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

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dynavax Technologies Corporation
• Treatments: Histamine; Histamine phosphate

Criteria

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.