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

Launched by SANOFI · Apr 4, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the long-term safety and effectiveness of a medication called lunsekimig for adults with chronic rhinosinusitis with nasal polyps (CRSwNP). This study is designed for those who have previously participated in another lunsekimig trial and found that their symptoms were not well controlled. Over the course of about 56 weeks, participants will receive treatment for 52 weeks, followed by a 4-week follow-up period to monitor their health.

To be eligible for this trial, participants must have completed the earlier study and be using a specific nasal spray called mometasone furoate. Participants should also be willing to attend regular study visits and follow the study guidelines. However, individuals with a history of serious allergic reactions to lunsekimig or those who have experienced significant side effects during the earlier study may not be able to participate. Overall, this trial aims to provide more insight into how lunsekimig can help manage CRSwNP symptoms over an extended period.

Gender

ALL

Eligibility criteria

• 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