Identification of Potential Biomarkers of Response to Peptide Immunotherapy for Ragweed Allergy
Phase 2
Completed
- Conditions
- Ragweed Allergy
- Interventions
- Biological: ToleroMune RagweedBiological: Placebo
- Registration Number
- NCT01361412
- Lead Sponsor
- Circassia Limited
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ToleroMune Ragweed 4 ToleroMune Ragweed - ToleroMune Ragweed Regimen 3 ToleroMune Ragweed - ToleroMune Ragweed Regimen 2 ToleroMune Ragweed - Placebo Placebo Placebo ToleroMune Ragweed Regimen 1 ToleroMune Ragweed -
- Primary Outcome Measures
Name Time Method Identification of potential plasma biomarkers of response to peptide immunotherapy 6 months after start of dosing 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Cetero Research
🇨🇦Mississauga, Ontario, Canada