RecruitingPhase 3NCT06338995

A Study of Lebrikizumab (LY3650150) in Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lebrikizumab/LY3650150 in Participants With Chronic Rhinosinusitis With Nasal Polyps on Background Intranasal Corticosteroids

Sponsor

Eli Lilly and Company

Enrollment

510 participants

Start Date

Apr 29, 2024

Study Type

INTERVENTIONAL

Conditions

Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Summary

The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in participants with chronic rhinosinusitis and nasal polyps treated with intranasal corticosteroids. The study will last about 18 months.

Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called LY3650150, a drug called Placebo, and others for people with chronic rhinosinusitis with nasal polyps (crswnp). The study is currently recruiting participants at 202 locations. People eligible for this study include aged 12 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLY3650150

Administered SC.

DRUGPlacebo

Administered SC.

DRUGStandard therapy for INCS

Administered as intranasal spray.

Locations(202)

AllerVie Clinical Research

Birmingham, Alabama, United States

University of Alabama at Birmingham

Birmingham, Alabama, United States

Medovation Research

Huntsville, Alabama, United States

Novak Clinical Research - Tucson - North La Cholla Boulevard

Tucson, Arizona, United States

Keck Medicine of USC

Arcadia, California, United States

University of California, Irvine

Irvine, California, United States

ADCRC

La Mesa, California, United States

Ark Clinical Research

Long Beach, California, United States

DaVinci Research LLC

Roseville, California, United States

Breathe Clear Institute

Torrance, California, United States

Colorado ENT & Allergy

Colorado Springs, Colorado, United States

Bioresearch Partner-Kendale Lakes

Miami, Florida, United States

Orlando ENT & Allergy

Orlando, Florida, United States

NuLine Clinical Trial Center

Pompano Beach, Florida, United States

University of South Florida

Tampa, Florida, United States

MJ Research

Tampa, Florida, United States

Treasure Valley Medical Research

Boise, Idaho, United States

Entopy Research LLC

Chicago, Illinois, United States

Chicago ENT

Chicago, Illinois, United States

EMEDR

Overland Park, Kansas, United States

South Louisiana Ear, Nose, Throat & Facial Plastic Surgery - PPDS

Mandeville, Louisiana, United States

Chesapeake Clinical Research, Inc.

White Marsh, Maryland, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

University of Missouri

Columbia, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Circuit Clinical/Mercer Allergy and Pulmonary Associates

Hamilton, New Jersey, United States

Madison ENT & Facial Plastic Surgery

New York, New York, United States

New York Allergy and Sinus Center

New York, New York, United States

Equity Medical

The Bronx, New York, United States

UCMC

Cincinnati, Ohio, United States

Optimed Research, LTD

Columbus, Ohio, United States

Charleston ENT

Charleston, South Carolina, United States

Medical University of South Carolina- Department of Otolaryngology and Head and Neck Surgery

Charleston, South Carolina, United States

Alina Clinical Trials

Dallas, Texas, United States

UT Southwestern Medical Center

Dallas, Texas, United States

University of Texas Physicians Department of Otorhinolaryngology Clinc

Houston, Texas, United States

Ear Nose and Throat Associates of Texas PA

McKinney, Texas, United States

Alamo ENT Associates

San Antonio, Texas, United States

Eastern Virginia Medical School

Norfolk, Virginia, United States

Richmond Ear Nose and Throat

Richmond, Virginia, United States

The Medical College of Wisconsin

Milwaukee, Wisconsin, United States

CEMLO - Centro de Especialidades Médicas Lobos

Beunos Aires, Argentina

Fundacion Respirar

Buenos Aires, Argentina

Centro Platense en Investigaciones Respiratorias - CEPIR

Buenos Aires, Argentina

Fundacion CIDEA

Caba, Argentina

Centro de Investigaciones Clínicas - IESR - Rosario

Rosario, Argentina

Investigaciones en Patologías Respiratorias SRL

San Miguel de Tucumán, Argentina

CIMER-Centro Integral de Medicina Respiratoria

San Miguel de Tucumán, Argentina

Centro Respiratorio Infantil

Santa Fe, Argentina

CARE - Centro de Alergia y Enfermedades Respiratorias

Villa Crespo, Argentina

Pneumocare

Erpent, Belgium

UZ Gent

Ghent, Belgium

Cliniques Universitaires Saint-Luc Avenue Hippocrate 10

Woluwe-Saint-Lambert, Belgium

Multiprofile Hospital For Active Treatment Dr Tota Venkova A

Gabrovo, Bulgaria

Medical Center Medconsult Pleven OOD

Pleven, Bulgaria

Diagnostic-Consultative Centre Ascendent EOOD

Sofia, Bulgaria

Military Medical Academy - Multiprofile Hospital for Active Treatment - Sofia,

Sofia, Bulgaria

University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna

Sofia, Bulgaria

Multiprofile Hospital for Active treatment Trakia EOOD

Zagora, Bulgaria

St. Joseph's Hospital

Ontario, Canada

CSAC

Québec, Canada

The Gordon and Leslie Diamond Health Care Centre

Vancouver, Canada

St Paul's Sinus Centre

Vancouver, Canada

Peking University Third Hospital

Beijing, China

Beijing Hospital

Beijing, China

Beijing Tongren Hospital

Beijing, China

The First Affiliated Hospital of Bengbu Medical College

Bengbu, China

The Third Xiangya Hospital of Central South University

Changsha, China

Sichuan Provincial People's Hospital

Chengdu, China

The First People's Hospital of Foshan

Foshan, China

The First Affiliated Hospital Of Fujian Medical University

Fuzhou, China

Shenzhen Second People's Hospital

Guangdong, China

Hainan General Hospital

Haikou, China

Hangzhou First People's Hospital

Hangzhou, China

Huai'an First People's Hospital

Huai'an, China

The First Affiliated Hospital of Nanchang University

Nanchang, China

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, China

Ningbo Medical Center Lihuili Hospital

Ningbo, China

The first Affilliated Hospital Shandong First Medical University

Shandong, China

Tongji Hospital of Tongji University

Shanghai, China

Shengjing Hospital of China Medical University

Shenyang, China

The First Hospital of Shanxi Medical University

Taiyuan, China

Tianjin People's Hospital

Tianjin, China

Tonghua Central Hospital

Tonghua, China

The 2nd Affiliated Hospital of Wenzhou Medical University

Wenzhou Avenue, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, China

Renmin Hospital of Wuhan University

Wuhan, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, China

First People's Hospital of Yinchuan

Yinchuan, China

Aalborg Universitetshospital Medicinerhuset Lungemedicinsk Forskningsenhed

Aalborg, Denmark

Aarhus University Hospital, Dept. of Ear-Nose-Throat

Aarhus, Denmark

Bispebjerg Hospital Department of Respiratory Medicine

Copenhagen, Denmark

Sjællands Universitets Hospital

Køge, Denmark

Department otorhinolaryngology - Head and Neck Surgery, Helsinki Univerity Hospital

Helsinki, Finland

Departmentof Allergy, Skin and Allergy Hospital, Helsinki Univerity Hospital

Helsinki, Finland

Charite-Universitatsmedizin Berlin

Berlin, Germany

HNO Zentrum am Kudamm

Berlin, Germany

Praxis für HNO und Allergologie

Dresden, Germany

Universitätsklinikum Carl Gustav Carus an der TU Dresden

Dresden, Germany

IKF Pneumologie

Frankfurt am Main, Germany

Universitätsklinikum Jena

Jena, Germany

Universitätsklinikum Schleswig-Holstein

Lübeck, Germany

HNO Praxis

Sachsen, Germany

Ujpesti Egeszsegugyi Szolgaltato

Budapest, Hungary

Komarom-Esztergom Varmegyei Szent Borbala Korhaz

Tatabánya, Hungary

AOU Careggi- University of Florence

Florence, Italy

Ospedale San Raffaele

Milan, Italy

AOU Federico II Via Pansini

Naples, Italy

Azienda Ospedaliera Di Padova

Padova, Italy

Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara

Pisa, Italy

Fondazione Policlinico A. Gemelli IRCCS

Rome, Italy

ASST Brianza - Vimercate Hospital

Vimercate, Italy

Toyota Memorial Hospital

Aichi, Japan

Clinic Kashiwanoha

Chiba, Japan

University of Yamanashi Hospital

Chūō, Japan

University of Fukui Hospital

Fukui, Japan

Saiseikai Fukuoka General Hospital

Fukuoak, Japan

Matsuda Hospital

Fukuoka, Japan

Kyushu University Hospital

Fukuoka, Japan

Osaka Habikino Medical Center

Habikino-shi, Japan

Kansai Medical University Hospital

Hirakata, Japan

Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital

Hokkaido, Japan

Hyogo Medical University Hospital

Hyōgo, Japan

Takarazuka City Hospital

Hyōgo, Japan

Ibaraki Prefectural Central Hospital

Ibaraki, Japan

Kagoshima Kouseiren Hospital

Kagoshima, Japan

Yokohama City Minato Red Cross Hospital

Kanagawa, Japan

Odawara Municipal Hospital

Kanagawa, Japan

Tokai University Hospital

Kanagawa, Japan

Kimitsu Chuo Hospital

Kisarazu, Japan

1-8-1, Kishinoura

Kitakyushu, Japan

3-54-2, Kotohirahommachi

Kumamoto, Japan

Kyosai Hospital

Minami-Alps, Japan

Tohoku Medical and Pharmaceutical University Hospital

Miyagi, Japan

Ritsuzankai Iida Hospital

Nagano, Japan

Asahioka, 1-24

Niigata, Japan

Niigata University Medical & Dental Hospital

Niigata, Japan

Japan Community Health care Organization Osaka Hospital

Osaka, Japan

Kansai Electric Power Hospital

Osaka, Japan

Toho University Sakura Medical Center

Sakura, Japan

8-2 Otemachi

Shizuoka, Japan

Toho University Ohashi Medical Center

Tokyo, Japan

Nihon University Itabashi Hospital

Tokyo, Japan

Mie University Hospital

Tsu, Japan

JCHO Shimonoseki Medical center

Yamaguchi, Japan

Yamaguchi University Hospital

Yamaguchi, Japan

Yokohama Minami Kyosai Hospital

Yokohama, Japan

Avenida Independencia

Aguascalientes, Mexico

Calle Pascual Orozco #2125 col. Magisterial Universidad

Chihuahua City, Mexico

Calle Penitenciaria

Guadalajara Jalsico, Mexico

Miguel Hidalgo 2525, Consultorio 2 Urgencias

Nuevo León, Mexico

Humboldt 302 Col. Centro

Oaxaca City, Mexico

Niepubliczny Zakład Opieki Zdrowotnej E-Vita

Bialystok, Poland

Centrum Medyczne Pratia Katowice

Katowice, Poland

Centrum Medyczne Angelius Provita

Katowice, Poland

B&R Clinical Sp. z o.o

Kielce, Poland

Centrum Medyczne All-Med

Krakow, Poland

Centrum Medyczne Promed ul. Olszańska 5G

Krakow, Poland

Specjalistyczny Niepubliczny Zakład Opieki Zdrowotnej Alergologia Plus Ośrodek Diagnostyki

Poznan, Poland

WIM-PIB

Warsaw, Poland

Centrum Medyczne Biotamed Morawska Barbara

Wieliczka, Poland

EMC INSTYTUT MEDYCZNY S.A. Przychodnia

Wroclaw, Poland

Centrum Medyczne Oporów

Wroclaw, Poland

Unidade Local de Saúde de Almada-Seixal, E.P.E.

Almada, Portugal

ULS da Região de Aveiro, EPE - Hospital Infante D. Pedro

Aveiro, Portugal

Centro Clínico Académico - Braga (2CA-Braga) (Hospital de Braga)

Braga, Portugal

Unidade Local de Saúde Loures-Odivelas

Loures, Portugal

ULS do Algarve, EPE - Hospital de Portimão

Seco Portimao Faro, Portugal

Hospital Pedro Hispano

Senhora da Hora, Portugal

Centrul Medical Unirea SRL

Brasov, Romania

Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L

Brasov, Romania

Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L

Brasov, Romania

Delta Health Care S.R.L

Bucharest, Romania

Delta Health Care S.R.L

Bucharest, Romania

Cardiomed S.R.L

Cluj-Napoca, Romania

Centrul de Excelenta in Rinologie S.R.L

Dolj, Romania

Inje University Haeundae Paik Hospital

Busan, South Korea

CHA Bundang Medical Center

Gyeonggi-do, South Korea

Pusan National University Hospital

Pusan, South Korea

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Korea University Anam Hospital

Seoul, South Korea

SNUH - Seoul National University Hospital

Seoul, South Korea

The Catholic University of Korea

Seoul, South Korea

Korea University Guro Hospital

Seoul, South Korea

SMG-SNU Boramae Medical Center

Seoul, South Korea

Ajou University Hospital

Suwon, South Korea

Hospital Universitario Virgen de la Macarena Avenida Dr. Fedriani

Andalucia, Spain

Centro Médico Teknon

Barcelona, Spain

Hospital Universitario de Jerez

Cadiz, Spain

Hospital Clínico Universitario de Santiago

Galícia, Spain

FutureMeds DKF

Madrid, Spain

Hospital Universitario Fundación Jiménez Díaz

Madrid, Spain

Clinica Universidad de Navarra

Pamplona, Spain

Taipei Medical University Shuang Ho Hospital

New Taipei City, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Bristol Royal Infirmary University Hospitals

Bristol, United Kingdom

Charing Cross Hospital

Chelsea, United Kingdom

James Paget University Hospitals NHS Foundation Trust

Great Yarmouth, United Kingdom

Royal Berkshire NHS Foundation Trust

London, United Kingdom

Guys and St Thomas' NHS Foundation Trust

London, United Kingdom

Newcastle upon Tyne Hospitals NHSFT Freeman Hospital

Newcastle upon Tyne, United Kingdom

Stepping Hill Hospital

Stockport, United Kingdom

View Full Details on ClinicalTrials.gov

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