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

This study is currently recruiting participants.

Verified January 2013 by Circassia Limited

Sponsor:

Collaborator:

Adiga Life Sciences

Information provided by (Responsible Party):

Circassia Limited

ClinicalTrials.gov Identifier:

NCT01383590

First received: June 23, 2011

Last updated: January 28, 2013

Last verified: January 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	June 23, 2011
Last Updated Date	January 28, 2013
Start Date ^ICMJE	October 2011
Estimated Primary Completion Date	December 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 27, 2011)	Identification of potential plasma biomarkers of response to peptide immunotherapy [ Time Frame: 6 months following last treatment ] [ Designated as safety issue: No ] 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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01383590 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 27, 2011)	Symptom scores for ocular and nasal symptoms [ Time Frame: 4 weeks following treatment ] [ Designated as safety issue: No ] Interleukin production and eosinophil level changes [ Time Frame: 4 weeks following treatment ] [ Designated as safety issue: No ] Functional genomic changes [ Time Frame: 4 weeks following treatment ] [ Designated as safety issue: No ] Changes in urine metabolomic profiles [ Time Frame: 4 weeks following treatment ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Identification of Potential Biomarkers of Peptide Immunotherapy. Part 1 - Proteomics Analysis
Official Title ^ICMJE	Identification of Potential Biomarkers of Peptide Immunotherapy. Part 1 - Proteomics Analysis
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Cat Allergy
Intervention ^ICMJE	Biological: Cat-PAD Intradermal injection 1 x 4 administrations 4 weeks apart.
Study Arm (s)	Experimental: Cat-PAD Intervention: Biological: Cat-PAD
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	10
Estimated Completion Date	December 2013
Estimated Primary Completion Date	December 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: 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 Exclusion Criteria: 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)
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Canada

Administrative Information
NCT Number ^ICMJE	NCT01383590
Other Study ID Numbers ^ICMJE	RES-003
Has Data Monitoring Committee	No
Responsible Party	Circassia Limited
Study Sponsor ^ICMJE	Circassia Limited
Collaborators ^ICMJE	Adiga Life Sciences
Investigators ^ICMJE	Not Provided
Information Provided By	Circassia Limited
Verification Date	January 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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