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

October 6, 2011 updated by: Circassia Limited

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

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 Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Mississauga, Ontario, Canada, L4W 1N2
        • Cetero Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Intradermal injection 1x8 administrations, 2 weeks apart
Experimental: ToleroMune Ragweed 4
Intradermal administration 1x8 administrations, 2 weeks apart
Experimental: ToleroMune Ragweed Regimen 3
Intradermal administration 1x8 administrations, 2 weeks apart
Experimental: ToleroMune Ragweed Regimen 2
Intradermal administration 1x8 administrations, 2 weeks apart
Experimental: ToleroMune Ragweed Regimen 1
Intradermal administration 1x8 administrations, 2 weeks apart

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of potential plasma biomarkers of response to peptide immunotherapy
Time Frame: 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
6 months after start of dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Deepen Patel, MD, CCFP, Cetero Research, San Antonio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

May 24, 2011

First Submitted That Met QC Criteria

May 25, 2011

First Posted (Estimate)

May 26, 2011

Study Record Updates

Last Update Posted (Estimate)

October 7, 2011

Last Update Submitted That Met QC Criteria

October 6, 2011

Last Verified

October 1, 2011

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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