2024-516814-39-00招募中3 期
A randomized, double blind, placebo controlled, parallel group, 52week Phase 3 trial to investigate the efficacy, safety, and tolerability of itepekimab in adult participants with inadequately-controlled chronic rhinosinusitis with nasal polyps
Sanofi-Aventis Recherche & Developpement45 个研究点 分布在 10 个国家目标入组 131 人开始时间: 2025年3月31日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 131
- 试验地点
- 45
- 主要终点
- Change from baseline in the endoscopic NPS
研究概览
简要总结
To evaluate the efficacy of itepekimab compared with placebo on nasal polyps (NP) size and nasal congestion.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •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: o Prior sinonasal surgery for nasal polyps (NP). o Worsening symptoms of chronic rhinosinusitis (CRS) requiring treatment with systemic corticosteroid(s) (SCS) within the prior 1 years before screening (Visit 1).
- •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: o 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 o 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: o Is not a women of childbearing potential (WOCBP), OR o 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 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 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.
- •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 nonevaluable 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, 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 XhanceTM during the screening period. In Japan and China INCS other than MFNS are permitted.
结局指标
主要结局
Change from baseline in the endoscopic NPS
Change from baseline in the endoscopic NPS
Change from baseline in the NCS
Change from baseline in the NCS
次要结局
- Change from baseline in endoscopic NPS
- Change from baseline in NCS
- Change from baseline in opacification of sinuses assessed by Computed Tomography (CT) scan using the LMK score
- Change from baseline in the TSS (nasal congestion/obstruction, anterior/posterior rhinorrhea, and loss of sense of smell)
- Change from baseline in loss of smell severity score using the daily CRSwNP sinonasal symptom eDiary, and UPSIT score
- Change from baseline in SNOT22 total score
- Change from baseline in PROMIS SDSF8b scores
- Proportion of participants with CRSwNP requiring systemic corticosteroid(s) (SCS) or surgery for CRS
- Annualized rate of SCS course or surgery for CRS
- Time to first either SCS or surgery for CRS
- Change from baseline in pre BD FEV1 (in mL) in participants with co-morbid asthma
- Change from baseline in ACQ 5 score in participants with co-morbid asthma
- Change from the baseline in NPS and NCS in the subgroup of patients with aspirin-exacerbated respiratory disease (AERD)
- Proportion of participants with AERD requiring SCS or surgery for CRS
- Annualized rate of SCS course or surgery for CRS in participants with AERD
- Time to first either SCS or surgery for CRS in participants with AERD
- Change from baseline in pre BD FEV1 (in ml) in participants with AERD
- Proportion of NPS responders (defined as participants with improvement by at least 1 point in NPS)
- Proportion of NPS responders (defined as participants with improvement by at least 2 points in NPS)
- Incidence of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), treatment-emergent adverse events of special interest (TEAESIs) and TEAEs leading to treatment discontinuation
- Itepekimab concentration in serum
- Incidence of treatment emergent anti itepekimab antibody (ADA) responses
研究者
Clinical Sciences and Operations
Scientific
Sanofi-Aventis Recherche & Developpement
研究点 (45)
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