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A Study of SCH 697243 in Participants With Grass Pollen Allergy Symptoms, With or Without Asthma (P08067)

Primary Purpose

Rhinitis Allergic, Conjunctivitis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Grass (Phleum pratense) pollen allergen extract
Placebo for SCH 697243
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

Eligibility Criteria

5 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Must have a clinical history of significant allergic rhinoconjunctivitis to grass (with or without asthma)
  • Must have a positive skin prick test response to Phleum pratense (Timothy grass)
  • Must be positive for specific immunoglobulin E (IgE) against Phleum pratense (Timothy grass)
  • Must have an forced expiratory volume in 1 second (FEV1) of at least 70% of predicted value at

Screening

- Safety laboratory tests and vital signs conducted at the Screening Visit must be within normal

limits or clinically acceptable to the investigator/sponsor

Exclusion Criteria:

  • Has a clinical history of symptomatic seasonal allergic rhinitis and/or asthma due to another allergen during or potentially overlapping the GPS
  • Has a clinical history of significant symptomatic perennial allergic rhinitis and/or asthma due to an allergen to which the participant is regularly exposed
  • Has received an immunosuppressive treatment within 3 months prior to the Screening Visit
  • Has a clinical history of severe asthma
  • Has a history of anaphylaxis with cardiorespiratory symptoms
  • Has a history of self-injectable epinephrine use
  • Has a history of chronic urticaria and angioedema
  • Has a clinical history of chronic sinusitis during the 2 years prior to the Screening Visit
  • Has current severe atopic dermatitis
  • Is breast-feeding, pregnant, or intending to become pregnant
  • Had previous treatment by immunotherapy with any grass pollen allergen for more than 1 month within the 5 years prior to the Screening Visit
  • Ongoing treatment with any specific immunotherapy at the time of the Screening Visit
  • Has a known history of allergy, hypersensitivity or intolerance to the ingredients of the study drug (except for Phleum pratense), rescue medications, or self-injectable epinephrine
  • Has any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study. Specific examples include but are not limited to hypertension being treated with beta blockers, coronary artery disease, arrhythmia, stroke, ocular conditions requiring topical beta blockers, any condition requiring the use of beta blockers
  • Has used any investigational drugs within 30 days of the Screening Visit
  • Is participating in any other clinical study
  • Is a family member of the investigational study staff conducting this study
  • Is unable to meet medication washout requirements
  • Is unlikely to be able to complete the trial, for any reason, or likely to travel for extended periods of time during the GPS, which in the opinion of the investigator will compromise the data
  • Has a clinically significant abnormal vital sign or laboratory value that would preclude participation in the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    SCH 697243

    Placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    Average Total Combined Rhinoconjunctivitis Daily Symptom Score (DSS) and Rhinoconjunctivitis Daily Medication Score (DMS) Over the Entire Grass Pollen Season (GPS)
    The total combined score was the sum of the rhinoconjunctivitis DSS and rhinoconjunctivitis DMS for the entire GPS (total score range: 0 to 54), with a lower score representing less rhinoconjunctivitis symptoms and use of medications. For rhinoconjunctivitis DSS, participants assessed a total of 6 rhinoconjunctivitis symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, and watery eyes) each on a scale of 0 to 3 (0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms; score range: 0 to 18), with a lower score representing less rhinoconjunctivitis symptoms. For rhinoconjunctivitis DMS, participants reported their use of specific rescue medications with specific scores assigned to each medication (score range: 0 to 36), with a lower score representing less use of medications for rhinoconjunctivitis.

    Secondary Outcome Measures

    Average Rhinoconjunctivitis DSS Over the Entire GPS
    For rhinoconjunctivitis DSS, participants assessed a total of 6 rhinoconjunctivitis symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, and watery eyes) each on a scale of 0 to 3 (0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms; score range: 0 to 18), with a lower score representing less rhinoconjunctivitis symptoms.
    Average Total Combined Rhinoconjunctivitis DSS and Rhinoconjunctivitis DMS Over the Peak GPS
    The total combined score was the sum of the rhinoconjunctivitis DSS and rhinoconjunctivitis DMS for the entire GPS (total score range: 0 to 54), with a lower score representing less rhinoconjunctivitis symptoms and use of medications. For rhinoconjunctivitis DSS, participants assessed a total of 6 rhinoconjunctivitis symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, and watery eyes) each on a scale of 0 to 3 (0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms; score range: 0 to 18), with a lower score representing less rhinoconjunctivitis symptoms. For rhinoconjunctivitis DMS, participants reported their use of specific rescue medications with specific scores assigned to each medication (score range: 0 to 36), with a lower score representing less use of medications for rhinoconjunctivitis.
    Average Rhinoconjunctivitis Quality of Life Questionnaire With Standardized Activities for Participants ≥12 Years of Age (RQLQ12+) Over the Peak GPS
    The RQLQ12+ consists of 7 domains: Activities, Sleep, Non-Nose/Eye Symptoms, Practical Problems, Nasal Symptoms, Eye Symptoms, Emotional. Participants reflect on their experience over the previous 7 days and assess 28 items on a scale of 0 to 6 (0=Not troubled, 6=Extremely troubled; score range: 0-6 [mean of all domain scores]), with a higher score indicating more significant impairment due to seasonal allergic rhinoconjunctivitis.
    Average Rhinoconjunctivitis DMS Over the Entire GPS
    For rhinoconjunctivitis DMS, participants reported their use of specific rescue medications with specific scores assigned to each medication (score range: 0 to 36), with a lower score representing less use of medications for rhinoconjunctivitis.
    Average Rhinoconjunctivitis DSS Over the Peak GPS
    For rhinoconjunctivitis DSS, participants assessed a total of 6 rhinoconjunctivitis symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, and watery eyes) each on a scale of 0 to 3 (0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms; score range: 0 to 18), with a lower score representing less rhinoconjunctivitis symptoms.
    Average Rhinoconjunctivitis DMS Over the Peak GPS
    For rhinoconjunctivitis DMS, participants reported their use of specific rescue medications with specific scores assigned to each medication (score range: 0 to 36), with a lower score representing less use of medications for rhinoconjunctivitis.
    Average Paediatric Standardised Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Overall Score Over the Peak GPS (Participants 6 to <12 Years of Age)
    For PRQLQ, participants assessed a total of 19 items within 5 domains: Nose Symptoms, Eye Symptoms, Practical Problems, Activity Limitation and Other Symptoms, each on a scale of 0 to 6 (0=Not troubled, 6=Extremely troubled; score range: 0 to 6 [mean of all domain scores]), with a higher score indicating more significant impairment due to seasonal allergic rhinoconjunctivitis.

    Full Information

    First Posted
    April 6, 2011
    Last Updated
    January 18, 2017
    Sponsor
    ALK-Abelló A/S
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01385371
    Brief Title
    A Study of SCH 697243 in Participants With Grass Pollen Allergy Symptoms, With or Without Asthma (P08067)
    Official Title
    A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Grass (Phleum Pratense) Sublingual Tablet (SCH 697243) in Subjects Between 5 and 65 Years of Age, With a History of Grass Pollen-Induced Rhinoconjunctivitis, With or Without Asthma (Protocol No. P08067)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2011 (undefined)
    Primary Completion Date
    August 2012 (Actual)
    Study Completion Date
    August 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    ALK-Abelló A/S

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This is a study to evaluate the efficacy and safety of grass sublingual tablet (SCH 697243) versus placebo in the treatment of grass pollen-induced allergic hayfever symptoms. Participants will receive either the sublingual grass tablet or a placebo tablet during the study. It is expected that those participants receiving the active sublingual grass tablet will have less hayfever symptoms and need less medications to treat hayfever symptoms during the grass pollen season.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    1501 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    SCH 697243
    Arm Type
    Experimental
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Biological
    Intervention Name(s)
    Grass (Phleum pratense) pollen allergen extract
    Other Intervention Name(s)
    SCH 697243
    Intervention Description
    One dissolving tablet sublingually once daily
    Intervention Type
    Biological
    Intervention Name(s)
    Placebo for SCH 697243
    Intervention Description
    One dissolving tablet sublingually once daily
    Primary Outcome Measure Information:
    Title
    Average Total Combined Rhinoconjunctivitis Daily Symptom Score (DSS) and Rhinoconjunctivitis Daily Medication Score (DMS) Over the Entire Grass Pollen Season (GPS)
    Description
    The total combined score was the sum of the rhinoconjunctivitis DSS and rhinoconjunctivitis DMS for the entire GPS (total score range: 0 to 54), with a lower score representing less rhinoconjunctivitis symptoms and use of medications. For rhinoconjunctivitis DSS, participants assessed a total of 6 rhinoconjunctivitis symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, and watery eyes) each on a scale of 0 to 3 (0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms; score range: 0 to 18), with a lower score representing less rhinoconjunctivitis symptoms. For rhinoconjunctivitis DMS, participants reported their use of specific rescue medications with specific scores assigned to each medication (score range: 0 to 36), with a lower score representing less use of medications for rhinoconjunctivitis.
    Time Frame
    Entire GPS (expected average duration of 5 to 6 weeks)
    Secondary Outcome Measure Information:
    Title
    Average Rhinoconjunctivitis DSS Over the Entire GPS
    Description
    For rhinoconjunctivitis DSS, participants assessed a total of 6 rhinoconjunctivitis symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, and watery eyes) each on a scale of 0 to 3 (0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms; score range: 0 to 18), with a lower score representing less rhinoconjunctivitis symptoms.
    Time Frame
    Entire GPS (expected average duration of 5 to 6 weeks)
    Title
    Average Total Combined Rhinoconjunctivitis DSS and Rhinoconjunctivitis DMS Over the Peak GPS
    Description
    The total combined score was the sum of the rhinoconjunctivitis DSS and rhinoconjunctivitis DMS for the entire GPS (total score range: 0 to 54), with a lower score representing less rhinoconjunctivitis symptoms and use of medications. For rhinoconjunctivitis DSS, participants assessed a total of 6 rhinoconjunctivitis symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, and watery eyes) each on a scale of 0 to 3 (0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms; score range: 0 to 18), with a lower score representing less rhinoconjunctivitis symptoms. For rhinoconjunctivitis DMS, participants reported their use of specific rescue medications with specific scores assigned to each medication (score range: 0 to 36), with a lower score representing less use of medications for rhinoconjunctivitis.
    Time Frame
    Peak GPS (expected average duration of 2 weeks)
    Title
    Average Rhinoconjunctivitis Quality of Life Questionnaire With Standardized Activities for Participants ≥12 Years of Age (RQLQ12+) Over the Peak GPS
    Description
    The RQLQ12+ consists of 7 domains: Activities, Sleep, Non-Nose/Eye Symptoms, Practical Problems, Nasal Symptoms, Eye Symptoms, Emotional. Participants reflect on their experience over the previous 7 days and assess 28 items on a scale of 0 to 6 (0=Not troubled, 6=Extremely troubled; score range: 0-6 [mean of all domain scores]), with a higher score indicating more significant impairment due to seasonal allergic rhinoconjunctivitis.
    Time Frame
    Peak GPS (expected average duration of 2 weeks)
    Title
    Average Rhinoconjunctivitis DMS Over the Entire GPS
    Description
    For rhinoconjunctivitis DMS, participants reported their use of specific rescue medications with specific scores assigned to each medication (score range: 0 to 36), with a lower score representing less use of medications for rhinoconjunctivitis.
    Time Frame
    Entire GPS (expected average duration of 5 to 6 weeks)
    Title
    Average Rhinoconjunctivitis DSS Over the Peak GPS
    Description
    For rhinoconjunctivitis DSS, participants assessed a total of 6 rhinoconjunctivitis symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, and watery eyes) each on a scale of 0 to 3 (0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms; score range: 0 to 18), with a lower score representing less rhinoconjunctivitis symptoms.
    Time Frame
    Peak GPS (expected average duration of 2 weeks)
    Title
    Average Rhinoconjunctivitis DMS Over the Peak GPS
    Description
    For rhinoconjunctivitis DMS, participants reported their use of specific rescue medications with specific scores assigned to each medication (score range: 0 to 36), with a lower score representing less use of medications for rhinoconjunctivitis.
    Time Frame
    Peak GPS (expected average duration of 2 weeks)
    Title
    Average Paediatric Standardised Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Overall Score Over the Peak GPS (Participants 6 to <12 Years of Age)
    Description
    For PRQLQ, participants assessed a total of 19 items within 5 domains: Nose Symptoms, Eye Symptoms, Practical Problems, Activity Limitation and Other Symptoms, each on a scale of 0 to 6 (0=Not troubled, 6=Extremely troubled; score range: 0 to 6 [mean of all domain scores]), with a higher score indicating more significant impairment due to seasonal allergic rhinoconjunctivitis.
    Time Frame
    Peak GPS (expected average duration of 2 weeks)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Must have a clinical history of significant allergic rhinoconjunctivitis to grass (with or without asthma) Must have a positive skin prick test response to Phleum pratense (Timothy grass) Must be positive for specific immunoglobulin E (IgE) against Phleum pratense (Timothy grass) Must have an forced expiratory volume in 1 second (FEV1) of at least 70% of predicted value at Screening - Safety laboratory tests and vital signs conducted at the Screening Visit must be within normal limits or clinically acceptable to the investigator/sponsor Exclusion Criteria: Has a clinical history of symptomatic seasonal allergic rhinitis and/or asthma due to another allergen during or potentially overlapping the GPS Has a clinical history of significant symptomatic perennial allergic rhinitis and/or asthma due to an allergen to which the participant is regularly exposed Has received an immunosuppressive treatment within 3 months prior to the Screening Visit Has a clinical history of severe asthma Has a history of anaphylaxis with cardiorespiratory symptoms Has a history of self-injectable epinephrine use Has a history of chronic urticaria and angioedema Has a clinical history of chronic sinusitis during the 2 years prior to the Screening Visit Has current severe atopic dermatitis Is breast-feeding, pregnant, or intending to become pregnant Had previous treatment by immunotherapy with any grass pollen allergen for more than 1 month within the 5 years prior to the Screening Visit Ongoing treatment with any specific immunotherapy at the time of the Screening Visit Has a known history of allergy, hypersensitivity or intolerance to the ingredients of the study drug (except for Phleum pratense), rescue medications, or self-injectable epinephrine Has any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study. Specific examples include but are not limited to hypertension being treated with beta blockers, coronary artery disease, arrhythmia, stroke, ocular conditions requiring topical beta blockers, any condition requiring the use of beta blockers Has used any investigational drugs within 30 days of the Screening Visit Is participating in any other clinical study Is a family member of the investigational study staff conducting this study Is unable to meet medication washout requirements Is unlikely to be able to complete the trial, for any reason, or likely to travel for extended periods of time during the GPS, which in the opinion of the investigator will compromise the data Has a clinically significant abnormal vital sign or laboratory value that would preclude participation in the study

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24468255
    Citation
    Maloney J, Bernstein DI, Nelson H, Creticos P, Hebert J, Noonan M, Skoner D, Zhou Y, Kaur A, Nolte H. Efficacy and safety of grass sublingual immunotherapy tablet, MK-7243: a large randomized controlled trial. Ann Allergy Asthma Immunol. 2014 Feb;112(2):146-153.e2. doi: 10.1016/j.anai.2013.11.018. Epub 2013 Dec 21.
    Results Reference
    result
    PubMed Identifier
    26507709
    Citation
    Nolte M, Barber D, Maloney J, Li Z, Kaur A, Galan A, Andersen JS, Nolte H. Timothy specific IgE levels are associated with efficacy and safety of timothy grass sublingual immunotherapy tablet. Ann Allergy Asthma Immunol. 2015 Dec;115(6):509-515.e2. doi: 10.1016/j.anai.2015.09.018. Epub 2015 Oct 21.
    Results Reference
    derived
    PubMed Identifier
    25685162
    Citation
    Hebert J, Blaiss M, Waserman S, Kim H, Creticos P, Maloney J, Kaur A, Li Z, Nelson H, Nolte H. The efficacy and safety of the Timothy grass allergy sublingual immunotherapy tablet in Canadian adults and children. Allergy Asthma Clin Immunol. 2014 Oct 30;10(1):53. doi: 10.1186/1710-1492-10-53. eCollection 2014.
    Results Reference
    derived

    Learn more about this trial

    A Study of SCH 697243 in Participants With Grass Pollen Allergy Symptoms, With or Without Asthma (P08067)

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