A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel Group Phase 3 Efficacy and Safety Study of Lebrikizumab/ LY3650150 in Adults With Chronic Rhinosinusitis With Nasal Polyps on a Background Therapy With Intranasal Corticosteroids

Status: Recruiting
Location: See all (172) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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:

‣ 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

⁃ 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.

Locations
United States
Alabama
AllerVie Clinical Research
NOT_YET_RECRUITING
Birmingham
University of Alabama at Birmingham
RECRUITING
Birmingham
California
Keck Medicine of USC
NOT_YET_RECRUITING
Arcadia
University of California, Irvine
RECRUITING
Irvine
DaVinci Research LLC
RECRUITING
Roseville
Breathe Clear Institute
NOT_YET_RECRUITING
Torrance
Colorado
Colorado ENT & Allergy
RECRUITING
Colorado Springs
Florida
Orlando ENT & Allergy
NOT_YET_RECRUITING
Orlando
NuLine Clinical Trial Center
NOT_YET_RECRUITING
Pompano Beach
University of South Florida
NOT_YET_RECRUITING
Tampa
Idaho
Treasure Valley Medical Research
RECRUITING
Boise
Illinois
Chicago ENT
RECRUITING
Chicago
Louisiana
South Louisiana Ear, Nose, Throat & Facial Plastic Surgery - PPDS
RECRUITING
Mandeville
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Maryland
Chesapeake Clinical Research, Inc.
NOT_YET_RECRUITING
White Marsh
Missouri
University of Missouri
NOT_YET_RECRUITING
Columbia
Washington University School of Medicine
NOT_YET_RECRUITING
St Louis
New York
Madison ENT & Facial Plastic Surgery
RECRUITING
New York
Equity Medical
NOT_YET_RECRUITING
The Bronx
Ohio
UCMC
NOT_YET_RECRUITING
Cincinnati
Optimed Research, LTD
RECRUITING
Columbus
Pennsylvania
Specialty Physician Associates
NOT_YET_RECRUITING
Bethlehem
South Carolina
Medical University of South Carolina- Department of Otolaryngology and Head and Neck Surgery
NOT_YET_RECRUITING
Charleston
Texas
UT Southwestern Medical Center
NOT_YET_RECRUITING
Dallas
University of Texas Physicians Department of Otorhinolaryngology Clinc
RECRUITING
Houston
Ear Nose and Throat Associates of Texas PA
RECRUITING
Mckinney
Alamo ENT Associates
RECRUITING
San Antonio
Virginia
Eastern Virginia Medical School
NOT_YET_RECRUITING
Norfolk
Richmond Ear Nose and Throat
NOT_YET_RECRUITING
Richmond
Wisconsin
The Medical College of Wisconsin
NOT_YET_RECRUITING
Milwaukee
Other Locations
Argentina
CEMLO - Centro de Especialidades Médicas Lobos
NOT_YET_RECRUITING
Beunos Aires
Centro Platense en Investigaciones Respiratorias - CEPIR
NOT_YET_RECRUITING
Buenos Aires
Fundacion Respirar
NOT_YET_RECRUITING
Buenos Aires
Fundacion CIDEA
NOT_YET_RECRUITING
Caba
Centro de Investigaciones Clínicas - IESR - Rosario
NOT_YET_RECRUITING
Rosario
CIMER-Centro Integral de Medicina Respiratoria
NOT_YET_RECRUITING
San Miguel De Tucumán
Investigaciones en Patologías Respiratorias SRL
NOT_YET_RECRUITING
San Miguel De Tucumán
Centro Respiratorio Infantil
NOT_YET_RECRUITING
Santa Fe
CARE - Centro de Alergia y Enfermedades Respiratorias
NOT_YET_RECRUITING
Villa Crespo
Belgium
Pneumocare
RECRUITING
Erpent
UZ Gent
NOT_YET_RECRUITING
Ghent
Cliniques Universitaires Saint-Luc Avenue Hippocrate 10
NOT_YET_RECRUITING
Woluwe-saint-lambert
Bulgaria
Multiprofile Hospital For Active Treatment Dr Tota Venkova A
RECRUITING
Gabrovo
Medical Center Medconsult Pleven OOD
NOT_YET_RECRUITING
Pleven
Diagnostic-Consultative Centre Ascendent EOOD
RECRUITING
Sofia
Military Medical Academy - Multiprofile Hospital for Active Treatment - Sofia,
NOT_YET_RECRUITING
Sofia
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna
RECRUITING
Sofia
Multiprofile Hospital for Active treatment Trakia EOOD
NOT_YET_RECRUITING
Zagora
Canada
St. Joseph's Hospital
NOT_YET_RECRUITING
Ontario
CSAC
NOT_YET_RECRUITING
Québec
St Paul's Sinus Centre
NOT_YET_RECRUITING
Vancouver
The Gordon and Leslie Diamond Health Care Centre
NOT_YET_RECRUITING
Vancouver
China
Beijing Hospital
NOT_YET_RECRUITING
Beijing
Beijing Tongren Hospital
RECRUITING
Beijing
Peking University Third Hospital
RECRUITING
Beijing
The First Affiliated Hospital of Bengbu Medical College
NOT_YET_RECRUITING
Bengbu
The Third Xiangya Hospital of Central South University
RECRUITING
Changsha
Sichuan Provincial People's Hospital
RECRUITING
Chengdu
The First People's Hospital of Foshan
RECRUITING
Foshan
The First Affiliated Hospital Of Fujian Medical University
RECRUITING
Fuzhou
Shenzhen Second People's Hospital
RECRUITING
Guangdong
Hainan General Hospital
NOT_YET_RECRUITING
Haikou
Hangzhou First People's Hospital
RECRUITING
Hangzhou
Huai'an First People's Hospital
RECRUITING
Huai'an
The First Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
The People's Hospital of Guangxi Zhuang Autonomous Region
RECRUITING
Nanning
Ningbo Medical Center Lihuili Hospital
NOT_YET_RECRUITING
Ningbo
The first Affilliated Hospital Shandong First Medical University
RECRUITING
Shandong
Tongji Hospital of Tongji University
RECRUITING
Shanghai
Shengjing Hospital of China Medical University
RECRUITING
Shenyang
The First Hospital of Shanxi Medical University
RECRUITING
Taiyuan
Tianjin People's Hospital
RECRUITING
Tianjin
Tonghua Central Hospital
NOT_YET_RECRUITING
Tonghua
The 2nd Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou Avenue
Renmin Hospital of Wuhan University
RECRUITING
Wuhan
Union Hospital Tongji Medical College Huazhong University of Science and Technology
RECRUITING
Wuhan
The Affiliated Hospital of Xuzhou Medical University
RECRUITING
Xuzhou
First People's Hospital of Yinchuan
RECRUITING
Yinchuan
Denmark
Aalborg Universitetshospital Medicinerhuset Lungemedicinsk Forskningsenhed
NOT_YET_RECRUITING
Aalborg
Aarhus University Hospital, Dept. of Ear-Nose-Throat
RECRUITING
Aarhus
Bispebjerg Hospital Department of Respiratory Medicine
NOT_YET_RECRUITING
Copenhagen
Sjællands Universitets Hospital
RECRUITING
Køge
Germany
Charite-Universitatsmedizin Berlin
NOT_YET_RECRUITING
Berlin
HNO Zentrum am Kudamm
RECRUITING
Berlin
Praxis für HNO und Allergologie
RECRUITING
Dresden
Universitätsklinikum Carl Gustav Carus an der TU Dresden
RECRUITING
Dresden
IKF Pneumologie
NOT_YET_RECRUITING
Frankfurt Am Main
Universitätsklinikum Jena
NOT_YET_RECRUITING
Jena
Universitätsklinikum Schleswig-Holstein
NOT_YET_RECRUITING
Lübeck
HNO Praxis
RECRUITING
Sachsen
Italy
AOU Careggi- University of Florence
NOT_YET_RECRUITING
Florence
Ospedale San Raffaele
NOT_YET_RECRUITING
Milan
AOU Federico II Via Pansini
RECRUITING
Napoli
Azienda Ospedaliera Di Padova
RECRUITING
Padua
Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara
NOT_YET_RECRUITING
Pisa
Fondazione Policlinico A. Gemelli IRCCS
RECRUITING
Rome
ASST Brianza - Vimercate Hospital
RECRUITING
Vimercate
Japan
Toyota Memorial Hospital
RECRUITING
Aichi
Clinic Kashiwanoha
RECRUITING
Chiba
University of Yamanashi Hospital
RECRUITING
Chūō
University of Fukui Hospital
NOT_YET_RECRUITING
Fukui
Saiseikai Fukuoka General Hospital
NOT_YET_RECRUITING
Fukuoak
Kyushu University Hospital
RECRUITING
Fukuoka
Matsuda Hospital
RECRUITING
Fukuoka
Osaka Habikino Medical Center
RECRUITING
Habikino-shi
Kansai Medical University Hospital
NOT_YET_RECRUITING
Hirakata
Hyogo Medical University Hospital
NOT_YET_RECRUITING
Hyōgo
Takarazuka City Hospital
RECRUITING
Hyōgo
Ibaraki Prefectural Central Hospital
RECRUITING
Ibaraki
Kagoshima Kouseiren Hospital
RECRUITING
Kagoshima
Odawara Municipal Hospital
RECRUITING
Kanagawa
Yokohama City Minato Red Cross Hospital
RECRUITING
Kanagawa
Kimitsu Chuo Hospital
RECRUITING
Kisarazu
1-8-1, Kishinoura
RECRUITING
Kitakyushu
3-54-2, Kotohirahommachi
RECRUITING
Kumamoto
Kyosai Hospital
RECRUITING
Minami-alps
Tohoku Medical and Pharmaceutical University Hospital
RECRUITING
Miyagi
Ritsuzankai Iida Hospital
RECRUITING
Nagano
Asahioka, 1-24
RECRUITING
Niigata
Niigata University Medical & Dental Hospital
RECRUITING
Niigata
Japan Community Health care Organization Osaka Hospital
RECRUITING
Osaka
Kansai Electric Power Hospital
RECRUITING
Osaka
8-2 Otemachi
RECRUITING
Shizuoka
Nihon University Itabashi Hospital
RECRUITING
Tokyo
Toho University Ohashi Medical Center
RECRUITING
Tokyo
Mie University Hospital
RECRUITING
Tsu
JCHO Shimonoseki Medical center
RECRUITING
Yamaguchi
Poland
Niepubliczny Zakład Opieki Zdrowotnej E-Vita
RECRUITING
Bialystok
Centrum Medyczne Angelius Provita
RECRUITING
Katowice
Centrum Medyczne Pratia Katowice
RECRUITING
Katowice
B&R Clinical Sp. z o.o
RECRUITING
Kielce
Centrum Medyczne All-Med
RECRUITING
Krakow
Centrum Medyczne Promed ul. Olszańska 5G
RECRUITING
Krakow
Specjalistyczny Niepubliczny Zakład Opieki Zdrowotnej Alergologia Plus Ośrodek Diagnostyki
RECRUITING
Poznan
WIM-PIB
NOT_YET_RECRUITING
Warsaw
Centrum Medyczne Biotamed Morawska Barbara
RECRUITING
Wieliczka
Centrum Medyczne Oporów
RECRUITING
Wroclaw
EMC INSTYTUT MEDYCZNY S.A. Przychodnia
RECRUITING
Wroclaw
Portugal
Unidade Local de Saúde Loures-Odivelas
NOT_YET_RECRUITING
Loures
Hospital Pedro Hispano
NOT_YET_RECRUITING
Senhora Da Hora
Republic of Korea
Inje University Haeundae Paik Hospital
RECRUITING
Busan
CHA Bundang Medical Center
NOT_YET_RECRUITING
Gyeonggi-do
Pusan National University Hospital
RECRUITING
Pusan
Seoul National University Bundang Hospital
RECRUITING
Seongnam-si
Korea University Anam Hospital
RECRUITING
Seoul
Korea University Guro Hospital
NOT_YET_RECRUITING
Seoul
SMG-SNU Boramae Medical Center
RECRUITING
Seoul
SNUH - Seoul National University Hospital
RECRUITING
Seoul
The Catholic University of Korea
RECRUITING
Seoul
Ajou University Hospital
RECRUITING
Suwon
Romania
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L
RECRUITING
Brasov
Centrul Medical Unirea SRL
RECRUITING
Brasov
Delta Health Care S.R.L
RECRUITING
Bucharest
Delta Health Care S.R.L
RECRUITING
Bucharest
Cardiomed S.R.L
RECRUITING
Cluj-napoca
Centrul de Excelenta in Rinologie S.R.L
RECRUITING
Dolj
Spain
Hospital Universitario Virgen de la Macarena Avenida Dr. Fedriani
RECRUITING
Andalucia
Centro Médico Teknon
RECRUITING
Barcelona
Hospital Universitario de Jerez
RECRUITING
Cadiz
Hospital Clínico Universitario de Santiago
NOT_YET_RECRUITING
Galícia
FutureMeds DKF
RECRUITING
Madrid
Hospital Universitario Fundación Jiménez Díaz
RECRUITING
Madrid
Clinica Universidad de Navarra
NOT_YET_RECRUITING
Pamplona
Taiwan
Taipei Medical University Shuang Ho Hospital
RECRUITING
New Taipei City
National Taiwan University Hospital
RECRUITING
Taipei
United Kingdom
Bristol Royal Infirmary University Hospitals
RECRUITING
Bristol
Charing Cross Hospital
NOT_YET_RECRUITING
Chelsea
James Paget University Hospitals NHS Foundation Trust
RECRUITING
Great Yarmouth
Guys and St Thomas' NHS Foundation Trust
RECRUITING
London
Royal Berkshire NHS Foundation Trust
RECRUITING
London
Newcastle upon Tyne Hospitals NHSFT Freeman Hospital
NOT_YET_RECRUITING
Newcastle Upon Tyne
Stepping Hill Hospital
RECRUITING
Stockport
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2024-04-29
Estimated Completion Date: 2027-02
Participants
Target number of participants: 510
Treatments
Experimental: Lebrikizumab every 2 weeks (Q2W)/ every 4 weeks (Q4W)
Lebrikizumab will be given as Subcutaneous (SC) injection. Participants will receive background therapy with intranasal corticosteroids (INCS).
Experimental: Lebrikizumab Q2W/every 8 weeks (Q8W)
Lebrikizumab will be given as SC injection. Participants will receive background therapy with INCS.
Placebo_comparator: Placebo Q2W/Q4W
Placebo will be given as SC injection. Participants will receive background therapy with INCS.
Sponsors
Leads: Eli Lilly and Company

This content was sourced from clinicaltrials.gov

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