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)
2 other identifiers
interventional
1,482
0 countries
N/A
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2013
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 2, 2012
CompletedFirst Posted
Study publicly available on registry
October 4, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedResults Posted
Study results publicly available
March 3, 2017
CompletedSeptember 15, 2017
September 1, 2017
2.2 years
October 2, 2012
January 11, 2017
September 14, 2017
Conditions
Outcome Measures
Primary Outcomes (3)
Average Total Combined Rhinitis Score (TCRS) During Last 8 Weeks of Treatment
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)
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
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 Outcomes (4)
Average Rhinitis Daily Symptom Score (Rhinitis DSS) During 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
Last 8 weeks of treatment (Weeks 44 to 52)
Average Total Combined Rhinoconjunctivitis Score (TCS) During 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
Last 8 weeks of treatment (Weeks 44 to 52)
Study Arms (2)
MK-8237
EXPERIMENTALMK-8237 12 Development Units (DU) rapidly dissolving tablets administered sublingually once daily (q.d.).
Placebo
PLACEBO COMPARATORPlacebo to MK-8237 rapidly dissolving tablets administered sublingually q.d.
Interventions
MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d.
Placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d.
Self-injectable epinephrine (preferred dose of 0.30 mg) administered intramuscularly as needed for rescue medication.
Loratadine tablet 10 mg administered orally as needed for rescue medication.
Olopatadine hydrochloride ophthalmic drops 0.1% administered as needed for rescue medication.
Mometasone furoate monohydrate nasal spray 50 mcg administered intranasally as needed for rescue medication.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ALK-Abelló A/Slead
- Merck Sharp & Dohme LLCcollaborator
Related Publications (5)
Nolte H, Bernstein DI, Nelson HS, Kleine-Tebbe J, Sussman GL, Seitzberg D, Rehm D, Kaur A, Li Z, Lu S. Efficacy of house dust mite sublingual immunotherapy tablet in North American adolescents and adults in a randomized, placebo-controlled trial. J Allergy Clin Immunol. 2016 Dec;138(6):1631-1638. doi: 10.1016/j.jaci.2016.06.044. Epub 2016 Aug 10.
PMID: 27521719RESULTHorn A, Bernstein DI, Okubo K, Dalgaard T, Hels O, Sorensen HF, Henriksen M, Azuma R, Mikler J, Nolte H. House dust mite sublingual immunotherapy tablet safety in adolescents with allergic rhinoconjunctivitis: Worldwide clinical trial results. Ann Allergy Asthma Immunol. 2023 Jun;130(6):797-804.e2. doi: 10.1016/j.anai.2023.03.006. Epub 2023 Mar 15.
PMID: 36924936DERIVEDFortescue R, Kew KM, Leung MST. Sublingual immunotherapy for asthma. Cochrane Database Syst Rev. 2020 Sep 14;9(9):CD011293. doi: 10.1002/14651858.CD011293.pub3.
PMID: 32926419DERIVEDBernstein DI, Kleine-Tebbe J, Nelson HS, Bardelas JA Jr, Sussman GL, Lu S, Rehm D, Svanholm Fogh B, Nolte H. SQ house dust mite sublingual immunotherapy tablet subgroup efficacy and local application site reaction duration. Ann Allergy Asthma Immunol. 2018 Jul;121(1):105-110. doi: 10.1016/j.anai.2018.04.007. Epub 2018 Apr 12.
PMID: 29656145DERIVEDNolte H, Bernstein DI, Sussman GL, Svanholm Fogh B, Lu S, Husoy B, Nelson HS. Impact of Adverse Event Solicitation on the Safety Profile of SQ House Dust Mite Sublingual Immunotherapy Tablet. J Allergy Clin Immunol Pract. 2018 Nov-Dec;6(6):2081-2086.e1. doi: 10.1016/j.jaip.2018.01.037. Epub 2018 Feb 10.
PMID: 29432959DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Corporate Development
- Organization
- Merck Sharp & Dohme Corp.
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2012
First Posted
October 4, 2012
Study Start
January 1, 2013
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
September 15, 2017
Results First Posted
March 3, 2017
Record last verified: 2017-09