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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 | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

NCT06914908•Sanofi

View on ClinicalTrials.gov

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.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

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.
•Concurrent participation in any clinical study other than the parent study, including non-interventional studies.
•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.
•NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

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

Key Dates

Start Date

May 12, 2025

Primary Completion Date

January 29, 2031

Completion Date

January 29, 2031

Last Updated

March 10, 2026

Enrollment

ESTIMATED participants

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Interventions

lunsekimig

DRUG

Mometasone furoate nasal spray (MFNS)

DRUG

Contacts

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610 Contact-US@sanofi.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 10, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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