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An Evaluation of the Efficacy and Safety of TOLAMBA™ for Ragweed-Allergic Rhinitis in an Environmental Exposure Chamber

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00537355
Recruitment Status : Completed
First Posted : October 1, 2007
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Dynavax Technologies Corporation

Tracking Information
First Submitted Date  ICMJE September 27, 2007
First Posted Date  ICMJE October 1, 2007
Last Update Posted Date April 16, 2019
Study Start Date  ICMJE September 2007
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2007)
Total Nasal Symptom Score (TNSS) [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2007)
  • Total Non-Nasal Symptom Score (TNNSS) [ Time Frame: 3 months ]
  • Total Symptom Score (TSS) [ Time Frame: 3 months ]
  • quality of life questionnaire [ Time Frame: 3 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Evaluation of the Efficacy and Safety of TOLAMBA™ for Ragweed-Allergic Rhinitis in an Environmental Exposure Chamber
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of TOLAMBA™ in the Control of Symptoms of Ragweed-Allergic Rhinitis in an Environmental Exposure Chamber (EEC) Model
Brief Summary

This will be a randomized, double-blind, placebo-controlled, parallel-group, multicenter study. After passing the initial Screening Visit, subjects will be in the environmental exposure chamber(EEC), a room with a controlled amount of ragweed pollen, for 4 hours each day on 4 consecutive days. At the last visit, subjects who have achieved a minimum Total Nasal Symptom Score (TNSS) will be randomized to receive either TOLAMBA or placebo treatments. Subjects will receive 6 weekly subcutaneous (under the skin) injections of the study drug. About three weeks after the last injection, subjects will be asked to be in the EEC for 2 consecutive days (Visits 11 and 12, Days 60 and 61). Approximately 3 weeks after Visit 12 (Day 61), the subjects will again be in the EEC for 4 consecutive days (Visits 13-16, Days 82-85).

During all EEC visits, the subjects will be exposed to ragweed pollen at an average concentration of 3500 ± 500 pollen grains per cubic meter. Each EEC visit will last 4 hours. During each EEC visit, patients will be asked to record symptom scores for nasal and non-nasal symptoms at scheduled time points.

The total duration of a subject's participation in this study is expected to be a minimum of 85 days.

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 will be a randomized, double-blind, placebo-controlled, parallel-group, multicenter study. After passing the initial Screening Visit, subjects will be in the environmental exposure chamber(EEC), a room with a controlled amount of ragweed pollen, for 4 hours each day on 4 consecutive days. At the last visit, subjects who have achieved a minimum Total Nasal Symptom Score (TNSS) will be randomized to receive either TOLAMBA or placebo treatments. Subjects will receive 6 weekly subcutaneous (under the skin) injections of the study drug. About three weeks after the last injection, subjects will be asked to be in the EEC for 2 consecutive days (Visits 11 and 12, Days 60 and 61). Approximately 3 weeks after Visit 12 (Day 61), the subjects will again be in the EEC for 4 consecutive days (Visits 13-16, Days 82-85).

During all EEC visits, the subjects will be exposed to ragweed pollen at an average concentration of 3500 ± 500 pollen grains per cubic meter. Each EEC visit will last 4 hours. During each EEC visit, patients will be asked to record symptom scores for nasal and non-nasal symptoms at scheduled time points.

The total duration of a subject's participation in this study is expected to be a minimum of 85 days.

Comparison: Allergy symptoms of subjects treated with TOLAMBA™ compared with subjects treated with placebo.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Rhinitis, Allergic, Seasonal
Intervention  ICMJE
  • Biological: Amb a 1 Immunostimulatory Oligoribonucleotide Conjugate
    6 weekly subcutaneous injections (escalating doses of 3 mcg to 30 mcg)
    Other Name: TOLAMBA™
  • Drug: Histamine
    6 weekly subcutaneous injections (escalating doses of 0.22 mcg to 1.1 mcg)
    Other Name: Histatrol
Study Arms  ICMJE
  • Active Comparator: TOLAMBA™
    Intervention: Biological: Amb a 1 Immunostimulatory Oligoribonucleotide Conjugate
  • Sham Comparator: Histamine
    Histamine simulates mild redness/swelling effect seen with active comparator, TOLAMBA™. Prevents study staff from easily identifying subjects who received active comparator.
    Intervention: Drug: Histamine
Publications * Campbell JD, Buchmann P, Kesting S, Cunningham CR, Coffman RL, Hessel EM. Allergen-specific T cell responses to immunotherapy monitored by CD154 and intracellular cytokine expression. Clin Exp Allergy. 2010 Jul;40(7):1025-35. doi: 10.1111/j.1365-2222.2010.03505.x. Epub 2010 Apr 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 8, 2008)
271
Original Estimated Enrollment  ICMJE
 (submitted: September 27, 2007)
300
Actual Study Completion Date  ICMJE May 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Is willing and able to give signed informed consent, and must have provided this consent.
  • Has a clinical history of seasonal allergic rhinitis with seasonal nasal allergy symptoms during each of the last 2 ragweed allergy seasons.
  • Has documentation of a positive skin test to ragweed allergen within 12 months of screening.
  • Has minimum qualifying symptom scores at the last visit of the Pre-Treatment EEC sessions (Visit 5, Day 4).
  • If female of childbearing potential, is not pregnant and is consistently using an acceptable birth control method.
  • Is normally active and otherwise judged to be in good health on the basis of medical history, physical examination and routine laboratory tests.

Exclusion Criteria:

  • A woman who is pregnant, breastfeeding, or planning a pregnancy.
  • Has a history of more than mild asthma that requires the use of a daily inhaled or oral corticosteroid, leukotriene inhibitor, or cromolyn; or a daily inhaled short or long acting β-agonist.
  • Has had any hospital admissions for asthma, a recent (within the past 12 months)asthma exacerbation that required either oral or inhaled corticosteroids, or a prior history of unstable asthma.
  • Has received immunotherapy within the last 2 years that has contained ragweed pollen extract.
  • Has previously participated in a clinical trial with TOLAMBA or another ragweed-based immunotherapy.
  • Has received immunotherapy for any allergens within 30 days prior to Visit 1.
  • Has the need for use of antihistamines or corticosteroids on a regular basis (systemic or topical).
  • Has received anti-immunoglobulin E (IgE) antibody (Xolair®) within the past 12 months.
  • Is currently taking monoamine oxidase (MAO) inhibitors.
  • Has taken any systemic corticosteroids, immunomodulators, or immune suppressive medications within 4 weeks prior to Visit 1.
  • Has taken any antihistamine within 7 days prior to Visit 1 skin testing.
  • Requires use of β-adrenergic blockers or other agents that may interfere with the use of adrenaline.
  • Known current alcohol or drug abuse.
  • Current participation in another clinical study involving an investigational drug or device, or participation in such a study within 30 days prior to Visit 1.
  • Has a history of generalized anaphylaxis requiring medical attention.
  • Has moderate or severe allergy symptoms at Visit 1.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00537355
Other Study ID Numbers  ICMJE DV1-SAR-11
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: The IND for Tolamba was withdrawn. There is no intention to conduct clinical studies with this compound. All studies were conducted in Canada, no U.S. sites participated in study. CT PRS states "DR" status will be removed from study. 3/1/2017 - no update
Responsible Party Dynavax Technologies Corporation
Study Sponsor  ICMJE Dynavax Technologies Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Eduardo Martins, MD, DPhil Dynavax Technologies Corporation
PRS Account Dynavax Technologies Corporation
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP