Efficacy and Safety Study of SCH 900237/MK-8237 in Children and Adults With House Dust Mite-Induced Allergic Rhinitis/Rhinoconjunctivitis (P05607)
NCT ID: NCT01700192
Last Updated: 2017-09-15
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
1482 participants
INTERVENTIONAL
2013-01-31
2015-04-30
Brief Summary
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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).
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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MK-8237
MK-8237 12 Development Units (DU) rapidly dissolving tablets administered sublingually once daily (q.d.).
MK-8237 tablets
MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d.
Rescue Medication: Self-Injectable Epinephrine
Self-injectable epinephrine (preferred dose of 0.30 mg) administered intramuscularly as needed for rescue medication.
Rescue Medication: Loratadine tablets
Loratadine tablet 10 mg administered orally as needed for rescue medication.
Rescue Medication: Olopatadine ophthalmic drops
Olopatadine hydrochloride ophthalmic drops 0.1% administered as needed for rescue medication.
Rescue Medication: Mometasone furoate nasal spray
Mometasone furoate monohydrate nasal spray 50 mcg administered intranasally as needed for rescue medication.
Placebo
Placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d.
Placebo tablets
Placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d.
Rescue Medication: Self-Injectable Epinephrine
Self-injectable epinephrine (preferred dose of 0.30 mg) administered intramuscularly as needed for rescue medication.
Rescue Medication: Loratadine tablets
Loratadine tablet 10 mg administered orally as needed for rescue medication.
Rescue Medication: Olopatadine ophthalmic drops
Olopatadine hydrochloride ophthalmic drops 0.1% administered as needed for rescue medication.
Rescue Medication: Mometasone furoate nasal spray
Mometasone furoate monohydrate nasal spray 50 mcg administered intranasally as needed for rescue medication.
Interventions
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MK-8237 tablets
MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d.
Placebo tablets
Placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d.
Rescue Medication: Self-Injectable Epinephrine
Self-injectable epinephrine (preferred dose of 0.30 mg) administered intramuscularly as needed for rescue medication.
Rescue Medication: Loratadine tablets
Loratadine tablet 10 mg administered orally as needed for rescue medication.
Rescue Medication: Olopatadine ophthalmic drops
Olopatadine hydrochloride ophthalmic drops 0.1% administered as needed for rescue medication.
Rescue Medication: Mometasone furoate nasal spray
Mometasone furoate monohydrate nasal spray 50 mcg administered intranasally as needed for rescue medication.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
ALK-Abelló A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
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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.
Horn 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.
Fortescue 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.
Bernstein 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.
Nolte 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.
Other Identifiers
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MK-8237-001
Identifier Type: OTHER
Identifier Source: secondary_id
P05607
Identifier Type: -
Identifier Source: org_study_id