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

NCT ID: NCT01361412

Last Updated: 2011-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2011-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Ragweed Allergy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ToleroMune Ragweed 4

Group Type EXPERIMENTAL

ToleroMune Ragweed

Intervention Type BIOLOGICAL

Intradermal administration 1x8 administrations, 2 weeks apart

ToleroMune Ragweed Regimen 3

Group Type EXPERIMENTAL

ToleroMune Ragweed

Intervention Type BIOLOGICAL

Intradermal administration 1x8 administrations, 2 weeks apart

ToleroMune Ragweed Regimen 2

Group Type EXPERIMENTAL

ToleroMune Ragweed

Intervention Type BIOLOGICAL

Intradermal administration 1x8 administrations, 2 weeks apart

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Intradermal injection 1x8 administrations, 2 weeks apart

ToleroMune Ragweed Regimen 1

Group Type EXPERIMENTAL

ToleroMune Ragweed

Intervention Type BIOLOGICAL

Intradermal administration 1x8 administrations, 2 weeks apart

Interventions

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ToleroMune Ragweed

Intradermal administration 1x8 administrations, 2 weeks apart

Intervention Type BIOLOGICAL

Placebo

Intradermal injection 1x8 administrations, 2 weeks apart

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Enrolled in study TR002 but have not yet commenced dosing
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Adiga Life Sciences, Inc.

INDUSTRY

Sponsor Role collaborator

Cetero Research, San Antonio

NETWORK

Sponsor Role collaborator

Circassia Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Deepen Patel, MD, CCFP

Role: PRINCIPAL_INVESTIGATOR

Cetero Research, San Antonio

Locations

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Cetero Research

Mississauga, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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TR002A

Identifier Type: -

Identifier Source: org_study_id