Study Stopped
Interim data indicated that subjects exhibited no meaningful allergic disease during the first ragweed season, making it impossible to measure treatment effect.
Efficacy and Safety Study of TOLAMBA™ in Ragweed-Allergic Adults
A Randomized, Double-Masked, Placebo-Controlled, Multicenter, Dose-Regimen Study of the Efficacy and Safety of TOLAMBA™ in Ragweed-Allergic Rhinitis Adults
1 other identifier
interventional
738
1 country
28
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2006
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 11, 2006
CompletedFirst Posted
Study publicly available on registry
October 13, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedApril 16, 2019
April 1, 2019
1.1 years
October 11, 2006
April 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in total nasal symptom score during the peak period of the ragweed pollen season.
Two years
Study Arms (3)
1
EXPERIMENTALTOLAMBA™ dose-intense regimen
2
EXPERIMENTALTOLAMBA™ lower-dose regimen
3
PLACEBO COMPARATORInterventions
Escalating doses, 6 weekly subcutaneous (under the skin) injections
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Center Of Research Excellence
Oxford, Alabama, 36203, United States
Atlanta Allergy & Asthma Clinic
Stockbridge, Georgia, 30281, United States
Clinical Research of Atlanta
Stockbridge, Georgia, 30281, United States
Sneeze, Wheeze, and Itch Associates
Normal, Illinois, 61761, United States
Research Center of Indiana
Indianapolis, Indiana, 46208, United States
Asthma and Allergy Research Center
Minneapolis, Minnesota, 55416, United States
Clinical Research Institute
Plymouth, Minnesota, 55441, United States
Clinical Research of the Ozarks
Columbia, Missouri, 65203, United States
Clinical Research of The Ozarks
Rolla, Missouri, 65401, United States
Clinical Research Center
St Louis, Missouri, 63141, United States
Clinical Research of the Ozarks
Warrensburg, Missouri, 64093, United States
Midwest Allergy & Asthma Clinic
Omaha, Nebraska, 68130, United States
Creighton University
Omaha, Nebraska, 68131, United States
Asthma & Allergy Center
Papillion, Nebraska, 68046, United States
Princeton Center for Clinical Research
Skillman, New Jersey, 08558, United States
Allergy & Asthma Center
High Point, North Carolina, 27262, United States
Allergy & Respiratory Center
Canton, Ohio, 44718, United States
Bernstein Clinical Research Center
Cincinnati, Ohio, 45231, United States
Allergy, Asthma and Clinical Research Center
Oklahoma City, Oklahoma, 73120, United States
Asthma & Allergy Research Associates
Upland, Pennsylvania, 19013, United States
AARA Research Center
Dallas, Texas, 75231, United States
Pharmaceutical Research & Consulting
Dallas, Texas, 75231, United States
Kerrville Allergy and Asthma Associates
Kerrville, Texas, 78028, United States
Central Texas Health Research
New Braunfels, Texas, 78130, United States
Sylvana Research
San Antonio, Texas, 78229, United States
Asthma, Allergy & Sinus Center
Greenfield, Wisconsin, 53228, United States
University of Wisconsin Madison Medical School
Madison, Wisconsin, 53792, United States
Advanced Healthcare
Milwaukee, Wisconsin, 53209, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Eduardo Martins, MD, DPhil
Dynavax Technologies Corporation
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2006
First Posted
October 13, 2006
Study Start
April 1, 2006
Primary Completion
May 1, 2007
Study Completion
March 1, 2008
Last Updated
April 16, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share
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