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

Circassia Limited20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

Ragweed Allergy

Interventions

ToleroMune RagweedBIOLOGICAL

Intradermal administration 1x8 administrations, 2 weeks apart

PlaceboBIOLOGICAL

Intradermal injection 1x8 administrations, 2 weeks apart

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Cetero Research

Mississauga, Ontario, Canada

Outcomes

Primary Outcomes

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

Time frame: 6 months after start of dosing

Data from ClinicalTrials.gov

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