Efficacy and Safety Study of SCH 900237/MK-8237 in Children and Adults With House Dust Mite-Induced Allergic Rhinitis/Rhinoconjunctivitis (P05607)
Condition: Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Nonseasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: MK-8237 tablets; Placebo tablets; Rescue Medication: Self-Injectable Epinephrine; Rescue Medication: Loratadine tablets; Rescue Medication: Olopatadine ophthalmic drops; Rescue Medication: Mometasone furoate nasal spray
Intervention description: MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d.; Placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d.; Self-injectable epinephrine (preferred dose of 0.30 mg) administered intramuscularly as needed for rescue medication.; Loratadine tablet 10 mg administered orally as needed for rescue medication.; Olopatadine hydrochloride ophthalmic drops 0.1% administered as needed for rescue medication.; Mometasone furoate monohydrate nasal spray 50 mcg administered intranasally as needed for rescue medication.
Intervention MeSH terms: Mometasone Furoate; Loratadine; Olopatadine Hydrochloride; Epinephrine; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1482.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the efficacy and safety of MK-8237 (SCH 900237) in the
      treatment of House Dust Mite (HDM)-Induced Allergic Rhinitis/Rhinoconjunctivitis (AR/ARC) in
      children and adults.

      The primary hypothesis of this study is that administration of MK-8237, compared to placebo,
      results in significant reduction in the average total combined rhinitis score (TCRS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of AR/ARC 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) an acceptable method
             of birth control within the projected duration of the study

          -  Able to read, understand and complete questionnaires and diaries

        Exclusion Criteria:

          -  Clinically relevant history of symptomatic ARC caused by animal dander, molds and/or
             cockroach (e.g. present in the home, job, daycare, etc.) or other perennial allergen

          -  History of symptomatic seasonal ARC and/or asthma due to an allergen to which the
             participant is sensitized and regularly exposed

          -  Nasal condition that could confound the efficacy or safety assessments (e.g., nasal
             polyposis)

          -  Received an immunosuppressive treatment within 3 months prior to screening

          -  Unstable or severe asthma, or has experienced a 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 [SABAs]) at any time within 3 months prior to
             screening

          -  Asthma requiring high-dose inhaled corticosteroids (ICS) within 6 months prior to
             screening

          -  History of anaphylaxis with cardiorespiratory symptoms with prior immunotherapy,
             unknown cause or inhalant allergen

          -  History of chronic urticaria and/or angioedema within 2 years prior to screening

          -  History of chronic sinusitis during 2 years prior to screening

          -  Pregnant, breastfeeding, or expecting to conceive within the projected duration of the
             study

          -  Previous immunotherapy treatment with any HDM allergen for more than 1 month within 5
             years prior to screening

          -  Previous exposure to MK-8237

          -  Receiving ongoing treatment with any specific immunotherapy at screening

          -  Known history of allergy, hypersensitivity or intolerance to investigational medicinal
             products (except for D. pteronyssinus and/or D. farinae), rescue medications or
             self-injectable epinephrine

          -  Unable to meet medication washout requirements prior to screening

          -  Unable or unwilling to comply with the use of self-injectable epinephrine

          -  Business or personal relationship with investigational site personnel or Sponsor who
             is directly involved with the conduct of the study

          -  Likely to travel for extended periods of time during the efficacy assessment period

          -  Participating in a different investigational study at any site during this study