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: April 13, 2026
Sponsor: Sanofi
Overall Status: Active - Recruiting

Phase

2

Condition

Sinusitis

Sinus Infections

Soft Tissue Infections

Treatment

Mometasone furoate nasal spray (MFNS)

lunsekimig

Clinical Study ID

NCT06914908
LTS18300
2024-515912-27
U1111-1308-9807
  • 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 above information is not intended to contain all considerations relevant to a patient's potential 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

  • Investigational Site Number : 0320002

    Rosario, Santa Fe Province 2000
    Argentina

    Active - Recruiting

  • Investigational Site Number : 0320002

    Rosario 3838583, Santa Fe Province 3836276 2000
    Argentina

    Site Not Available

  • Investigational Site Number : 0320001

    Buenos Aires, 1121
    Argentina

    Active - Recruiting

  • Investigational Site Number : 0320001

    Buenos Aires 3435910, 1121
    Argentina

    Site Not Available

  • Investigational Site Number : 0320003

    Mendoza, 5500
    Argentina

    Active - Recruiting

  • Investigational Site Number : 0320003

    Mendoza 3844421, 5500
    Argentina

    Site Not Available

  • Investigational Site Number : 0560002

    Ghent, 9000
    Belgium

    Active - Recruiting

  • Investigational Site Number : 0560002

    Ghent 2797656, 9000
    Belgium

    Site Not Available

  • Investigational Site Number : 0560001

    Leuven, 3000
    Belgium

    Site Not Available

  • Investigational Site Number : 1000001

    Sofia, 1612
    Bulgaria

    Active - Recruiting

  • Investigational Site Number : 1000001

    Sofia 727011, 1612
    Bulgaria

    Site Not Available

  • Investigational Site Number : 6160004

    Poznan, Greater Poland Voivodeship 60-693
    Poland

    Active - Recruiting

  • Investigational Site Number : 6160004

    Poznan 3088171, Greater Poland Voivodeship 3337498 60-693
    Poland

    Site Not Available

  • Investigational Site Number : 6160002

    Krakow, Lesser Poland Voivodeship 30-033
    Poland

    Active - Recruiting

  • Investigational Site Number : 6160002

    Krakow 3094802, Lesser Poland Voivodeship 858786 31-033
    Poland

    Site Not Available

  • Investigational Site Number : 6160007

    Wroclaw, Lower Silesian Voivodeship 50-750
    Poland

    Active - Recruiting

  • Investigational Site Number : 6160007

    Wroclaw 3081368, Lower Silesian Voivodeship 3337492 50-750
    Poland

    Site Not Available

  • Investigational Site Number : 6160001

    Warsaw, Masovian Voivodeship 00-909
    Poland

    Active - Recruiting

  • Investigational Site Number : 6160005

    Warsaw, Masovian Voivodeship 02-507
    Poland

    Active - Recruiting

  • Investigational Site Number : 6160003

    Katowice, Silesian Voivodeship 40-611
    Poland

    Active - Recruiting

  • Investigational Site Number : 6160003

    Katowice 3096472, Silesian Voivodeship 3337497 40-611
    Poland

    Site Not Available

  • Investigational Site Number : 8260004

    Gloucester, Gloucestershire GL1 3NN
    United Kingdom

    Active - Recruiting

  • Investigational Site Number : 8260003

    Manchester, M13 9WL
    United Kingdom

    Active - Recruiting

  • Investigational Site Number : 8260001

    Newcastle upon Tyne, NE7 7DN
    United Kingdom

    Active - Recruiting

  • Investigational Site Number : 8260001

    Newcastle upon Tyne 2641673, NE7 7DN
    United Kingdom

    Site Not Available

  • Modena Allergy + Asthma- Site Number : 8400005

    La Jolla, California 92037
    United States

    Active - Recruiting

  • Sacramento Ear Nose & Throat - Roseville- Site Number : 8400003

    Roseville, California 95661
    United States

    Active - Recruiting

  • Allergy & Rheumatology- Site Number : 8400005

    La Jolla 5363943, California 5332921 92037
    United States

    Active - Recruiting

  • Modena Allergy + Asthma- Site Number : 8400005

    La Jolla 5363943, California 5332921 92037
    United States

    Site Not Available

  • Treasure Valley Medical Research- Site Number : 8400002

    Boise, Idaho 83706
    United States

    Site Not Available

  • Treasure Valley Medical Research- Site Number : 8400002

    Boise 5586437, Idaho 5596512 83706
    United States

    Site Not Available

  • Essential Medical Research- Site Number : 8400020

    Tulsa, Oklahoma 74137
    United States

    Active - Recruiting

  • Essential Medical Research- Site Number : 8400020

    Tulsa 4553433, Oklahoma 4544379 74137
    United States

    Site Not Available

  • McGovern Medical School - UT Physicians Dermatology - Bellaire Station- Site Number : 8400017

    Bellaire, Texas 77401
    United States

    Active - Recruiting

  • Pharmaceutical Research & Consulting- Site Number : 8400004

    Dallas, Texas 75231
    United States

    Active - Recruiting

  • ENT Associates of Texas - McKinne- Site Number : 8400014

    McKinney, Texas 75070
    United States

    Active - Recruiting

  • Alamo ENT Associates- Site Number : 8400001

    San Antonio, Texas 78258
    United States

    Active - Recruiting

  • McGovern Medical School - UT Physicians Dermatology - Bellaire Station- Site Number : 8400017

    Bellaire 4673353, Texas 4736286 77401
    United States

    Site Not Available

  • Pharmaceutical Research & Consulting- Site Number : 8400004

    Dallas 4684888, Texas 4736286 75231
    United States

    Site Not Available

  • ENT Associates of Texas - McKinne- Site Number : 8400014

    McKinney 4710178, Texas 4736286 75070
    United States

    Site Not Available

  • Alamo ENT Associates- Site Number : 8400001

    San Antonio 4726206, Texas 4736286 78258
    United States

    Site Not Available

  • Eastern Virginia Medical School (EVMS) Medical Group- Site Number : 8400008

    Norfolk, Virginia 23510
    United States

    Active - Recruiting

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