secondary
| Measure | Time frame |
|---|---|
| Changes in urine metabolomic profiles | 4 weeks following treatment |
| Symptom scores for ocular and nasal symptoms | 4 weeks following treatment |
| Interleukin production and eosinophil level changes | 4 weeks following treatment |
| Functional genomic changes | 4 weeks following treatment |
Countries
Canada
Outcome results
None listed