Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MK-8237-001 | Other Identifier | Merck Protocol ID |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-8237 | Experimental | MK-8237 12 Development Units (DU) rapidly dissolving tablets administered sublingually once daily (q.d.). |
|
| Placebo | Placebo Comparator | Placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-8237 tablets | Biological | MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Average Rhinitis Daily Symptom Score (Rhinitis DSS) During Last 8 Weeks of Treatment | 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27521719 | Result | 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. | |
| 36924936 |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | MK-8237 | Participants took MK-8237 12 development unit (DU) rapidly dissolving tablets administered sublingually once daily (q.d.) for up to one year. |
| FG001 | Placebo | Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo tablets | Biological | Placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. |
|
| Rescue Medication: Self-Injectable Epinephrine | Drug | Self-injectable epinephrine (preferred dose of 0.30 mg) administered intramuscularly as needed for rescue medication. |
|
| Rescue Medication: Loratadine tablets | Drug | Loratadine tablet 10 mg administered orally as needed for rescue medication. |
|
| Rescue Medication: Olopatadine ophthalmic drops | Drug | Olopatadine hydrochloride ophthalmic drops 0.1% administered as needed for rescue medication. |
|
| Rescue Medication: Mometasone furoate nasal spray | Drug | Mometasone furoate monohydrate nasal spray 50 mcg administered intranasally as needed for rescue medication. |
|
| Average Rhinitis Daily Medication Score (Rhinitis DMS) During Last 8 Weeks of Treatment |
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 | 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 | 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) |
| 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. |
| 32926419 | Derived | 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. |
| 29656145 | Derived | 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. |
| 29432959 | Derived | 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. |
| Treated |
|
| All Participants as Treated (APaT) |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Baseline Characteristics refer to all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | MK-8237 | Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year. |
| BG001 | Placebo | Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | 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. | The analysis population consists of all randomized participants who received at least 1 dose of study drug and had data available. | Posted | Mean | Standard Deviation | Score on a Scale | Last 8 weeks of treatment (Weeks 44 to 52) |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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. | The All Participants as Treated (APaT) population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received). | Posted | Number | Participants | Up to 54 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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. | The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received). | Posted | Number | Participants | Up to 52 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Average Rhinitis Daily Symptom Score (Rhinitis DSS) During Last 8 Weeks of Treatment | 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. | The analysis population consists of all randomized participants who received at least 1 dose of study drug and had data available. | Posted | Mean | Standard Deviation | Score on a Scale | Last 8 weeks of treatment (Weeks 44 to 52) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Average Rhinitis Daily Medication Score (Rhinitis DMS) During Last 8 Weeks of Treatment | 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. | The analysis population consists of all randomized participants who received at least 1 dose of study drug and had data available. | Posted | Mean | Standard Deviation | Score on a Scale | Last 8 weeks of treatment (Weeks 44 to 52) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Average Total Combined Rhinoconjunctivitis Score (TCS) During Last 8 Weeks of Treatment | 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. | The analysis population consists of all randomized participants who received at least 1 dose of study drug and had data available. | Posted | Mean | Standard Deviation | Score on a Scale | Last 8 weeks of treatment (Weeks 44 to 52) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Average Allergic Rhinitis/Rhinoconjunctivitis Symptoms Assessed by Visual Analogue Scale (VAS) During Last 8 Weeks of Treatment | 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). | The analysis population consists of all randomized participants who received at least 1 dose of study drug and had data available. | Posted | Mean | Standard Deviation | Score on a Scale | Last 8 weeks of treatment (Weeks 44 to 52) |
|
|
Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
Not provided
| 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 took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year. | 11 | 743 | 642 | 743 | ||
| EG001 | Placebo | Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year. | 7 | 738 | 389 | 738 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pericarditis | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Tympanic membrane perforation | Ear and labyrinth disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment | Due to overdose; classified as SAE by sponsor but does not meet International Council for Harmonisation (ICH) SAE criteria. |
|
| Oral pruritus | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment | Due to overdose; classified as SAE by sponsor but does not meet ICH SAE criteria. |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Food allergy | Immune system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Infected bites | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hepatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 18.0 | Systematic Assessment |
| |
| Bipolar I disorder | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment | Due to overdose; classified as SAE by sponsor but does not meet ICH SAE criteria. |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hypertensive emergency | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Alcohol abuse | Psychiatric disorders | MedDRA v. 18.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pruritus | Ear and labyrinth disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Glossodynia | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Lip swelling | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Mouth swelling | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Oral pruritus | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Palatal swelling | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Paraesthesia oral | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Swollen tongue | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Tongue ulceration | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pharyngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Corporate 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 |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| Male |
|
| Treatment Difference Relative to Placebo |
| -17.2 |
| 2-Sided |
| 95 |
| -25.0 |
| -9.7 |
| Superiority or Other |
|
|
|
|
|
|
|
|
|
|