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Ragweed Allergy

  • Number
  • Type
  • Age Range
  • Length of Study
  • Compensation*
  • 3641
  • Ragweed Allergy
  • 4 to 17 years of age
  • 6-18 months
  • $455


*Qualified participants may receive compensation for time and travel, up to the amount listed.

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).

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 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
  • 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.