A Phase IIb, Randomized, Placebo-Controlled, Dose-Finding Clinical Trial to Study the Safety and Efficacy of MK-8237 Using an Environmental Exposure Chamber in Subjects With House Dust Induced Allergic Rhinitis/Rhinoconjunctivitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 124
- 主要终点
- Average Total Nasal Symptom Score (TNSS) During Environmental Exposure Chamber (EEC) Challenge Session at Week 24
研究概览
简要总结
The purpose of this study is to evaluate the dose-related effectiveness, the safety and the tolerability of MK-8237, compared to placebo, in the treatment of house dust mite (HDM)-induced allergic rhinitis/rhinoconjunctivitis in adults. The primary hypothesis is that administration of MK-8237, compared to placebo, results in dose-related improvement in the average total nasal symptom score (TNSS) determined during environmental exposure chamber (EEC) challenge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of allergic rhinitis/rhinoconjunctivitis 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) 2 acceptable methods of birth control within the projected duration of the study.
排除标准
- •Sensitized and regularly exposed to animal dander and molds, (e.g. present in the home, job, etc.)
- •Sensitized and regularly exposed to seasonal allergens (i.e., birch or grass pollen)
- •Immunosuppressive treatment within 3 months prior to screening (except steroids for allergic and asthma symptoms)
- •History of chronic urticaria and/or angioedema within 2 years prior to screening
- •Previous immunotherapy treatment with any HDM allergen for more than 1 month within 3 years prior to screening
- •Ongoing treatment with any specific immunotherapy
- •History of anaphylaxis with cardiorespiratory symptoms with prior immunotherapy, due to an unknown cause or to an inhalant allergen
- •Unstable uncontrolled/partially controlled or severe asthma, or 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 [SABA]) within 3 months prior to screening
- •Asthma requiring medium- or high-dose inhaled corticosteroid (ICS) within 12 months prior to screening
- •Chronic sinusitis within 2 years prior to screening
- •Nasal condition that could confound the efficacy or safety assessments (e.g., nasal polyps)
- •Pregnant, breastfeeding or planning to become pregnant during the study
- •Participation in a different investigational study at any site during the same time frame of this study
- •Direct association with the administration of the study or a family member of the study staff
研究组 & 干预措施
Placebo
Placebo rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks
干预措施: Placebo (Drug)
MK-8237 6 Developmental Units (DU)
MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks
干预措施: MK-8237 6 DU (Drug)
MK-8237 12 DU
MK-8237 12 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks
干预措施: MK-8237 12 DU (Drug)
结局指标
主要结局
Average Total Nasal Symptom Score (TNSS) During Environmental Exposure Chamber (EEC) Challenge Session at Week 24
时间窗: Week 24
The average total TNSS included the evaluation of 4 nasal symptoms: itchy nose, blocked nose, runny nose, and sneezing. The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 24. TNSS was the total of scores for the 4 nasal symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TNSS ranged from 0 to 12 points. The 24-week TNSS was analyzed using the analysis of covariance (ANCOVA) model with treatment and baseline TNSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TNSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms.
次要结局
- Average TNSS During EEC Challenge Session at Week 16(Week 16)
- Average TSS (TNSS + TOSS) During EEC Challenge Session at Week 16(Week 16)
- Average TSS (TNSS + TOSS) During EEC Challenge Session at Week 8(Week 8)
- Average Total Ocular Symptom Score (TOSS) During EEC Challenge Session at Week 24(Week 24)
- Average TOSS During EEC Challenge Session at Week 8(Week 8)
- HDM-specific Immunoglobulin G4 (IgG4) Levels at Week 8(Week 8)
- Average TNSS During EEC Challenge Session at Week 8(Week 8)
- Average Total Symptom Score (TSS [TNSS + TOSS]) During EEC Challenge Session at Week 24(Week 24)
- Change From Baseline in HDM-specific IgG4 Levels at Week 8(Time Frame: Baseline and Week 8)
- Percentage of Participants Who Experienced At Least One Adverse Event (AE)(From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks))
- Percentage of Participants Who Discontinued Study Drug Due to an AE(From first dose to last dose of treatment (Up to 24 weeks))
- Average TOSS During EEC Challenge Session at Week 16(Week 16)
- HDM-specific Immunoglobulin E (IgE) Levels at Week 8(Week 8)
- Change From Baseline in HDM-specific IgE Levels at Week 8(Baseline and Week 8)