Safety Study of MK-8237 Treatment in House-Dust-Mite Allergic Adolescents (MK-8237-008)
2 other identifiers
interventional
195
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the safety of two doses (6 Development Units \[DU\] and 12 DU) of MK-8237 sublingual tablets compared to Placebo in adolescents with house dust mite-induced allergic rhinitis/rhinoconjunctivitis. The primary hypothesis is that at least one dose of MK-8237 sublingual tablet is safe and well-tolerated in adolescents with house dust mite-induced allergic rhinitis/rhinoconjunctivitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2012
Shorter than P25 for phase_1
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
August 31, 2012
CompletedFirst Posted
Study publicly available on registry
September 5, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedResults Posted
Study results publicly available
February 13, 2017
CompletedSeptember 15, 2017
September 1, 2017
7 months
August 31, 2012
December 20, 2016
September 14, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Participants Who Experienced At Least One Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. A serious adverse event (SAE) was an AE that resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, was associated with an overdose, was another important medical event.
From first dose to last dose of treatment plus 2 weeks of follow-up, up to 42 days
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event
The percentage of participants who had study treatment stopped due to an AE. Discontinuations were reported for all randomized participants who received ≥1 dose of study treatment.
From first dose to last dose of treatment, up to 28 days
Study Arms (3)
MK-8237 6 DU
EXPERIMENTALMK-8237 6 DU rapidly dissolving tablet administered sublingually once daily for 28 days
MK-8237 12 DU
EXPERIMENTALMK-8237 12 DU rapidly dissolving tablet administered sublingually once daily for 28 days
Placebo
PLACEBO COMPARATORPlacebo rapidly dissolving tablet administered sublingually once daily for 28 days
Interventions
Eligibility Criteria
You may qualify if:
- History of physician-diagnosed allergic rhinitis/rhinoconjunctivitis to house dust of at least 6 months duration (with or without asthma)
- History of controlled asthma for the prior 1 month if participant has asthma, defined by not exceeding 2 days of symptoms per week; not more than 2 days of albuterol/short acting beta-agonist \[SABA\] use per week; and not wakening more than twice a month at night due to asthma symptoms
- Agrees to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control from screening and through the duration of the study
You may not qualify if:
- Unable to meet medication washout requirements
- History of chronic urticaria and/or chronic angioedema within prior 2 years
- History of anaphylaxis with cardiorespiratory symptoms with prior immunotherapy due to an unknown cause or to an inhalant allergen
- Unstable, uncontrolled 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 SABAs) at any time within prior 3 months
- History of chronic sinusitis during within prior 2 years
- Pregnant or breast-feeding, or expecting to conceive within the projected duration of the study
- Known history of allergy, hypersensitivity or intolerance to investigational medicinal products except for Dermatophagoides pteronyssinus (D. pteronyssinus) and/or Dermatophagoides farina (D. farina) or self-injectable epinephrine
- Business or personal relationship with investigational site personnel or Sponsor who is directly involved with the conduct of the trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ALK-Abelló A/Slead
- Merck Sharp & Dohme LLCcollaborator
Related Publications (2)
Maloney J, Prenner BM, Bernstein DI, Lu S, Gawchik S, Berman G, Kaur A, Li Z, Nolte H. Safety of house dust mite sublingual immunotherapy standardized quality tablet in children allergic to house dust mites. Ann Allergy Asthma Immunol. 2016 Jan;116(1):59-65. doi: 10.1016/j.anai.2015.10.024. Epub 2015 Nov 6.
PMID: 26553448RESULTFortescue 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: 32926419DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical 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 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2012
First Posted
September 5, 2012
Study Start
October 1, 2012
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
September 15, 2017
Results First Posted
February 13, 2017
Record last verified: 2017-09