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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
Sponsor: Sanofi
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.
Official title: 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
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
64
Start Date
2025-05-12
Completion Date
2031-01-29
Last Updated
2026-03-10
Healthy Volunteers
No
Conditions
Interventions
lunsekimig
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Mometasone furoate nasal spray (MFNS)
Pharmaceutical form: Intranasal spray Route of administration: intranasal
Locations (20)
Modena Allergy + Asthma- Site Number : 8400005
La Jolla, California, United States
Treasure Valley Medical Research- Site Number : 8400002
Boise, Idaho, United States
Essential Medical Research- Site Number : 8400020
Tulsa, Oklahoma, United States
McGovern Medical School - UT Physicians Dermatology - Bellaire Station- Site Number : 8400017
Bellaire, Texas, United States
Pharmaceutical Research & Consulting- Site Number : 8400004
Dallas, Texas, United States
ENT Associates of Texas - McKinne- Site Number : 8400014
McKinney, Texas, United States
Alamo ENT Associates- Site Number : 8400001
San Antonio, Texas, United States
Investigational Site Number : 0320002
Rosario, Santa Fe Province, Argentina
Investigational Site Number : 0320001
Buenos Aires, Argentina
Investigational Site Number : 0320003
Mendoza, Argentina
Investigational Site Number : 0560002
Ghent, Belgium
Investigational Site Number : 0560001
Leuven, Belgium
Investigational Site Number : 1000001
Sofia, Bulgaria
Investigational Site Number : 6160004
Poznan, Greater Poland Voivodeship, Poland
Investigational Site Number : 6160002
Krakow, Lesser Poland Voivodeship, Poland
Investigational Site Number : 6160007
Wroclaw, Lower Silesian Voivodeship, Poland
Investigational Site Number : 6160001
Warsaw, Masovian Voivodeship, Poland
Investigational Site Number : 6160003
Katowice, Silesian Voivodeship, Poland
Investigational Site Number : 8260003
Manchester, United Kingdom
Investigational Site Number : 8260001
Newcastle upon Tyne, United Kingdom