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

NCT01383590 | Completed Phase 1

• 1 other identifier: RES-003
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Cat Allergy

Keywords

Cat allergy; Rhinoconjunctivitis; Immunotherapy; Cat-PAD

Outcome Measures

Primary Outcomes (1)

• Identification of potential plasma biomarkers of response to peptide immunotherapy

  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.

  6 months following last treatment

Secondary Outcomes (4)

• Symptom scores for ocular and nasal symptoms

  4 weeks following treatment

• Interleukin production and eosinophil level changes

  4 weeks following treatment

• Functional genomic changes

  4 weeks following treatment

• Changes in urine metabolomic profiles

  4 weeks following treatment

Study Arms (1)

Cat-PAD

EXPERIMENTAL

Biological: Cat-PAD

Interventions

Cat-PAD BIOLOGICAL

Intradermal injection 1 x 4 administrations 4 weeks apart.

Cat-PAD

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Circassia Limited: lead
• Adiga Life Sciences, Inc.: collaborator

Study Sites (1)

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

Related Publications (1)

• Neighbour H, Soliman M, Steacy LM, Hickey P, Forbes B, Larche M, Ellis AK. The Allergic Rhinitis Clinical Investigator Collaborative (AR-CIC): verification of nasal allergen challenge procedures in a study utilizing an investigational immunotherapy for cat allergy. Clin Transl Allergy. 2018 Apr 12;8:15. doi: 10.1186/s13601-018-0198-7. eCollection 2018.

  PMID: 29682277 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2011
• First Posted: June 28, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 22, 2014

Record last verified: 2014-01

Locations

CA (1)