drugset / Trial / NCT06454240

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

NCT06454240

Phase 2 Completed 79 enrolled Sanofi
RandomizedParallel-groupQuadruple-blindTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Lunsekimig Monoclonal antibody Subcutaneous