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A Proof-of-concept Study of Lunsekimig Compared With Placebo in Adults With Chronic Rhinosinusitis With Nasal Polyps
Sponsor: Sanofi
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.
Official title: A Randomized Phase 2, Double-blind, Placebo-controlled, Parallel-group, 2-arm Study to Assess the Efficacy, Safety, and Tolerability of Subcutaneous Lunsekimig in Adult Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
79
Start Date
2024-07-17
Completion Date
2026-04-23
Last Updated
2026-02-05
Healthy Volunteers
No
Conditions
Interventions
lunsekimig
Pharmaceutical form:solution for injection-Route of administration:subcutaneous
placebo
Pharmaceutical form:solution for injection-Route of administration:subcutaneous
Locations (29)
Allergy & Rheumatology- Site Number : 8400005
La Jolla, California, United States
Sacramento Ear Nose & Throat - Roseville- Site Number : 8400003
Roseville, California, United States
Senta Clinic- Site Number : 8400025
San Diego, California, United States
James A Haley Veterans' Hospital- Site Number : 8400015
Tampa, Florida, United States
Emory University Hospital Midtown- Site Number : 8400012
Atlanta, Georgia, United States
The Allergy Group - Asthma & Allergy Boise- Site Number : 8400002
Boise, Idaho, United States
Harvard Medical School - Brigham and Women's Hospital Site Number : 8400016
Boston, Massachusetts, 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
Gary Gross Pharmaceutical Research & Consulting, Inc. Site Number : 8400004
Dallas, Texas, United States
Berkson Medical - McKinney- Site Number : 8400014
McKinney, Texas, United States
Alamo ENT Associates Site Number : 8400001
San Antonio, Texas, United States
Advanced Research Institute - Odgen- Site Number : 8400022
Ogden, Utah, United States
Eastern Virginia Medical School (EVMS) Medical Group- Site Number : 8400008
Norfolk, Virginia, 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 : 6160002
Krakow, Lesser Poland Voivodeship, Poland
Investigational Site Number : 6160001
Warsaw, Masovian Voivodeship, Poland
Investigational Site Number : 6160005
Warsaw, Masovian Voivodeship, Poland
Investigational Site Number : 6160003
Katowice, Silesian Voivodeship, Poland
Investigational Site Number : 6160004
Poznan, Poland
Investigational Site Number : 6160007
Wroclaw, Poland
Investigational Site Number : 8260004
Gloucester, Gloucestershire, United Kingdom
Investigational Site Number : 8260003
Manchester, United Kingdom
Investigational Site Number : 8260001
Newcastle upon Tyne, United Kingdom