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

NCT06454240 | Completed Phase 2 DMC FDA Drug

• 3 other identifiers: ACT182072024-511261-11U1111-1300-6978
• Study Type: interventional
• Target: 79
• Locations: 6 countries
• Sites: 29

Brief Summary

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.

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Outcome Measures

Primary Outcomes (1)

• Change in bilateral endoscopic nasal polyp score (NPS).

  This score (NPS) is the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. NP is graded based on polyp size where: 0- no polyps and 4- large polyps causing complete obstruction of the inferior nasal cavity.

  From baseline to Week 24

Secondary Outcomes (17)

• Change in patient-reported nasal congestion/obstruction score

  From baseline to Week 24

• Change in Lund-Mackay CT score

  From baseline to Week 24

• Change in the percent of maxillary sinus volume occupied by disease on CT scan.

  From baseline to Week 24

• Change in SNOT-22 total score.

  From baseline to Week 24

• Change in patient-reported total symptom score (nasal congestion/obstruction, anterior or posterior rhinorrhea, and loss of smell).

  From baseline to Week 24

Study Arms (2)

Arm 1

PLACEBO COMPARATOR

Participant will receive placebo subcutaneous (SC) every 4 weeks and intranasal mometasone furoate nasal spray (MFNS) for 24 weeks.

Drug: placebo

Arm 2

EXPERIMENTAL

Participant will receive lunsekimig subcutaneous (SC) every 4 weeks and intranasal mometasone furoate nasal spray (MFNS) for 24 weeks.

Drug: lunsekimig

Interventions

lunsekimig DRUG

Pharmaceutical form:solution for injection-Route of administration:subcutaneous

Also known as: SAR443765

Arm 2

placebo DRUG

Pharmaceutical form:solution for injection-Route of administration:subcutaneous

Arm 1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (29)

Allergy & Rheumatology- Site Number : 8400005

La Jolla, California, 92037, United States

Location

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

Roseville, California, 95661, United States

Location

Senta Clinic- Site Number : 8400025

San Diego, California, 92018, United States

Location

James A Haley Veterans' Hospital- Site Number : 8400015

Tampa, Florida, 33612, United States

Location

Emory University Hospital Midtown- Site Number : 8400012

Atlanta, Georgia, 30308, United States

Location

The Allergy Group - Asthma & Allergy Boise- Site Number : 8400002

Boise, Idaho, 83706, United States

Location

Harvard Medical School - Brigham and Women's Hospital Site Number : 8400016

Boston, Massachusetts, 02115, United States

Location

Essential Medical Research- Site Number : 8400020

Tulsa, Oklahoma, 74137, United States

Location

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

Bellaire, Texas, 77401, United States

Location

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

Dallas, Texas, 75231, United States

Location

Berkson Medical - McKinney- Site Number : 8400014

McKinney, Texas, 75070, United States

Location

Alamo ENT Associates Site Number : 8400001

San Antonio, Texas, 78258, United States

Location

Advanced Research Institute - Odgen- Site Number : 8400022

Ogden, Utah, 84405, United States

Location

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

Norfolk, Virginia, 23510, United States

Location

Investigational Site Number : 0320002

Rosario, Santa Fe Province, 2000, Argentina

Location

Investigational Site Number : 0320001

Buenos Aires, 1121, Argentina

Location

Investigational Site Number : 0320003

Mendoza, 5500, Argentina

Location

Investigational Site Number : 0560002

Ghent, 9000, Belgium

Location

Investigational Site Number : 0560001

Leuven, 3000, Belgium

Location

Investigational Site Number : 1000001

Sofia, 1612, Bulgaria

Location

Investigational Site Number : 6160002

Krakow, Lesser Poland Voivodeship, 31-033, Poland

Location

Investigational Site Number : 6160001

Warsaw, Masovian Voivodeship, 00-909, Poland

Location

Investigational Site Number : 6160005

Warsaw, Masovian Voivodeship, 02-507, Poland

Location

Investigational Site Number : 6160003

Katowice, Silesian Voivodeship, 40-611, Poland

Location

Investigational Site Number : 6160004

Poznan, 60-693, Poland

Location

Investigational Site Number : 6160007

Wroclaw, 53-034, Poland

Location

Investigational Site Number : 8260004

Gloucester, Gloucestershire, GL1 3NN, United Kingdom

Location

Investigational Site Number : 8260003

Manchester, M13 9WL, United Kingdom

Location

Investigational Site Number : 8260001

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Related Links

• Chronic Rhinosinusitis with Nasal Polyps
• ACT18207 Plain Language Results Summary

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 12, 2024
• Study Start: July 17, 2024
• Primary Completion: January 29, 2026
• Study Completion: April 23, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

PL (6); AR (3); GB (3); US (14); BE (2); BU (1)