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| ID | Type | Description | Link |
|---|---|---|---|
| MK-8237-008 | Other Identifier | Merck Protocol Number |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-8237 6 DU | Experimental | MK-8237 6 DU rapidly dissolving tablet administered sublingually once daily for 28 days |
|
| MK-8237 12 DU | Experimental | MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily for 28 days |
|
| Placebo | Placebo Comparator | Placebo rapidly dissolving tablet administered sublingually once daily for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-8237 6 DU | Biological |
|
| |
| MK-8237 12 DU |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26553448 | Result | 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. | |
| 32926419 | Derived |
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Participants must have had a clinical history of allergic rhinitis/rhinoconjunctivitis (with or without asthma) to house dust of 6 months duration or more and had a positive skin prick test response to Dermatophagoides pteronyssinus or Dermatophagoides farina at the screening visit. Other inclusion and exclusion criteria applied.
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| ID | Title | Description |
|---|---|---|
| FG000 | MK-8237 12 Development Units (DU) | Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.) for 28 days |
| FG001 | MK-8237 6 DU | Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d. for 28 days |
| FG002 | Placebo | Participants received a rapidly dissolving placebo tablet administered sublingually q.d. for 28 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MK-8237 12 DU | Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.) for 28 days |
| BG001 | MK-8237 6 DU | Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d. for 28 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All randomized participants who receive at least one dose of study treatment | Posted | Number | Percentage of participants | From first dose to last dose of treatment plus 2 weeks of follow-up, up to 42 days |
From first dose to last dose of treatment plus 2 weeks of follow-up, up to 42 days
Adverse events for all randomized participants who receive at least one dose of study treatment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MK-8237 12 DU | Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.) for 28 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pruritus | Ear and labyrinth disorders | MedDRA 16.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D012221 | Rhinitis, Allergic, Perennial |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| Biological |
|
|
| Placebo | Biological |
|
| 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. |
| BG002 | Placebo | Participants received a rapidly dissolving placebo tablet administered sublingually q.d. for 28 days |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | MK-8237 12 DU | Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.) for 28 days |
| OG001 | MK-8237 6 DU | Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d. for 28 days |
| OG002 | Placebo | Participants received a rapidly dissolving placebo tablet administered sublingually q.d. for 28 days |
|
|
|
| Primary | 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. | All randomized participants who receive at least one dose of study treatment | Posted | Number | Percentage of participants | From first dose to last dose of treatment, up to 28 days |
|
|
|
|
| 0 |
| 65 |
| 29 |
| 65 |
| EG001 | MK-8237 6 DU | Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d. for 28 days | 0 | 65 | 27 | 65 |
| EG002 | Placebo | Participants received a rapidly dissolving placebo tablet administered sublingually q.d. for 28 days | 0 | 65 | 12 | 65 |
| Lip swelling | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Oral pruritus | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Paraesthesia oral | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Tongue pruritus | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
The Sponsor has the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Percent Difference |
| 6.2 |
| 2-Sided |
| 95 |
| 0.4 |
| 14.8 |
Estimate based on Miettinen & Nurminen method stratified by asthma status. |
| Superiority or Other |