Long-term evaluation of lunsekimig for chronic rhinosinusitis with nasal polyps

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

Phase 2 Interventional Sanofi · NCT06914908

This study is testing how well lunsekimig works over a longer period for adults with chronic rhinosinusitis and nasal polyps who have already participated in a previous trial.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment64 (estimated)
SexAll
SponsorSanofi Industry-sponsored
Locations24 sites (La Jolla, California and 23 other locations)
Trial IDNCT06914908 on ClinicalTrials.gov

What this trial studies

This study is an extension of a previous clinical trial focusing on the long-term safety, tolerability, and efficacy of lunsekimig in adults with chronic rhinosinusitis with nasal polyps (CRSwNP). Participants who have previously completed a lunsekimig study will receive treatment for up to 52 weeks, followed by a 4-week follow-up period. The study aims to gather data on how well lunsekimig works over an extended timeframe in managing CRSwNP symptoms. Additionally, participants will continue using mometasone furoate nasal spray as part of their treatment regimen.

Who should consider this trial

Good fit: Ideal candidates are adults who have previously participated in a lunsekimig study and have inadequately controlled CRSwNP.

Not a fit: Patients who have had a hypersensitivity reaction to lunsekimig or are currently participating in other clinical studies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a long-term treatment option for patients suffering from chronic rhinosinusitis with nasal polyps.

How similar studies have performed: Other studies on lunsekimig have shown promise, but this specific long-term evaluation is novel.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

La Jolla, California and 23 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions Chronic Rhinosinusitis With Nasal Polyps
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.