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

Cat Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01383603
• Other study ID #: RES-004
• Status: Completed
• Phase: Phase 1
• First received: June 23, 2011
• Last updated: June 10, 2014
• Start date: October 2011
• Est. completion date: May 2014

Study information

• Verified date: June 2014
• Source: Circassia Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cat Allergy

Intervention

Biological:
• Cat-PAD
Intradermal injection 1 x 4 administrations 4 weeks apart

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Circassia Limited	Adiga Life Sciences, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of a change in gene expression over the course of and potentially attributable to Cat-PAD treatment.		6 months following treatment	No
Secondary	Symptom scores for ocular and nasal symptoms		4 weeks following treatment	No
Secondary	Interleukin production and eosinophil level changes		4 weeks following treatment	No
Secondary	Functional genomic changes		4 weeks following treatment	No
Secondary	Changes in urine metabolomic profiles		4 weeks following treatment	No