A Phase III, Randomized, Placebo-Controlled Clinical Trial to Study the Efficacy and Safety of MK-3641, a Ragweed (Ambrosia Artemisiifolia) Sublingual Immunotherapy Tablet, in Children With a History of Ragweed-Induced Rhinoconjunctivitis With or Without Asthma.
The purpose of this study is to assess the efficacy and safety of MK-3641 (short ragweed [Ambrosia artemisiifolia] extract, MK-3641, SCH 039641, RAGWITEK™) sublingual immunotherapy tablets in children aged 5 to 17 years with ragweed-induced rhinoconjunctivitis with or without asthma. The primary hypothesis of this study is that administration of MK-3641 sublingual immunotherapy tablets to children 5 to 17 years of age, compared with placebo, will result in a significant reduction in rhinoconjunctivitis symtoms and medication use over the peak ragweed season (RS).
- 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 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.
- 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
- 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 MK-3641
- 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
For more information, please call 309-452-0995 and ask to speak to a coordinator.