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

Enrolling by invitation · Phase 2

Conditions studied: Chronic Rhinosinusitis With Nasal Polyps

In brief

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 148 weeks per participant, including 144 weeks of treatment period and 4 weeks of follow-up.

Key facts

Study ID

NCT06914908

Run by

Sanofi

People needed

71

Starts

2025-05-12

Expected to finish

2031-01-29

Last updated by the study team

2026-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants who have completed the treatment period and the follow up period in CRSwNP lunsekimig parent study, including EOS visit, as per protocol
• Participants receiving therapy with intranasal mometasone furoate nasal spray (MFNS)
• Participants who are able and willing to participate in this extension study, and to comply with requested study visits and procedures

You may not qualify if…

• Participants are excluded from the study if any of the following criteria apply:
• Prior hypersensitivity reaction to lunsekimig or to any of the excipients used in the presentation or in preparation for administration of lunsekimig, or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
• Participants who, during their participation in the parent study, developed an adverse event (AE) or a serious adverse event (SAE) deemed related to lunsekimig, which in the opinion of the Investigator could indicate that continued treatment with lunsekimig may present an unreasonable risk for the participant
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Where it is running

• Modena Allergy + Asthma- Site Number : 8400005 — La Jolla, California, United States
• Sacramento Ear Nose & Throat - Roseville- Site Number : 8400003 — Roseville, 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
• 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 : 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 : 6160005 — Warsaw, Masovian Voivodeship, Poland
• Investigational Site Number : 6160003 — Katowice, Silesian Voivodeship, 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

Full record on ClinicalTrials.gov

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