A Proof-of-concept Study of Lunsekimig Compared With Placebo in Adults With Chronic Rhinosinusitis With Nasal Polyps
NCT ID: NCT06454240
Last Updated: 2025-09-19
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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ACTIVE_NOT_RECRUITING
PHASE2
79 participants
INTERVENTIONAL
2024-07-17
2027-04-09
Brief Summary
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The purpose of this study is to assess the efficacy, safety, and tolerability of add-on therapy with subcutaneous lunsekimig in adult participants (aged 18 to 70 years, inclusive) with CRSwNP who are inadequately controlled on intranasal corticosteroid treatment. Participants with and without co-morbid asthma will be included in the study, and lung function will be assessed in both groups.
The study duration will be up to approximately 40 weeks per participant, including 4 weeks of screening run-in period, 24 weeks of intervention period, and 12 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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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm 1
Participant will receive placebo subcutaneous (SC) every 4 weeks and intranasal mometasone furoate nasal spray (MFNS) for 24 weeks.
placebo
Pharmaceutical form:solution for injection-Route of administration:subcutaneous
Arm 2
Participant will receive lunsekimig subcutaneous (SC) every 4 weeks and intranasal mometasone furoate nasal spray (MFNS) for 24 weeks.
lunsekimig
Pharmaceutical form:solution for injection-Route of administration:subcutaneous
Interventions
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lunsekimig
Pharmaceutical form:solution for injection-Route of administration:subcutaneous
placebo
Pharmaceutical form:solution for injection-Route of administration:subcutaneous
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Ongoing symptoms for at least 2 months prior to screening, including:
* Nasal congestion, blockage, or obstruction with moderate or severe symptom severity at screening (Score 2 or 3 on NC Score) and a weekly average severity score of at least 1 (range 0 to 3) at randomization (NC Score: 0=no symptoms, 1=mild, 2=moderate, and 3=severe).
* At least 1 of the following 2 symptoms: (1) partial loss of smell (hyposmia) or total loss of smell (anosmia); (2) anterior and/or posterior rhinorrhea.
Exclusion Criteria
* Patient who has received any therapies such as for example systemic corticosteroids, anti-IgE therapy, monoclonal antibody and some others in the specified timeframe(s) prior to the screening visit
* Patients who have undergone any nasal/sinus surgery within 6 months before screening or for whom NPS cannot be determined accurately on endoscopy due to anatomic changes to the nasal cavity from past nasal/sinus surgery
* Patients with conditions/concomitant diseases making them non evaluable for the primary efficacy endpoint
* Signs or a CT scan suggestive of Allergic fungal rhinosinusitis
* Active/chronic helminthic infection
* History of human immunodeficiency virus (HIV) infection or positive HIV screen (Anti-HIV- and HIV-2 antibodies) at screening visit
* Patients with positive or indeterminate hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody at screening visit NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
18 Years
70 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Locations
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Allergy & Rheumatology- Site Number : 8400005
La Jolla, California, United States
Sacramento Ear Nose & Throat - Roseville- Site Number : 8400003
Roseville, California, United States
Senta Clinic- Site Number : 8400025
San Diego, California, United States
James A Haley Veterans' Hospital- Site Number : 8400015
Tampa, Florida, United States
Emory University Hospital Midtown- Site Number : 8400012
Atlanta, Georgia, United States
The Allergy Group - Asthma & Allergy Boise- Site Number : 8400002
Boise, Idaho, United States
Harvard Medical School - Brigham and Women's Hospital Site Number : 8400016
Boston, Massachusetts, United States
Essential Medical Research- Site Number : 8400020
Tulsa, Oklahoma, United States
McGovern Medical School - UT Physicians Dermatology - Bellaire Station- Site Number : 8400017
Bellaire, Texas, United States
Gary Gross Pharmaceutical Research & Consulting, Inc. Site Number : 8400004
Dallas, Texas, United States
Berkson Medical - McKinney- Site Number : 8400014
McKinney, Texas, United States
Alamo ENT Associates Site Number : 8400001
San Antonio, Texas, United States
Advanced Research Institute - Odgen- Site Number : 8400022
Ogden, Utah, United States
Eastern Virginia Medical School (EVMS) Medical Group- Site Number : 8400008
Norfolk, Virginia, 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 : 0560001
Leuven, , Belgium
Investigational Site Number : 1000001
Sofia, , Bulgaria
Investigational Site Number : 6160002
Krakow, Lesser Poland Voivodeship, Poland
Investigational Site Number : 6160001
Warsaw, Masovian Voivodeship, Poland
Investigational Site Number : 6160005
Warsaw, Masovian Voivodeship, Poland
Investigational Site Number : 6160003
Katowice, Silesian Voivodeship, Poland
Investigational Site Number : 6160004
Poznan, , Poland
Investigational Site Number : 6160007
Wroclaw, , Poland
Investigational Site Number : 8260004
Gloucester, Gloucestershire, United Kingdom
Investigational Site Number : 8260003
Manchester, , United Kingdom
Investigational Site Number : 8260001
Newcastle upon Tyne, , United Kingdom
Countries
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Related Links
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Chronic Rhinosinusitis with Nasal Polyps
ACT18207 Plain Language Results Summary
Other Identifiers
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2024-511261-11
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1300-6978
Identifier Type: OTHER
Identifier Source: secondary_id
ACT18207
Identifier Type: -
Identifier Source: org_study_id
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