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

April 11, 2019 updated by: Dynavax Technologies Corporation

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

738

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Oxford, Alabama, United States, 36203
        • Center Of Research Excellence
    • Georgia
      • Stockbridge, Georgia, United States, 30281
        • Atlanta Allergy & Asthma Clinic
      • Stockbridge, Georgia, United States, 30281
        • Clinical Research of Atlanta
    • Illinois
      • Normal, Illinois, United States, 61761
        • Sneeze, Wheeze, and Itch Associates
    • Indiana
      • Indianapolis, Indiana, United States, 46208
        • Research Center of Indiana
    • Minnesota
      • Minneapolis, Minnesota, United States, 55416
        • Asthma and Allergy Research Center
      • Plymouth, Minnesota, United States, 55441
        • Clinical Research Institute
    • Missouri
      • Columbia, Missouri, United States, 65203
        • Clinical Research of the Ozarks
      • Rolla, Missouri, United States, 65401
        • Clinical Research of the Ozarks
      • Saint Louis, Missouri, United States, 63141
        • Clinical Research Center
      • Warrensburg, Missouri, United States, 64093
        • Clinical Research of the Ozarks
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Creighton University
      • Omaha, Nebraska, United States, 68130
        • Midwest Allergy & Asthma Clinic
      • Papillion, Nebraska, United States, 68046
        • Asthma & Allergy Center
    • New Jersey
      • Skillman, New Jersey, United States, 08558
        • Princeton Center for Clinical Research
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Allergy & Asthma Center
    • Ohio
      • Canton, Ohio, United States, 44718
        • Allergy & Respiratory Center
      • Cincinnati, Ohio, United States, 45231
        • Bernstein Clinical Research Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Allergy, Asthma and Clinical Research Center
    • Pennsylvania
      • Upland, Pennsylvania, United States, 19013
        • Asthma & Allergy Research Associates
    • Texas
      • Dallas, Texas, United States, 75231
        • AARA Research Center
      • Dallas, Texas, United States, 75231
        • Pharmaceutical Research & Consulting
      • Kerrville, Texas, United States, 78028
        • Kerrville Allergy and Asthma Associates
      • New Braunfels, Texas, United States, 78130
        • Central Texas Health Research
      • San Antonio, Texas, United States, 78229
        • Sylvana Research
    • Wisconsin
      • Greenfield, Wisconsin, United States, 53228
        • Asthma, Allergy & Sinus Center
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Madison Medical School
      • Milwaukee, Wisconsin, United States, 53209
        • Advanced Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 3
Biological: Histamine base
Escalating doses, 6 weekly subcutaneous (under the skin) injections
Experimental: 1
TOLAMBA™ dose-intense regimen
Biological: Amb a 1 immunostimulatory oligodeoxyribonucleotide conjugate
Escalating doses, 6 weekly subcutaneous (under the skin) injections
Other Names:
  • TOLAMBA™
Experimental: 2
TOLAMBA™ lower-dose regimen
Biological: Amb a 1 immunostimulatory oligodeoxyribonucleotide conjugate
Escalating doses, 6 weekly subcutaneous (under the skin) injections
Other Names:
  • TOLAMBA™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in total nasal symptom score during the peak period of the ragweed pollen season.
Time Frame: Two years
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dynavax Technologies Corporation

Investigators

  • Study Director: Eduardo Martins, MD, DPhil, Dynavax Technologies Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

October 11, 2006

First Submitted That Met QC Criteria

October 11, 2006

First Posted (Estimate)

October 13, 2006

Study Record Updates

Last Update Posted (Actual)

April 16, 2019

Last Update Submitted That Met QC Criteria

April 11, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DV1-SAR-09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The IND for Tolamba was withdrawn, it was reported to the agency that there was no plan to conduct clinical studies with this compound. [per email from EA 18Dec2015. 3/1/2017 - No update

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rhinitis, Allergic, Seasonal

Clinical Trials on Amb a 1 immunostimulatory oligodeoxyribonucleotide conjugate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Togo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe