Dose Selection Study of Efficacy and Safety of Different Doses of Grass MATA MPL and Grass MATA Using mEECs™
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 2

Summary: 
      There is increasing evidence that the effectiveness of allergy immunotherapy to control
      symptoms of rhinoconjunctivitis is related to the cumulative dose of allergen or allergoid
      administered during a single regimen of subcutaneous (SC) injections or of sublingual
      administration. The current therapeutic dose regimen for Grass MATA MPL is a course of four
      injections of 300, 800, 2000 and 2000 SU (Standardized Units), administered at weekly
      intervals (cumulative dose 5100 SU). Two new cumulative doses of the Grass MATA MPL 10200 SU
      and 18200 SU are being developed to compare with the current dose. The study is designed to
      explore the benefit/risk of increasing the cumulative allergen dose of the Grass MATA MPL
      immunotherapy comparing these doses with the current dose of Grass MATA MPL, Grass MATA
      (without MPL) and placebo.
    

Detailed description: 
      This study will be conducted outside the grass pollen season and is comprised of five
      periods.

        -  Period 1: Screening visit

        -  Period 2: Eligibility and baseline symptom assessments in the mobile environmental
           exposure chamber (mEEC™)

        -  Period 3: Six treatment visits, during which the study drug will be injected

        -  Period 4: Post-treatment efficacy assessments in the mEEC™

        -  Period 5: Safety follow-up

      Period 1 is the screening visit (Visit 1), and will occur 3 to 28 days before Visit 2.

      Period 2 includes the pre-randomization, grass pollen exposure visits, which consist of four
      3 hour sessions in the mEEC™ (Visits 2, 3, 4 and 5) during which patients will be exposed to
      grass pollen and record nasal and non nasal symptoms using electronic diaries (electronic
      Patient Data Acquisition Tablet: ePDAT™) prior to entry and every 30 minutes post entry into
      the mEEC™. Patients will attend mEEC™ visits on consecutive days. To be eligible for
      randomization and proceed to Treatment (Period 3), patients must achieve the following by the
      final pre treatment mEEC™ (Visit 5):

        -  Minimum qualifying Total Symptom Score (TSS) of at least 12 out of a possible 24 on at
           least one exposure using ePDAT™

        -  Total Nasal Symptom Score (TNSS) of at least 7 out of a possible 12 using ePDAT™

        -  Runny nose score of at least 2 out of 3 on at least two time points.

      Period 3 includes the six treatment visits (Visit 6, 7, 8, 9, 10 and 11). After each
      injection, patients will be kept under observation by personnel qualified to manage systemic
      allergic reactions at the site for at least 30 minutes. This period can be extended by the
      investigator in response to injection site or systemic allergic reactions. The observation
      will be followed up by a telephone call approximately 24 hours later.

      Period 4 consists of four 3 hour sessions (Visits 12, 13, 14 and 15) in the mEEC™ during
      which patients will be exposed to grass pollen and record post-treatment TSS using the ePDAT™
      as in Period 2.

      Period 5 consists of an End of Study (EOS) safety follow-up visit (Visit 16) between 2 and 14
      days after the last EEC visit. A telephone follow-up will be made at approximately 3, 6, and
      12 months following the last injection with detailed enquiry with regard to expected and
      non-expected AEs, with special attention to New Onset Autoimmune Disorders (NOAD) and
      Neuro-inflammatory (NI) disease. For subjects who withdraw early, similar follow up will be
      done at approximately 1, 3, 6, and 12 months following the last injection.
    

Intervention name(s): Placebo (0.5ml); Placebo (1.0ml); Grass MATA MPL (0.5ml) 5100SU; Grass MATA MPL (1.0ml) 10200SU; Grass MATA MPL (1.0ml) 18200SU; Grass MATA (0.5ml) 5100SU
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment