Efficacy and Safety Study of SCH 900237/MK-8237 in Children and Adults With House Dust Mite-Induced Allergic Rhinitis/Rhinoconjunctivitis (P05607)

Study Overview
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Brief Summary
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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).

Official Title
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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)

Conditions
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Rhinitis, Allergic, Perennial, Rhinitis, Allergic, Nonseasonal

Intervention / Treatment
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* Biological: MK-8237 tablets
* Biological: Placebo tablets
* Drug: Rescue Medication: Self-Injectable Epinephrine
* Drug: Rescue Medication: Loratadine tablets
* Drug: Rescue Medication: Olopatadine ophthalmic drops
* Drug: Rescue Medication: Mometasone furoate nasal spray


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MK-8237<br>MK-8237 12 Development Units (DU) rapidly dissolving tablets administered sublingually once daily (q.d.). | Biological: MK-8237 tablets<br>* MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d.<br>* Other names: SCH 900237;Drug: Rescue Medication: Self-Injectable Epinephrine<br>* Self-injectable epinephrine (preferred dose of 0.30 mg) administered intramuscularly as needed for rescue medication.<br>Drug: Rescue Medication: Loratadine tablets<br>* Loratadine tablet 10 mg administered orally as needed for rescue medication.<br>Drug: Rescue Medication: Olopatadine ophthalmic drops<br>* Olopatadine hydrochloride ophthalmic drops 0.1% administered as needed for rescue medication.<br>Drug: Rescue Medication: Mometasone furoate nasal spray<br>* Mometasone furoate monohydrate nasal spray 50 mcg administered intranasally as needed for rescue medication.<br>|
| Placebo Comparator: Placebo<br>Placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. | Biological: Placebo tablets<br>* Placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d.<br>Drug: Rescue Medication: Self-Injectable Epinephrine<br>* Self-injectable epinephrine (preferred dose of 0.30 mg) administered intramuscularly as needed for rescue medication.<br>Drug: Rescue Medication: Loratadine tablets<br>* Loratadine tablet 10 mg administered orally as needed for rescue medication.<br>Drug: Rescue Medication: Olopatadine ophthalmic drops<br>* Olopatadine hydrochloride ophthalmic drops 0.1% administered as needed for rescue medication.<br>Drug: Rescue Medication: Mometasone furoate nasal spray<br>* Mometasone furoate monohydrate nasal spray 50 mcg administered intranasally as needed for rescue medication.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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) |