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

This study is currently recruiting participants.
Verified January 2013 by Circassia Limited
Sponsor:
Collaborator:
Adiga Life Sciences
Information provided by (Responsible Party):
Circassia Limited
ClinicalTrials.gov Identifier:
NCT01383590
First received: June 23, 2011
Last updated: January 28, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Cat Allergy
 Biological: Cat-PAD
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Identification of Potential Biomarkers of Peptide Immunotherapy. Part 1 - Proteomics Analysis

Resource links provided by NLM:

MedlinePlus related topics: Allergy
U.S. FDA Resources

Further study details as provided by Circassia Limited:

Primary Outcome Measures:
  • Identification of potential plasma biomarkers of response to peptide immunotherapy [ Time Frame: 6 months following last treatment ] [ Designated as safety issue: No ]
    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:
  • Symptom scores for ocular and nasal symptoms [ Time Frame: 4 weeks following treatment ] [ Designated as safety issue: No ]
  • Interleukin production and eosinophil level changes [ Time Frame: 4 weeks following treatment ] [ Designated as safety issue: No ]
  • Functional genomic changes [ Time Frame: 4 weeks following treatment ] [ Designated as safety issue: No ]
  • Changes in urine metabolomic profiles [ Time Frame: 4 weeks following treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: October 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cat-PAD Biological: Cat-PAD
Intradermal injection 1 x 4 administrations 4 weeks apart.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01383590

Locations
Canada, Ontario
Kingston General Hospital Recruiting
Kingston, Ontario, Canada, K7L 2V7
Contact: Lisa M Steacy     613-549-6666 ext 3941     steacyl@kgh.kari.net    
Contact: Crystal Malone     613-548-2336        
Principal Investigator: Anne K Ellis, MD            
Sponsors and Collaborators
Circassia Limited
Adiga Life Sciences
  More Information

No publications provided

Responsible Party: Circassia Limited
ClinicalTrials.gov Identifier: NCT01383590     History of Changes
Other Study ID Numbers: RES-003
Study First Received: June 23, 2011
Last Updated: January 28, 2013
Health Authority: Canada: Health Canada

Keywords provided by Circassia Limited:
Cat allergy
Rhinoconjunctivitis
Immunotherapy
Cat-PAD

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013