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

Primary Purpose

Rhinitis, Allergic, Seasonal

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Amb a 1 immunostimulatory oligodeoxyribonucleotide conjugate
Histamine base
Sponsored by
Dynavax Technologies Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rhinitis, Allergic, Seasonal focused on measuring Ragweed, Allergy, Allergic, Rhinitis, Hay Fever, Seasonal, Treatment, Immunotherapy, Vaccine

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Center Of Research Excellence
  • Atlanta Allergy & Asthma Clinic
  • Clinical Research of Atlanta
  • Sneeze, Wheeze, and Itch Associates
  • Research Center of Indiana
  • Asthma and Allergy Research Center
  • Clinical Research Institute
  • Clinical Research of the Ozarks
  • Clinical Research of The Ozarks
  • Clinical Research Center
  • Clinical Research of the Ozarks
  • Midwest Allergy & Asthma Clinic
  • Creighton University
  • Asthma & Allergy Center
  • Princeton Center for Clinical Research
  • Allergy & Asthma Center
  • Allergy & Respiratory Center
  • Bernstein Clinical Research Center
  • Allergy, Asthma and Clinical Research Center
  • Asthma & Allergy Research Associates
  • AARA Research Center
  • Pharmaceutical Research & Consulting
  • Kerrville Allergy and Asthma Associates
  • Central Texas Health Research
  • Sylvana Research
  • Asthma, Allergy & Sinus Center
  • University of Wisconsin Madison Medical School
  • Advanced Healthcare

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

Arm Description

TOLAMBA™ dose-intense regimen

TOLAMBA™ lower-dose regimen

Outcomes

Primary Outcome Measures

Change from baseline in total nasal symptom score during the peak period of the ragweed pollen season.

Secondary Outcome Measures

Full Information

First Posted
October 11, 2006
Last Updated
April 11, 2019
Sponsor
Dynavax Technologies Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00387738
Brief Title
Efficacy and Safety Study of TOLAMBA™ in Ragweed-Allergic Adults
Official Title
A Randomized, Double-Masked, Placebo-Controlled, Multicenter, Dose-Regimen Study of the Efficacy and Safety of TOLAMBA™ in Ragweed-Allergic Rhinitis Adults
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
Interim data indicated that subjects exhibited no meaningful allergic disease during the first ragweed season, making it impossible to measure treatment effect.
Study Start Date
April 2006 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dynavax Technologies Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis, Allergic, Seasonal
Keywords
Ragweed, Allergy, Allergic, Rhinitis, Hay Fever, Seasonal, Treatment, Immunotherapy, Vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
738 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
TOLAMBA™ dose-intense regimen
Arm Title
2
Arm Type
Experimental
Arm Description
TOLAMBA™ lower-dose regimen
Arm Title
3
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Amb a 1 immunostimulatory oligodeoxyribonucleotide conjugate
Other Intervention Name(s)
TOLAMBA™
Intervention Description
Escalating doses, 6 weekly subcutaneous (under the skin) injections
Intervention Type
Biological
Intervention Name(s)
Histamine base
Intervention Description
Escalating doses, 6 weekly subcutaneous (under the skin) injections
Primary Outcome Measure Information:
Title
Change from baseline in total nasal symptom score during the peak period of the ragweed pollen season.
Time Frame
Two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo Martins, MD, DPhil
Organizational Affiliation
Dynavax Technologies Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Center Of Research Excellence
City
Oxford
State/Province
Alabama
ZIP/Postal Code
36203
Country
United States
Facility Name
Atlanta Allergy & Asthma Clinic
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Clinical Research of Atlanta
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Sneeze, Wheeze, and Itch Associates
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Research Center of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46208
Country
United States
Facility Name
Asthma and Allergy Research Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Clinical Research Institute
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55441
Country
United States
Facility Name
Clinical Research of the Ozarks
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
Clinical Research of The Ozarks
City
Rolla
State/Province
Missouri
ZIP/Postal Code
65401
Country
United States
Facility Name
Clinical Research Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Clinical Research of the Ozarks
City
Warrensburg
State/Province
Missouri
ZIP/Postal Code
64093
Country
United States
Facility Name
Midwest Allergy & Asthma Clinic
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Creighton University
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Asthma & Allergy Center
City
Papillion
State/Province
Nebraska
ZIP/Postal Code
68046
Country
United States
Facility Name
Princeton Center for Clinical Research
City
Skillman
State/Province
New Jersey
ZIP/Postal Code
08558
Country
United States
Facility Name
Allergy & Asthma Center
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Allergy & Respiratory Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Bernstein Clinical Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45231
Country
United States
Facility Name
Allergy, Asthma and Clinical Research Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Asthma & Allergy Research Associates
City
Upland
State/Province
Pennsylvania
ZIP/Postal Code
19013
Country
United States
Facility Name
AARA Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Pharmaceutical Research & Consulting
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Kerrville Allergy and Asthma Associates
City
Kerrville
State/Province
Texas
ZIP/Postal Code
78028
Country
United States
Facility Name
Central Texas Health Research
City
New Braunfels
State/Province
Texas
ZIP/Postal Code
78130
Country
United States
Facility Name
Sylvana Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Asthma, Allergy & Sinus Center
City
Greenfield
State/Province
Wisconsin
ZIP/Postal Code
53228
Country
United States
Facility Name
University of Wisconsin Madison Medical School
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Advanced Healthcare
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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
Links:
URL
http://www.aaaai.org
Description
American Academy of Allergy, Asthma & Immunology
URL
http://www.dynavax.com
Description
Dynavax Web Page

Learn more about this trial

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

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