jRCT2031260006招募中不适用
A randomized, double-blind, parallel-group, 52-week trial to investigate the efficacy, safety, and tolerability of itepekimab in adult Japanese participants with inadequately-controlled chronic rhinosinusitis with nasal polyps
未提供0 个研究点目标入组 20 人开始时间: 待定
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Participants must be 18 years of age or older.
- •Participants with a history of chronic rhinosinusitis with nasal polyp(s) (CRSwNP) for at least 1 year.
- •Participants must have at least one of the following features:
- •- Prior sinonasal surgery for nasal polyp.
- •- Worsening symptoms of chronic rhinosinusitis (CRS) requiring treatment with systemic corticosteroid(s) (SCS) within the prior 1 year.
- •An endoscopic bilateral Nasal Polyp Score (NPS) of at least 5 out of maximum score of 8 (with a minimum score of 2 in each nasal cavity).
- •Ongoing symptoms (for at least 12 weeks before Visit 1) of:
- •- Nasal congestion/blockade/obstruction with moderate or severe symptom (score of 2 or 3), AND
- •- At least one of the following two symptoms: loss of smell or rhinorrhea (anterior/posterior).
- •Not currently on and have not been receiving intranasal corticosteroids (INCS) for at least one month.
- •A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:
- •- Is not a women of childbearing potential (WOCBP), OR
- •- Is a WOCBP and agrees to use a contraceptive method that is highly effective, with a failure rate of <1% during the study (at a minimum until 20 weeks after the last dose of study intervention).
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Participants with a history of clinically significant renal, hepatic, metabolic, neurologic, hematologic, ophthalmologic, respiratory (excluding those with asthma and aspirin-exacerbated respiratory disease[s] [AERD] which may be included in the study), gastrointestinal, cardiovascular, cerebrovascular, or other significant medical illness or disorder, which, in the judgment of the Investigator, could interfere with the study or require treatment that might interfere with the study.
- •Participants who are currently smoking tobacco and/or vaping, or participants in whom smoking/vaping cessation has occurred <6 months. Nicotine replacement therapy and/or noninhaled tobacco product use are not considered current smoking of tobacco.
- •Participants with a history of a severe systemic hypersensitivity reaction to a monoclonal antibody (mAb).
- •Participants with conditions/concomitant diseases making them non-evaluable or for the primary efficacy endpoint.
- •Participants with nasal cavity malignant tumor and benign tumors (eg, papilloma, blood boil, etc).
- •Participants with severe uncontrolled asthma with history of 2 and/or more exacerbations, requiring SCS or 1 hospitalization requiring SCS in the past year.
- •Participants treated with INCS, intranasal emitting devices/stents, nasal spray using exhalation delivery system such as Xhance one month prior during the screening period.
- •Participants who have undergone any sinus intranasal surgery (including polypectomy) within 6 months before Visit
- •Participants who received SCS 1 month prior to Screening (Visit 1) or during the screening period (between Visit 1 and Visit 2).
- •Known allergy to itepekimab or its excipients, or any drug or other allergy that, in the opinion of the Investigator, contraindicates participation in this study.
- •The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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