NCT06914908

Long-term Safety and Efficacy Evaluation of Lunsekimig in Adult Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Who Completed a Previous Lunsekimig CRSwNP Study

A Single-arm Extension Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Lunsekimig in Adult Participants With Inadequately Controlled Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Who Completed a Previous Lunsekimig CRSwNP Clinical Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This is a single-arm extension study to investigate the long-term safety, tolerability, and efficacy of lunsekimig in adult participants with inadequately controlled CRSwNP who have completed a previous lunsekimig CRSwNP clinical study (also referred to as the parent study ACT18207). The study duration will be up to approximately 56 weeks per participant, 52 weeks of treatment period, and 4 weeks of follow-up.

Conditions

• Chronic Rhinosinusitis With Nasal Polyps

Interventions

Type	Name	Description
DRUG	lunsekimig	Pharmaceutical form: solution for injection Route of administration: subcutaneous
DRUG	Mometasone furoate nasal spray (MFNS)	Pharmaceutical form: Intranasal spray Route of administration: intranasal

Timeline

• Start date: 2025-05-12
• Primary completion: 2031-01-29
• Completion: 2031-01-29
• First posted: 2025-04-07
• Last updated: 2026-04-14

Locations

24 sites across 6 countries: United States, Argentina, Belgium, Bulgaria, Poland, United Kingdom

Regulatory

• FDA-regulated drug study