drugset / Trial / NCT06454240
A Proof-of-concept Study of Lunsekimig Compared With Placebo in Adults With Chronic Rhinosinusitis With Nasal Polyps
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lunsekimig | Monoclonal antibody | — | Subcutaneous |