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OpenTrials
Completed

NCT Number: NCT01361412

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

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.

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Key information

Conditions

Ragweed Allergy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cetero Research

Mississauga, Ontario, L4W 1N2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ToleroMune Ragweed

Biological

Intradermal administration 1x8 administrations, 2 weeks apart

Placebo

Biological

Intradermal injection 1x8 administrations, 2 weeks apart

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Circassia Limited

Industry

Collaborators

  • Adiga Life Sciences, Inc.
  • Cetero Research, San Antonio

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
May 26, 2011
Registry last updated
Oct 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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