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| Sponsored by: |
Dynavax Technologies Corporation |
| Information provided by: | Dynavax Technologies Corporation |
| ClinicalTrials.gov Identifier: | NCT00537355 |
Purpose
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.
| Condition | Intervention | Phase |
|
Rhinitis, Allergic, Seasonal |
Biological: Amb a 1 Immunostimulatory Oligoribonucleotide Conjugate Drug: Histamine |
Phase II |
| MedlinePlus related topics: | Allergy Hay Fever |
| ChemIDplus related topics: | Histamine Histamine dihydrochloride Histamine phosphate |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | 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 |
| Enrollment: | 271 |
| Study Start Date: | September 2007 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
| TOLAMBA™: Active Comparator |
Biological: Amb a 1 Immunostimulatory Oligoribonucleotide Conjugate
6 weekly subcutaneous injections (escalating doses of 3 mcg to 30 mcg)
|
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Histamine: Sham Comparator
Histamine simulates mild redness/swelling effect seen with active comparator, TOLAMBA™. Prevents study staff from easily identifying subjects who received active comparator.
|
Drug: Histamine
6 weekly subcutaneous injections (escalating doses of 0.22 mcg to 1.1 mcg)
|
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.
Eligibility
| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Canada | |||||
| Centre De Recherche Appliquée en Allergie De Québec | |||||
| Quebec, Canada, GIV 4M6 | |||||
| Canada, Ontario | |||||
| Allied Research International Inc. | |||||
| Mississauga, Ontario, Canada, L4W 1N2 | |||||
| Alpha Medical Research Inc. | |||||
| Mississauga, Ontario, Canada, L5A 3V4 | |||||
| Allergy & Asthma Research Centre | |||||
| Ottawa, Ontario, Canada, K1Y 4G2 | |||||
| Canada, Quebec | |||||
| Division of Clinical Immunology and Allergy, The McGill University Health Centre | |||||
| Montreal, Quebec, Canada, H3G 1A4 | |||||
| Anapharm | |||||
| Montreal, Quebec, Canada, H3X 2H9 | |||||
| Dynavax Technologies Corporation |
| Study Director: | Eduardo Martins, MD, DPhil | Dynavax Technologies Corporation |
More Information
sponsor website 
  |
| Responsible Party: | Dynavax Technologies Corporation ( Eduardo Martins, MD, DPhil / Vice President, Clinical Development ) |
| Study ID Numbers: | DV1-SAR-11 |
| First Received: | September 27, 2007 |
| Last Updated: | October 6, 2008 |
| ClinicalTrials.gov Identifier: | NCT00537355 |
| Health Authority: | Canada: Health Canada |
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