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

Study on Long-term Safety and Efficacy of Investigational Medication in Adults with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

Recruiting
All
Phase 2
64 participants needed
7 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, tolerability, and effectiveness of an investigational medication in adults with chronic rhinosinusitis with nasal polyps (CRSwNP). Participants in this study have already completed a previous study with the investigational medication for CRSwNP.

The study involves a single group of participants who will continue to receive the investigational medication. Participants will be monitored for safety and any side effects. They will also continue using a nasal spray as part of their treatment. This study aims to gather more information on how well the investigational medication works over a longer period.

  • Who can participate: Adults aged 18 and over who have completed a previous study with the investigational medication for CRSwNP and are currently using a specific nasal spray may join. Participants must be willing to attend all study visits and follow procedures.
  • Study details: Participants will continue to receive the investigational medication and use a nasal spray. They will be monitored for any side effects and overall health during the study.
  • Study timelines: The study will last up to 56 weeks.
Updated on 09 Mar 2026. Study ID: NCT06914908

Find a study site near you

We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
United States Only: Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language