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Safety Study of MK-8237 Treatment in House-Dust-Mite Allergic Adolescents (MK-8237-008)

Primary Purpose

Rhinitis, Allergic, Perennial, Rhinitis, Allergic, Nonseasonal

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
MK-8237 6 DU
MK-8237 12 DU
Placebo
Sponsored by
ALK-Abelló A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhinitis, Allergic, Perennial

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • History of physician-diagnosed allergic rhinitis/rhinoconjunctivitis to house dust of at least 6 months duration (with or without asthma)
  • History of controlled asthma for the prior 1 month if participant has asthma, defined by not exceeding 2 days of symptoms per week; not more than 2 days of albuterol/short acting beta-agonist [SABA] use per week; and not wakening more than twice a month at night due to asthma symptoms
  • Agrees to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control from screening and through the duration of the study

Exclusion Criteria:

  • Unable to meet medication washout requirements
  • History of chronic urticaria and/or chronic angioedema within prior 2 years
  • History of anaphylaxis with cardiorespiratory symptoms with prior immunotherapy due to an unknown cause or to an inhalant allergen
  • Unstable, uncontrolled 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 SABAs) at any time within prior 3 months
  • History of chronic sinusitis during within prior 2 years
  • Pregnant or breast-feeding, or expecting to conceive within the projected duration of the study
  • Known history of allergy, hypersensitivity or intolerance to investigational medicinal products except for Dermatophagoides pteronyssinus (D. pteronyssinus) and/or Dermatophagoides farina (D. farina) or self-injectable epinephrine
  • Business or personal relationship with investigational site personnel or Sponsor who is directly involved with the conduct of the trial

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    MK-8237 6 DU

    MK-8237 12 DU

    Placebo

    Arm Description

    MK-8237 6 DU rapidly dissolving tablet administered sublingually once daily for 28 days

    MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily for 28 days

    Placebo rapidly dissolving tablet administered sublingually once daily for 28 days

    Outcomes

    Primary Outcome Measures

    Percentage of Participants Who Experienced At Least One Adverse Event (AE)
    An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. A serious adverse event (SAE) was an AE that resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, was associated with an overdose, was another important medical event.
    Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event
    The percentage of participants who had study treatment stopped due to an AE. Discontinuations were reported for all randomized participants who received ≥1 dose of study treatment.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 31, 2012
    Last Updated
    September 14, 2017
    Sponsor
    ALK-Abelló A/S
    Collaborators
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01678807
    Brief Title
    Safety Study of MK-8237 Treatment in House-Dust-Mite Allergic Adolescents (MK-8237-008)
    Official Title
    Safety Study of MK-8237 Treatment in House-Dust-Mite Allergic Adolescents (Protocol 008)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2012 (undefined)
    Primary Completion Date
    May 2013 (Actual)
    Study Completion Date
    May 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    ALK-Abelló A/S
    Collaborators
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the safety of two doses (6 Development Units [DU] and 12 DU) of MK-8237 sublingual tablets compared to Placebo in adolescents with house dust mite-induced allergic rhinitis/rhinoconjunctivitis. The primary hypothesis is that at least one dose of MK-8237 sublingual tablet is safe and well-tolerated in adolescents with house dust mite-induced allergic rhinitis/rhinoconjunctivitis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rhinitis, Allergic, Perennial, Rhinitis, Allergic, Nonseasonal

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    195 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    MK-8237 6 DU
    Arm Type
    Experimental
    Arm Description
    MK-8237 6 DU rapidly dissolving tablet administered sublingually once daily for 28 days
    Arm Title
    MK-8237 12 DU
    Arm Type
    Experimental
    Arm Description
    MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily for 28 days
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo rapidly dissolving tablet administered sublingually once daily for 28 days
    Intervention Type
    Biological
    Intervention Name(s)
    MK-8237 6 DU
    Other Intervention Name(s)
    SCH 900237
    Intervention Type
    Biological
    Intervention Name(s)
    MK-8237 12 DU
    Other Intervention Name(s)
    SCH 900237
    Intervention Type
    Biological
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    Percentage of Participants Who Experienced At Least One Adverse Event (AE)
    Description
    An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. A serious adverse event (SAE) was an AE that resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, was associated with an overdose, was another important medical event.
    Time Frame
    From first dose to last dose of treatment plus 2 weeks of follow-up, up to 42 days
    Title
    Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event
    Description
    The percentage of participants who had study treatment stopped due to an AE. Discontinuations were reported for all randomized participants who received ≥1 dose of study treatment.
    Time Frame
    From first dose to last dose of treatment, up to 28 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: History of physician-diagnosed allergic rhinitis/rhinoconjunctivitis to house dust of at least 6 months duration (with or without asthma) History of controlled asthma for the prior 1 month if participant has asthma, defined by not exceeding 2 days of symptoms per week; not more than 2 days of albuterol/short acting beta-agonist [SABA] use per week; and not wakening more than twice a month at night due to asthma symptoms Agrees to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control from screening and through the duration of the study Exclusion Criteria: Unable to meet medication washout requirements History of chronic urticaria and/or chronic angioedema within prior 2 years History of anaphylaxis with cardiorespiratory symptoms with prior immunotherapy due to an unknown cause or to an inhalant allergen Unstable, uncontrolled 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 SABAs) at any time within prior 3 months History of chronic sinusitis during within prior 2 years Pregnant or breast-feeding, or expecting to conceive within the projected duration of the study Known history of allergy, hypersensitivity or intolerance to investigational medicinal products except for Dermatophagoides pteronyssinus (D. pteronyssinus) and/or Dermatophagoides farina (D. farina) or self-injectable epinephrine Business or personal relationship with investigational site personnel or Sponsor who is directly involved with the conduct of the trial
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26553448
    Citation
    Maloney J, Prenner BM, Bernstein DI, Lu S, Gawchik S, Berman G, Kaur A, Li Z, Nolte H. Safety of house dust mite sublingual immunotherapy standardized quality tablet in children allergic to house dust mites. Ann Allergy Asthma Immunol. 2016 Jan;116(1):59-65. doi: 10.1016/j.anai.2015.10.024. Epub 2015 Nov 6.
    Results Reference
    result
    PubMed Identifier
    32926419
    Citation
    Fortescue R, Kew KM, Leung MST. Sublingual immunotherapy for asthma. Cochrane Database Syst Rev. 2020 Sep 14;9(9):CD011293. doi: 10.1002/14651858.CD011293.pub3.
    Results Reference
    derived

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    Safety Study of MK-8237 Treatment in House-Dust-Mite Allergic Adolescents (MK-8237-008)

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