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

June 2, 2026 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

510

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

Study Locations

  • Argentina
      • Beunos Aires, Argentina, B7240KJB
        • Recruiting
        • CEMLO - Centro de Especialidades Médicas Lobos
        • Contact:
          • Phone Number: 54 2227419356
        • Principal Investigator:
          • Dabove Fabian Horacio
      • Buenos Aires, Argentina, C1426BP
        • Recruiting
        • Fundación Respirar
        • Principal Investigator:
          • Maria De Salvo
        • Contact:
          • Phone Number: 541170781548 int 130
      • Buenos Aires, Argentina
        • Recruiting
        • Centro Platense en Investigaciones Respiratorias - CEPIR
        • Principal Investigator:
          • Gabriel Garcia
        • Contact:
          • Phone Number: 2216075432
      • Caba, Argentina, C1121ABE
        • Not yet recruiting
        • Fundacion Cidea
        • Principal Investigator:
          • Jorge Máspero
        • Contact:
          • Phone Number: +54 1149615466 ext 1005
      • Rosario, Argentina, CP 2000
        • Recruiting
        • Centro de Investigaciones Clínicas - IESR - Rosario
        • Contact:
          • Phone Number: 54 9 341 360 2129
        • Principal Investigator:
          • Matias Ardusso
      • San Miguel de Tucumán, Argentina
        • Not yet recruiting
        • CIMER-Centro Integral de Medicina Respiratoria
        • Principal Investigator:
          • María Rojas
        • Contact:
          • Phone Number: 54 3816324041
      • San Miguel de Tucumán, Argentina, CP4000
        • Recruiting
        • Investigaciones en Patologías Respiratorias SRL
        • Principal Investigator:
          • Ana Maria Stok
        • Contact:
          • Phone Number: 54 3815312192
      • Santa Fe, Argentina, 2000
        • Not yet recruiting
        • Centro Respiratorio Infantil
        • Principal Investigator:
          • Gabriel Gattolin
        • Contact:
          • Phone Number: 54 93424736908
      • Villa Crespo, Argentina, C1414AIF
        • Recruiting
        • CARE - Centro de Alergia y Enfermedades Respiratorias
        • Principal Investigator:
          • Melina Verena Heinze
        • Contact:
          • Phone Number: 54 1165430113
  • Belgium
      • Erpent, Belgium, 5101
        • Recruiting
        • Pneumocare
        • Principal Investigator:
          • Jean-Benoît Martinot
        • Contact:
          • Phone Number: +32495823443 +32494384578
      • Ghent, Belgium, 9000
        • Recruiting
        • UZ Gent
        • Principal Investigator:
          • Philippe Gevaert
        • Contact:
          • Phone Number: +32 93322973
      • Woluwe-Saint-Lambert, Belgium, 1200
        • Recruiting
        • Cliniques Universitaires Saint-Luc Avenue Hippocrate 10
        • Principal Investigator:
          • Valerie Hox
        • Contact:
          • Phone Number: +3227643651
  • Bulgaria
      • Gabrovo, Bulgaria, 1431
        • Recruiting
        • Multiprofile Hospital For Active Treatment Dr Tota Venkova A
        • Principal Investigator:
          • Dimitar Dimitrov
        • Contact:
          • Phone Number: +359899619477
      • Pleven, Bulgaria, 5800
        • Recruiting
        • Medical center Medconsult Pleven OOD
        • Contact:
          • Phone Number: +359889897039
        • Principal Investigator:
          • Georgi Nikolov
      • Sofia, Bulgaria, 1431
        • Not yet recruiting
        • Military Medical Academy - Multiprofile Hospital for Active Treatment - Sofia,
        • Contact:
          • Phone Number: +359899157816
        • Principal Investigator:
          • Ventzislav Tzvetkov
      • Sofia, Bulgaria, 1202
        • Recruiting
        • Diagnostic-Consultative Centre Ascendent EOOD
        • Contact:
          • Phone Number: +359 877519494
        • Principal Investigator:
          • Emiliya Yordanova
      • Sofia, Bulgaria, 1527
        • Recruiting
        • University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna
        • Contact:
          • Phone Number: +359888867615
        • Principal Investigator:
          • Yulian Rangachev
      • Zagora, Bulgaria, 1504
        • Not yet recruiting
        • Multiprofile Hospital for Active treatment Trakia EOOD
        • Contact:
          • Phone Number: +359888130652
        • Principal Investigator:
          • Petar Rouev
  • Canada
      • Ontario, Canada, N6A 4V2
        • Recruiting
        • St. Joseph's Hospital
        • Principal Investigator:
          • Leigh Sowerby
        • Contact:
          • Phone Number: 519-933-5483
      • Québec, Canada
        • Recruiting
        • CSAC
        • Principal Investigator:
          • Remi Gagnon
        • Contact:
          • Phone Number: 418-780-0881 x 229
      • Vancouver, Canada, V5Z 1M9
        • Not yet recruiting
        • The Gordon and Leslie Diamond Health Care Centre
        • Contact:
          • Phone Number: 605-875-8296
        • Principal Investigator:
          • Arif Janjua
      • Vancouver, Canada, V6Z 1Y6
        • Not yet recruiting
        • St Paul's Sinus Centre
        • Contact:
          • Phone Number: 604-806-9462
        • Principal Investigator:
          • Amin Javer
  • China
      • Beijing, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • Principal Investigator:
          • Yan Yan
        • Contact:
          • Phone Number: 15611963579/82265531
      • Beijing, China, 100730
        • Recruiting
        • Beijing Tongren Hospital
        • Principal Investigator:
          • Chengshuo Wang
        • Contact:
          • Phone Number: 13269208812
      • Beijing, China, 100730
        • Not yet recruiting
        • Beijing Hospital
        • Principal Investigator:
          • yi yang
        • Contact:
          • Phone Number: 15001384090
      • Bengbu, China, 233004
        • Not yet recruiting
        • The First Affiliated Hospital of Bengbu Medical College
        • Contact:
          • Phone Number: 13855282539
        • Principal Investigator:
          • Yuefeng Han
      • Changsha, China, 410013
        • Recruiting
        • The Third Xiangya Hospital of Central South University
        • Principal Investigator:
          • Guolin Tan
        • Contact:
          • Phone Number: 0731-88618931/15974183357
      • Chengdu, China, 610072
        • Recruiting
        • Sichuan Provincial People's Hospital
        • Contact:
          • Phone Number: 028-87776073/18228061516
        • Principal Investigator:
          • Jiangang Fan
      • Foshan, China, 528000
        • Recruiting
        • The First People's Hospital of Foshan
        • Principal Investigator:
          • Qingqing Yu
        • Contact:
          • Phone Number: 18038865188
      • Fuzhou, China, 350000
        • Recruiting
        • The First Affiliated Hospital of Fujian Medical University
        • Principal Investigator:
          • chang Lin
        • Contact:
          • Phone Number: 13799400365
      • Guangdong, China
        • Recruiting
        • Shenzhen Second People's Hospital
        • Principal Investigator:
          • Yongtian Lu
        • Contact:
          • Phone Number: 18680309468
      • Haikou, China, 570311
        • Not yet recruiting
        • Hainan General Hospital
        • Principal Investigator:
          • Xin Wei
        • Contact:
          • Phone Number: 13807688943
      • Hangzhou, China
        • Recruiting
        • Hangzhou First People's Hospital
        • Principal Investigator:
          • Yong Li
        • Contact:
          • Phone Number: 15967138168/0571-56007501
      • Huai'an, China, 223300
        • Recruiting
        • Huai'an First People's Hospital
        • Principal Investigator:
          • Xin Jin
        • Contact:
          • Phone Number: 15252382626
      • Nanchang, China, 330006
        • Recruiting
        • The First Affiliated Hospital of NanChang University
        • Principal Investigator:
          • Jing Ye
        • Contact:
          • Phone Number: +8613407913590
      • Nanning, China, 530021
        • Recruiting
        • The People's Hospital of Guangxi Zhuang Autonomous Region
        • Principal Investigator:
          • Shenhong Qu
        • Contact:
          • Phone Number: 18776882290
      • Ningbo, China
        • Not yet recruiting
        • Ningbo medical center lihuili hospital
        • Contact:
          • Phone Number: 15058001932
        • Principal Investigator:
          • Zhisen Shen
      • Shandong, China, 250014
        • Recruiting
        • The first Affilliated Hospital Shandong First Medical University
        • Contact:
          • Phone Number: 13685411586
        • Principal Investigator:
          • Fei Han
      • Shanghai, China
        • Recruiting
        • Tongji Hospital of Tongji University
        • Principal Investigator:
          • Shaoqing Yu
        • Contact:
          • Phone Number: 661121219
      • Shenyang, China, 110004
        • Recruiting
        • Shengjing Hospital Of China Medical University
        • Contact:
          • Phone Number: 18940254987/18940254497
        • Principal Investigator:
          • Zhiwei Cao
      • Taiyuan, China, 30001
        • Recruiting
        • The First Hospital of Shanxi Medical University
        • Principal Investigator:
          • Qinna Zhang
        • Contact:
          • Phone Number: 13834132096
      • Tianjin, China, 300121
        • Recruiting
        • Tianjin People's Hospital
        • Contact:
          • Phone Number: 13820004151
        • Principal Investigator:
          • Xiangli Yang
      • Tonghua, China, 134001
        • Not yet recruiting
        • Tonghua Central Hospital
        • Principal Investigator:
          • Yaowu Dong
        • Contact:
          • Phone Number: 13180668096
      • Wenzhou Avenue, China, 325038
        • Recruiting
        • The 2nd Affiliated Hospital of Wenzhou Medical University
        • Principal Investigator:
          • Liyan Ni
        • Contact:
          • Phone Number: 15868710383
      • Wuhan, China, 430022
        • Recruiting
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
        • Principal Investigator:
          • Jianjun Chen
        • Contact:
          • Phone Number: 18971294483/19971138040
      • Wuhan, China, 430060
        • Recruiting
        • Renmin Hospital of Wuhan University
        • Principal Investigator:
          • Yu Xu
        • Contact:
          • Phone Number: 18171485631
      • Xuzhou, China, 221006
        • Recruiting
        • The Affiliated Hospital of Xuzhou Medical University
        • Principal Investigator:
          • Wen Liu
        • Contact:
          • Phone Number: 15105212626
      • Yinchuan, China, 750002
        • Recruiting
        • First People's Hospital of Yinchuan
        • Principal Investigator:
          • Ruixia Ma
        • Contact:
          • Phone Number: 13895671107
  • Denmark
      • Aalborg, Denmark
        • Recruiting
        • Aalborg Universitetshospital Medicinerhuset Lungemedicinsk Forskningsenhed
        • Contact:
          • Phone Number: +45 9766 0672
        • Principal Investigator:
          • Ulla Møller Weinreich
      • Aarhus, Denmark, 8200
        • Recruiting
        • Aarhus University Hospital, Dept. of Ear-Nose-Throat
        • Principal Investigator:
          • Tejs Ehlers Klug
        • Contact:
          • Phone Number: +4561389346
      • Copenhagen, Denmark
        • Not yet recruiting
        • Bispebjerg Hospital Department of Respiratory Medicine
        • Contact:
          • Phone Number: +4530914739
        • Principal Investigator:
          • Asger Sverrild
      • Køge, Denmark
        • Recruiting
        • Sjællands Universitets Hospital
        • Contact:
          • Phone Number: +45 47 32 96 52
        • Principal Investigator:
          • Preben Homøe
  • Finland
      • Helsinki, Finland, 00130
        • Not yet recruiting
        • Department otorhinolaryngology - Head and Neck Surgery, Helsinki Univerity Hospital
        • Principal Investigator:
          • Marie Lundberg
        • Contact:
          • Phone Number: +358947176610
      • Helsinki, Finland, 00250
        • Not yet recruiting
        • Departmentof Allergy, Skin and Allergy Hospital, Helsinki Univerity Hospital
        • Principal Investigator:
          • Annina Lyly
        • Contact:
          • Phone Number: +358947176610
  • Germany
      • Berlin, Germany, 10117
        • Recruiting
        • Charite-Universitatsmedizin Berlin
        • Contact:
          • Phone Number: +4930450655227
        • Principal Investigator:
          • Heidi Olze
      • Berlin, Germany, 10629
        • Recruiting
        • HNO Zentrum am Kudamm
        • Contact:
          • Phone Number: 030 88774203
        • Principal Investigator:
          • Önder Göktas
      • Dresden, Germany, 01139
        • Recruiting
        • Praxis für HNO und Allergologie
        • Principal Investigator:
          • Yury Yarin
        • Contact:
          • Phone Number: +491743195510
      • Dresden, Germany, 74, 01307
        • Recruiting
        • Universitätsklinikum Carl Gustav Carus an der TU Dresden
        • Contact:
          • Phone Number: +4935145813506
        • Principal Investigator:
          • Philipp Nahrath
      • Frankfurt am Main, Germany, 60596
        • Recruiting
        • IKF Pneumologie
        • Principal Investigator:
          • Marc Kornmann
        • Contact:
          • Phone Number: +4969695972580
      • Jena, Germany, 07747
        • Not yet recruiting
        • Universitatsklinikum Jena
        • Principal Investigator:
          • Orlando Guntinas-Lichius
        • Contact:
          • Phone Number: +49 36 419 32 54 01
      • Lübeck, Germany, 23538
        • Not yet recruiting
        • Universitätsklinikum Schleswig-Holstein
        • Principal Investigator:
          • Anke Leichtle
        • Contact:
          • Phone Number: +49 451 500 42001
      • Sachsen, Germany, 01067
        • Recruiting
        • HNO Praxis
        • Contact:
          • Phone Number: 0351 320 10 160
        • Principal Investigator:
          • Udo Schäfer
  • Hungary
      • Budapest, Hungary, 1046
        • Recruiting
        • Ujpesti Egeszsegugyi Szolgaltato
        • Contact:
          • Phone Number: 36703810940
        • Principal Investigator:
          • Attila Laszlo Velich
      • Tatabánya, Hungary, H-2800
        • Recruiting
        • Komarom-Esztergom Varmegyei Szent Borbala Korhaz
        • Contact:
          • Phone Number: 3664515526
        • Principal Investigator:
          • Irma Lehocz
  • Italy
      • Florence, Italy, 50134
        • Recruiting
        • AOU Careggi- University of Florence
        • Principal Investigator:
          • Alessandra Vultaggio
        • Contact:
          • Phone Number: 0557949450
      • Milan, Italy, 20132
        • Not yet recruiting
        • Ospedale San Raffaele
        • Contact:
          • Phone Number: +390226435075
        • Principal Investigator:
          • Giulia Danè
      • Naples, Italy, 80131
        • Recruiting
        • AOU Federico II Via Pansini
        • Contact:
          • Phone Number: +90817462596
        • Principal Investigator:
          • Aikaterini Detoraki
      • Padova, Italy, 35128
        • Recruiting
        • Azienda Ospedaliera di Padova
        • Principal Investigator:
          • Giancarlo Ottaviano
        • Contact:
          • Phone Number: +39 0498212343
      • Pisa, Italy, 56126
        • Recruiting
        • Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara
        • Principal Investigator:
          • Veronica Seccia
      • Rome, Italy, 800168
        • Recruiting
        • Fondazione Policlinico A. Gemelli IRCCS
        • Contact:
          • Phone Number: +39 06 30156022
        • Principal Investigator:
          • Galli Jacopo
      • Vimercate, Italy, 20871
        • Recruiting
        • ASST Brianza - Vimercate Hospital
        • Contact:
          • Phone Number: +39 0396654635
        • Principal Investigator:
          • Federico Quarta
  • Japan
      • Aichi, Japan
        • Recruiting
        • Toyota Memorial Hospital
        • Principal Investigator:
          • Toshiaki Furuta
        • Contact:
          • Phone Number: 81120023812
      • Chiba, Japan
        • Recruiting
        • Clinic Kashiwanoha
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Yasuko Murakawa
      • Chūō, Japan, 409-3821
        • Recruiting
        • University of Yamanashi Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Daiju Sakurai
      • Fukui, Japan
        • Recruiting
        • University of Fukui Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Tetsuji Takabayashi
      • Fukuoak, Japan, 810-0001
        • Recruiting
        • Saiseikai Fukuoka General Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Tetsuya Koyama
      • Fukuoka, Japan, 812-8582
        • Recruiting
        • Kyushu University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Ryota Higuchi
      • Fukuoka, Japan, 812-0053
        • Recruiting
        • Matsuda Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Yoshiki Esaki
      • Habikino-shi, Japan, 583-8588
        • Recruiting
        • Osaka Habikino Medical Center
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Kayoko Kawashima
      • Hirakata, Japan, 573-1191
        • Recruiting
        • Kansai Medical University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Yoshiki Kobayashi
      • Hokkaido, Japan, 060-0033
        • Recruiting
        • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Hiroaki Netsu
      • Hyōgo, Japan, 665-0827
        • Recruiting
        • Takarazuka City Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Takenori Haruna
      • Hyōgo, Japan, 663-8131
        • Recruiting
        • Hyogo Medical University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Kenzo Tsuzuki
      • Ibaraki, Japan
        • Recruiting
        • Ibaraki Prefectural Central Hospital
        • Principal Investigator:
          • Bungo Nishimura
        • Contact:
          • Phone Number: 81120023812
      • Kagoshima, Japan, 890-0062
        • Recruiting
        • Kagoshima Kouseiren Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Takao Makise
      • Kanagawa, Japan, 259-1193
        • Recruiting
        • Tokai University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Koichiro Wasano
      • Kanagawa, Japan, 250-8558
        • Recruiting
        • Odawara Municipal Hospital
        • Principal Investigator:
          • Masako Terasaki
        • Contact:
          • Phone Number: 81120023812
      • Kanagawa, Japan, 231-0801
        • Recruiting
        • Yokohama City Minato Red Cross Hospital
        • Principal Investigator:
          • Takahide Taguchi
        • Contact:
          • Phone Number: 81120023812
      • Kisarazu, Japan, 292-8535
        • Recruiting
        • Kimitsu Chuo Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Naoki Takahashi
      • Kitakyushu, Japan, 806-8501
        • Recruiting
        • 1-8-1, Kishinoura
        • Principal Investigator:
          • Koji Koike
        • Contact:
          • Phone Number: 81120023812
      • Kumamoto, Japan, 860-0814
        • Recruiting
        • 3-54-2, Kotohirahommachi
        • Principal Investigator:
          • Masayuki Karaki
        • Contact:
          • Phone Number: 81120023812
      • Minami-Alps, Japan, 400-0405
        • Recruiting
        • Kyosai Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Tomonori Endo
      • Miyagi, Japan
        • Recruiting
        • Tohoku Medical And Pharmaceutical University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Nobuo Ohta
      • Nagano, Japan, 395-0056
        • Recruiting
        • Ritsuzankai Iida Hospital
        • Principal Investigator:
          • Shigetoshi Horiguchi
        • Contact:
          • Phone Number: 81120023812
      • Niigata, Japan, 951-8520
        • Recruiting
        • Niigata University Medical & Dental Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Wakasugi Ryo
      • Niigata, Japan, 940-8621
        • Recruiting
        • Asahioka, 1-24
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Hisashi Kamada
      • Osaka, Japan, 553-0003
        • Recruiting
        • Japan Community Health Care Organization Osaka Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Yohei Maeda
      • Osaka, Japan, 553-0003
        • Recruiting
        • Kansai Electric Power Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Akihiko Fujita
      • Sakura, Japan, 285-0841
        • Recruiting
        • Toho University Sakura Medical Center
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Munetaka Ushio
      • Shizuoka, Japan, 420-0853
        • Recruiting
        • 8-2 Otemachi
        • Principal Investigator:
          • Taiji Kawasaki
        • Contact:
          • Phone Number: 81120023812
      • Tokyo, Japan, 153-8515
        • Recruiting
        • Toho University Ohashi Medical Center
        • Principal Investigator:
          • Mamoru Yoshikawa
        • Contact:
          • Phone Number: 81120023812
      • Tokyo, Japan, 173-0032
        • Recruiting
        • Nihon University Itabashi Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Kikuta Shu
      • Tsu, Japan, 514-8507
        • Recruiting
        • Mie University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Ishigami Eisuke
      • Yamaguchi, Japan, 755-8505
        • Recruiting
        • Yamaguchi University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Kazuma Sugahara
      • Yamaguchi, Japan, 750-0061
        • Recruiting
        • JCHO Shimonoseki Medical center
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Kuniyoshi Tanaka
      • Yokohama, Japan, 236-0037
        • Recruiting
        • Yokohama Minami Kyosai Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Ryo Ikoma
  • Mexico
      • Aguascalientes, Mexico, 20116
        • Not yet recruiting
        • Avenida Independencia
        • Contact:
          • Phone Number: (+52) 449-994-9458
        • Principal Investigator:
          • Erika Nayeli Duron Lopez
      • Chihuahua City, Mexico, CP 31200
        • Not yet recruiting
        • Calle Pascual Orozco #2125 col. Magisterial Universidad
        • Contact:
          • Phone Number: 526142850691/ 526395010490
        • Principal Investigator:
          • Jesus Antonio Lujan Reyes
      • Guadalajara Jalsico, Mexico, 44100
        • Not yet recruiting
        • Calle Penitenciaria
        • Contact:
          • Phone Number: 523338259344 +523338256493
        • Principal Investigator:
          • Ana Guadalupe
      • Nuevo León, Mexico, 64060
        • Not yet recruiting
        • Miguel Hidalgo 2525, Consultorio 2 Urgencias
        • Contact:
          • Phone Number: +52 811 517 2010
        • Principal Investigator:
          • Victor Samuel Zuñiga Marquez
      • Oaxaca City, Mexico, 68000
        • Not yet recruiting
        • Humboldt 302 Col. Centro
        • Contact:
          • Phone Number: +52 951 514 7056
        • Principal Investigator:
          • Lorenzo Tobias Avendaño Santiago
  • Poland
      • Bialystok, Poland, 15-879
        • Recruiting
        • Niepubliczny Zakład Opieki Zdrowotnej E-Vita
        • Contact:
          • Phone Number: 881225023
        • Principal Investigator:
          • Ewa Michnowska-Tryburska
      • Katowice, Poland, 40-611
        • Recruiting
        • Centrum Medyczne Angelius Provita
        • Principal Investigator:
          • Tomasz Grzegorzek
        • Contact:
          • Phone Number: +48 721-210-110
      • Katowice, Poland, 40-081
        • Recruiting
        • Centrum Medyczne Pratia Katowice
        • Contact:
          • Phone Number: +48 516 339 109
        • Principal Investigator:
          • Santa Vanaga-Besser
      • Kielce, Poland, 25-426
        • Recruiting
        • B&R Clinical Sp. z o.o
        • Contact:
          • Phone Number: +48 695822532
        • Principal Investigator:
          • Marcin Zawadzki
      • Krakow, Poland, 30-033
        • Recruiting
        • Centrum Medyczne ALL-MED
        • Principal Investigator:
          • Grazyna Pulka
        • Contact:
          • Phone Number: 608 623 715
      • Krakow, Poland, 31-513
        • Recruiting
        • Centrum Medyczne Promed ul. Olszańska 5G
        • Principal Investigator:
          • Piotr Lach
        • Contact:
          • Phone Number: 602460190
      • Poznan, Poland, 60-693
        • Recruiting
        • Specjalistyczny Niepubliczny Zakład Opieki Zdrowotnej Alergologia Plus Ośrodek Diagnostyki
        • Contact:
          • Phone Number: +48 61 656 21 65
        • Principal Investigator:
          • Michal Springer
      • Warsaw, Poland
        • Recruiting
        • WIM-PIB
        • Contact:
          • Phone Number: +48261816279; +48261817019
        • Principal Investigator:
          • Dariusz Jurkiewicz
      • Wieliczka, Poland, 32-020
        • Recruiting
        • Centrum Medyczne Biotamed Morawska Barbara
        • Contact:
          • Phone Number: +48 606 242 877
        • Principal Investigator:
          • Piotr Morawski
      • Wroclaw, Poland, 52-416
        • Recruiting
        • Centrum Medyczne Oporow
        • Contact:
          • Phone Number: +48 71 712 70 77
        • Principal Investigator:
          • Yogen Abelak
      • Wroclaw, Poland, 50-220
        • Recruiting
        • EMC INSTYTUT MEDYCZNY S.A. Przychodnia
        • Contact:
          • Phone Number: +48 698 659 313
        • Principal Investigator:
          • Marita Nittner-Marszalska
  • Portugal
      • Almada, Portugal
        • Not yet recruiting
        • Unidade Local de Saúde de Almada-Seixal, E.P.E.
        • Contact:
          • Phone Number: +351 212 727 246
        • Principal Investigator:
          • Luis Antunes
      • Aveiro, Portugal, 3814-501
        • Recruiting
        • ULS da Região de Aveiro, EPE - Hospital Infante D. Pedro
        • Contact:
          • Phone Number: (+351)911547254 or 93134164
        • Principal Investigator:
          • Maria Luisa Azevedo
      • Braga, Portugal, 4710-243
        • Not yet recruiting
        • Centro Clínico Académico - Braga (2CA-Braga) (Hospital de Braga)
        • Principal Investigator:
          • Daniel Miranda
        • Contact:
          • Phone Number: +351925822071/+351912490649
      • Loures, Portugal
        • Recruiting
        • Unidade Local de Saúde Loures-Odivelas
        • Contact:
          • Phone Number: +351 219847259
        • Principal Investigator:
          • Luis Rodrigues
      • Seco Portimao Faro, Portugal, 8500-338
        • Recruiting
        • ULS do Algarve, EPE - Hospital de Portimão
        • Principal Investigator:
          • Natacha Santos
        • Contact:
          • Phone Number: +351 961 900 354
      • Senhora da Hora, Portugal, 4464-513
        • Recruiting
        • Hospital Pedro Hispano
        • Contact:
          • Phone Number: +351 917 316 904
        • Principal Investigator:
          • Miguel Viana
  • Romania
      • Brasov, Romania, 500091
        • Recruiting
        • Centrul Medical Unirea SRL
        • Principal Investigator:
          • Catalin Stefan
        • Contact:
          • Phone Number: 754049720
      • Brasov, Romania, 500450
        • Recruiting
        • Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L
        • Principal Investigator:
          • Valeriu Bronescu
        • Contact:
          • Phone Number: +40722872726
      • Bucharest, Romania, 14142
        • Recruiting
        • Delta Health Care S.R.L
        • Contact:
          • Phone Number: 0722.103.328
        • Principal Investigator:
          • Sorina Dindere
      • Cluj-Napoca, Romania, 400015
        • Recruiting
        • Cardiomed S.R.L
        • Contact:
          • Phone Number: +40745151216
        • Principal Investigator:
          • Gheorghe Doinel Radeanu
      • Dolj, Romania, 200222
        • Recruiting
        • Centrul de Excelenta in Rinologie S.R.L
        • Contact:
          • Phone Number: +40 766 409 438
        • Principal Investigator:
          • Mihaela-Roxana Mitroi
  • South Korea
      • Busan, South Korea, 48108
        • Recruiting
        • Inje University Haeundae Paik Hospital
        • Contact:
          • Phone Number: 82-51-797-0064
        • Principal Investigator:
          • Yong Wan Kim
      • Gyeonggi-do, South Korea, 13496
        • Recruiting
        • CHA Bundang Medical Center
        • Contact:
          • Phone Number: 82-31-780-3447
        • Principal Investigator:
          • Jae Cheul Ahn
      • Pusan, South Korea, 49241
        • Recruiting
        • Pusan National University Hospital
        • Contact:
          • Phone Number: 82-51-240-7079
        • Principal Investigator:
          • Kyu Sup Cho
      • Seongnam-si, South Korea, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
          • Phone Number: +82-31-787-8763
        • Principal Investigator:
          • JEONG WHUN KIM
      • Seoul, South Korea, 02841
        • Recruiting
        • Korea University Anam Hospital
        • Contact:
          • Phone Number: 82-2-920-5362
        • Principal Investigator:
          • Tae Hoon Kim
      • Seoul, South Korea, 08308
        • Not yet recruiting
        • Korea University Guro Hospital
        • Contact:
          • Phone Number: 82-2-2626-1624
        • Principal Investigator:
          • Heung-Man Lee
      • Seoul, South Korea, 03080
        • Recruiting
        • SNUH - Seoul National University Hospital
        • Contact:
          • Phone Number: 82 2 2072 1688
        • Principal Investigator:
          • Dong-Young Kim
      • Seoul, South Korea, 06591
        • Recruiting
        • The Catholic University of Korea
        • Principal Investigator:
          • Soo-Whan Kim
        • Contact:
          • Phone Number: 82-2-2258-2540
      • Seoul, South Korea, 7061
        • Recruiting
        • SMG-SNU Boramae Medical Center
        • Principal Investigator:
          • Dae Woo Kim
        • Contact:
          • Phone Number: +8228703928
      • Suwon, South Korea, 16499
        • Recruiting
        • Ajou University Hospital
        • Principal Investigator:
          • Hyun-Jun Kim
        • Contact:
          • Phone Number: 82-31-219-4252
  • Spain
      • Andalucia, Spain, 41009
        • Recruiting
        • Hospital Universitario Virgen de la Macarena Avenida Dr. Fedriani
        • Principal Investigator:
          • Serafin Sanchez Gomez
        • Contact:
          • Phone Number: +34 676366754
      • Barcelona, Spain, 8022
        • Recruiting
        • Centro Médico Teknon
        • Principal Investigator:
          • Isam Alobid
        • Contact:
          • Phone Number: +34 932906239
      • Cadiz, Spain, 11407
        • Recruiting
        • Hospital Universitario de Jerez
        • Principal Investigator:
          • Alfonso Del Cuvillo Bernal
        • Contact:
          • Phone Number: (+34) 956032505
      • Galícia, Spain, 15706
        • Not yet recruiting
        • Hospital Clínico Universitario de Santiago
        • Contact:
          • Phone Number: +34 981950915
        • Principal Investigator:
          • Gabriel Martinez Capoccioni
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Universitario Fundacion Jimenez Díaz
        • Principal Investigator:
          • Jose Villacampa Auba
        • Contact:
          • Phone Number: +34915504800 Ext 2374
      • Madrid, Spain, 28002
        • Recruiting
        • FutureMeds DKF
        • Contact:
          • Phone Number: +34621151370
        • Principal Investigator:
          • Paula Cabrera Freitag
      • Pamplona, Spain, 31008
        • Recruiting
        • Clinica Universidad de Navarra
        • Principal Investigator:
          • Gastaminza Gabriel
        • Contact:
          • Phone Number: +34948255400EXT4125
  • Taiwan
      • New Taipei City, Taiwan, 23561
        • Recruiting
        • Taipei Medical University Shuang Ho Hospital
        • Contact:
          • Phone Number: +886-2-22490088 ext:1164
        • Principal Investigator:
          • Cheng-Jung Wu
      • Taipei, Taiwan, 10002
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
          • Phone Number: +886972652505
        • Principal Investigator:
          • Yi-Tsen Lin
  • United Kingdom
      • Bristol, United Kingdom, BS2 8HW
        • Recruiting
        • Bristol Royal Infirmary University Hospitals
        • Contact:
          • Phone Number: 0117 3424175
        • Principal Investigator:
          • Warren Bennett
      • Chelsea, United Kingdom, W6 8RF
        • Recruiting
        • Charing Cross Hospital
        • Principal Investigator:
          • Catherina Rennie
        • Contact:
          • Phone Number: +44(0)2033134333
      • Great Yarmouth, United Kingdom, NR31 6LA
        • Recruiting
        • James Paget University Hospitals NHS Foundation Trust
        • Principal Investigator:
          • Carl Philpott
        • Contact:
          • Phone Number: 01493 453273
      • London, United Kingdom, SE1 7EH
        • Recruiting
        • Guys and St Thomas' NHS Foundation Trust
        • Contact:
          • Phone Number: +44 (0)2071888315
        • Principal Investigator:
          • Claire Hopkins
      • London, United Kingdom, RG1 5AN
        • Recruiting
        • Royal Berkshire NHS Foundation Trust
        • Contact:
          • Phone Number: 0118 3226996
        • Principal Investigator:
          • Robert Almeyda
      • Newcastle upon Tyne, United Kingdom, NE7 7DN
        • Recruiting
        • Newcastle upon Tyne Hospitals NHSFT Freeman Hospital
        • Contact:
          • Phone Number: +44 (0)191 2137181 Ext: 37181
        • Principal Investigator:
          • Isma Iqbal
      • Stockport, United Kingdom, SK2 7JE
        • Recruiting
        • Stepping Hill Hospital
        • Principal Investigator:
          • Milan Rudic
        • Contact:
          • Phone Number: 0161 419 5818 or 548
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University of Alabama at Birmingham
        • Principal Investigator:
          • Do Yeon Cho
        • Contact:
          • Phone Number: 205-934-7191
      • Birmingham, Alabama, United States, 35209
        • Not yet recruiting
        • Allervie Clinical Research
        • Principal Investigator:
          • Weily Soong
    • California
      • Arcadia, California, United States, 91007
        • Not yet recruiting
        • Keck Medicine of USC
        • Principal Investigator:
          • Kevin Hur
      • Irvine, California, United States, 92697
        • Recruiting
        • University of California, Irvine
        • Principal Investigator:
          • Naveen Bhandarkar
      • Roseville, California, United States, 95661
        • Recruiting
        • DaVinci Research LLC
        • Principal Investigator:
          • Randall Ow
        • Contact:
          • Phone Number: 916-374-6730
      • Torrance, California, United States, 90503
        • Recruiting
        • Breathe Clear Institute
        • Principal Investigator:
          • Steven Davis
        • Contact:
          • Phone Number: 310-372-0700
    • Colorado
      • Colorado Springs, Colorado, United States, 80923
        • Recruiting
        • Colorado ENT & Allergy
        • Principal Investigator:
          • Bryan Davis
        • Contact:
          • Phone Number: 719-867-7804
    • Florida
      • Orlando, Florida, United States, 32825
        • Not yet recruiting
        • Orlando ENT & Allergy
        • Principal Investigator:
          • Cecelia Damask
      • Pompano Beach, Florida, United States, 33060
        • Not yet recruiting
        • NuLine Clinical Trial Center
        • Contact:
          • Phone Number: 954-280-7701
        • Principal Investigator:
          • Jacqueline DeNobriga
      • Tampa, Florida, United States, 33613
        • Recruiting
        • University of South Florida
        • Principal Investigator:
          • Seong Cho
        • Contact:
          • Phone Number: 813-631-4024
    • Idaho
      • Boise, Idaho, United States, 83706
        • Recruiting
        • Treasure Valley Medical Research
        • Principal Investigator:
          • Neetu Talreja
        • Contact:
          • Phone Number: 208-813-6505
    • Illinois
      • Chicago, Illinois, United States, 60657
        • Recruiting
        • Chicago ENT
        • Contact:
          • Phone Number: 773-289-1823
        • Principal Investigator:
          • Kirk Shepard
      • Chicago, Illinois, United States, 60616
        • Recruiting
        • Entopy Research LLC
        • Contact:
          • Phone Number: 312-399-9337
        • Principal Investigator:
          • Pravin Muniyappa
    • Louisiana
      • Mandeville, Louisiana, United States, 70471
        • Recruiting
        • South Louisiana Ear, Nose, Throat & Facial Plastic Surgery - PPDS
        • Principal Investigator:
          • James Connolly
    • Maryland
      • White Marsh, Maryland, United States, 21162
        • Recruiting
        • Chesapeake Clinical Research, Inc.
        • Contact:
          • Phone Number: 410-931-1966 extension 103
        • Principal Investigator:
          • Sudhir Sekhsaria
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Brigham and Women's Hospital
        • Principal Investigator:
          • Stella Lee
        • Contact:
          • Phone Number: 617-732-6410
    • Missouri
      • Columbia, Missouri, United States, 65212
        • Recruiting
        • University of Missouri
        • Principal Investigator:
          • Christine Franzese
        • Contact:
          • Phone Number: 573-882-7150
      • St Louis, Missouri, United States, 63141
        • Not yet recruiting
        • Washington University School of Medicine
        • Contact:
          • Phone Number: 314-996-0186
        • Principal Investigator:
          • H James Wedner
    • New Jersey
      • Hamilton, New Jersey, United States, 08619
        • Not yet recruiting
        • Circuit Clinical/Mercer Allergy and Pulmonary Associates
        • Principal Investigator:
          • Peter Ricketti
        • Contact:
          • Phone Number: 201-725-9407
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • Madison ENT & Facial Plastic Surgery
        • Contact:
          • Phone Number: 551-655-4979
        • Principal Investigator:
          • Stacey Silvers
      • New York, New York, United States, 10016
        • Recruiting
        • New York Allergy and Sinus Center
        • Contact:
          • Phone Number: 212-686-6321
        • Principal Investigator:
          • Robert Lin
      • The Bronx, New York, United States, 10455
        • Recruiting
        • Equity Medical
        • Contact:
          • Phone Number: 332-264-0155
        • Principal Investigator:
          • Alissa McInerney
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Not yet recruiting
        • UCMC
        • Principal Investigator:
          • Ahmad Sedaghat
      • Columbus, Ohio, United States, 43235
        • Recruiting
        • Optimed Research, LTD
        • Principal Investigator:
          • Donald McNeil
        • Contact:
          • Phone Number: 614-430-3030
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Not yet recruiting
        • Medical University of South Carolina- Department of Otolaryngology and Head and Neck Surgery
        • Contact:
          • Phone Number: 843-792-1356
        • Principal Investigator:
          • Rodney Schlosser
    • Texas
      • Dallas, Texas, United States, 75390-9035
        • Not yet recruiting
        • UT Southwestern Medical Center
        • Contact:
          • Phone Number: 214-633-4608
        • Principal Investigator:
          • Sei Chung
      • Dallas, Texas, United States, 75209
        • Recruiting
        • Alina Clinical Trials
        • Principal Investigator:
          • Barbara Baxter
        • Contact:
          • Phone Number: 214-363-1411
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas Physicians Department of Otorhinolaryngology Clinc
        • Contact:
          • Phone Number: 713-704-4137
        • Principal Investigator:
          • Amber Luong
      • McKinney, Texas, United States, 75070-5735
        • Recruiting
        • Ear Nose and Throat Associates of Texas PA
        • Principal Investigator:
          • Dale Ehmer, Jr.
      • San Antonio, Texas, United States, 78258-3227
        • Recruiting
        • Alamo ENT Associates
        • Contact:
          • Phone Number: 210-545-0404
        • Principal Investigator:
          • Jeffrey Rosenbloom
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • Eastern Virginia Medical School
        • Contact:
          • Phone Number: 757-388-6238
        • Principal Investigator:
          • Kent Lam
      • Richmond, Virginia, United States, 23235
        • Not yet recruiting
        • Richmond Ear Nose and Throat
        • Principal Investigator:
          • Michael Armstrong
        • Contact:
          • Phone Number: 804-622-3768
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226-3548
        • Recruiting
        • The Medical College of Wisconsin
        • Principal Investigator:
          • David Poetker
        • Contact:
          • Phone Number: 414-805-3145,414-314-0430

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lebrikizumab Q2W/every 8 weeks (Q8W)
Lebrikizumab will be given as SC injection. Participants will receive background therapy with INCS.
Drug: LY3650150
Administered SC.
Drug: Standard therapy for INCS
Administered as intranasal spray.
Placebo Comparator: Placebo Q2W/Q4W
Placebo will be given as SC injection. Participants will receive background therapy with INCS.
Drug: Placebo
Administered SC.
Drug: Standard therapy for INCS
Administered as intranasal spray.
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).

Note: Enrollment of adolescents will be open-label, with all adolescents assigned to the lebrikizumab Q2W/Q4W treatment arm.
Drug: LY3650150
Administered SC.
Drug: Standard therapy for INCS
Administered as intranasal spray.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline (CFBL) in Participant Reported Nasal Congestion Score (NCS) Severity
Time Frame: Baseline, Week 24
NCS severity is rated by study participants using a 4-point scale (range from 0 to 3), where 0 corresponds to no symptoms and 3 corresponds to severe symptoms. Study participants are asked to record the severity of nasal congestion for the previous 24 hours. This assessment will be collected in the participant eDiary.
Baseline, Week 24
Mean CFBL in Endoscopic Nasal Polyp Score (NPS)
Time Frame: Baseline, Week 24
The endoscopic NPS is assessed by a centralized, blinded, independent review of nasal endoscopy video recordings. The total score is the sum of the right and left nasal cavity scores. For each nasal cavity, endoscopic NPS is graded based on polyp size from 0 to 4, where 0 = no polyps and 4 = large polyps.
Baseline, Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change in Opacification of Sinuses Measured by the Lund Mackay score (LMK)
Time Frame: Baseline, Week 24
Central read on sinus computed tomography (CT) scans for the Lund Mackay score (LMK) will be performed. Review of the CT scans of the right and left frontal sinuses will include the use of a scoring system. The LMK scoring system is a 3-point grading scale where 0 = normal, 1 = partial opacification, and 2 = total opacification. The total score is the sum of the scores from each side and ranges from 0 to 24, where 0 indicates no disease and 24 indicates the most severe disease.
Baseline, Week 24
Mean change in Forced Expiratory Volume in 1 Second (FEV1)
Time Frame: Baseline, Week 24
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.
Baseline, Week 24
Mean CFBL in Severity of Loss of Smell
Time Frame: Baseline, Week 24
Participants will be asked about the severity of loss of smell using a 4-point scale, where 0 corresponds to no symptoms and 3 corresponds to severe symptoms. Study participants are asked to record the severity of loss of smell, for the previous 24 hours. This assessment will be collected in the participant eDiary.
Baseline, Week 24
Mean CFBL in Postnasal Drip
Time Frame: Baseline, Week 24
Postnasal drip is rated by study participants using a 4-point scale, where 0 corresponds to no symptoms and 3 corresponds to severe symptoms. Study participants are asked to record the severity of their postnasal drip, at its worst, for the previous 24 hours. This assessment will be collected in the participant eDiary.
Baseline, Week 24
Mean Change from Baseline by Visit for the 22-item Sino-nasal Outcome Test (SNOT-22)
Time Frame: Baseline, Week 24
The 22-item Sino-nasal outcome test assessing sino-nasal and auricular function, psychological impact, productivity, and sleep quality. Participants will be asked to recall their experiences over the past 2 weeks and rate their symptoms on a scale ranging from 0, which corresponds to no problem, to 5, which corresponds to problem as bad as it can be.
Baseline, Week 24
Mean Change from Baseline by Visit for the Nasal Peak Inspiratory Flow (NPIF)
Time Frame: Baseline, Week 24
NPIF measures the maximum inspiratory flow rate through both nostrils during inspiration with results expressed in liters per min (L/min). Participants with NPIF results >120 L/min represent no nasal obstruction.
Baseline, Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2024

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

March 25, 2024

First Submitted That Met QC Criteria

March 25, 2024

First Posted (Actual)

April 1, 2024

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18790
  • J2T-MC-KGBU (Other Identifier: Eli Lilly and Company)
  • 2023-508760-29-00 (Other Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual participant level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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