A Proof-of-concept Study of Lunsekimig Compared With Placebo in Adults With Chronic Rhinosinusitis With Nasal Polyps

Summary

This is a parallel, Phase 2, 2-arm, multicenter, randomized, double-blind, placebo-controlled, proof-of-concept study for treatment of CRSwNP. The purpose of this study is to assess the efficacy, safety, and tolerability of add-on therapy with subcutaneous lunsekimig in adult participants (aged 18 to 70 years, inclusive) with CRSwNP who are inadequately controlled on intranasal corticosteroid treatment. Participants with and without co-morbid asthma will be included in the study, and lung function will be assessed in both groups. The study duration will be up to approximately 40 weeks per participant, including 4 weeks of screening run-in period, 24 weeks of intervention period, and 12 weeks of follow-up.

Timeline

Start

2024-07-17

Primary completion

2026-01-29

Completion

2026-04-23

Outcome

Met primary endpoint

release “The DUET phase 2a proof-of-concept study (clinical study identifier: NCT06454240 ), of lunsekimig in chronic rhinosinusitis with nasal polyps (CRSwNP), met its primary endpoint” sanofi.com ↗

Drugs

Indications