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Withdrawn NCT07484230

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

Conditions: Chronic Rhinosinusitis With Nasal Polyps

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Sponsor: Sanofi

Summary

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

Eligibility Criteria

Inclusion Criteria: * 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 \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07484230). StuddyBuddy aggregates publicly available trial information.