NCT06691113

A Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Itepekimab (Anti--IL-33 mAb) in Participants With Chronic Rhinosinusitis Without Nasal Polyps

A Randomized, Double-blind, Placebo-controlled, Proof-of-Concept (PoC) Study to Assess the Efficacy, Safety and Tolerability of Itepekimab in Participants With Inadequately Controlled Chronic Rhinosinusitis Without Nasal Polyps

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

ACT18421 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 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 in male and female participants with chronic rhinosinusitis without nasal polyps (CRSsNP) aged 18 years of age and older. Study details include: * The study duration (4-week screening, 24--week intervention, 20--week safety followup) will be 48 weeks. * The intervention duration will be 24 weeks. * The number of visits will be 7 site visits and 8 phone/remote visits.

Conditions

• Chronic Rhinosinusitis Without 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: 2024-12-16
• Primary completion: 2026-08-07
• Completion: 2027-02-09
• First posted: 2024-11-15
• Last updated: 2025-11-12

Locations

57 sites across 13 countries: United States, Argentina, Belgium, Canada, Chile, China, France, Italy, Poland, Portugal, Romania, South Korea, Spain

Regulatory

• FDA-regulated drug study