Identification of Potential Biomarkers of Peptide Immunotherapy. Part 1 - Proteomics Analysis

Circassia Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Cat Allergy

Treatments

Biological: Cat-PAD

Study type

Interventional

Funder types

Industry

Identifiers

NCT01383590

RES-003

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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)