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

September 14, 2017 updated by: ALK-Abelló A/S

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1482

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MK-8237
MK-8237 12 Development Units (DU) rapidly dissolving tablets administered sublingually once daily (q.d.).
Biological: MK-8237 tablets
MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d.
Other Names:
  • SCH 900237
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.
Placebo Comparator: Placebo
Placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d.
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.
Biological: Placebo tablets
Placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Total Combined Rhinitis Score (TCRS) During Last 8 Weeks of Treatment
Time Frame: Last 8 weeks of treatment (Weeks 44 to 52)
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.
Last 8 weeks of treatment (Weeks 44 to 52)
Number of Participants Who Experience At Least One Adverse Event (AE)
Time Frame: Up to 54 weeks
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.
Up to 54 weeks
Number of Participants Who Discontinue Study Drug Due to an AE
Time Frame: Up to 52 weeks
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.
Up to 52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Rhinitis Daily Symptom Score (Rhinitis DSS) During Last 8 Weeks of Treatment
Time Frame: Last 8 weeks of treatment (Weeks 44 to 52)
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.
Last 8 weeks of treatment (Weeks 44 to 52)
Average Rhinitis Daily Medication Score (Rhinitis DMS) During Last 8 Weeks of Treatment
Time Frame: Last 8 weeks of treatment (Weeks 44 to 52)
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.
Last 8 weeks of treatment (Weeks 44 to 52)
Average Total Combined Rhinoconjunctivitis Score (TCS) During Last 8 Weeks of Treatment
Time Frame: Last 8 weeks of treatment (Weeks 44 to 52)
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.
Last 8 weeks of treatment (Weeks 44 to 52)
Average Allergic Rhinitis/Rhinoconjunctivitis Symptoms Assessed by Visual Analogue Scale (VAS) During Last 8 Weeks of Treatment
Time Frame: Last 8 weeks of treatment (Weeks 44 to 52)
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).
Last 8 weeks of treatment (Weeks 44 to 52)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ALK-Abelló A/S

Collaborators

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

October 2, 2012

First Submitted That Met QC Criteria

October 2, 2012

First Posted (Estimate)

October 4, 2012

Study Record Updates

Last Update Posted (Actual)

September 15, 2017

Last Update Submitted That Met QC Criteria

September 14, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P05607
  • MK-8237-001 (Other Identifier: Merck Protocol ID)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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