A Proof-of-concept Study of Lunsekimig Compared With Placebo in Adults With Chronic Rhinosinusitis With Nasal Polyps

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Rhinosinusitis With Nasal Polyps

In brief

This is a parallel, Phase 2, 2-arm, multicenter, randomized, double-blind, placebo-controlled, proof-of-concept study for treatment of CRSwNP. 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.

Key facts

Study ID

NCT06454240

Run by

Sanofi

People needed

79

Starts

2024-07-17

Expected to finish

2026-04-23

Last updated by the study team

2026-04-28

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A minimum bilateral nasal polyp score of 5 out of a maximum score of 8 for both nostrils (with at least a score of 2 for each nostril) despite use of intranasal corticosteroid treatment for at least 2 months prior to screening
• 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.

You may not qualify if…

• Participants are excluded from the study if any of the following criteria apply:
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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