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RECRUITING

NCT06834360

PHASE3

A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps

Sponsor: Sanofi

View on ClinicalTrials.gov

Summary

EFC18419 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 study with 3 treatment groups. The purpose of the study is to evaluate the efficacy, safety and tolerability of 2 dosing regimens of itepekimab compared to placebo as add-on therapy to intranasal corticosteroids (INCS) in male and female participants with chronic rhinosinusitis with nasal polyps (CRSwNP) aged 18 years of age and older. Study details include: * The study duration per participant (4-week screening, 52-week treatment, 20-week safety follow-up) will be up to 76 weeks. For participants transitioning to the LTS18420 study, the study duration will be 56 weeks. * The treatment duration will be up to 52 weeks. * The number of visits will be 9 site visits and 20 phone/home visits.

Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Phase 3 Trial to Investigate the Efficacy, Safety, and Tolerability of Itepekimab in Adult Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

210

Start Date

2025-02-06

Completion Date

2027-12-13

Last Updated

2026-04-03

Healthy Volunteers

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Interventions

DRUG

Itepekimab (SAR440340)

Pharmaceutical form: Solution for injection in prefilled syringe. Route of administration: Subcutaneous

DRUG

Placebo

Pharmaceutical form: Solution for injection in prefilled syringe. Route of administration: Subcutaneous

DRUG

Mometasone furoate nasal spray (MFNS)

Pharmaceutical form: Solution for administration via spray pump. Route of administration: Intranasal spray

Inclusion Criteria: * Participants must be 18 years of age or older. * Participants with a history of chronic rhinosinusitis with nasal polyps (CRSwNP) for at least 1 year prior to screening * Participants must have at least one of the following features: * Prior sinonasal surgery for nasal polyps (NP). * Worsening symptoms of chronic rhinosinusitis (CRS) requiring treatment with systemic corticosteroid(s) (SCS) within the prior 1 year before screening (Visit 1). * An endoscopic bilateral Nasal Polyp Score (NPS) of at least 5 out of maximum score of 8 (with a minimum score of 2 in each nasal cavity) at screening and randomization. * Ongoing symptoms (for at least 12 weeks before Visit 1) of: * Nasal congestion/blockade/obstruction with moderate or severe (symptom severity score 2 or 3) at Visit 1 and a weekly average severity of greater than 1 in the week before randomization (Visit 2), AND * At least one of the following two symptoms: loss of smell or rhinorrhea (anterior/posterior). * A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies: * Is not a women of childbearing potential (WOCBP), OR * Is a WOCBP and agrees to use a contraceptive method that is highly effective, with a failure rate of \<1% during the study (at a minimum until 20 weeks after the last dose of study intervention). Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Participants with a history of clinically significant renal, hepatic, metabolic, neurologic, hematologic, ophthalmologic, respiratory (excluding those with asthma and aspirin-exacerbated respiratory disease (AERD) which may be included in the study), gastrointestinal, cardiovascular, cerebrovascular, or other significant medical illness or disorder, which, in the judgment of the Investigator, could interfere with the study or require treatment that might interfere with the study. * Participants who are currently smoking tobacco and/or vaping, or participants in whom smoking/vaping cessation has occurred \<6 months prior to Screening (Visit 1). Nicotine replacement therapy and/or noninhaled tobacco product use are not considered current smoking of tobacco. * Participants meet any contraindications for mometasone furoate nasal spray (MFNS) such as hypersensitivity to MFNS or any of its components; or participants with uncontrolled opportunistic infections. * Participants with a history of a severe systemic hypersensitivity reaction to a mAb. * Participants with conditions/concomitant diseases making them non-evaluable at Visit 1 or for the primary efficacy endpoint. * Participants with nasal cavity malignant tumor and benign tumors (eg, papilloma, blood boil etc). * Participants with severe uncontrolled asthma with history of 2 and/or more exacerbations, requiring SCS or 1 hospitalization requiring SCS in the past year. * History of concomitant lung disease (other than asthma, eg, COPD, interstitial lung disease) which in the opinion of the Investigator could interfere with performance and interpretation of spirometry. * Participants treated with intranasal corticosteroid(s) (INCS) (MFNS is permitted), intranasal emitting devices/stents, nasal spray using exhalation delivery system such as XhanceTM during the screening period. In Japan and China INCS other than MFNS are permitted. * Participants who have undergone any sinus intranasal surgery (including polypectomy) within 6 months before Visit 1. * Participants who received SCS 1 month prior to Screening (Visit 1) or during the screening period (between Visit 1 and Visit 2). * Known allergy to itepekimab or its excipients, or any drug or other allergy that, in the opinion of the Investigator, contraindicates participation in this study. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Locations (108)

Excel ENT of Alabama- Site Number : 8400052

Birmingham, Alabama, United States

Velocity Clinical Research - San Diego- Site Number : 8400041

La Mesa, California, United States

Cedars-Sinai Medical Center- Site Number : 8400030

Los Angeles, California, United States

One of a Kind CLinical Research Center- Site Number : 8400034

Napa, California, United States

University of Florida - Jacksonville- Site Number : 8400053

Jacksonville, Florida, United States

University of Miami Don Suffer Clinical Research Building- Site Number : 8400036

Miami, Florida, United States

Advanced Research Institute - New Port Richey- Site Number : 8400014

New Port Richey, Florida, United States

University of Illinois at Chicago- Site Number : 8400003

Chicago, Illinois, United States

Advanced ENT & Allergy - Louisville- Site Number : 8400007

Louisville, Kentucky, United States

Velocity Clinical Research - Lafayette- Site Number : 8400026

Lafayette, Louisiana, United States

Johns Hopkins Hospital- Site Number : 8400017

Baltimore, Maryland, United States

University of Cincinnati Medical Center- Site Number : 8400022

Cincinnati, Ohio, United States

Allergy, Asthma and Clinical Research- Site Number : 8400002

Oklahoma City, Oklahoma, United States

Thomas Jefferson University Hospital- Site Number : 8400044

Philadelphia, Pennsylvania, United States

Spartanburg-Greer ENT & Allergy- Site Number : 8400039

Greer, South Carolina, United States

Ear and Sinus Institute- Site Number : 8400048

Fort Worth, Texas, United States

Investigational Site Number : 0320005

San Miguel de Tucumán, Tucumán Province, Argentina

Investigational Site Number : 0320002

Buenos Aires, Argentina

Investigational Site Number : 0320001

Buenos Aires, Argentina

Investigational Site Number : 0320004

Corrientes, Argentina

Investigational Site Number : 0320003

Mendoza, Argentina

Investigational Site Number : 0360003

Bella Vista, New South Wales, Australia

Investigational Site Number : 0360002

Brisbane, Queensland, Australia

Investigational Site Number : 0360001

Spearwood, Western Australia, Australia

Investigational Site Number : 0560004

Gesves, Namur, Belgium

Investigational Site Number : 0560006

Alken, Belgium

Investigational Site Number : 0560002

Ghent, Belgium

Investigational Site Number : 0560001

Leuven, Belgium

Private Practice - Dr. Nelson Rosário- Site Number : 0760001

Curitiba, Paraná, Brazil

Centro de Pesquisa Clínica de Marília - CPCLIM- Site Number : 0760002

Marília, São Paulo, Brazil

Fundação Faculdade Regional de Medicina de São José do Rio Preto- Site Number : 0760005

São José do Rio Preto, São Paulo, Brazil

Clinica de Alergia Martti Antila- Site Number : 0760003

Sorocaba, São Paulo, Brazil

Investigational Site Number : 1240017

Vancouver, British Columbia, Canada

Investigational Site Number : 1240019

Burlington, Ontario, Canada

Investigational Site Number : 1240015

Cambridge, Ontario, Canada

Investigational Site Number : 1240014

Ottawa, Ontario, Canada

Investigational Site Number : 1240003

Québec, Quebec, Canada

Investigational Site Number : 1240012

Québec, Quebec, Canada

Investigational Site Number : 1520003

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1520002

Quillota, Región de Valparaíso, Chile

Investigational Site Number : 1520001

Concepción, Región del Biobío, Chile

Investigational Site Number : 1520004

Talcahuano, Región del Biobío, Chile

Investigational Site Number : 1560020

Baotou, China

Investigational Site Number : 1560001

Beijing, China

Investigational Site Number : 1560004

Chengdu, China

Investigational Site Number : 1560025

Chongqing, China

Investigational Site Number : 1560019

Hangzhou, China

Investigational Site Number : 1560005

Hefei, China

Investigational Site Number : 1560002

Jinan, China

Investigational Site Number : 1560012

Jingzhou, China

Investigational Site Number : 1560021

Nanning, China

Investigational Site Number : 1560006

Shenyang, China

Investigational Site Number : 1560024

Suzhou, China

Investigational Site Number : 1560017

Taiyuan, China

Investigational Site Number : 1560023

Taiyuan, China

Investigational Site Number : 1560014

Wuhan, China

Investigational Site Number : 1560003

Yantai, China

Investigational Site Number : 1560009

Zibo, China

Investigational Site Number : 2030002

Hradec Králové, Czechia

Investigational Site Number : 2030003

Pardubice, Czechia

Investigational Site Number : 2030005

Pilsen, Czechia

Investigational Site Number : 2030004

Prague, Czechia

Investigational Site Number : 2030001

Prague, Czechia

Investigational Site Number : 2080001

Aarhus, Denmark

Investigational Site Number : 2080004

Copenhagen, Denmark

Investigational Site Number : 2080002

Køge, Denmark

Investigational Site Number : 2500011

Bordeaux, France

Investigational Site Number : 2500004

Marseille, France

Investigational Site Number : 2500001

Nantes, France

Investigational Site Number : 2500010

Poitiers, France

Investigational Site Number : 2500014

Pontoise, France

Investigational Site Number : 2500007

Toulouse, France

Investigational Site Number : 2760001

Dresden, Germany

Investigational Site Number : 2760002

Leipzig, Germany

Investigational Site Number : 3480005

Budapest, Hungary

Investigational Site Number : 3480001

Szeged, Hungary

Investigational Site Number : 3760003

Haifa, Israel

Investigational Site Number : 3760004

Jerusalem, Israel

Investigational Site Number : 3760001

Nahariya, Israel

Investigational Site Number : 3760002

Rehovot, Israel

Investigational Site Number : 3800001

Milan, Milano, Italy

Investigational Site Number : 3800005

Naples, Napoli, Italy

Investigational Site Number : 3800003

Catania, Italy

Investigational Site Number : 2500005

Toyama, Japan

Investigational Site Number : 4840001

Guadalajara, Jalisco, Mexico

Investigational Site Number : 4840008

Monterrey, Nuevo León, Mexico

Investigational Site Number : 4840002

Veracruz, Mexico

Investigational Site Number : 5280002

Amsterdam, Netherlands

Investigational Site Number : 5280001

Utrecht, Netherlands

Investigational Site Number : 6160004

Poznan, Greater Poland Voivodeship, Poland

Investigational Site Number : 6160005

Wroclaw, Lower Silesian Voivodeship, Poland

Investigational Site Number : 6160002

Lodz, Lódzkie, Poland

Investigational Site Number : 6160001

Bielsko-Biala, Silesian Voivodeship, Poland

Investigational Site Number : 6420003

Brasov, Romania

Investigational Site Number : 6420002

Brasov, Romania

Investigational Site Number : 6420001

Bucharest, Romania

Investigational Site Number : 7240006

Barcelona, Barcelona [Barcelona], Spain

Investigational Site Number : 7240002

Santander, Cantabria, Spain

Investigational Site Number : 7240004

L'Hospitalet de Llobregat, Catalunya [Cataluña], Spain

Investigational Site Number : 7240008

Pamplona, Navarre, Spain

Investigational Site Number : 7240010

Madrid, Spain

Investigational Site Number : 7240012

Madrid, Spain

Investigational Site Number : 7920003

Ankara, Turkey (Türkiye)

Investigational Site Number : 7920001

Bursa, Turkey (Türkiye)

Investigational Site Number : 7920002

Istanbul, Turkey (Türkiye)

Investigational Site Number : 8260002

Wigan, Lancashire, United Kingdom

Investigational Site Number : 8260001

London, London, City of, United Kingdom

Investigational Site Number : 8260003

Taunton, Somerset, United Kingdom

Clinical Research Directory

A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (108)