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

Phase 1

Completed

• Conditions: Cat Allergy
• Interventions: Biological: Cat-PAD

• Registration Number: NCT01383590
• Lead Sponsor: Circassia Limited

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-23
• Study First Submitted QC: 2011-06-27
• Study First Posted: 2011-06-28
• Study Start: 2011-10
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-21
• Last Update Posted: 2014-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cat-PAD	Cat-PAD	-

Primary Outcome Measures

Name	Time	Method
Identification of potential plasma biomarkers of response to peptide immunotherapy	6 months following last treatment	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.

Secondary Outcome Measures

Name	Time	Method
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
Changes in urine metabolomic profiles	4 weeks following treatment

Trial Locations

Locations (1)

Kingston General Hospital; 🇨🇦 Kingston, Ontario, Canada