Identification of Potential Biomarkers of Response to Peptide Immunotherapy for Ragweed Allergy

Ragweed Allergy Clinical Trial

Official title:

An Optional Research Study to Identify Potential Biomarkers of Response to Peptide Immunotherapy for Ragweed Allergy in Subjects Already Enrolled in Clinical Study TR002

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01361412
• Other study ID #: TR002A
• Status: Completed
• Phase: Phase 2
• First received: May 24, 2011
• Last updated: October 6, 2011
• Start date: March 2011
• Est. completion date: September 2011

Study information

• Verified date: October 2011
• Source: Circassia Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to identify changes in potential biomarkers after peptide immunotherapy for that may subsequently be developed as biomarkers that correlate with clinical efficacy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Enrolled in study TR002 but have not yet commenced dosing

Exclusion Criteria:

• None; no criteria additional to TR002 exclusion criteria are applicable to this study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Hypersensitivity
• Ragweed Allergy
• Rhinitis, Allergic, Seasonal

Intervention

Biological:
• ToleroMune Ragweed
Intradermal administration 1x8 administrations, 2 weeks apart
• Placebo
Intradermal injection 1x8 administrations, 2 weeks apart

Locations

Country	Name	City	State
Canada	Cetero Research	Mississauga	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Circassia Limited	Adiga Life Sciences, Inc., Cetero Research, San Antonio

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 treatmen	6 months after start of dosing	No