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NCT06338995PHASE3Recruiting

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

Eli Lilly and Company

Start Date

4/29/2024

Completion Date

3/1/2028

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 Criteria

Age Range: 12 years to No maximum

Inclusion Criteria: * Physician-diagnosed chronic rhinosinusitis (CRS) with bilateral nasal polyps (NP). * Prior treatment with systemic corticosteroids (SCS) within the last 2 years (or a medical contraindication or intolerance to SCS), prior surgery for NP, or both. * Endoscopic bilateral NPS score of at least 5 out of 8, with a minimum score of 2 in each nasal cavity performed at screening and baseline. * Ongoing symptoms for at least 8 weeks prior to study entry (screening), including: 1. Nasal congestion with moderate or severe symptom severity (score 2 or 3) at screening and a weekly average severity score of at least 1 (range 0 to 3) at randomization, and 2. At least one other symptom, such as partial loss of smell (hyposmia), total loss of smell (anosmia), or anterior or posterior rhinorrhea. * Have concomitant asthma must be stable in the 3 months prior to screening using permitted regular asthma treatment. * Adolescent participants ≥12 to \<18 years of age and weighing ≥40 kg at time of Visit 1. Exclusion Criteria: * Have received a dose of lebrikizumab. * Have received treatment with any rescue medication and/or have the need for surgery for NP during screening and/or run-in period. * Allergen immunotherapy (subcutaneous immunotherapy \[SCIT\]/sublingual immunotherapy \[SLIT\]) initiated within 6 months prior to screening, that is not on a stable dose (3 months prior to screening). * Has received a biologic treatment approved for use in CRSwNP, asthma, or AD, even if administered to treat a different condition, within 4 months or 5 half-lives, whichever is longer, prior to screening. * Have received treatment with any biologic or systemic immunosuppressants for inflammatory disease or autoimmune disease prior to the baseline visit: 1. B cell-depleting biologics, including rituximab, within 6 months. 2. other biologics within 5 half-lives (if known) or 8 weeks, whichever is longer. 3. Systemic immunosuppressants within 4 weeks prior to baseline. * Have had any sinus intranasal surgery (including nasal polypectomy) within 6 months prior to screening * Have had prior sino-nasal surgery or sinus surgery changing lateral wall structure of the nose making it difficult to assess endoscopic NPS * Have a presence of any of the following conditions that may impact the assessment of endpoints at screening or baseline: 1. Nasal septal deviation occluding at least one nostril. 2. Antrochoanal polyps. 3. Acute sinusitis, acute nasal infection, or acute upper respiratory infection. 4. Ongoing rhinitis medicamentosa. 5. Presence of another diagnosis associated with NP (ie, eosinophilic granulomatosis with polyangiitis, granulomatosis with polyangiitis, Young's syndrome, primary ciliary dyskinesia, cystic fibrosis). Note: for adolescents, documentation for ruling out cystic fibrosis and primary ciliary dyskinesia is required. 6. A nasal cavity tumor (malignant or benign). 7. Evidence of fungal rhinosinusitis. * Have anosmia from COVID or any reason other than CRSwNP. * Participants with forced expiratory volume in 1 second (FEV1) 50% or less (of predicted normal) at screening. * Female participant who is pregnant, breastfeeding, or is planning to become pregnant, or to breastfeed during the study.

Interventions

DRUG

LY3650150

DRUG

Placebo

DRUG

Standard therapy for INCS

Interested in This Trial?

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Conditions

Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Locations

AllerVie Clinical Research

Birmingham, Alabama 35209

United States

University of Alabama at Birmingham

Birmingham, Alabama 35233

United States

Medovation Research

Huntsville, Alabama 35801

United States

Novak Clinical Research - Tucson - North La Cholla Boulevard

Tucson, Arizona 85741

United States

Keck Medicine of USC

Arcadia, California 91007

United States

University of California, Irvine

Irvine, California 92697

United States

ADCRC

La Mesa, California 91942

United States

Ark Clinical Research

Long Beach, California 90815

United States

DaVinci Research LLC

Roseville, California 95661

United States

Breathe Clear Institute

Torrance, California 90503

United States

Colorado ENT & Allergy

Colorado Springs, Colorado 80923

United States

Bioresearch Partner-Kendale Lakes

Miami, Florida 33155

United States

Orlando ENT & Allergy

Orlando, Florida 32825

United States

NuLine Clinical Trial Center

Pompano Beach, Florida 33060

United States

University of South Florida

Tampa, Florida 33613

United States

MJ Research

Tampa, Florida 33615

United States

Treasure Valley Medical Research

Boise, Idaho 83706

United States

Entopy Research LLC

Chicago, Illinois 60616

United States

Chicago ENT

Chicago, Illinois 60657

United States

EMEDR

Overland Park, Kansas 66211

United States

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

Mandeville, Louisiana 70471

United States

Chesapeake Clinical Research, Inc.

White Marsh, Maryland 21162

United States

Brigham and Women's Hospital

Boston, Massachusetts 02215

United States

University of Missouri

Columbia, Missouri 65212

United States

Washington University School of Medicine

St Louis, Missouri 63141

United States

Circuit Clinical/Mercer Allergy and Pulmonary Associates

Hamilton, New Jersey 08619

United States

Madison ENT & Facial Plastic Surgery

New York, New York 10016

United States

New York Allergy and Sinus Center

New York, New York 10016

United States

Equity Medical

The Bronx, New York 10455

United States

UCMC

Cincinnati, Ohio 45267

United States

Optimed Research, LTD

Columbus, Ohio 43235

United States

Charleston ENT

Charleston, South Carolina 29406

United States

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

Charleston, South Carolina 29425

United States

Alina Clinical Trials

Dallas, Texas 75209

United States

UT Southwestern Medical Center

Dallas, Texas 75390-9035

United States

University of Texas Physicians Department of Otorhinolaryngology Clinc

Houston, Texas 77030

United States

Ear Nose and Throat Associates of Texas PA

McKinney, Texas 75070-5735

United States

Alamo ENT Associates

San Antonio, Texas 78258-3227

United States

Eastern Virginia Medical School

Norfolk, Virginia 23507

United States

Richmond Ear Nose and Throat

Richmond, Virginia 23235

United States

The Medical College of Wisconsin

Milwaukee, Wisconsin 53226-3548

United States

CEMLO - Centro de Especialidades Médicas Lobos

Beunos Aires, B7240KJB

Argentina

Fundacion Respirar

Buenos Aires, C1426BP

Argentina

Centro Platense en Investigaciones Respiratorias - CEPIR

Buenos Aires,

Argentina

Fundacion CIDEA

Caba, C1121ABE

Argentina

Centro de Investigaciones Clínicas - IESR - Rosario

Rosario, CP 2000

Argentina

Investigaciones en Patologías Respiratorias SRL

San Miguel de Tucumán, CP4000

Argentina

CIMER-Centro Integral de Medicina Respiratoria

San Miguel de Tucumán,

Argentina

Centro Respiratorio Infantil

Santa Fe, 2000

Argentina

CARE - Centro de Alergia y Enfermedades Respiratorias

Villa Crespo, C1414AIF

Argentina

Pneumocare

Erpent, 5101

Belgium

UZ Gent

Ghent, 9000

Belgium

Cliniques Universitaires Saint-Luc Avenue Hippocrate 10

Woluwe-Saint-Lambert, 1200

Belgium

Multiprofile Hospital For Active Treatment Dr Tota Venkova A

Gabrovo, 1431

Bulgaria

Medical Center Medconsult Pleven OOD

Pleven, 5800

Bulgaria

Diagnostic-Consultative Centre Ascendent EOOD

Sofia, 1202

Bulgaria

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

Sofia, 1431

Bulgaria

University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna

Sofia, 1527

Bulgaria

Multiprofile Hospital for Active treatment Trakia EOOD

Zagora, 1504

Bulgaria

St. Joseph's Hospital

Ontario, N6A 4V2

Canada

CSAC

Québec,

Canada

The Gordon and Leslie Diamond Health Care Centre

Vancouver, V5Z 1M9

Canada

St Paul's Sinus Centre

Vancouver, V6Z 1Y6

Canada

Peking University Third Hospital

Beijing, 100191

China

Beijing Hospital

Beijing, 100730

China

Beijing Tongren Hospital

Beijing, 100730

China

The First Affiliated Hospital of Bengbu Medical College

Bengbu, 233004

China

The Third Xiangya Hospital of Central South University

Changsha, 410013

China

Sichuan Provincial People's Hospital

Chengdu, 610072

China

The First People's Hospital of Foshan

Foshan, 528000

China

The First Affiliated Hospital Of Fujian Medical University

Fuzhou, 350000

China

Shenzhen Second People's Hospital

Guangdong,

China

Hainan General Hospital

Haikou, 570311

China

Hangzhou First People's Hospital

Hangzhou,

China

Huai'an First People's Hospital

Huai'an, 223300

China

The First Affiliated Hospital of Nanchang University

Nanchang, 330006

China

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, 530021

China

Ningbo Medical Center Lihuili Hospital

Ningbo,

China

The first Affilliated Hospital Shandong First Medical University

Shandong, 250014

China

Tongji Hospital of Tongji University

Shanghai,

China

Shengjing Hospital of China Medical University

Shenyang, 110004

China

The First Hospital of Shanxi Medical University

Taiyuan, 30001

China

Tianjin People's Hospital

Tianjin, 300121

China

Tonghua Central Hospital

Tonghua, 134001

China

The 2nd Affiliated Hospital of Wenzhou Medical University

Wenzhou Avenue, 325038

China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, 430022

China

Renmin Hospital of Wuhan University

Wuhan, 430060

China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, 221006

China

First People's Hospital of Yinchuan

Yinchuan, 750002

China

Aalborg Universitetshospital Medicinerhuset Lungemedicinsk Forskningsenhed

Aalborg,

Denmark

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

Aarhus, 8200

Denmark

Bispebjerg Hospital Department of Respiratory Medicine

Copenhagen,

Denmark

Sjællands Universitets Hospital

Køge,

Denmark

Department otorhinolaryngology - Head and Neck Surgery, Helsinki Univerity Hospital

Helsinki, 00130

Finland

Departmentof Allergy, Skin and Allergy Hospital, Helsinki Univerity Hospital

Helsinki, 00250

Finland

Charite-Universitatsmedizin Berlin

Berlin, 10117

Germany

HNO Zentrum am Kudamm

Berlin, 10629

Germany

Praxis für HNO und Allergologie

Dresden, 01139

Germany

Universitätsklinikum Carl Gustav Carus an der TU Dresden

Dresden, 74, 01307

Germany

IKF Pneumologie

Frankfurt am Main, 60596

Germany

Universitätsklinikum Jena

Jena, 07747

Germany

Universitätsklinikum Schleswig-Holstein

Lübeck, 23538

Germany

HNO Praxis

Sachsen, 01067

Germany

Ujpesti Egeszsegugyi Szolgaltato

Budapest, 1046

Hungary

Komarom-Esztergom Varmegyei Szent Borbala Korhaz

Tatabánya, H-2800

Hungary

AOU Careggi- University of Florence

Florence, 50134

Italy

Ospedale San Raffaele

Milan, 20132

Italy

AOU Federico II Via Pansini

Naples, 80131

Italy

Azienda Ospedaliera Di Padova

Padova, 35128

Italy

Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara

Pisa, 56126

Italy

Fondazione Policlinico A. Gemelli IRCCS

Rome, 800168

Italy

ASST Brianza - Vimercate Hospital

Vimercate, 20871

Italy

Toyota Memorial Hospital

Aichi,

Japan

Clinic Kashiwanoha

Chiba,

Japan

University of Yamanashi Hospital

Chūō, 409-3821

Japan

University of Fukui Hospital

Fukui,

Japan

Saiseikai Fukuoka General Hospital

Fukuoak, 810-0001

Japan

Matsuda Hospital

Fukuoka, 812-0053

Japan

Kyushu University Hospital

Fukuoka, 812-8582

Japan

Osaka Habikino Medical Center

Habikino-shi, 583-8588

Japan

Kansai Medical University Hospital

Hirakata, 573-1191

Japan

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

Hokkaido, 060-0033

Japan

Hyogo Medical University Hospital

Hyōgo, 663-8131

Japan

Takarazuka City Hospital

Hyōgo, 665-0827

Japan

Ibaraki Prefectural Central Hospital

Ibaraki,

Japan

Kagoshima Kouseiren Hospital

Kagoshima, 890-0062

Japan

Yokohama City Minato Red Cross Hospital

Kanagawa, 231-0801

Japan

Odawara Municipal Hospital

Kanagawa, 250-8558

Japan

Tokai University Hospital

Kanagawa, 259-1193

Japan

Kimitsu Chuo Hospital

Kisarazu, 292-8535

Japan

1-8-1, Kishinoura

Kitakyushu, 806-8501

Japan

3-54-2, Kotohirahommachi

Kumamoto, 860-0814

Japan

Kyosai Hospital

Minami-Alps, 400-0405

Japan

Tohoku Medical and Pharmaceutical University Hospital

Miyagi,

Japan

Ritsuzankai Iida Hospital

Nagano, 395-0056

Japan

Asahioka, 1-24

Niigata, 940-8621

Japan

Niigata University Medical & Dental Hospital

Niigata, 951-8520

Japan

Japan Community Health care Organization Osaka Hospital

Osaka, 553-0003

Japan

Kansai Electric Power Hospital

Osaka, 553-0003

Japan

Toho University Sakura Medical Center

Sakura, 285-0841

Japan

8-2 Otemachi

Shizuoka, 420-0853

Japan

Toho University Ohashi Medical Center

Tokyo, 153-8515

Japan

Nihon University Itabashi Hospital

Tokyo, 173-0032

Japan

Mie University Hospital

Tsu, 514-8507

Japan

JCHO Shimonoseki Medical center

Yamaguchi, 750-0061

Japan

Yamaguchi University Hospital

Yamaguchi, 755-8505

Japan

Yokohama Minami Kyosai Hospital

Yokohama, 236-0037

Japan

Avenida Independencia

Aguascalientes, 20116

Mexico

Calle Pascual Orozco #2125 col. Magisterial Universidad

Chihuahua City, CP 31200

Mexico

Calle Penitenciaria

Guadalajara Jalsico, 44100

Mexico

Miguel Hidalgo 2525, Consultorio 2 Urgencias

Nuevo León, 64060

Mexico

Humboldt 302 Col. Centro

Oaxaca City, 68000

Mexico

Niepubliczny Zakład Opieki Zdrowotnej E-Vita

Bialystok, 15-879

Poland

Centrum Medyczne Pratia Katowice

Katowice, 40-081

Poland

Centrum Medyczne Angelius Provita

Katowice, 40-611

Poland

B&R Clinical Sp. z o.o

Kielce, 25-426

Poland

Centrum Medyczne All-Med

Krakow, 30-033

Poland

Centrum Medyczne Promed ul. Olszańska 5G

Krakow, 31-513

Poland

Specjalistyczny Niepubliczny Zakład Opieki Zdrowotnej Alergologia Plus Ośrodek Diagnostyki

Poznan, 60-693

Poland

WIM-PIB

Warsaw,

Poland

Centrum Medyczne Biotamed Morawska Barbara

Wieliczka, 32-020

Poland

EMC INSTYTUT MEDYCZNY S.A. Przychodnia

Wroclaw, 50-220

Poland

Centrum Medyczne Oporów

Wroclaw, 52-416

Poland

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

Almada,

Portugal

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

Aveiro, 3814-501

Portugal

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

Braga, 4710-243

Portugal

Unidade Local de Saúde Loures-Odivelas

Loures,

Portugal

ULS do Algarve, EPE - Hospital de Portimão

Seco Portimao Faro, 8500-338

Portugal

Hospital Pedro Hispano

Senhora da Hora, 4464-513

Portugal

Centrul Medical Unirea SRL

Brasov, 500091

Romania

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

Brasov, 500450

Romania

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

Brasov, 500450

Romania

Delta Health Care S.R.L

Bucharest, 14142

Romania

Delta Health Care S.R.L

Bucharest, 14142

Romania

Cardiomed S.R.L

Cluj-Napoca, 400015

Romania

Centrul de Excelenta in Rinologie S.R.L

Dolj, 200222

Romania

Inje University Haeundae Paik Hospital

Busan, 48108

South Korea

CHA Bundang Medical Center

Gyeonggi-do, 13496

South Korea

Pusan National University Hospital

Pusan, 49241

South Korea

Seoul National University Bundang Hospital

Seongnam-si, 13620

South Korea

Korea University Anam Hospital

Seoul, 02841

South Korea

SNUH - Seoul National University Hospital

Seoul, 03080

South Korea

The Catholic University of Korea

Seoul, 06591

South Korea

Korea University Guro Hospital

Seoul, 08308

South Korea

SMG-SNU Boramae Medical Center

Seoul, 7061

South Korea

Ajou University Hospital

Suwon, 16499

South Korea

Hospital Universitario Virgen de la Macarena Avenida Dr. Fedriani

Andalucia, 41009

Spain

Centro Médico Teknon

Barcelona, 8022

Spain

Hospital Universitario de Jerez

Cadiz, 11407

Spain

Hospital Clínico Universitario de Santiago

Galícia, 15706

Spain

FutureMeds DKF

Madrid, 28002

Spain

Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040

Spain

Clinica Universidad de Navarra

Pamplona, 31008

Spain

Taipei Medical University Shuang Ho Hospital

New Taipei City, 23561

Taiwan

National Taiwan University Hospital

Taipei, 10002

Taiwan

Bristol Royal Infirmary University Hospitals

Bristol, BS2 8HW

United Kingdom

Charing Cross Hospital

Chelsea, W6 8RF

United Kingdom

James Paget University Hospitals NHS Foundation Trust

Great Yarmouth, NR31 6LA

United Kingdom

Royal Berkshire NHS Foundation Trust

London, RG1 5AN

United Kingdom

Guys and St Thomas' NHS Foundation Trust

London, SE1 7EH

United Kingdom

Newcastle upon Tyne Hospitals NHSFT Freeman Hospital

Newcastle upon Tyne, NE7 7DN

United Kingdom

Stepping Hill Hospital

Stockport, SK2 7JE

United Kingdom