Back to resultsIdentification of Potential Biomarkers of Peptide Immunotherapy. Part 2 - Gene Array Analysis
Primary Purpose
Cat Allergy
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Cat-PAD
Sponsored by
About this trial
This is an interventional treatment trial for Cat Allergy focused on measuring Cat Allergy, Rhinoconjunctivitis, Immunotherapy, Cat-PAD
Eligibility 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)
Sites / Locations
- St. Joseph's Healthcare Hamilton
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cat-PAD
Arm Description
Outcomes
Primary Outcome Measures
Identification of a change in gene expression over the course of and potentially attributable to Cat-PAD treatment.
Secondary Outcome Measures
Symptom scores for ocular and nasal symptoms
Interleukin production and eosinophil level changes
Functional genomic changes
Changes in urine metabolomic profiles
Full Information
NCT ID
NCT01383603
First Posted
June 23, 2011
Last Updated
June 10, 2014
Sponsor
Circassia Limited
Collaborators
Adiga Life Sciences, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01383603
Brief Title
Identification of Potential Biomarkers of Peptide Immunotherapy. Part 2 - Gene Array Analysis
Official Title
Identification of Potential Biomarkers of Peptide Immunotherapy. Part 2 - Gene Array Analysis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Circassia Limited
Collaborators
Adiga Life Sciences, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cat Allergy
Keywords
Cat Allergy, Rhinoconjunctivitis, Immunotherapy, Cat-PAD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cat-PAD
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Cat-PAD
Intervention Description
Intradermal injection 1 x 4 administrations 4 weeks apart
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Symptom scores for ocular and nasal symptoms
Time Frame
4 weeks following treatment
Title
Interleukin production and eosinophil level changes
Time Frame
4 weeks following treatment
Title
Functional genomic changes
Time Frame
4 weeks following treatment
Title
Changes in urine metabolomic profiles
Time Frame
4 weeks following treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Facility Information:
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L9C3N6
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
29682277
Citation
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.
Results Reference
derived
Learn more about this trial
Identification of Potential Biomarkers of Peptide Immunotherapy. Part 2 - Gene Array Analysis
We'll reach out to this number within 24 hrs