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OpenTrials
Completed

NCT Number: NCT01383603

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

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.

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Key information

Conditions

Cat Allergy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L9C3N6, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cat-PAD

Biological

Intradermal injection 1 x 4 administrations 4 weeks apart

Primary outcomes

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

    Time frame: 6 months following treatment

Secondary outcomes

  1. Symptom scores for ocular and nasal symptoms

    Time frame: 4 weeks following treatment

  2. Interleukin production and eosinophil level changes

    Time frame: 4 weeks following treatment

  3. Functional genomic changes

    Time frame: 4 weeks following treatment

  4. Changes in urine metabolomic profiles

    Time frame: 4 weeks following treatment

Sponsors and collaborators

Lead sponsor

Circassia Limited

Industry

Collaborators

  • Adiga Life Sciences, Inc.

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jun 28, 2011
Registry last updated
Jun 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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