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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Merck Sharp & Dohme Corp.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01700192
First received: October 2, 2012
Last updated: July 17, 2014
Last verified: July 2014

October 2, 2012
July 17, 2014
January 2013
February 2015   (final data collection date for primary outcome measure)
  • Average Total Combined Rhinitis Score (TCRS) [ Time Frame: Last 8 weeks of treatment ] [ Designated as safety issue: No ]
  • Number of Participants Who Experience At Least One Adverse Event [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: Yes ]
  • Number of Participants Who Discontinue Study Drug Due to an Adverse Event [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: Yes ]
  • Average Total Combined Daily Symptom and Medication Scores (TCS) [ Time Frame: Week 44 to Week 52 ] [ Designated as safety issue: No ]
  • Number of Participants Who Experience At Least One Adverse Event [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
  • Number of Participants Who Discontinue Study Drug Due to an Adverse Event [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01700192 on ClinicalTrials.gov Archive Site
  • Average Rhinitis Daily Symptom Score (Rhinitis DSS) [ Time Frame: Last 8 weeks of treatment ] [ Designated as safety issue: No ]
  • Average Total Combined Rhinoconjunctivitis Score (TCS) [ Time Frame: Last 8 weeks of treatment ] [ Designated as safety issue: No ]
  • Average Rhinitis Daily Medication Score (Rhinitis DMS) [ Time Frame: Last 8 weeks of treatment ] [ Designated as safety issue: No ]
  • Average Allergic Rhinitis/Rhinoconjunctivitis Symptoms Assessed by Visual Analogue Scale (VAS) [ Time Frame: Last 8 weeks of treatment ] [ Designated as safety issue: No ]
  • Average Daily Symptom Score (DSS) [ Time Frame: Week 44 to Week 52 ] [ Designated as safety issue: No ]
  • Average Visual Analogue Scale (VAS) Score [ Time Frame: Week 44 to Week 52 ] [ Designated as safety issue: No ]
  • Average Daily Medication Score (DMS) [ Time Frame: Week 44 to Week 52 ] [ Designated as safety issue: No ]
  • Average Total Nasal Symptom Score (TNSS) [ Time Frame: Week 44 to Week 52 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Long-Term Efficacy and Safety Study of SCH 900237/MK-8237 in Children and Adults With House Dust Mite-Induced Allergic Rhinitis/Rhinoconjunctivitis (P05607)
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)

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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Rhinitis, Allergic, Perennial
  • Rhinitis, Allergic, Nonseasonal
  • Biological: MK-8237 tablets
    MK-8237 12 DU rapidly dissolving tablets administered sublingually once daily
    Other Name: SCH 900237
  • Biological: Placebo tablets

    Placebo to MK-8237 rapidly dissolving tablets administered sublingually once

    daily

  • Drug: Rescue Medication: Self-Injectable Epinephrine
    Self-injectable epinephrine preferred dose of 0.30 mg administered intramuscularly as needed for rescue medication
  • Drug: Rescue Medication: Loratadine tablets
    Loratadine tablet 10 mg administered orally as needed for rescue medication
  • Drug: Rescue Medication: Olopatadine ophthalmic drops
    Olopatadine hydrochloride ophthalmic drops 0.1% administered as needed for rescue medication
  • Drug: Rescue Medication: Mometasone furoate nasal spray
    Mometasone furoate monohydrate nasal spray 50 mcg administered intranasally as needed for rescue medication
  • Experimental: MK-8237
    MK-8237 12 Development Units (DU) rapidly dissolving tablets administered sublingually once daily
    Interventions:
    • Biological: MK-8237 tablets
    • Drug: Rescue Medication: Self-Injectable Epinephrine
    • Drug: Rescue Medication: Loratadine tablets
    • Drug: Rescue Medication: Olopatadine ophthalmic drops
    • Drug: Rescue Medication: Mometasone furoate nasal spray
  • Placebo Comparator: Placebo
    Placebo to MK-8237 rapidly dissolving tablets administered sublingually once daily
    Interventions:
    • Biological: Placebo tablets
    • Drug: Rescue Medication: Self-Injectable Epinephrine
    • Drug: Rescue Medication: Loratadine tablets
    • Drug: Rescue Medication: Olopatadine ophthalmic drops
    • Drug: Rescue Medication: Mometasone furoate nasal spray
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1500
February 2015
February 2015   (final data collection date for primary outcome measure)

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
Both
12 Years and older
No
Contact: Toll Free Number 1-888-577-8839
United States,   Canada
 
NCT01700192
P05607, MK-8237-001
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP