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RECRUITING

NCT06338995

PHASE3

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

Sponsor: Eli Lilly and Company

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

510

Start Date

2024-04-29

Completion Date

2028-03

Last Updated

2026-10-07

Healthy Volunteers

Conditions

Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Interventions

DRUG

LY3650150

Administered SC.

DRUG

Placebo

Administered SC.

DRUG

Standard therapy for INCS

Administered as intranasal spray.

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.

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

Policonsultorio CEPIR

Buenos Aires, Argentina

Fundacion Respirar

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

And 102 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (202)