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

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ClinicalTrials.gov Identifier: NCT01361412
Recruitment Status : Completed
First Posted : May 26, 2011
Last Update Posted : October 7, 2011
Sponsor:
Collaborators:
Adiga Life Sciences, Inc.
Cetero Research, San Antonio
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Ragweed Allergy Biological: ToleroMune Ragweed Biological: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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
Study Start Date : March 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
U.S. FDA Resources

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



Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01361412


Locations
Canada, Ontario
Cetero Research
Mississauga, Ontario, Canada, L4W 1N2
Sponsors and Collaborators
Circassia Limited
Adiga Life Sciences, Inc.
Cetero Research, San Antonio
Investigators
Principal Investigator: Deepen Patel, MD, CCFP Cetero Research, San Antonio

Responsible Party: Circassia Limited
ClinicalTrials.gov Identifier: NCT01361412     History of Changes
Other Study ID Numbers: TR002A
First Posted: May 26, 2011    Key Record Dates
Last Update Posted: October 7, 2011
Last Verified: October 2011

Keywords provided by Circassia Limited:
ragweed allergy
immunotherapy

Additional relevant MeSH terms:
Hypersensitivity
Rhinitis, Allergic, Seasonal
Immune System Diseases
Rhinitis, Allergic
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate