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Efficacy and Safety Study of RAGWITEK™ (MK-3641) in Children With Ragweed-Induced Rhinoconjunctivitis With or Without Asthma (MK-3641-008)

This study is currently recruiting participants.
Verified November 2017 by Merck Sharp & Dohme Corp.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02478398
First Posted: June 23, 2015
Last Update Posted: November 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
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 allergic rhinitis/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 symptoms and medication use over the peak ragweed season (RS).

Condition Intervention Phase
Rhinitis, Allergic, Seasonal Biological: MK-3641 Biological: Placebo Drug: Self-injectable epinephrine Drug: Albuterol/Salbutamol Drug: Loratadine Drug: Olopatadine Drug: Mometasone furoate monohydrate Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Average Total Combined Score (TCS) During the Peak Ragweed Season (RS) [ Time Frame: 15 days ]

Secondary Outcome Measures:
  • Average TCS During the Entire RS [ Time Frame: Approximately 10 weeks ]
  • Average Rhinoconjunctivitis Daily Symptom Score (DSS) During the Peak RS [ Time Frame: 15 days ]
  • Average Rhinoconjunctivitis Daily Medication Score (DMS) During the Peak RS [ Time Frame: 15 days ]
  • Percentage of Participants Reporting Pre-specified Local Application Site Reactions [ Time Frame: Up to 30 weeks ]
  • Percentage of Participants Reporting Anaphylaxis and/or Systemic Allergic Reactions [ Time Frame: Up to 30 weeks ]
  • Percentage of Participants Treated with Epinephrine [ Time Frame: Up to 30 weeks ]

Estimated Enrollment: 1000
Actual Study Start Date: July 20, 2015
Estimated Study Completion Date: November 30, 2018
Estimated Primary Completion Date: November 30, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK-3641
Participants receive one MK-3641 sublingual tablet containing 12 units of Ambrosia artemisiifolia major allergen number 1 (Amb a 1-U), once daily (QD) for up to 28 weeks. Participants may use study-provided rescue medication(s) as needed to treat rhinoconjunctivitis symptoms.
Biological: MK-3641 Drug: Self-injectable epinephrine
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 rescue medication
Drug: Albuterol/Salbutamol
Inhalation albuterol 90 mcg/puff or salbutamol 100 mcg/puff metered dose inhaler (MDI), as needed for rescue medication
Drug: Loratadine
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 rescue medication
Drug: Olopatadine
Opthalmic solution, 1 drop (0.1%) per affected eye twice daily (BID), as needed for rescue medication
Drug: Mometasone furoate monohydrate
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 rescue medication
Placebo Comparator: Placebo
Participants receive one placebo sublingual tablet, QD for up to 28 weeks. Participants may use study-provided rescue medication(s) as needed to treat rhinoconjunctivitis symptoms.
Biological: Placebo Drug: Self-injectable epinephrine
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 rescue medication
Drug: Albuterol/Salbutamol
Inhalation albuterol 90 mcg/puff or salbutamol 100 mcg/puff metered dose inhaler (MDI), as needed for rescue medication
Drug: Loratadine
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 rescue medication
Drug: Olopatadine
Opthalmic solution, 1 drop (0.1%) per affected eye twice daily (BID), as needed for rescue medication
Drug: Mometasone furoate monohydrate
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 rescue medication

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02478398


Contacts
Contact: Toll Free Number 1-888-577-8839

  Show 56 Study Locations
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02478398     History of Changes
Other Study ID Numbers: 3641-008
2014-004341-27 ( EudraCT Number )
First Submitted: June 22, 2015
First Posted: June 23, 2015
Last Update Posted: November 27, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Epinephrine
Albuterol
Loratadine
Olopatadine Hydrochloride
Mometasone Furoate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics