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

This study has been completed.
Sponsor:
Collaborators:
Adiga Life Sciences
Cetero Research, San Antonio
Information provided by (Responsible Party):
Circassia Limited
ClinicalTrials.gov Identifier:
NCT01361412
First received: May 24, 2011
Last updated: October 6, 2011
Last verified: October 2011
  Purpose

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 Intervention Phase
Ragweed Allergy
Biological: ToleroMune Ragweed
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Circassia Limited:

Primary Outcome Measures:
  • Identification of potential plasma biomarkers of response to peptide immunotherapy [ Time Frame: 6 months after start of dosing ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 20
Study Start Date: March 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01361412

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

No publications provided

Responsible Party: Circassia Limited
ClinicalTrials.gov Identifier: NCT01361412     History of Changes
Other Study ID Numbers: TR002A
Study First Received: May 24, 2011
Last Updated: October 6, 2011
Health Authority: Canada: Health Canada

Keywords provided by Circassia Limited:
ragweed allergy
immunotherapy

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

ClinicalTrials.gov processed this record on July 29, 2014