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

May 19, 2026 updated by: Sanofi

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1121
        • Investigational Site Number : 0320001
      • Mendoza, Argentina, 5500
        • Investigational Site Number : 0320003
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, 2000
        • Investigational Site Number : 0320002
  • Belgium
      • Ghent, Belgium, 9000
        • Investigational Site Number : 0560002
      • Leuven, Belgium, 3000
        • Investigational Site Number : 0560001
  • Bulgaria
      • Sofia, Bulgaria, 1612
        • Investigational Site Number : 1000001
  • Poland
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 60-693
        • Investigational Site Number : 6160004
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 30-033
        • Investigational Site Number : 6160002
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 50-750
        • Investigational Site Number : 6160007
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 00-909
        • Investigational Site Number : 6160001
      • Warsaw, Masovian Voivodeship, Poland, 02-507
        • Investigational Site Number : 6160005
    • Silesian Voivodeship
      • Katowice, Silesian Voivodeship, Poland, 40-611
        • Investigational Site Number : 6160003
  • United Kingdom
      • Manchester, United Kingdom, M13 9wl
        • Investigational Site Number : 8260003
      • Newcastle upon Tyne, United Kingdom, NE7 7DN
        • Investigational Site Number : 8260001
    • Gloucestershire
      • Gloucester, Gloucestershire, United Kingdom, GL1 3NN
        • Investigational Site Number : 8260004
  • United States
    • California
      • La Jolla, California, United States, 92037
        • Modena Allergy + Asthma- Site Number : 8400005
      • Roseville, California, United States, 95661
        • Sacramento Ear Nose & Throat - Roseville- Site Number : 8400003
    • Idaho
      • Boise, Idaho, United States, 83706
        • Treasure Valley Medical Research- Site Number : 8400002
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74137
        • Essential Medical Research- Site Number : 8400020
    • Texas
      • Bellaire, Texas, United States, 77401
        • McGovern Medical School - UT Physicians Dermatology - Bellaire Station- Site Number : 8400017
      • Dallas, Texas, United States, 75231
        • Pharmaceutical Research & Consulting- Site Number : 8400004
      • McKinney, Texas, United States, 75070
        • ENT Associates of Texas - McKinne- Site Number : 8400014
      • San Antonio, Texas, United States, 78258
        • Alamo ENT Associates- Site Number : 8400001
    • Virginia
      • Norfolk, Virginia, United States, 23510
        • Eastern Virginia Medical School (EVMS) Medical Group- Site Number : 8400008

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lunsekimig
Participant will receive lunsekimig subcutaneous (SC) every 4 weeks and intranasal mometasone furoate nasal spray (MFNS) daily for 52 weeks.
Drug: lunsekimig
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Other Names:
  • SAR443765
Drug: Mometasone furoate nasal spray (MFNS)
Pharmaceutical form: Intranasal spray Route of administration: intranasal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of participants with treatment-emergent adverse events (TEAEs) including
Time Frame: From baseline to end of study (approximately 56 weeks)
From baseline to end of study (approximately 56 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in SNOT-22 total score
Time Frame: From the parent study baseline to Week 52
The SNOT-22 is a 22-item health-related outcomes assessment. The 22-question SNOT-22 is scored as 0 (no problem) to 5 (problem as bad as it can be) with a total range from 0 to 110 (higher scores indicate poorer outcomes).
From the parent study baseline to Week 52
Change in rhinosinusitis visual analog scale (VAS)
Time Frame: From the parent study baseline to Week 52
The VAS for rhinosinusitis is used to evaluate the total severity. The participant is asked to indicate along a 10 centimeter straight horizontal line (VAS) the answer to the question: "How troublesome are your symptoms of your rhinosinusitis". The VAS ranks from 0 (Not troublesome) to 10 (Worst thinkable troublesome) and is measured in centimeters
From the parent study baseline to Week 52
Change in University of Pennsylvania Smell Identification Test (UPSIT) score
Time Frame: From the parent study baseline to Week 52
The UPSIT test is a rapid and easy-to-administer method to quantitatively assess human olfactory function. The test consists of four booklets, each containing 10 odorants with one odorant per page. Above each odorant strip is a multiple-choice question with four alternative words to describe the odor. Score depends on the amount of answers out of 40 possible correct answers.
From the parent study baseline to Week 52
Serum lunsekimig concentrations
Time Frame: From baseline to end of study (approximately 56 weeks)
From baseline to end of study (approximately 56 weeks)
Anti-drug antibodies (ADA) against lunsekimig
Time Frame: From baseline to end of study (approximately 56 weeks)
From baseline to end of study (approximately 56 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2025

Primary Completion (Estimated)

January 29, 2031

Study Completion (Estimated)

January 29, 2031

Study Registration Dates

First Submitted

April 4, 2025

First Submitted That Met QC Criteria

April 4, 2025

First Posted (Actual)

April 7, 2025

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LTS18300
  • 2024-515912-27 (Registry Identifier: CTIS)
  • U1111-1308-9807 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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