A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Adult Japanese Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps

Ki vehet részt

• 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)

Ki nem vehet részt

• 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 conditions/concomitant diseases making them non-evaluable or for the primary efficacy endpoint
• 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 1
• Participants who received SCS 1 month prior to Screening (Visit 1) or during the screening period (between Visit 1 and Visit 2)
• 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 with a history of a severe systemic hypersensitivity reaction to a mAb
• 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
• 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
• Participants are excluded from the study if any of the following criteria apply: