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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Nonseasonal

Intervention: MK-8237 tablets (Biological); Placebo tablets (Biological); Rescue Medication: Self-Injectable Epinephrine (Drug); Rescue Medication: Loratadine tablets (Drug); Rescue Medication: Olopatadine ophthalmic drops (Drug); Rescue Medication: Mometasone furoate nasal spray (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.


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).

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome:

Average Total Combined Rhinitis Score (TCRS)

Number of Participants Who Experience At Least One Adverse Event

Number of Participants Who Discontinue Study Drug Due to an Adverse Event

Secondary outcome:

Average Rhinitis Daily Symptom Score (Rhinitis DSS)

Average Total Combined Rhinoconjunctivitis Score (TCS)

Average Rhinitis Daily Medication Score (Rhinitis DMS)

Average Allergic Rhinitis/Rhinoconjunctivitis Symptoms Assessed by Visual Analogue Scale (VAS)


Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.


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


- 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


- 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

Locations and Contacts

Additional Information

Starting date: January 2013
Last updated: May 13, 2015

Page last updated: August 23, 2015

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