jRCT2031250095尚未招募不适用
A randomized, double-blind, placebo-controlled, parallel-group, 52-week Phase 3 trial to investigate the efficacy, safety, and tolerability of itepekimab in adult participants with inadequately-controlled chronic rhinosinusitis with nasal polyps
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Sanofi K.K.
- 入组人数
- 210
- 主要终点
- Change from baseline in the endoscopic NPS
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 Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Participants are eligible to be included in the study only if all of the following criteria apply:
- •Participants must be 18 years of age or older
- •Participants with a history of chronic rhinosinusitis with nasal polyps (CRSwNP) for at least 1 year prior to screening
- •Participants must have at least one of the following features:
- •- Prior sinonasal surgery for nasal polyps (NP)
- •- Worsening symptoms of chronic rhinosinusitis (CRS) requiring treatment with systemic corticosteroid(s) (SCS) within the prior 2 years before screening (Visit 1)
- •- Worsening symptoms of CRS in the past 2 years which would have required treatment with SCS, however participant is intolerant or has a contraindication to SCS
- •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) at screening and randomization
- •Ongoing symptoms (for at least 12 weeks before Visit 1) of:
- •- Nasal congestion/blockade/obstruction with moderate or severe (symptom severity score 2 or 3) at Visit 1 and a weekly average severity of greater than 1 in the week before randomization (Visit 2), AND
- •- At least one of the following two symptoms: loss of smell or rhinorrhea (anterior/posterior)
- •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 [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 prior to Screening (Visit 1). Nicotine replacement therapy and/or noninhaled tobacco product use are not considered current smoking of tobacco
- •Participants meet any contraindications for mometasone furoate nasal spray (MFNS) such as hypersensitivity to MFNS or any of its components; or participants with uncontrolled opportunistic infections
- •Participants with a history of a severe systemic hypersensitivity reaction to a mAb
- •Participants with conditions/concomitant diseases making them non-evaluable at Visit 1 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
- •History of concomitant lung disease (other than asthma, eg, chronic obstructive pulmonary disease [COPD], interstitial lung disease) which in the opinion of the Investigator could interfere with performance and interpretation of spirometry
- •Participants treated with intranasal corticosteroid(s) (INCS) (MFNS is permitted), intranasal emitting devices/stents, nasal spray using exhalation delivery system such as Xhance during the screening period. In Japan and China INCS other than MFNS are permitted
- •Participants who have undergone any sinus intranasal surgery (including polypectomy) within 6 months before Visit 1
- •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.
结局指标
主要结局
Change from baseline in the endoscopic NPS
时间窗: Baseline to Week 24
The NPS is the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. NP is graded based on polyp size from 0 to 4 with higher scores indicating larger polyps. The sum of right and left nostril scores ranges from 0 (no polyps) to 8 (large polyps).
Change from baseline in the nasal congestion score (NCS)
时间窗: Baseline to Week 24
The NCS is scored using a 0-3 categorical scale where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms. Outcome value is defined as the preceding 28-day average of morning scores recorded in electronic diary (eDiary).
次要结局
未报告次要终点
研究者
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