NCT06834360

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

A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Phase 3 Trial to Investigate the Efficacy, Safety, and Tolerability of Itepekimab in Adult Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

EFC18419 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 study with 3 treatment groups. The purpose of the study is to evaluate the efficacy, safety and tolerability of 2 dosing regimens of itepekimab compared to placebo as add-on therapy to intranasal corticosteroids (INCS) in male and female participants with chronic rhinosinusitis with nasal polyps (CRSwNP) aged 18 years of age and older. Study details include: * The study duration per participant (4-week screening, 52-week treatment, 20-week safety follow-up) will be up to 76 weeks. For participants transitioning to the LTS18420 study, the study duration will be 56 weeks. * The treatment duration will be up to 52 weeks. * The number of visits will be 9 site visits and 20 phone/home visits.

Conditions

• Chronic Rhinosinusitis With Nasal Polyps

Interventions

Type	Name	Description
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
DRUG	Mometasone furoate nasal spray (MFNS)	Pharmaceutical form: Solution for administration via spray pump. Route of administration: Intranasal spray

Timeline

• Start date: 2025-02-06
• Primary completion: 2027-01-08
• Completion: 2027-12-13
• First posted: 2025-02-19
• Last updated: 2026-04-03

Locations

108 sites across 23 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Czechia, Denmark, France, Germany, Hungary, Israel, Italy, Japan, Mexico, Netherlands, Poland, Romania, Spain, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study