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Identification of Potential Biomarkers of Peptide Immunotherapy. Part 2 - Gene Array 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:
NCT01383603
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 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.


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

Study Type: Interventional
Study Design: 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 2 - Gene Array 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 a change in gene expression over the course of and potentially attributable to Cat-PAD treatment. [ Time Frame: 6 months following treatment ] [ Designated as safety issue: No ]

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.
  • 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01383603

Locations
Canada, Ontario
St. Joseph's Healthcare Hamilton Recruiting
Hamilton, Ontario, Canada, L9C3N6
Contact: Shauna Denis, RRT     905-522-1155 ext 33565     sdenis@stjosham.on.ca    
Principal Investigator: Helen Neighbour, MD            
Sponsors and Collaborators
Circassia Limited
Adiga Life Sciences
  More Information

No publications provided

Responsible Party: Circassia Limited
ClinicalTrials.gov Identifier: NCT01383603     History of Changes
Other Study ID Numbers: RES-004
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 16, 2013