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

This study has been completed.
Sponsor:
Collaborator:
Adiga Life Sciences
Information provided by (Responsible Party):
Circassia Limited
ClinicalTrials.gov Identifier:
NCT01383603
First received: June 23, 2011
Last updated: June 10, 2014
Last verified: June 2014
  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:


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 ]

Enrollment: 10
Study Start Date: October 2011
Study Completion Date: May 2014
Primary Completion Date: May 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01383603

Locations
Canada, Ontario
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L9C3N6
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: June 10, 2014
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on October 19, 2014