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NCT00387738 Clinical Trial

Efficacy and Safety Study of TOLAMBA™ in Ragweed-Allergic Adults

Rhinitis, Allergic, Seasonal Clinical Trial

Official title:
A Randomized, Double-Masked, Placebo-Controlled, Multicenter, Dose-Regimen Study of the Efficacy and Safety of TOLAMBA™ in Ragweed-Allergic Rhinitis Adults

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00387738
Other study ID # DV1-SAR-09
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date April 2006
Est. completion date March 2008

Study information
Verified date April 2019
Source Dynavax Technologies Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to find out if a new investigational vaccine, TOLAMBA™, is safe and effective in reducing the symptoms of ragweed allergy.

Description:

Ragweed allergy is the most common seasonal allergy in North America. Allergen immunotherapy is a therapeutic option for patients who have allergy symptoms that cannot be adequately controlled by avoidance of the allergen or medication. It may also be appropriate for those who cannot tolerate their medications due to side effects or have difficulties with medication compliance. This study compares the safety and efficacy of two different dosing regimens of TOLAMBA™ with placebo in reducing the symptoms of ragweed-allergic adults over two consecutive ragweed pollen seasons.

Comparison(s): Subject-rated allergy symptoms of subjects treated with TOLAMBA™ dose-intense regimen or TOLAMBA™ lower-dose regimen, compared with subjects treated with placebo.

Recruitment information / eligibility
Status Terminated
Enrollment 738
Est. completion date March 2008
Est. primary completion date May 2007
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- Has a history of ragweed allergic rhinitis (hayfever) during at least the last 2 consecutive seasons that has required treatment with antihistamines, decongestants and/or nasal steroids, but where symptom relief has been incomplete

- Is willing to stay in their ragweed area during the historical peak period of the local ragweed season, and willing to travel for no more than 2 weeks (cumulative time) outside of their ragweed area during the entire season

Exclusion Criteria:

- Has had any hospital admissions for asthma

- Has smoked within the past year, or has a =10-pack per year smoking history

- Has had any previous immunotherapy with ragweed pollen extract, or was in a previous clinical trial with TOLAMBA™

- Has used Xolair within the past 12 months

- Has a history of anaphylaxis

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Amb a 1 immunostimulatory oligodeoxyribonucleotide conjugate
Escalating doses, 6 weekly subcutaneous (under the skin) injections
• Histamine base
Escalating doses, 6 weekly subcutaneous (under the skin) injections

Locations
Country Name City State
United States Allergy & Respiratory Center Canton Ohio
United States Bernstein Clinical Research Center Cincinnati Ohio
United States Clinical Research of the Ozarks Columbia Missouri
United States AARA Research Center Dallas Texas
United States Pharmaceutical Research & Consulting Dallas Texas
United States Asthma, Allergy & Sinus Center Greenfield Wisconsin
United States Allergy & Asthma Center High Point North Carolina
United States Research Center of Indiana Indianapolis Indiana
United States Kerrville Allergy and Asthma Associates Kerrville Texas
United States University of Wisconsin Madison Medical School Madison Wisconsin
United States Advanced Healthcare Milwaukee Wisconsin
United States Asthma and Allergy Research Center Minneapolis Minnesota
United States Central Texas Health Research New Braunfels Texas
United States Sneeze, Wheeze, and Itch Associates Normal Illinois
United States Allergy, Asthma and Clinical Research Center Oklahoma City Oklahoma
United States Creighton University Omaha Nebraska
United States Midwest Allergy & Asthma Clinic Omaha Nebraska
United States Center Of Research Excellence Oxford Alabama
United States Asthma & Allergy Center Papillion Nebraska
United States Clinical Research Institute Plymouth Minnesota
United States Clinical Research of The Ozarks Rolla Missouri
United States Clinical Research Center Saint Louis Missouri
United States Sylvana Research San Antonio Texas
United States Princeton Center for Clinical Research Skillman New Jersey
United States Atlanta Allergy & Asthma Clinic Stockbridge Georgia
United States Clinical Research of Atlanta Stockbridge Georgia
United States Asthma & Allergy Research Associates Upland Pennsylvania
United States Clinical Research of the Ozarks Warrensburg Missouri

Sponsors (1)
Lead Sponsor Collaborator
Dynavax Technologies Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in total nasal symptom score during the peak period of the ragweed pollen season. Two years
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