A Study of Lebrikizumab (LY3650150) in Adult Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)
NCT ID: NCT06338995
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
510 participants
INTERVENTIONAL
2024-04-29
2028-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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).
LY3650150
Administered SC.
Standard therapy for INCS
Administered as intranasal spray.
Lebrikizumab Q2W/every 8 weeks (Q8W)
Lebrikizumab will be given as SC injection. Participants will receive background therapy with INCS.
LY3650150
Administered SC.
Standard therapy for INCS
Administered as intranasal spray.
Placebo Q2W/Q4W
Placebo will be given as SC injection. Participants will receive background therapy with INCS.
Placebo
Administered SC.
Standard therapy for INCS
Administered as intranasal spray.
Interventions
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LY3650150
Administered SC.
Placebo
Administered SC.
Standard therapy for INCS
Administered as intranasal spray.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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).
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.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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AllerVie Clinical Research
Birmingham, Alabama, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
Keck Medicine of USC
Arcadia, California, United States
University of California, Irvine
Irvine, California, United States
DaVinci Research LLC
Roseville, California, United States
Breathe Clear Institute
Torrance, California, United States
Colorado ENT & Allergy
Colorado Springs, Colorado, United States
Orlando ENT & Allergy
Orlando, Florida, United States
NuLine Clinical Trial Center
Pompano Beach, Florida, United States
University of South Florida
Tampa, Florida, United States
Treasure Valley Medical Research
Boise, Idaho, United States
Entopy Research LLC
Chicago, Illinois, United States
Chicago ENT
Chicago, Illinois, United States
South Louisiana Ear, Nose, Throat & Facial Plastic Surgery - PPDS
Mandeville, Louisiana, United States
Chesapeake Clinical Research, Inc.
White Marsh, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
University of Missouri
Columbia, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Circuit Clinical/Mercer Allergy and Pulmonary Associates
Hamilton, New Jersey, United States
Madison ENT & Facial Plastic Surgery
New York, New York, United States
New York Allergy and Sinus Center
New York, New York, United States
Equity Medical
The Bronx, New York, United States
UCMC
Cincinnati, Ohio, United States
Optimed Research, LTD
Columbus, Ohio, United States
Specialty Physician Associates
Bethlehem, Pennsylvania, United States
Medical University of South Carolina- Department of Otolaryngology and Head and Neck Surgery
Charleston, South Carolina, United States
Alina Clinical Trials
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
University of Texas Physicians Department of Otorhinolaryngology Clinc
Houston, Texas, United States
Ear Nose and Throat Associates of Texas PA
McKinney, Texas, United States
Alamo ENT Associates
San Antonio, Texas, United States
Eastern Virginia Medical School
Norfolk, Virginia, United States
Richmond Ear Nose and Throat
Richmond, Virginia, United States
The Medical College of Wisconsin
Milwaukee, Wisconsin, United States
CEMLO - Centro de Especialidades Médicas Lobos
Beunos Aires, , Argentina
Fundacion Respirar
Buenos Aires, , Argentina
Centro Platense en Investigaciones Respiratorias - CEPIR
Buenos Aires, , Argentina
Fundacion CIDEA
Caba, , Argentina
Centro de Investigaciones Clínicas - IESR - Rosario
Rosario, , Argentina
Investigaciones en Patologías Respiratorias SRL
San Miguel de Tucumán, , Argentina
CIMER-Centro Integral de Medicina Respiratoria
San Miguel de Tucumán, , Argentina
Centro Respiratorio Infantil
Santa Fe, , Argentina
CARE - Centro de Alergia y Enfermedades Respiratorias
Villa Crespo, , Argentina
Pneumocare
Erpent, , Belgium
UZ Gent
Ghent, , Belgium
Cliniques Universitaires Saint-Luc Avenue Hippocrate 10
Woluwe-Saint-Lambert, , Belgium
Multiprofile Hospital For Active Treatment Dr Tota Venkova A
Gabrovo, , Bulgaria
Medical Center Medconsult Pleven OOD
Pleven, , Bulgaria
Diagnostic-Consultative Centre Ascendent EOOD
Sofia, , Bulgaria
Military Medical Academy - Multiprofile Hospital for Active Treatment - Sofia,
Sofia, , Bulgaria
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna
Sofia, , Bulgaria
Multiprofile Hospital for Active treatment Trakia EOOD
Zagora, , Bulgaria
St. Joseph's Hospital
Ontario, , Canada
CSAC
Québec, , Canada
The Gordon and Leslie Diamond Health Care Centre
Vancouver, , Canada
St Paul's Sinus Centre
Vancouver, , Canada
Peking University Third Hospital
Beijing, , China
Beijing Hospital
Beijing, , China
Beijing Tongren Hospital
Beijing, , China
The First Affiliated Hospital of Bengbu Medical College
Bengbu, , China
The Third Xiangya Hospital of Central South University
Changsha, , China
Sichuan Provincial People's Hospital
Chengdu, , China
The First People's Hospital of Foshan
Foshan, , China
The First Affiliated Hospital Of Fujian Medical University
Fuzhou, , China
Shenzhen Second People's Hospital
Guangdong, , China
Hainan General Hospital
Haikou, , China
Hangzhou First People's Hospital
Hangzhou, , China
Huai'an First People's Hospital
Huai'an, , China
The First Affiliated Hospital of Nanchang University
Nanchang, , China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, , China
Ningbo Medical Center Lihuili Hospital
Ningbo, , China
The first Affilliated Hospital Shandong First Medical University
Shandong, , China
Tongji Hospital of Tongji University
Shanghai, , China
Shengjing Hospital of China Medical University
Shenyang, , China
The First Hospital of Shanxi Medical University
Taiyuan, , China
Tianjin People's Hospital
Tianjin, , China
Tonghua Central Hospital
Tonghua, , China
The 2nd Affiliated Hospital of Wenzhou Medical University
Wenzhou Avenue, , China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, , China
Renmin Hospital of Wuhan University
Wuhan, , China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, , China
First People's Hospital of Yinchuan
Yinchuan, , China
Aalborg Universitetshospital Medicinerhuset Lungemedicinsk Forskningsenhed
Aalborg, , Denmark
Aarhus University Hospital, Dept. of Ear-Nose-Throat
Aarhus, , Denmark
Bispebjerg Hospital Department of Respiratory Medicine
Copenhagen, , Denmark
Sjællands Universitets Hospital
Køge, , Denmark
Charite-Universitatsmedizin Berlin
Berlin, , Germany
HNO Zentrum am Kudamm
Berlin, , Germany
Praxis für HNO und Allergologie
Dresden, , Germany
Universitätsklinikum Carl Gustav Carus an der TU Dresden
Dresden, , Germany
IKF Pneumologie
Frankfurt am Main, , Germany
Universitätsklinikum Jena
Jena, , Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, , Germany
HNO Praxis
Sachsen, , Germany
Ujpesti Egeszsegugyi Szolgaltato
Budapest, , Hungary
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Tatabánya, , Hungary
AOU Careggi- University of Florence
Florence, , Italy
Ospedale San Raffaele
Milan, , Italy
AOU Federico II Via Pansini
Napoli, , Italy
Azienda Ospedaliera Di Padova
Padua, , Italy
Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara
Pisa, , Italy
Fondazione Policlinico A. Gemelli IRCCS
Rome, , Italy
ASST Brianza - Vimercate Hospital
Vimercate, , Italy
Toyota Memorial Hospital
Aichi, , Japan
Clinic Kashiwanoha
Chiba, , Japan
University of Yamanashi Hospital
Chūō, , Japan
University of Fukui Hospital
Fukui, , Japan
Saiseikai Fukuoka General Hospital
Fukuoak, , Japan
Matsuda Hospital
Fukuoka, , Japan
Kyushu University Hospital
Fukuoka, , Japan
Osaka Habikino Medical Center
Habikino-shi, , Japan
Kansai Medical University Hospital
Hirakata, , Japan
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
Hokkaido, , Japan
Hyogo Medical University Hospital
Hyōgo, , Japan
Takarazuka City Hospital
Hyōgo, , Japan
Ibaraki Prefectural Central Hospital
Ibaraki, , Japan
Kagoshima Kouseiren Hospital
Kagoshima, , Japan
Yokohama City Minato Red Cross Hospital
Kanagawa, , Japan
Odawara Municipal Hospital
Kanagawa, , Japan
Tokai University Hospital
Kanagawa, , Japan
Kimitsu Chuo Hospital
Kisarazu, , Japan
1-8-1, Kishinoura
Kitakyushu, , Japan
3-54-2, Kotohirahommachi
Kumamoto, , Japan
Kyosai Hospital
Minami-Alps, , Japan
Tohoku Medical and Pharmaceutical University Hospital
Miyagi, , Japan
Ritsuzankai Iida Hospital
Nagano, , Japan
Asahioka, 1-24
Niigata, , Japan
Niigata University Medical & Dental Hospital
Niigata, , Japan
Japan Community Health care Organization Osaka Hospital
Osaka, , Japan
Kansai Electric Power Hospital
Osaka, , Japan
Toho University Sakura Medical Center
Sakura, , Japan
8-2 Otemachi
Shizuoka, , Japan
Toho University Ohashi Medical Center
Tokyo, , Japan
Nihon University Itabashi Hospital
Tokyo, , Japan
Mie University Hospital
Tsu, , Japan
JCHO Shimonoseki Medical center
Yamaguchi, , Japan
Yamaguchi University Hospital
Yamaguchi, , Japan
Yokohama Minami Kyosai Hospital
Yokohama, , Japan
Avenida Independencia
Aguascalientes, , Mexico
Calle Pascual Orozco #2125 col. Magisterial Universidad
Chihuahua City, , Mexico
Calle Penitenciaria
Guadalajara Jalsico, , Mexico
Miguel Hidalgo 2525, Consultorio 2 Urgencias
Nuevo León, , Mexico
Humboldt 302 Col. Centro
Oaxaca City, , Mexico
Niepubliczny Zakład Opieki Zdrowotnej E-Vita
Bialystok, , Poland
Centrum Medyczne Pratia Katowice
Katowice, , Poland
Centrum Medyczne Angelius Provita
Katowice, , Poland
B&R Clinical Sp. z o.o
Kielce, , Poland
Centrum Medyczne All-Med
Krakow, , Poland
Centrum Medyczne Promed ul. Olszańska 5G
Krakow, , Poland
Specjalistyczny Niepubliczny Zakład Opieki Zdrowotnej Alergologia Plus Ośrodek Diagnostyki
Poznan, , Poland
WIM-PIB
Warsaw, , Poland
Centrum Medyczne Biotamed Morawska Barbara
Wieliczka, , Poland
EMC INSTYTUT MEDYCZNY S.A. Przychodnia
Wroclaw, , Poland
Centrum Medyczne Oporów
Wroclaw, , Poland
Unidade Local de Saúde de Almada-Seixal, E.P.E.
Almada, , Portugal
ULS da Região de Aveiro, EPE - Hospital Infante D. Pedro
Aveiro, , Portugal
Centro Clínico Académico - Braga (2CA-Braga) (Hospital de Braga)
Braga, , Portugal
Unidade Local de Saúde Loures-Odivelas
Loures, , Portugal
ULS do Algarve, EPE - Hospital de Portimão
Seco Portimao Faro, , Portugal
Hospital Pedro Hispano
Senhora da Hora, , Portugal
Centrul Medical Unirea SRL
Brasov, , Romania
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L
Brasov, , Romania
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L
Brasov, , Romania
Delta Health Care S.R.L
Bucharest, , Romania
Delta Health Care S.R.L
Bucharest, , Romania
Cardiomed S.R.L
Cluj-Napoca, , Romania
Centrul de Excelenta in Rinologie S.R.L
Dolj, , Romania
Inje University Haeundae Paik Hospital
Busan, , South Korea
CHA Bundang Medical Center
Gyeonggi-do, , South Korea
Pusan National University Hospital
Pusan, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
SNUH - Seoul National University Hospital
Seoul, , South Korea
The Catholic University of Korea
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
SMG-SNU Boramae Medical Center
Seoul, , South Korea
Ajou University Hospital
Suwon, , South Korea
Hospital Universitario Virgen de la Macarena Avenida Dr. Fedriani
Andalucia, , Spain
Centro Médico Teknon
Barcelona, , Spain
Hospital Universitario de Jerez
Cadiz, , Spain
Hospital Clínico Universitario de Santiago
Galícia, , Spain
FutureMeds DKF
Madrid, , Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, , Spain
Clinica Universidad de Navarra
Pamplona, , Spain
Taipei Medical University Shuang Ho Hospital
New Taipei City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Bristol Royal Infirmary University Hospitals
Bristol, , United Kingdom
Charing Cross Hospital
Chelsea, , United Kingdom
James Paget University Hospitals NHS Foundation Trust
Great Yarmouth, , United Kingdom
Royal Berkshire NHS Foundation Trust
London, , United Kingdom
Guys and St Thomas' NHS Foundation Trust
London, , United Kingdom
Newcastle upon Tyne Hospitals NHSFT Freeman Hospital
Newcastle upon Tyne, , United Kingdom
Stepping Hill Hospital
Stockport, , United Kingdom
Countries
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Central Contacts
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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Role: CONTACT
Phone: 1-317-615-4559
Email: [email protected]
Physicians interested in becoming principal investigators please contact
Role: CONTACT
Email: [email protected]
Facility Contacts
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Related Links
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A Study of Lebrikizumab (LY3650150) in Adult Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)
Other Identifiers
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J2T-MC-KGBU
Identifier Type: OTHER
Identifier Source: secondary_id
2023-508760-29-00
Identifier Type: OTHER
Identifier Source: secondary_id
18790
Identifier Type: -
Identifier Source: org_study_id