Efficacy and Safety Study of RAGWITEK™ (MK-3641) in Children With Ragweed-Induced Rhinoconjunctivitis With or Without Asthma (MK-3641-008)
Condition: Rhinitis, Allergic, Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: Short ragweed pollen allergen extract; Placebo; Self-injectable epinephrine; Albuterol/Salbutamol; Loratadine; Olopatadine; Mometasone furoate monohydrate
Intervention description: One sublingual tablet containing 12 units of Amb a 1-U, once daily (QD) for up to 35 weeks.; One placebo sublingual tablet, QD for up to 35 weeks.; Intramuscular (IM) injection with suggested doses of 0.15 mg for participants weighing 15-30 kg (33-66 pounds) or 0.3 mg for participants weighing ≥30 kg (≥66 pounds), as needed for severe allergic reactions. Epinephrine was only provided in countries/study sites where it was a regulatory requirement.; Inhalation of albuterol 90 mcg/puff or salbutamol 100 mcg/puff metered dose inhaler (MDI), as needed as asthma rescue medication for those participants with asthma; 5 mg (1 mg/mL syrup or 5 mg tablet) for participants 5 years old or 10 mg (1 mg/mL syrup or 10 mg tablet) for participants 6 to 17 years old, as needed for rhinoconjunctivitis symptoms; Opthalmic solution, 1 drop (0.1%) per affected eye twice daily (BID), as needed for rhinoconjunctivitis symptoms; Intranasal spray, at doses of 1 spray (50 mcg/ spray) per nostril for participants 5 to 11 years old or 2 sprays (50 mcg/spray) per nostril for participants 12 to 17 years old, as needed for rhinoconjunctivitis symptoms
Intervention MeSH terms: Mometasone Furoate; Loratadine; Olopatadine Hydrochloride; Epinephrine; Albuterol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1025.0
Sex: All
Minimum age: 4 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the efficacy and safety of short ragweed pollen
      allergen extract (MK-3641, SCH 039641, RAGWITEK™) sublingual immunotherapy tablets in
      children aged 5 to 17 years with ragweed-induced allergic rhinitis/rhinoconjunctivitis with
      or without asthma. The primary hypothesis of this study is that administration of short
      ragweed pollen allergen extract sublingual immunotherapy tablets to children 5 to 17 years of
      age, compared with placebo, will result in a significant reduction in the combination of
      rhinoconjunctivitis symptoms and medication use over the peak ragweed season (RS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is between the ages of 4 and 17 years (inclusive) at enrollment in this study and is
             at least 5 years old at randomization

          -  Has a clinical history of significant ragweed pollen-induced allergic
             rhinitis/rhinoconjunctivitis of ≥1 year (at least 1 season for ages 4 to 6 years) or
             ≥2 years (at least 2 seasons for ages 7 to 17 years) duration diagnosed by a physician
             (with or without asthma) and have received treatment for the condition during the
             previous ragweed season

          -  If female, agrees to remain abstinent or use (or have their partner use) an acceptable
             method of birth control within the projected duration of the study.

        Exclusion Criteria:

          -  Has a clinical history of symptomatic seasonal allergic rhinitis (and/or asthma) due
             to another allergen, which has required regular medication during, or potentially
             overlapping, the ragweed season

          -  Has a clinical history of significant symptomatic perennial allergic rhinitis and/or
             asthma due to an allergen to which the subject is regularly exposed during the ragweed
             season which would interfere with assessment of the treatment effect

          -  Has any nasal condition that could confound the efficacy or safety assessments (e.g.,
             nasal polyposis).

          -  Has asthma requiring high daily doses of inhaled corticosteroids within the 6 months
             prior to the Screening visit

          -  Is either >7 years old and cannot perform reproducible FEV1 maneuvers despite
             coaching; OR is ≤7 years old and cannot perform reproducible FEV1 maneuvers despite
             coaching and has current symptoms of asthma characterized by recurrent episodes of
             wheezing, or episodes of cough, wheeze, difficulty in breathing, or chest tightness

          -  Has severe, unstable, or uncontrolled asthma, as judged by the clinical investigator,
             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) at any time within the last 3 months prior to the Screening or Randomization
             visits

          -  Has a history of anaphylaxis with cardiorespiratory symptoms with prior immunotherapy,
             unknown cause, or inhalant allergen

          -  Has a diagnosis of eosinophilic esophagitis

          -  Has a history of chronic urticaria and/or chronic angioedema

          -  Has a clinical history of chronic sinusitis during the 2 years prior to the Screening
             or Randomization visits

          -  Has current severe atopic dermatitis

          -  Has a history of allergy, hypersensitivity, or intolerance to the ingredients of the
             study drug (except for Ambrosia artemisiifolia), rescue medications, or
             self-injectable epinephrine

          -  Has previously received short ragweed pollen allergen extract

          -  Has previously been randomized into this study

          -  Is participating in any other clinical study or plans to participate in another
             clinical study during the duration of this study