Identification of Potential Biomarkers of Peptide Immunotherapy. Part 2 - Gene Array Analysis

Circassia Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Cat Allergy

Treatments

Biological: Cat-PAD

Study type

Interventional

Funder types

Industry

Identifiers

NCT01383603

RES-004

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 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.

Enrollment

10 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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)