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NOT YET RECRUITING
NCT07484230
PHASE3

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

Sponsor: Sanofi

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-05-08

Completion Date

2028-10-10

Last Updated

2026-03-20

Healthy Volunteers

No

Interventions

DRUG

Itepekimab (SAR440340)

Pharmaceutical form: Solution for injection in prefilled syringe. Route of administration: Subcutaneous

DRUG

Placebo

Pharmaceutical form: Solution for injection in prefilled syringe. Route of administration: Subcutaneous