An Evaluation of the Efficacy and Safety of TOLAMBA™ for Ragweed-Allergic Rhinitis in an Environmental Exposure Chamber
Condition: Rhinitis, Allergic, Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Amb a 1 Immunostimulatory Oligoribonucleotide Conjugate; Histamine
Intervention type(s): Biological; Drug
Intervention description(s): 6 weekly subcutaneous injections (escalating doses of 3 mcg to 30 mcg); 6 weekly subcutaneous injections (escalating doses of 0.22 mcg to 1.1 mcg)
Other intervention name(s): TOLAMBA™; Histatrol
Intervention MeSH terms: Histamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ragweed; ragweed allergy; allergy; allergies; allergic; seasonal allergic rhinitis; allergic rhinitis