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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01361412
Enrollment
20
Registered
2011-05-26
Start date
2011-03-31
Completion date
2011-09-30
Last updated
2011-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ragweed Allergy

Keywords

ragweed allergy, immunotherapy

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.

Interventions

BIOLOGICALToleroMune Ragweed

Intradermal administration 1x8 administrations, 2 weeks apart

BIOLOGICALPlacebo

Intradermal injection 1x8 administrations, 2 weeks apart

Sponsors

Adiga Life Sciences, Inc.
CollaboratorINDUSTRY
Cetero Research, San Antonio
CollaboratorNETWORK
Circassia Limited
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Enrolled in study TR002 but have not yet commenced dosing

Exclusion criteria

* None; no criteria additional to TR002

Design outcomes

Primary

MeasureTime frameDescription
Identification of potential plasma biomarkers of response to peptide immunotherapy6 months after start of dosingBlood 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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026