Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)Phase 3NCT06338995
A Study of Lebrikizumab (LY3650150) in Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)
A Phase 3 study testing LY3650150 and Standard therapy for INCS in people with Chronic Rhinosinusitis With Nasal Polyps (CRSwNP), run by Eli Lilly and Company at 202 sites in 20 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
- What is being tested?
- LY3650150 and Standard therapy for INCS
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 510 participants
- Where
- 202 sitesin 20 countries
- Study dates
- 29 Apr 2024to Mar 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
- Adolescent participants ≥12 to <18 years of age and weighing ≥40 kg at time of Visit 1.
Who cannot join
- 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:
- B cell-depleting biologics, including rituximab, within 6 months.
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- other biologics within 5 half-lives (if known) or 8 weeks, whichever is longer.
- 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:
- Nasal septal deviation occluding at least one nostril.
- Antrochoanal polyps.
- Acute sinusitis, acute nasal infection, or acute upper respiratory infection.
- Ongoing rhinitis medicamentosa.
- 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.
- A nasal cavity tumor (malignant or benign).
- 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.
Trial locations and contacts
202 sites in 20 countries. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
202 sites in 20 countries
United States41 sites, 41 recruiting
- Not yet recruiting
Keck Medicine of USC
Arcadia, California, 91007
Kevin Hur
- Not yet recruiting
AllerVie Clinical Research
Birmingham, Alabama, 35209
Weily Soong
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35233
205-934-7191
Do Yeon Cho
- Recruiting
Treasure Valley Medical Research
Boise, Idaho, 83706
208-813-6505
Neetu Talreja
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02215
617-732-6410
Stella Lee
- Not yet recruiting
Charleston ENT
Charleston, South Carolina, 29406
843-793-0274
Thomas Murphy
- Not yet recruiting
Medical University of South Carolina- Department of Otolaryngology and Head and Neck Surgery
Charleston, South Carolina, 29425
843-792-1356
Rodney Schlosser
- Recruiting
Entopy Research LLC
Chicago, Illinois, 60616
312-399-9337
Pravin Muniyappa
- Recruiting
Chicago ENT
Chicago, Illinois, 60657
773-289-1823
Kirk Shepard
- Not yet recruiting
UCMC
Cincinnati, Ohio, 45267
Ahmad Sedaghat
- Recruiting
Colorado ENT & Allergy
Colorado Springs, Colorado, 80923
719-867-7804
Bryan Davis
- Recruiting
University of Missouri
Columbia, Missouri, 65212
573-882-7150
Christine Franzese
- Recruiting
Optimed Research, LTD
Columbus, Ohio, 43235
614-430-3030
Donald McNeil
- Recruiting
Alina Clinical Trials
Dallas, Texas, 75209
214-363-1411
Barbara Baxter
- Not yet recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390-9035
214-633-4608
Sei Chung
- Not yet recruiting
Circuit Clinical/Mercer Allergy and Pulmonary Associates
Hamilton, New Jersey, 08619
201-725-9407
Peter Ricketti
- Recruiting
University of Texas Physicians Department of Otorhinolaryngology Clinc
Houston, Texas, 77030
713-704-4137
Amber Luong
- Recruiting
Medovation Research
Huntsville, Alabama, 35801
256-322-1553
William McFeely
- Recruiting
University of California, Irvine
Irvine, California, 92697
Naveen Bhandarkar
- Recruiting
ADCRC
La Mesa, California, 91942
619-464-3353
Geoffrey Pitzer
- Recruiting
Ark Clinical Research
Long Beach, California, 90815
562-997-1000
Kenneth Kim
- Recruiting
South Louisiana Ear, Nose, Throat & Facial Plastic Surgery - PPDS
Mandeville, Louisiana, 70471
James Connolly
- Recruiting
Ear Nose and Throat Associates of Texas PA
McKinney, Texas, 75070-5735
Dale Ehmer, Jr.
- Recruiting
Bioresearch Partner-Kendale Lakes
Miami, Florida, 33155
833-489-4968
Octavio Carreno
- Recruiting
The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226-3548
414-805-3145,414-314-0430
David Poetker
- Recruiting
Madison ENT & Facial Plastic Surgery
New York, New York, 10016
551-655-4979
Stacey Silvers
- Recruiting
New York Allergy and Sinus Center
New York, New York, 10016
212-686-6321
Robert Lin
- Recruiting
Eastern Virginia Medical School
Norfolk, Virginia, 23507
757-388-6238
Kent Lam
- Not yet recruiting
Orlando ENT & Allergy
Orlando, Florida, 32825
Cecelia Damask
- Recruiting
EMEDR
Overland Park, Kansas, 66211
918-991-3578
Steven Ellis
- Not yet recruiting
NuLine Clinical Trial Center
Pompano Beach, Florida, 33060
954-280-7701
Jacqueline DeNobriga
- Not yet recruiting
Richmond Ear Nose and Throat
Richmond, Virginia, 23235
804-622-3768
Michael Armstrong
- Recruiting
DaVinci Research LLC
Roseville, California, 95661
916-374-6730
Randall Ow
- Recruiting
Alamo ENT Associates
San Antonio, Texas, 78258-3227
210-545-0404
Jeffrey Rosenbloom
- Not yet recruiting
Washington University School of Medicine
St Louis, Missouri, 63141
314-996-0186
H James Wedner
- Recruiting
University of South Florida
Tampa, Florida, 33613
813-631-4024
Seong Cho
- Not yet recruiting
MJ Research
Tampa, Florida, 33615
813-249-9100
Mario Gonzalez-Fernandez
- Recruiting
Equity Medical
The Bronx, New York, 10455
332-264-0155
Alissa McInerney
- Recruiting
Breathe Clear Institute
Torrance, California, 90503
310-372-0700
Steven Davis
- Recruiting
Novak Clinical Research - Tucson - North La Cholla Boulevard
Tucson, Arizona, 85741
520-909-2622
Robert Dean
- Recruiting
Chesapeake Clinical Research, Inc.
White Marsh, Maryland, 21162
410-931-1966 extension 103
Sudhir Sekhsaria
Japan35 sites, 35 recruiting
- Recruiting
Toyota Memorial Hospital
Aichi
81120023812
Toshiaki Furuta
- Recruiting
Clinic Kashiwanoha
Chiba
81120023812
Yasuko Murakawa
- Recruiting
University of Yamanashi Hospital
Chūō, 409-3821
81120023812
Daiju Sakurai
- Recruiting
University of Fukui Hospital
Fukui
81120023812
Tetsuji Takabayashi
- Recruiting
Saiseikai Fukuoka General Hospital
Fukuoak, 810-0001
81120023812
Tetsuya Koyama
- Recruiting
Matsuda Hospital
Fukuoka, 812-0053
81120023812
Yoshiki Esaki
- Recruiting
Kyushu University Hospital
Fukuoka, 812-8582
81120023812
Ryota Higuchi
- Recruiting
Osaka Habikino Medical Center
Habikino-shi, 583-8588
81120023812
Kayoko Kawashima
- Recruiting
Kansai Medical University Hospital
Hirakata, 573-1191
81120023812
Yoshiki Kobayashi
- Recruiting
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
Hokkaido, 060-0033
81120023812
Hiroaki Netsu
- Recruiting
Hyogo Medical University Hospital
Hyōgo, 663-8131
81120023812
Kenzo Tsuzuki
- Recruiting
Takarazuka City Hospital
Hyōgo, 665-0827
81120023812
Takenori Haruna
- Recruiting
Ibaraki Prefectural Central Hospital
Ibaraki
81120023812
Bungo Nishimura
- Recruiting
Kagoshima Kouseiren Hospital
Kagoshima, 890-0062
81120023812
Takao Makise
- Recruiting
Yokohama City Minato Red Cross Hospital
Kanagawa, 231-0801
81120023812
Takahide Taguchi
- Recruiting
Odawara Municipal Hospital
Kanagawa, 250-8558
81120023812
Masako Terasaki
- Recruiting
Tokai University Hospital
Kanagawa, 259-1193
81120023812
Koichiro Wasano
- Recruiting
Kimitsu Chuo Hospital
Kisarazu, 292-8535
81120023812
Naoki Takahashi
- Recruiting
1-8-1, Kishinoura
Kitakyushu, 806-8501
81120023812
Koji Koike
- Recruiting
3-54-2, Kotohirahommachi
Kumamoto, 860-0814
81120023812
Masayuki Karaki
- Recruiting
Kyosai Hospital
Minami-Alps, 400-0405
81120023812
Tomonori Endo
- Recruiting
Tohoku Medical and Pharmaceutical University Hospital
Miyagi
81120023812
Nobuo Ohta
- Recruiting
Ritsuzankai Iida Hospital
Nagano, 395-0056
81120023812
Shigetoshi Horiguchi
- Recruiting
Asahioka, 1-24
Niigata, 940-8621
81120023812
Hisashi Kamada
- Recruiting
Niigata University Medical & Dental Hospital
Niigata, 951-8520
81120023812
Wakasugi Ryo
- Recruiting
Japan Community Health care Organization Osaka Hospital
Osaka, 553-0003
81120023812
Yohei Maeda
- Recruiting
Kansai Electric Power Hospital
Osaka, 553-0003
81120023812
Akihiko Fujita
- Recruiting
Toho University Sakura Medical Center
Sakura, 285-0841
81120023812
Munetaka Ushio
- Recruiting
8-2 Otemachi
Shizuoka, 420-0853
81120023812
Taiji Kawasaki
- Recruiting
Toho University Ohashi Medical Center
Tokyo, 153-8515
81120023812
Mamoru Yoshikawa
- Recruiting
Nihon University Itabashi Hospital
Tokyo, 173-0032
81120023812
Kikuta Shu
- Recruiting
Mie University Hospital
Tsu, 514-8507
81120023812
Ishigami Eisuke
- Recruiting
JCHO Shimonoseki Medical center
Yamaguchi, 750-0061
81120023812
Kuniyoshi Tanaka
- Recruiting
Yamaguchi University Hospital
Yamaguchi, 755-8505
81120023812
Kazuma Sugahara
- Recruiting
Yokohama Minami Kyosai Hospital
Yokohama, 236-0037
81120023812
Ryo Ikoma
China26 sites, 26 recruiting
- Recruiting
Peking University Third Hospital
Beijing, 100191
15611963579/82265531
Yan Yan
- Not yet recruiting
Beijing Hospital
Beijing, 100730
15001384090
Yi Yang
- Recruiting
Beijing Tongren Hospital
Beijing, 100730
13269208812
Chengshuo Wang
- Not yet recruiting
The First Affiliated Hospital of Bengbu Medical College
Bengbu, 233004
13855282539
Yuefeng Han
- Recruiting
The Third Xiangya Hospital of Central South University
Changsha, 410013
0731-88618931/15974183357
Guolin Tan
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, 610072
028-87776073/18228061516
Jiangang Fan
- Recruiting
The First People's Hospital of Foshan
Foshan, 528000
18038865188
Qingqing Yu
- Recruiting
The First Affiliated Hospital Of Fujian Medical University
Fuzhou, 350000
13799400365
chang Lin
- Recruiting
Shenzhen Second People's Hospital
Guangdong
18680309468
Yongtian Lu
- Not yet recruiting
Hainan General Hospital
Haikou, 570311
13807688943
Xin Wei
- Recruiting
Hangzhou First People's Hospital
Hangzhou
15967138168/0571-56007501
Yong Li
- Recruiting
Huai'an First People's Hospital
Huai'an, 223300
15252382626
Xin Jin
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, 330006
+8613407913590
Jing Ye
- Recruiting
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, 530021
18776882290
Shenhong Qu
- Not yet recruiting
Ningbo Medical Center Lihuili Hospital
Ningbo
15058001932
Zhisen Shen
- Recruiting
The first Affilliated Hospital Shandong First Medical University
Shandong, 250014
13685411586
Fei Han
- Recruiting
Tongji Hospital of Tongji University
Shanghai
661121219
Shaoqing Yu
- Recruiting
Shengjing Hospital of China Medical University
Shenyang, 110004
18940254987/18940254497
Zhiwei Cao
- Recruiting
The First Hospital of Shanxi Medical University
Taiyuan, 30001
13834132096
Qinna Zhang
- Recruiting
Tianjin People's Hospital
Tianjin, 300121
13820004151
Xiangli Yang
- Not yet recruiting
Tonghua Central Hospital
Tonghua, 134001
13180668096
Yaowu Dong
- Recruiting
The 2nd Affiliated Hospital of Wenzhou Medical University
Wenzhou Avenue, 325038
15868710383
Liyan Ni
- Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430022
18971294483/19971138040
Jianjun Chen
- Recruiting
Renmin Hospital of Wuhan University
Wuhan, 430060
18171485631
Yu Xu
- Recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, 221006
15105212626
Wen Liu
- Recruiting
First People's Hospital of Yinchuan
Yinchuan, 750002
13895671107
Ruixia Ma
Poland11 sites, 11 recruiting
- Recruiting
Niepubliczny Zakład Opieki Zdrowotnej E-Vita
Bialystok, 15-879
881225023
Ewa Michnowska-Tryburska
- Recruiting
Centrum Medyczne Pratia Katowice
Katowice, 40-081
+48 516 339 109
Santa Vanaga-Besser
- Recruiting
Centrum Medyczne Angelius Provita
Katowice, 40-611
+48 721-210-110
Tomasz Grzegorzek
- Recruiting
B&R Clinical Sp. z o.o
Kielce, 25-426
+48 695822532
Marcin Zawadzki
- Recruiting
Centrum Medyczne All-Med
Krakow, 30-033
608 623 715
Grazyna Pulka
- Recruiting
Centrum Medyczne Promed ul. Olszańska 5G
Krakow, 31-513
602460190
Piotr Lach
- Recruiting
Specjalistyczny Niepubliczny Zakład Opieki Zdrowotnej Alergologia Plus Ośrodek Diagnostyki
Poznan, 60-693
+48 61 656 21 65
Michal Springer
- Recruiting
WIM-PIB
Warsaw
+48261816279; +48261817019
Dariusz Jurkiewicz
- Recruiting
Centrum Medyczne Biotamed Morawska Barbara
Wieliczka, 32-020
+48 606 242 877
Piotr Morawski
- Recruiting
EMC INSTYTUT MEDYCZNY S.A. Przychodnia
Wroclaw, 50-220
+48 698 659 313
Marita Nittner-Marszalska
- Recruiting
Centrum Medyczne Oporów
Wroclaw, 52-416
+48 71 712 70 77
Yogen Abelak
South Korea10 sites, 10 recruiting
- Recruiting
Inje University Haeundae Paik Hospital
Busan, 48108
82-51-797-0064
Yong Wan Kim
- Recruiting
CHA Bundang Medical Center
Gyeonggi-do, 13496
82-31-780-3447
Jae Cheul Ahn
- Recruiting
Pusan National University Hospital
Pusan, 49241
82-51-240-7079
Kyu Sup Cho
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, 13620
+82-31-787-8763
JEONG WHUN KIM
- Recruiting
Korea University Anam Hospital
Seoul, 02841
82-2-920-5362
Tae Hoon Kim
- Recruiting
SNUH - Seoul National University Hospital
Seoul, 03080
82 2 2072 1688
Dong-Young Kim
- Recruiting
The Catholic University of Korea
Seoul, 06591
82-2-2258-2540
Soo-Whan Kim
- Not yet recruiting
Korea University Guro Hospital
Seoul, 08308
82-2-2626-1624
Heung-Man Lee
- Recruiting
SMG-SNU Boramae Medical Center
Seoul, 7061
+8228703928
Dae Woo Kim
- Recruiting
Ajou University Hospital
Suwon, 16499
82-31-219-4252
Hyun-Jun Kim
Argentina9 sites, 9 recruiting
- Recruiting
CEMLO - Centro de Especialidades Médicas Lobos
Beunos Aires, B7240KJB
54 2227419356
Dabove Fabian Horacio
- Recruiting
Policonsultorio CEPIR
Buenos Aires, B1904CUL.
2216075432
Gabriel Garcia
- Recruiting
Fundacion Respirar
Buenos Aires, C1426BP
541170781548 int 130
Maria De Salvo
- Recruiting
Fundacion CIDEA
Caba, C1121ABE
+54 1149615466 ext 1005
Jorge Máspero
- Recruiting
Centro de Investigaciones Clínicas - IESR - Rosario
Rosario, CP 2000
54 9 341 360 2129
Matias Ardusso
- Recruiting
Investigaciones en Patologías Respiratorias SRL
San Miguel de Tucumán, CP4000
54 3815312192
Ana Maria Stok
- Recruiting
CIMER-Centro Integral de Medicina Respiratoria
San Miguel de Tucumán
54 3816324041
María Rojas
- Not yet recruiting
Centro Respiratorio Infantil
Santa Fe, 2000
54 93424736908
Gabriel Gattolin
- Recruiting
CARE - Centro de Alergia y Enfermedades Respiratorias
Villa Crespo, C1414AIF
54 1165430113
Melina Verena Heinze
Germany8 sites, 8 recruiting
- Recruiting
Charite-Universitatsmedizin Berlin
Berlin, 10117
+4930450655227
Heidi Olze
- Recruiting
HNO Zentrum am Kudamm
Berlin, 10629
030 88774203
Önder Göktas
- Recruiting
Praxis für HNO und Allergologie
Dresden, 01139
+491743195510
Yury Yarin
- Recruiting
Universitätsklinikum Carl Gustav Carus an der TU Dresden
Dresden, 74, 01307
+4935145813506
Philipp Nahrath
- Recruiting
IKF Pneumologie
Frankfurt am Main, 60596
+4969695972580
Marc Kornmann
- Not yet recruiting
Universitätsklinikum Jena
Jena, 07747
+49 36 419 32 54 01
Orlando Guntinas-Lichius
- Not yet recruiting
Universitätsklinikum Schleswig-Holstein
Lübeck, 23538
+49 451 500 42001
Anke Leichtle
- Recruiting
HNO Praxis
Sachsen, 01067
0351 320 10 160
Udo Schäfer
Italy7 sites, 7 recruiting
- Recruiting
AOU Careggi- University of Florence
Florence, 50134
0557949450
Alessandra Vultaggio
- Not yet recruiting
Ospedale San Raffaele
Milan, 20132
+390226435075
Giulia Danè
- Recruiting
AOU Federico II Via Pansini
Naples, 80131
+90817462596
Aikaterini Detoraki
- Recruiting
Azienda Ospedaliera Di Padova
Padova, 35128
+39 0498212343
Giancarlo Ottaviano
- Recruiting
Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara
Pisa, 56126
Veronica Seccia
- Recruiting
Fondazione Policlinico A. Gemelli IRCCS
Rome, 800168
+39 06 30156022
Galli Jacopo
- Recruiting
ASST Brianza - Vimercate Hospital
Vimercate, 20871
+39 0396654635
Federico Quarta
Romania7 sites, 7 recruiting
- Recruiting
Centrul Medical Unirea SRL
Brasov, 500091
754049720
Catalin Stefan
- Recruiting
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L
Brasov, 500450
+40722872726
Anemone Sorana Lupescu
- Recruiting
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L
Brasov, 500450
+40722872726
Valeriu Bronescu
- Recruiting
Delta Health Care S.R.L
Bucharest, 14142
0745017816
Corina Mella
- Recruiting
Delta Health Care S.R.L
Bucharest, 14142
0722.103.328
Sorina Dindere
- Recruiting
Cardiomed S.R.L
Cluj-Napoca, 400015
+40745151216
Gheorghe Doinel Radeanu
- Recruiting
Centrul de Excelenta in Rinologie S.R.L
Dolj, 200222
+40 766 409 438
Mihaela-Roxana Mitroi
Spain7 sites, 7 recruiting
- Recruiting
Hospital Universitario Virgen de la Macarena Avenida Dr. Fedriani
Andalucia, 41009
+34 676366754
Serafin Sanchez Gomez
- Recruiting
Centro Médico Teknon
Barcelona, 8022
+34 932906239
Isam Alobid
- Recruiting
Hospital Universitario de Jerez
Cadiz, 11407
(+34) 956032505
Alfonso Del Cuvillo Bernal
- Not yet recruiting
Hospital Clínico Universitario de Santiago
Galícia, 15706
+34 981950915
Gabriel Martinez Capoccioni
- Recruiting
FutureMeds DKF
Madrid, 28002
+34621151370
Paula Cabrera Freitag
- Recruiting
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
+34915504800 Ext 2374
Jose Villacampa Auba
- Recruiting
Clinica Universidad de Navarra
Pamplona, 31008
+34948255400EXT4125
Gastaminza Gabriel
United Kingdom7 sites, 7 recruiting
- Recruiting
Bristol Royal Infirmary University Hospitals
Bristol, BS2 8HW
0117 3424175
Warren Bennett
- Recruiting
Charing Cross Hospital
Chelsea, W6 8RF
+44(0)2033134333
Catherina Rennie
- Recruiting
James Paget University Hospitals NHS Foundation Trust
Great Yarmouth, NR31 6LA
01493 453273
Carl Philpott
- Recruiting
Royal Berkshire NHS Foundation Trust
London, RG1 5AN
0118 3226996
Robert Almeyda
- Recruiting
Guys and St Thomas' NHS Foundation Trust
London, SE1 7EH
+44 (0)2071888315
Claire Hopkins
- Recruiting
Newcastle upon Tyne Hospitals NHSFT Freeman Hospital
Newcastle upon Tyne, NE7 7DN
+44 (0)191 2137181 Ext: 37181
Isma Iqbal
- Recruiting
Stepping Hill Hospital
Stockport, SK2 7JE
0161 419 5818 or 548
Milan Rudic
Bulgaria6 sites, 6 recruiting
- Recruiting
Multiprofile Hospital For Active Treatment Dr Tota Venkova A
Gabrovo, 1431
+359899619477
Dimitar Dimitrov
- Recruiting
Medical Center Medconsult Pleven OOD
Pleven, 5800
+359889897039
Georgi Nikolov
- Recruiting
Diagnostic-Consultative Centre Ascendent EOOD
Sofia, 1202
+359 877519494
Emiliya Yordanova
- Not yet recruiting
Military Medical Academy - Multiprofile Hospital for Active Treatment - Sofia,
Sofia, 1431
+359899157816
Ventzislav Tzvetkov
- Recruiting
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna
Sofia, 1527
+359888867615
Yulian Rangachev
- Not yet recruiting
Multiprofile Hospital for Active treatment Trakia EOOD
Zagora, 1504
+359888130652
Petar Rouev
Portugal6 sites, 6 recruiting
- Not yet recruiting
Unidade Local de Saúde de Almada-Seixal, E.P.E.
Almada
+351 212 727 246
Luis Antunes
- Recruiting
ULS da Região de Aveiro, EPE - Hospital Infante D. Pedro
Aveiro, 3814-501
(+351)911547254 or 93134164
Maria Luisa Azevedo
- Recruiting
Centro Clínico Académico - Braga (2CA-Braga) (Hospital de Braga)
Braga, 4710-243
+351925822071/+351912490649
Daniel Miranda
- Recruiting
Unidade Local de Saúde Loures-Odivelas
Loures
+351 219847259
Luis Rodrigues
- Recruiting
ULS do Algarve, EPE - Hospital de Portimão
Seco Portimao Faro, 8500-338
+351 961 900 354
Natacha Santos
- Recruiting
Hospital Pedro Hispano
Senhora da Hora, 4464-513
+351 917 316 904
Miguel Viana
Mexico5 sites, 5 recruiting
- Recruiting
Avenida Independencia
Aguascalientes, 20116
(+52) 449-994-9458
Erika Nayeli Duron Lopez
- Recruiting
Calle Pascual Orozco #2125 col. Magisterial Universidad
Chihuahua City, CP 31200
526142850691/ 526395010490
Jesus Antonio Lujan Reyes
- Recruiting
Calle Penitenciaria
Guadalajara Jalsico, 44100
523338259344 +523338256493
Ana Guadalupe
- Recruiting
Miguel Hidalgo 2525, Consultorio 2 Urgencias
Nuevo León, 64060
+52 811 517 2010
Victor Samuel Zuñiga Marquez
- Recruiting
Humboldt 302 Col. Centro
Oaxaca City, 68000
+52 951 514 7056
Lorenzo Tobias Avendaño Santiago
Canada4 sites, 4 recruiting
- Recruiting
St. Joseph's Hospital
Ontario, N6A 4V2
519-933-5483
Leigh Sowerby
- Recruiting
CSAC
Québec
418-780-0881 x 229
Remi Gagnon
- Not yet recruiting
The Gordon and Leslie Diamond Health Care Centre
Vancouver, V5Z 1M9
605-875-8296
Arif Janjua
- Not yet recruiting
St Paul's Sinus Centre
Vancouver, V6Z 1Y6
604-806-9462
Amin Javer
Denmark4 sites, 4 recruiting
- Recruiting
Aalborg Universitetshospital Medicinerhuset Lungemedicinsk Forskningsenhed
Aalborg
+45 9766 0672
Ulla Møller Weinreich
- Recruiting
Aarhus University Hospital, Dept. of Ear-Nose-Throat
Aarhus, 8200
+4561389346
Tejs Ehlers Klug
- Not yet recruiting
Bispebjerg Hospital Department of Respiratory Medicine
Copenhagen
+4530914739
Asger Sverrild
- Recruiting
Sjællands Universitets Hospital
Køge
+45 47 32 96 52
Preben Homøe
Belgium3 sites, 3 recruiting
- Recruiting
Pneumocare
Erpent, 5101
+32495823443 +32494384578
Jean-Benoît Martinot
- Recruiting
UZ Gent
Ghent, 9000
+32 93322973
Philippe Gevaert
- Recruiting
Cliniques Universitaires Saint-Luc Avenue Hippocrate 10
Woluwe-Saint-Lambert, 1200
+3227643651
Valerie Hox
Finland2 sites, 2 recruiting
- Not yet recruiting
Department otorhinolaryngology - Head and Neck Surgery, Helsinki Univerity Hospital
Helsinki, 00130
+358947176610
Marie Lundberg
- Not yet recruiting
Departmentof Allergy, Skin and Allergy Hospital, Helsinki Univerity Hospital
Helsinki, 00250
+358947176610
Annina Lyly
Hungary2 sites, 2 recruiting
- Recruiting
Ujpesti Egeszsegugyi Szolgaltato
Budapest, 1046
36703810940
Attila Laszlo Velich
- Recruiting
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Tatabánya, H-2800
3664515526
Irma Lehocz
Taiwan2 sites, 2 recruiting
- Recruiting
Taipei Medical University Shuang Ho Hospital
New Taipei City, 23561
+886-2-22490088 ext:1164
Cheng-Jung Wu
- Recruiting
National Taiwan University Hospital
Taipei, 10002
+886972652505
Yi-Tsen Lin
About this study
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
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.
- Being tested
- LY3650150, Placebo, Standard therapy for INCS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3650150Drug
Administered SC.
PlaceboDrug
Administered SC.
Standard therapy for INCSDrug
Administered as intranasal spray.
| Study group | Role | What they receive |
|---|---|---|
| Lebrikizumab every 2 weeks (Q2W)/ every 4 weeks (Q4W) | Experimental | 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. Receives: Drug: LY3650150; Drug: Standard therapy for INCS |
| Lebrikizumab Q2W/every 8 weeks (Q8W) | Experimental | Lebrikizumab will be given as SC injection. Participants will receive background therapy with INCS. Receives: Drug: LY3650150; Drug: Standard therapy for INCS |
| Placebo Q2W/Q4W | Placebo comparator | Placebo will be given as SC injection. Participants will receive background therapy with INCS. Receives: Drug: Placebo; Drug: Standard therapy for INCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline (CFBL) in Participant Reported Nasal Congestion Score (NCS) Severity
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.
Measured: Baseline, Week 24
Mean CFBL in Endoscopic Nasal Polyp Score (NPS)
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.
Measured: Baseline, Week 24
Secondary outcomes (6)
Mean change in Opacification of Sinuses Measured by the Lund Mackay score (LMK)
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.
Measured: Baseline, Week 24
Mean change in Forced Expiratory Volume in 1 Second (FEV1)
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.
Measured: Baseline, Week 24
Mean CFBL in Severity of Loss of Smell
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.
Measured: Baseline, Week 24
Mean CFBL in Postnasal Drip
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.
Measured: Baseline, Week 24
Mean Change from Baseline by Visit for the 22-item Sino-nasal Outcome Test (SNOT-22)
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.
Measured: Baseline, Week 24
Mean Change from Baseline by Visit for the Nasal Peak Inspiratory Flow (NPIF)
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.
Measured: Baseline, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start29 Apr 2024
- Primary completionMay 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)Studies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, parallel group, placebo controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 510 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06338995
- Sponsor's protocol ID
- 18790
- Other IDs
- J2T-MC-KGBU, 2023-508760-29-00, 2023
- Status last verified
- Oct 2026
- First submitted
- 25 Mar 2024
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.