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
NCT ID: NCT06914908
Last Updated: 2026-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
64 participants
INTERVENTIONAL
2025-05-12
2031-01-29
Brief Summary
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The study duration will be up to approximately 56 weeks per participant, 52 weeks of treatment period, and 4 weeks of follow-up.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lunsekimig
Participant will receive lunsekimig subcutaneous (SC) every 4 weeks and intranasal mometasone furoate nasal spray (MFNS) daily for 52 weeks.
lunsekimig
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Mometasone furoate nasal spray (MFNS)
Pharmaceutical form: Intranasal spray Route of administration: intranasal
Interventions
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lunsekimig
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Mometasone furoate nasal spray (MFNS)
Pharmaceutical form: Intranasal spray Route of administration: intranasal
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Locations
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Modena Allergy + Asthma- Site Number : 8400005
La Jolla, California, United States
Treasure Valley Medical Research- Site Number : 8400002
Boise, Idaho, United States
Essential Medical Research- Site Number : 8400020
Tulsa, Oklahoma, United States
ENT Associates of Texas - McKinne- Site Number : 8400014
McKinney, Texas, United States
Alamo ENT Associates- Site Number : 8400001
San Antonio, Texas, United States
Investigational Site Number : 0320002
Rosario, Santa Fe Province, Argentina
Investigational Site Number : 0320001
Buenos Aires, , Argentina
Investigational Site Number : 0320003
Mendoza, , Argentina
Investigational Site Number : 0560002
Ghent, , Belgium
Investigational Site Number : 1000001
Sofia, , Bulgaria
Investigational Site Number : 6160004
Poznan, Greater Poland Voivodeship, Poland
Investigational Site Number : 6160002
Krakow, Lesser Poland Voivodeship, Poland
Investigational Site Number : 6160007
Wroclaw, Lower Silesian Voivodeship, Poland
Investigational Site Number : 6160003
Katowice, Silesian Voivodeship, Poland
Investigational Site Number : 8260001
Newcastle upon Tyne, , United Kingdom
Countries
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Central Contacts
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Trial Transparency email recommended (Toll free for US & Canada)
Role: CONTACT
Related Links
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LTS18300 Plain Language Results Summary
Other Identifiers
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2024-515912-27
Identifier Type: REGISTRY
Identifier Source: secondary_id
LTS18300
Identifier Type: -
Identifier Source: org_study_id
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