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

Last updated: May 16, 2025
Sponsor: Sanofi
Overall Status: Active - Recruiting

Phase

2

Condition

Sinus Infections

Polyps

Sinusitis

Treatment

Mometasone furoate nasal spray (MFNS)

lunsekimig

Clinical Study ID

NCT06914908
LTS18300
2024-515912-27
  • All Genders

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 56 weeks per participant, 52 weeks of treatment period, and 4 weeks of follow-up.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants who have completed the treatment period and the follow up period inCRSwNP 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 tocomply with requested study visits and procedures.

Exclusion

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 inthe presentation or in preparation for administration of lunsekimig, or otherallergy that, in the opinion of the Investigator, contraindicates participation inthe 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 anadverse event (AE) or a serious adverse event (SAE) deemed related to lunsekimig,which in the opinion of the Investigator could indicate that continued treatmentwith lunsekimig may present an unreasonable risk for the participant NOTE: The aboveinformation is not intended to contain all considerations relevant to a patient'spotential participation in a clinical trial

Study Design

Total Participants: 64
Treatment Group(s): 2
Primary Treatment: Mometasone furoate nasal spray (MFNS)
Phase: 2
Study Start date:
May 12, 2025
Estimated Completion Date:
January 29, 2031

Connect with a study center

  • Modena Allergy + Asthma- Site Number : 8400005

    La Jolla, California 92037
    United States

    Active - Recruiting

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