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

Phase 1

Completed

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

• Registration Number: NCT01383603
• 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 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.

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: 2014-05
• Study Completion: 2014-05
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-10
• Last Update Posted: 2014-06-11

Recruitment & Eligibility

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

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)

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 a change in gene expression over the course of and potentially attributable to Cat-PAD treatment.	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)

St. Joseph's Healthcare Hamilton; 🇨🇦 Hamilton, Ontario, Canada