NCT07484230撤回3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- Sanofi
- 入组人数
- 20
- 主要终点
- Change from baseline in the endoscopic NPS
研究概览
简要总结
This is a randomized, multicenter, double-blind, Phase 3 study with 2 parallel groups. The purpose of this study is to evaluate the efficacy, safety, and tolerability of 2 different dosing regimens of itepekimab monotherapy in Japanese participants aged 18 years or older with chronic rhinosinusitis with nasal polyp(s) (CRSwNP) who are not adequately controlled despite previous surgery and/or treatment with systemic corticosteroid(s) (SCS).
The total study duration par participant is approximately 76 week, including:
- A screening period for up to 4 weeks.
- A randomized study intervention period for up to 52 weeks
- A post-intervention safety follow-up for up to 20 weeks
- The number of visits will be 9 site visits and 20 phone/home visits
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Participants must be 18 years of age or older.
- •Participants with a history of CRSwNP for at least 1 year.
- •Participants must have at least one of the following features:
- •Prior sinonasal surgery for NP.
- •Worsening symptoms of CRS requiring treatment with SCS within the prior 1 year.
- •An endoscopic bilateral 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 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 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 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 intranasal corticosteroid(s) (INCS), intranasal emitting devices/stents, nasal spray using exhalation delivery system such as XhanceTM 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.
研究组 & 干预措施
Itepekimab low dose
Experimental
SC administration of Itepekimab low dose for 52 weeks
干预措施: Placebo (Drug)
Itepekimab low dose
Experimental
SC administration of Itepekimab low dose for 52 weeks
干预措施: Itepekimab (SAR440340) (Drug)
Itepekimab high dose
Experimental
Subcutaneous (SC) administration of Itepekimab high dose for 52 weeks
干预措施: Itepekimab (SAR440340) (Drug)
结局指标
主要结局
Change from baseline in the endoscopic NPS
时间窗: Baseline to Week 24
The Nasal Polyp Score (NPS) is the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. Nasal polyp 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).
次要结局
- Itepekimab concentration in serum(Baseline to EOS (Week 72))
- Incidence of treatment-emergent antidrug antibody (ADA) responses(Baseline to EOS (Week 72))
- Change from baseline in the NCS(Baseline to Week 24)
- Proportion of NPS responders (defined as participants with improvement by at least 1 points in NPS)(Week 24 and Week 52)
- Change from baseline in endoscopic NPS(Baseline to Week 52)
- Change from baseline in NCS(Baseline to Week 52)
- Change from baseline in the TSS (nasal congestion/obstruction, anterior/posterior rhinorrhea, and loss of sense of smell)(Baseline to Weeks 24 and 52)
- Change from baseline in loss of smell severity score using the daily CRSwNP sinonasal symptom eDiary(Baseline to Weeks 24 and 52)
- Incidence of TEAEs, TESAEs, TEAESIs and TEAEs leading to treatment discontinuation(Baseline to End of Study (EOS) (Week 72))
研究者
相似试验
尚未招募
2 期
A Phase II/III Clinical Study to Evaluate HLX07 in Combination With Serplulimab and Chemotherapy Versus Placebo in Combination With Serplulimab or Pembrolizumab and Chemotherapy as First-Line Treatment in Advanced Squamous Non-Small Cell Lung CancerSquamous NSCLCNCT07318883Shanghai Henlius Biotech720
尚未招募
3 期
Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)Female Pattern Hair LossFemale Pattern Hair Loss, Androgenic AlopeciaNCT07303322Eurofarma Laboratorios S.A.372
尚未招募
3 期
A Phase III Study of GS101 Injection to Dupixent®Atopic Dermatitis (AD)NCT07386743Jiangsu Genscend Biopharmaceutical Co., Ltd572
招募中
2 期
A Phase II Clinical Study on the Efficacy and Safety of HRS-1780 in Participants With Primary AldosteronismPrimary AldosteronismNCT07470983Shandong Suncadia Medicine Co., Ltd.60
尚未招募
3 期
Study of the Efficacy and Safety of OCS-01 Eye Drops in Subjects With Diabetic Macular Edema. (DIAMOND-2)Type 2 diabetes mellitus with ophthalmic complications,CTRI/2024/07/071429Oculis Operations SÃ rl350