A Dose-Ranging Study of the Safety and Effectiveness of MK-8237 in the Treatment of House Dust Mite (HDM) Induced Allergic Rhinitis/Rhinoconjunctivitis in Adults (MK-8237-003/P07627)
Condition: Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Nonseasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: Placebo; MK-8237 6 DU; MK-8237 12 DU
Intervention description: Placebo rapidly dissolving tablets administered sublingually once daily; MK-8237 6 DU rapidly dissolving tablets administered sublingually once daily; MK-8237 12 DU rapidly dissolving tablets administered sublingually once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 124.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the dose-related effectiveness, the safety and the
      tolerability of MK-8237, compared to placebo, in the treatment of house dust mite
      (HDM)-induced allergic rhinitis/rhinoconjunctivitis in adults. The primary hypothesis is that
      administration of MK-8237, compared to placebo, results in dose-related improvement in the
      average total nasal symptom score (TNSS) determined during environmental exposure chamber
      (EEC) challenge.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of allergic rhinitis/rhinoconjunctivitis to house dust of 1 year duration or
             more (with or without asthma)

          -  If female of childbearing potential, has a negative urine pregnancy test at screening
             and agrees to remain abstinent or use (or have their partner use) 2 acceptable methods
             of birth control within the projected duration of the study.

        Exclusion Criteria:

          -  Sensitized and regularly exposed to animal dander and molds, (e.g. present in the
             home, job, etc.)

          -  Sensitized and regularly exposed to seasonal allergens (i.e., birch or grass pollen)

          -  Immunosuppressive treatment within 3 months prior to screening (except steroids for
             allergic and asthma symptoms)

          -  History of chronic urticaria and/or angioedema within 2 years prior to screening

          -  Previous immunotherapy treatment with any HDM allergen for more than 1 month within 3
             years prior to screening

          -  Ongoing treatment with any specific immunotherapy

          -  History of anaphylaxis with cardiorespiratory symptoms with prior immunotherapy, due
             to an unknown cause or to an inhalant allergen

          -  Unstable uncontrolled/partially controlled or severe asthma, or life-threatening
             asthma attack or an occurrence of any clinical deterioration of asthma that resulted
             in emergency treatment, hospitalization due to asthma, or treatment with systemic
             corticosteroids (but allowing short-acting beta agonists [SABA]) within 3 months prior
             to screening

          -  Asthma requiring medium- or high-dose inhaled corticosteroid (ICS) within 12 months
             prior to screening

          -  Chronic sinusitis within 2 years prior to screening

          -  Nasal condition that could confound the efficacy or safety assessments (e.g., nasal
             polyps)

          -  Pregnant, breastfeeding or planning to become pregnant during the study

          -  Participation in a different investigational study at any site during the same time
             frame of this study

          -  Direct association with the administration of the study or a family member of the
             study staff