A Dose-Ranging Study of the Safety and Effectiveness of MK-8237 in the Treatment of House Dust Mite (HDM) Induced Allergic Rhinitis/Rhinoconjunctivitis in Adults (P07627)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01644617
First received: July 17, 2012
Last updated: September 3, 2014
Last verified: September 2014
  Purpose

The purpose of this study is to evaluate the dose-related effectiveness, the safety and the tolerability of MK-8237, compared to placebo, in the treatment of HDM-induced allergic rhinitis/rhinoconjunctivitis in adults.

Hypothesis: Administration of MK-8237, compared to placebo, results in dose-related improvement in Average Total Nasal Symptom Score (TNSS) during Environmental Exposure Chamber (EEC) Challenge.


Condition Intervention Phase
Rhinitis, Allergic, Perennial
Rhinitis, Allergic, Nonseasonal
Drug: Placebo
Drug: MK-8237 6 Development Units (DU)
Drug: MK-8237 12 DU
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase IIb, Randomized, Placebo-Controlled, Dose-Finding Clinical Trial to Study the Safety and Efficacy of MK-8237 Using an Environmental Exposure Chamber in Subjects With House Dust Induced Allergic Rhinitis/Rhinoconjunctivitis

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

Primary Outcome Measures:
  • Average Total Nasal Symptom Score (TNSS) During Environmental Exposure Chamber (EEC) Challenge Sessions [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    TNSS is the total of scores for 4 nasal symptoms (itchy nose, blocked nose, runny nose, and sneezing), each scored on a 4-point rating scale (0=no symptoms to 3=severe symptoms; TNSS range: 0 to 12 points).


Secondary Outcome Measures:
  • Average Total Symptom Score (TSS) During EEC Challenge Sessions [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    TSS is the sum of the TNSS and Total Ocular Symptom Score (TOSS). TOSS is the total of scores for 2 ocular symptom scores (gritty/feeling/red/itchy eyes and watery eyes), each scored on a 4-point scale (0=no symptoms to 3=severe symptoms; TOSS range: 0 to 6 points). (TSS range: 0 to 18 points).

  • Average Total Ocular Symptom Score (TOSS) During EEC Challenge Sessions [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • HDM-specific Immunoglobulin E (IgE) and HDM-specific Immunoglobulin G4 (IgG4) Levels [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Change from Pre-treatment in HDM-specific IgE and HDM-specific IgG4 Levels [ Time Frame: Pre-treatment (Week -6) and Week 8 ] [ Designated as safety issue: No ]
  • Number of Participants Who Experience At Least One Adverse Event (AE) [ Time Frame: From first dose of study drug through to 2 weeks after last dose of study drug (up to 26 weeks) ] [ Designated as safety issue: Yes ]

Enrollment: 124
Study Start Date: October 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Placebo rapidly dissolving tablets administered sublingually once daily
Experimental: MK-8237 6 DU Drug: MK-8237 6 Development Units (DU)
MK-8237 6 DU rapidly dissolving tablets administered sublingually once daily
Other Name: SCH 900237
Experimental: MK-8237 12 DU Drug: MK-8237 12 DU
MK-8237 12 DU rapidly dissolving tablets administered sublingually once daily
Other Name: SCH 900237

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • history of allergic rhinitis/rhinoconjunctivitis 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) 2

acceptable methods of birth control within the projected duration of the study.

Exclusion Criteria:

  • sensitized and regularly exposed to animal dander and molds, (e.g. present in the home, job, etc.)
  • sensitized and regularly exposed to seasonal allergens (i.e., Birch or grass pollen)
  • immunosuppressive treatment within 3 months prior to Screening (except steroids for allergic and asthma symptoms)
  • history of chronic urticaria and/or angioedema within 2 years prior to Screening
  • previous immunotherapy treatment with any HDM allergen for more than 1 month within 3 years prior to Screening
  • ongoing treatment with any specific immunotherapy
  • history of anaphylaxis with cardiorespiratory symptoms with prior immunotherapy, due to an unknown cause or to an inhalant allergen
  • unstable uncontrolled/partially controlled or severe asthma, or 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 [SABA]) within 3 months prior to Screening
  • asthma requiring medium- or high-dose inhaled corticosteroid (ICS) within 12 months prior to Screening
  • chronic sinusitis within 2 years prior to Screening
  • nasal condition that could confound the efficacy or safety assessments (e.g., nasal polyps)
  • pregnant, breastfeeding or planning to become pregnant during the study
  • participation in a different investigational study at any site during the same time frame of this study
  • direct association with the administration of the study or a family member of the study staff
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01644617     History of Changes
Other Study ID Numbers: P07627, 2012-001855-38, 8237-003
Study First Received: July 17, 2012
Last Updated: September 3, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on October 19, 2014