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

NCT01383603 | Completed Phase 1

• 1 other identifier: RES-004
• 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 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.

Conditions

Cat Allergy

Keywords

Cat Allergy; Rhinoconjunctivitis; Immunotherapy; Cat-PAD

Outcome Measures

Primary Outcomes (1)

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

  6 months following 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.
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L9C3N6, 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: NA
• 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: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: June 11, 2014

Record last verified: 2014-06

Locations

CA (1)