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

Long-term Study of Investigational Medication for Chronic Rhinosinusitis With Nasal Polyps

Recruiting
All
Phase 2
64 participants needed
8 Locations

Study Overview

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 Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Chronic Rhinosinusitis With Nasal Polyps
  • Gender: All

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

This study investigates the long-term safety and effectiveness of an investigational medication in adults with chronic rhinosinusitis with nasal polyps (CRSwNP). The study is for participants who have already completed a previous study with the same investigational medication for CRSwNP.

The focus of the study is to observe the safety and tolerability of the investigational medication when used over a longer period. It aims to ensure that the treatment remains safe and effective for participants with CRSwNP.

  • Who can participate: Adults aged 18 and older who have completed a previous study on the investigational medication for CRSwNP can join.
  • Study details: Participants will continue to receive the investigational treatment from the previous study. They will be monitored for safety and effectiveness during this extension study.
  • Study timelines: The study will last 56 weeks.
Updated on 13 Apr 2026. Study ID: NCT06914908

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