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Efficacy and Safety Study of SCH 900237/MK-8237 in Children and Adults With House Dust Mite-Induced Allergic Rhinitis/Rhinoconjunctivitis (P05607)

Primary Purpose

Rhinitis, Allergic, Perennial, Rhinitis, Allergic, Nonseasonal

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK-8237 tablets
Placebo tablets
Rescue Medication: Self-Injectable Epinephrine
Rescue Medication: Loratadine tablets
Rescue Medication: Olopatadine ophthalmic drops
Rescue Medication: Mometasone furoate nasal spray
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 - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • History of AR/ARC to house dust of 1 year duration or more (with or without asthma)
  • If female of childbearing potential, has a negative urine pregnancy test at Screening and agrees to remain abstinent or use (or have their partner use) an acceptable method of birth control within the projected duration of the study
  • Able to read, understand and complete questionnaires and diaries

Exclusion Criteria:

  • Clinically relevant history of symptomatic ARC caused by animal dander, molds and/or cockroach (e.g. present in the home, job, daycare, etc.) or other perennial allergen
  • History of symptomatic seasonal ARC and/or asthma due to an allergen to which the participant is sensitized and regularly exposed
  • Nasal condition that could confound the efficacy or safety assessments (e.g., nasal polyposis)
  • Received an immunosuppressive treatment within 3 months prior to screening
  • Unstable 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 short-acting beta agonists [SABAs]) at any time within 3 months prior to screening
  • Asthma requiring high-dose inhaled corticosteroids (ICS) within 6 months prior to screening
  • History of anaphylaxis with cardiorespiratory symptoms with prior immunotherapy, unknown cause or inhalant allergen
  • History of chronic urticaria and/or angioedema within 2 years prior to screening
  • History of chronic sinusitis during 2 years prior to screening
  • Pregnant, breastfeeding, or expecting to conceive within the projected duration of the study
  • Previous immunotherapy treatment with any HDM allergen for more than 1 month within 5 years prior to screening
  • Previous exposure to MK-8237
  • Receiving ongoing treatment with any specific immunotherapy at screening
  • Known history of allergy, hypersensitivity or intolerance to investigational medicinal products (except for D. pteronyssinus and/or D. farinae), rescue medications or self-injectable epinephrine
  • Unable to meet medication washout requirements prior to screening
  • Unable or unwilling to comply with the use of self-injectable epinephrine
  • Business or personal relationship with investigational site personnel or Sponsor who is directly involved with the conduct of the study
  • Likely to travel for extended periods of time during the efficacy assessment period
  • Participating in a different investigational study at any site during this study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    MK-8237

    Placebo

    Arm Description

    MK-8237 12 Development Units (DU) rapidly dissolving tablets administered sublingually once daily (q.d.).

    Placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d.

    Outcomes

    Primary Outcome Measures

    Average Total Combined Rhinitis Score (TCRS) During Last 8 Weeks of Treatment
    The TCRS is the sum of the rhinitis Daily Symptom Score (DSS; range: 0 to 12) and the rhinitis Daily Medication Score (DMS; range: 0 to 12); the total possible TCRS ranges from 0 to 24 points with higher scores indicative of greater symptom severity. The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.
    Number of Participants Who Experience At Least One Adverse Event (AE)
    An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
    Number of Participants Who Discontinue Study Drug Due to an AE
    An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

    Secondary Outcome Measures

    Average Rhinitis Daily Symptom Score (Rhinitis DSS) During Last 8 Weeks of Treatment
    The Rhinitis DSS ranges from a score of 0 to 12 (higher scores indicative of greater symptom severity). The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.
    Average Rhinitis Daily Medication Score (Rhinitis DMS) During Last 8 Weeks of Treatment
    The Rhinitis DMS ranges from a score of 0 to 12 (higher scores indicative of greater symptomatic medication use). The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.
    Average Total Combined Rhinoconjunctivitis Score (TCS) During Last 8 Weeks of Treatment
    The TCS is the sum of the rhinoconjunctivitis DSS (rhinitis DSS and conjunctivitis DSS; range: 0 to 18) and the rhinoconjunctivitis DMS (rhinitis DMS and conjunctivitis DMS; range: 0 to 20); the total possible TCS ranges from 0 to 38 points with higher scores indicative of greater symptom severity. The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.
    Average Allergic Rhinitis/Rhinoconjunctivitis Symptoms Assessed by Visual Analogue Scale (VAS) During Last 8 Weeks of Treatment
    Participants indicated the severity of symptoms in the past week on a VAS with a score range of 0 ("no symptoms") to 100 ("severe symptoms"). Symptoms were assessed during 2 clinic visits occurring during the final 8 weeks of treatment (VAS score reflects the mean of 2 scores).

    Full Information

    First Posted
    October 2, 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
    NCT01700192
    Brief Title
    Efficacy and Safety Study of SCH 900237/MK-8237 in Children and Adults With House Dust Mite-Induced Allergic Rhinitis/Rhinoconjunctivitis (P05607)
    Official Title
    A One-year Placebo-Controlled Study Evaluating the Efficacy and Safety of the House Dust Mite Sublingual Allergen Immunotherapy Tablet (SCH 900237/MK 8237) in Children and Adult Subjects With House Dust Mite-Induced Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma (Protocol No. P05607/001)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2013 (undefined)
    Primary Completion Date
    April 2015 (Actual)
    Study Completion Date
    April 2015 (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
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to assess the efficacy and safety of MK-8237 (SCH 900237) in the treatment of House Dust Mite (HDM)-Induced Allergic Rhinitis/Rhinoconjunctivitis (AR/ARC) in children and adults. The primary hypothesis of this study is that administration of MK-8237, compared to placebo, results in significant reduction in the average total combined rhinitis score (TCRS).

    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 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    1482 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    MK-8237
    Arm Type
    Experimental
    Arm Description
    MK-8237 12 Development Units (DU) rapidly dissolving tablets administered sublingually once daily (q.d.).
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d.
    Intervention Type
    Biological
    Intervention Name(s)
    MK-8237 tablets
    Other Intervention Name(s)
    SCH 900237
    Intervention Description
    MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d.
    Intervention Type
    Biological
    Intervention Name(s)
    Placebo tablets
    Intervention Description
    Placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d.
    Intervention Type
    Drug
    Intervention Name(s)
    Rescue Medication: Self-Injectable Epinephrine
    Intervention Description
    Self-injectable epinephrine (preferred dose of 0.30 mg) administered intramuscularly as needed for rescue medication.
    Intervention Type
    Drug
    Intervention Name(s)
    Rescue Medication: Loratadine tablets
    Intervention Description
    Loratadine tablet 10 mg administered orally as needed for rescue medication.
    Intervention Type
    Drug
    Intervention Name(s)
    Rescue Medication: Olopatadine ophthalmic drops
    Intervention Description
    Olopatadine hydrochloride ophthalmic drops 0.1% administered as needed for rescue medication.
    Intervention Type
    Drug
    Intervention Name(s)
    Rescue Medication: Mometasone furoate nasal spray
    Intervention Description
    Mometasone furoate monohydrate nasal spray 50 mcg administered intranasally as needed for rescue medication.
    Primary Outcome Measure Information:
    Title
    Average Total Combined Rhinitis Score (TCRS) During Last 8 Weeks of Treatment
    Description
    The TCRS is the sum of the rhinitis Daily Symptom Score (DSS; range: 0 to 12) and the rhinitis Daily Medication Score (DMS; range: 0 to 12); the total possible TCRS ranges from 0 to 24 points with higher scores indicative of greater symptom severity. The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.
    Time Frame
    Last 8 weeks of treatment (Weeks 44 to 52)
    Title
    Number of Participants Who Experience At Least One Adverse Event (AE)
    Description
    An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
    Time Frame
    Up to 54 weeks
    Title
    Number of Participants Who Discontinue Study Drug Due to an AE
    Description
    An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
    Time Frame
    Up to 52 weeks
    Secondary Outcome Measure Information:
    Title
    Average Rhinitis Daily Symptom Score (Rhinitis DSS) During Last 8 Weeks of Treatment
    Description
    The Rhinitis DSS ranges from a score of 0 to 12 (higher scores indicative of greater symptom severity). The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.
    Time Frame
    Last 8 weeks of treatment (Weeks 44 to 52)
    Title
    Average Rhinitis Daily Medication Score (Rhinitis DMS) During Last 8 Weeks of Treatment
    Description
    The Rhinitis DMS ranges from a score of 0 to 12 (higher scores indicative of greater symptomatic medication use). The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.
    Time Frame
    Last 8 weeks of treatment (Weeks 44 to 52)
    Title
    Average Total Combined Rhinoconjunctivitis Score (TCS) During Last 8 Weeks of Treatment
    Description
    The TCS is the sum of the rhinoconjunctivitis DSS (rhinitis DSS and conjunctivitis DSS; range: 0 to 18) and the rhinoconjunctivitis DMS (rhinitis DMS and conjunctivitis DMS; range: 0 to 20); the total possible TCS ranges from 0 to 38 points with higher scores indicative of greater symptom severity. The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.
    Time Frame
    Last 8 weeks of treatment (Weeks 44 to 52)
    Title
    Average Allergic Rhinitis/Rhinoconjunctivitis Symptoms Assessed by Visual Analogue Scale (VAS) During Last 8 Weeks of Treatment
    Description
    Participants indicated the severity of symptoms in the past week on a VAS with a score range of 0 ("no symptoms") to 100 ("severe symptoms"). Symptoms were assessed during 2 clinic visits occurring during the final 8 weeks of treatment (VAS score reflects the mean of 2 scores).
    Time Frame
    Last 8 weeks of treatment (Weeks 44 to 52)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: History of AR/ARC to house dust of 1 year duration or more (with or without asthma) If female of childbearing potential, has a negative urine pregnancy test at Screening and agrees to remain abstinent or use (or have their partner use) an acceptable method of birth control within the projected duration of the study Able to read, understand and complete questionnaires and diaries Exclusion Criteria: Clinically relevant history of symptomatic ARC caused by animal dander, molds and/or cockroach (e.g. present in the home, job, daycare, etc.) or other perennial allergen History of symptomatic seasonal ARC and/or asthma due to an allergen to which the participant is sensitized and regularly exposed Nasal condition that could confound the efficacy or safety assessments (e.g., nasal polyposis) Received an immunosuppressive treatment within 3 months prior to screening Unstable 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 short-acting beta agonists [SABAs]) at any time within 3 months prior to screening Asthma requiring high-dose inhaled corticosteroids (ICS) within 6 months prior to screening History of anaphylaxis with cardiorespiratory symptoms with prior immunotherapy, unknown cause or inhalant allergen History of chronic urticaria and/or angioedema within 2 years prior to screening History of chronic sinusitis during 2 years prior to screening Pregnant, breastfeeding, or expecting to conceive within the projected duration of the study Previous immunotherapy treatment with any HDM allergen for more than 1 month within 5 years prior to screening Previous exposure to MK-8237 Receiving ongoing treatment with any specific immunotherapy at screening Known history of allergy, hypersensitivity or intolerance to investigational medicinal products (except for D. pteronyssinus and/or D. farinae), rescue medications or self-injectable epinephrine Unable to meet medication washout requirements prior to screening Unable or unwilling to comply with the use of self-injectable epinephrine Business or personal relationship with investigational site personnel or Sponsor who is directly involved with the conduct of the study Likely to travel for extended periods of time during the efficacy assessment period Participating in a different investigational study at any site during this study
    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
    27521719
    Citation
    Nolte H, Bernstein DI, Nelson HS, Kleine-Tebbe J, Sussman GL, Seitzberg D, Rehm D, Kaur A, Li Z, Lu S. Efficacy of house dust mite sublingual immunotherapy tablet in North American adolescents and adults in a randomized, placebo-controlled trial. J Allergy Clin Immunol. 2016 Dec;138(6):1631-1638. doi: 10.1016/j.jaci.2016.06.044. Epub 2016 Aug 10.
    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
    PubMed Identifier
    29656145
    Citation
    Bernstein DI, Kleine-Tebbe J, Nelson HS, Bardelas JA Jr, Sussman GL, Lu S, Rehm D, Svanholm Fogh B, Nolte H. SQ house dust mite sublingual immunotherapy tablet subgroup efficacy and local application site reaction duration. Ann Allergy Asthma Immunol. 2018 Jul;121(1):105-110. doi: 10.1016/j.anai.2018.04.007. Epub 2018 Apr 12.
    Results Reference
    derived
    PubMed Identifier
    29432959
    Citation
    Nolte H, Bernstein DI, Sussman GL, Svanholm Fogh B, Lu S, Husoy B, Nelson HS. Impact of Adverse Event Solicitation on the Safety Profile of SQ House Dust Mite Sublingual Immunotherapy Tablet. J Allergy Clin Immunol Pract. 2018 Nov-Dec;6(6):2081-2086.e1. doi: 10.1016/j.jaip.2018.01.037. Epub 2018 Feb 10.
    Results Reference
    derived

    Learn more about this trial

    Efficacy and Safety Study of SCH 900237/MK-8237 in Children and Adults With House Dust Mite-Induced Allergic Rhinitis/Rhinoconjunctivitis (P05607)

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