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Clinical Trials in the UK / NCT06914908
Enrolling by invitation Phase 2

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

NCT06914908 · tracked via the Priya Life Science UK tracker
Sponsor
Sanofi
Phase
Phase 2
Started
2025-05-12
Last updated
2026-07-02

Condition(s) studied

Chronic Rhinosinusitis With Nasal Polyps

Investigational drug(s) / intervention(s)

LunsekimigMometasone furoate nasal spray (MFNS)

Lunsekimig: * Pharmaceutical form: solution for injection * Route of administration: subcutaneous

Mometasone furoate nasal spray (MFNS): * Pharmaceutical form: Solution for administration via spray pump * Route of administration: intranasal spray

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: 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

Primary outcome measure(s)

Trial sites (24)

FacilityCityRegionStatus
Modena Allergy + Asthma- Site Number : 8400005 La Jolla California
Sacramento Ear Nose & Throat - Roseville- Site Number : 8400003 Roseville California
Treasure Valley Medical Research- Site Number : 8400002 Boise Idaho
Essential Medical Research- Site Number : 8400020 Tulsa Oklahoma
McGovern Medical School - UT Physicians Dermatology - Bellaire Station- Site Number : 8400017 Bellaire Texas
Pharmaceutical Research & Consulting- Site Number : 8400004 Dallas Texas
ENT Associates of Texas - McKinne- Site Number : 8400014 McKinney Texas
Alamo ENT Associates- Site Number : 8400001 San Antonio Texas
Eastern Virginia Medical School (EVMS) Medical Group- Site Number : 8400008 Norfolk Virginia
Investigational Site Number : 0320002 Rosario Santa Fe Province
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
Investigational Site Number : 6160002 Krakow Lesser Poland Voivodeship
Investigational Site Number : 6160007 Wroclaw Lower Silesian Voivodeship
Investigational Site Number : 6160001 Warsaw Masovian Voivodeship
Investigational Site Number : 6160005 Warsaw Masovian Voivodeship
Investigational Site Number : 6160003 Katowice Silesian Voivodeship
Investigational Site Number : 8260004 Gloucester Gloucestershire
Investigational Site Number : 8260003 Manchester United Kingdom
Investigational Site Number : 8260001 Newcastle upon Tyne United Kingdom

More Sanofi trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06914908 on ClinicalTrials.gov ↗ ← All trials in the UK