Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

Exclusion Criteria

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Arm 1
Participant will receive placebo subcutaneous (SC) every 4 weeks and intranasal mometasone furoate nasal spray (MFNS) for 24 weeks.
  • Drug: placebo
    Pharmaceutical form:solution for injection-Route of administration:subcutaneous
Experimental
Arm 2
Participant will receive lunsekimig subcutaneous (SC) every 4 weeks and intranasal mometasone furoate nasal spray (MFNS) for 24 weeks.
  • Drug: lunsekimig
    Pharmaceutical form:solution for injection-Route of administration:subcutaneous
    Other names:
    • SAR443765

Recruiting Locations

Modena Allergy + Asthma Site Number : 8400005
La Jolla, California 92037

United Gastroenterologists - Murrieta- Site Number : 8400021
Murrieta, California 92563

Sacramento Ear Nose & Throat - Roseville- Site Number : 8400003
Roseville, California 95661

James A Haley Veterans Hospital Site Number : 8400015
Tampa, Florida 33612

Emory University Hospital Midtown- Site Number : 8400012
Atlanta, Georgia 30308

The Allergy Group - Asthma & Allergy Boise- Site Number : 8400002
Boise, Idaho 83706

Harvard Medical School - Brigham and Women's Hospital Site Number : 8400016
Boston, Massachusetts 02115

Vital Prospects Clinical Research Institute - Tulsa- Site Number : 8400010
Tulsa, Oklahoma 74136

Essential Medical Research- Site Number : 8400020
Tulsa, Oklahoma 74137

Gary Gross Pharmaceutical Research & Consulting, Inc. Site Number : 8400004
Dallas, Texas 75231

The University of Texas Health Science Center- Site Number : 8400017
Houston, Texas 77401

Berkson Medical Site Number : 8400014
McKinney, Texas 75070

Alamo ENT Associates Site Number : 8400001
San Antonio, Texas 78258

Advanced Research Institute - Odgen- Site Number : 8400022
Ogden, Utah 84405

More Details

NCT ID
NCT06454240
Status
Recruiting
Sponsor
Sanofi

Study Contact

Trial Transparency email recommended (Toll free for US & Canada)
800-633-1610
Contact-US@sanofi.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.