A Study of Lebrikizumab (LY3650150) in Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)
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
3 other identifiers
interventional
510
20 countries
194
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2024
Typical duration for phase_3
194 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2024
CompletedFirst Posted
Study publicly available on registry
April 1, 2024
CompletedStudy Start
First participant enrolled
April 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2028
April 20, 2026
April 1, 2026
3 years
March 25, 2024
April 17, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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.
Baseline, Week 24
Secondary Outcomes (6)
Mean change in Opacification of Sinuses Measured by the Lund Mackay score (LMK)
Baseline, Week 24
Mean change in Forced Expiratory Volume in 1 Second (FEV1)
Baseline, Week 24
Mean CFBL in Severity of Loss of Smell
Baseline, Week 24
Mean CFBL in Postnasal Drip
Baseline, Week 24
Mean Change from Baseline by Visit for the 22-item Sino-nasal Outcome Test (SNOT-22)
Baseline, Week 24
- +1 more secondary outcomes
Study Arms (3)
Lebrikizumab every 2 weeks (Q2W)/ every 4 weeks (Q4W)
EXPERIMENTALLebrikizumab 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.
Lebrikizumab Q2W/every 8 weeks (Q8W)
EXPERIMENTALLebrikizumab will be given as SC injection. Participants will receive background therapy with INCS.
Placebo Q2W/Q4W
PLACEBO COMPARATORPlacebo will be given as SC injection. Participants will receive background therapy with INCS.
Interventions
Administered SC.
Administered as intranasal spray.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (194)
AllerVie Clinical Research
Birmingham, Alabama, 35209, United States
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Keck Medicine of USC
Arcadia, California, 91007, United States
University of California, Irvine
Irvine, California, 92697, United States
DaVinci Research LLC
Roseville, California, 95661, United States
Breathe Clear Institute
Torrance, California, 90503, United States
Colorado ENT & Allergy
Colorado Springs, Colorado, 80923, United States
Orlando ENT & Allergy
Orlando, Florida, 32825, United States
NuLine Clinical Trial Center
Pompano Beach, Florida, 33060, United States
University of South Florida
Tampa, Florida, 33613, United States
Treasure Valley Medical Research
Boise, Idaho, 83706, United States
Entopy Research LLC
Chicago, Illinois, 60616, United States
Chicago ENT
Chicago, Illinois, 60657, United States
South Louisiana Ear, Nose, Throat & Facial Plastic Surgery - PPDS
Mandeville, Louisiana, 70471, United States
Chesapeake Clinical Research, Inc.
White Marsh, Maryland, 21162, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02215, United States
University of Missouri
Columbia, Missouri, 65212, United States
Washington University School of Medicine
St Louis, Missouri, 63141, United States
Circuit Clinical/Mercer Allergy and Pulmonary Associates
Hamilton, New Jersey, 08619, United States
Madison ENT & Facial Plastic Surgery
New York, New York, 10016, United States
New York Allergy and Sinus Center
New York, New York, 10016, United States
Equity Medical
The Bronx, New York, 10455, United States
UCMC
Cincinnati, Ohio, 45267, United States
Optimed Research, LTD
Columbus, Ohio, 43235, United States
Medical University of South Carolina- Department of Otolaryngology and Head and Neck Surgery
Charleston, South Carolina, 29425, United States
Alina Clinical Trials
Dallas, Texas, 75209, United States
UT Southwestern Medical Center
Dallas, Texas, 75390-9035, United States
University of Texas Physicians Department of Otorhinolaryngology Clinc
Houston, Texas, 77030, United States
Ear Nose and Throat Associates of Texas PA
McKinney, Texas, 75070-5735, United States
Alamo ENT Associates
San Antonio, Texas, 78258-3227, United States
Eastern Virginia Medical School
Norfolk, Virginia, 23507, United States
Richmond Ear Nose and Throat
Richmond, Virginia, 23235, United States
The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226-3548, United States
CEMLO - Centro de Especialidades Médicas Lobos
Beunos Aires, B7240KJB, Argentina
Fundacion Respirar
Buenos Aires, C1426BP, Argentina
Centro Platense en Investigaciones Respiratorias - CEPIR
Buenos Aires, Argentina
Fundacion CIDEA
Caba, C1121ABE, Argentina
Centro de Investigaciones Clínicas - IESR - Rosario
Rosario, CP 2000, Argentina
Investigaciones en Patologías Respiratorias SRL
San Miguel de Tucumán, CP4000, Argentina
CIMER-Centro Integral de Medicina Respiratoria
San Miguel de Tucumán, Argentina
Centro Respiratorio Infantil
Santa Fe, 2000, Argentina
CARE - Centro de Alergia y Enfermedades Respiratorias
Villa Crespo, C1414AIF, Argentina
Pneumocare
Erpent, 5101, Belgium
UZ Gent
Ghent, 9000, Belgium
Cliniques Universitaires Saint-Luc Avenue Hippocrate 10
Woluwe-Saint-Lambert, 1200, Belgium
Multiprofile Hospital For Active Treatment Dr Tota Venkova A
Gabrovo, 1431, Bulgaria
Medical Center Medconsult Pleven OOD
Pleven, 5800, Bulgaria
Diagnostic-Consultative Centre Ascendent EOOD
Sofia, 1202, Bulgaria
Military Medical Academy - Multiprofile Hospital for Active Treatment - Sofia,
Sofia, 1431, Bulgaria
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna
Sofia, 1527, Bulgaria
Multiprofile Hospital for Active treatment Trakia EOOD
Zagora, 1504, Bulgaria
St. Joseph's Hospital
Ontario, N6A 4V2, Canada
CSAC
Québec, Canada
The Gordon and Leslie Diamond Health Care Centre
Vancouver, V5Z 1M9, Canada
St Paul's Sinus Centre
Vancouver, V6Z 1Y6, Canada
Peking University Third Hospital
Beijing, 100191, China
Beijing Hospital
Beijing, 100730, China
Beijing Tongren Hospital
Beijing, 100730, China
The First Affiliated Hospital of Bengbu Medical College
Bengbu, 233004, China
The Third Xiangya Hospital of Central South University
Changsha, 410013, China
Sichuan Provincial People's Hospital
Chengdu, 610072, China
The First People's Hospital of Foshan
Foshan, 528000, China
The First Affiliated Hospital Of Fujian Medical University
Fuzhou, 350000, China
Shenzhen Second People's Hospital
Guangdong, China
Hainan General Hospital
Haikou, 570311, China
Hangzhou First People's Hospital
Hangzhou, China
Huai'an First People's Hospital
Huai'an, 223300, China
The First Affiliated Hospital of Nanchang University
Nanchang, 330006, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, 530021, China
Ningbo Medical Center Lihuili Hospital
Ningbo, China
The first Affilliated Hospital Shandong First Medical University
Shandong, 250014, China
Tongji Hospital of Tongji University
Shanghai, China
Shengjing Hospital of China Medical University
Shenyang, 110004, China
The First Hospital of Shanxi Medical University
Taiyuan, 30001, China
Tianjin People's Hospital
Tianjin, 300121, China
Tonghua Central Hospital
Tonghua, 134001, China
The 2nd Affiliated Hospital of Wenzhou Medical University
Wenzhou Avenue, 325038, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430022, China
Renmin Hospital of Wuhan University
Wuhan, 430060, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, 221006, China
First People's Hospital of Yinchuan
Yinchuan, 750002, China
Aalborg Universitetshospital Medicinerhuset Lungemedicinsk Forskningsenhed
Aalborg, Denmark
Aarhus University Hospital, Dept. of Ear-Nose-Throat
Aarhus, 8200, Denmark
Bispebjerg Hospital Department of Respiratory Medicine
Copenhagen, Denmark
Sjællands Universitets Hospital
Køge, Denmark
Department otorhinolaryngology - Head and Neck Surgery, Helsinki Univerity Hospital
Helsinki, 00130, Finland
Departmentof Allergy, Skin and Allergy Hospital, Helsinki Univerity Hospital
Helsinki, 00250, Finland
Charite-Universitatsmedizin Berlin
Berlin, 10117, Germany
HNO Zentrum am Kudamm
Berlin, 10629, Germany
Praxis für HNO und Allergologie
Dresden, 01139, Germany
Universitätsklinikum Carl Gustav Carus an der TU Dresden
Dresden, 74, 01307, Germany
IKF Pneumologie
Frankfurt am Main, 60596, Germany
Universitätsklinikum Jena
Jena, 07747, Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, 23538, Germany
HNO Praxis
Sachsen, 01067, Germany
Ujpesti Egeszsegugyi Szolgaltato
Budapest, 1046, Hungary
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Tatabánya, H-2800, Hungary
AOU Careggi- University of Florence
Florence, 50134, Italy
Ospedale San Raffaele
Milan, 20132, Italy
AOU Federico II Via Pansini
Naples, 80131, Italy
Azienda Ospedaliera Di Padova
Padova, 35128, Italy
Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara
Pisa, 56126, Italy
Fondazione Policlinico A. Gemelli IRCCS
Rome, 800168, Italy
ASST Brianza - Vimercate Hospital
Vimercate, 20871, Italy
Toyota Memorial Hospital
Aichi, Japan
Clinic Kashiwanoha
Chiba, Japan
University of Yamanashi Hospital
Chūō, 409-3821, Japan
University of Fukui Hospital
Fukui, Japan
Saiseikai Fukuoka General Hospital
Fukuoak, 810-0001, Japan
Matsuda Hospital
Fukuoka, 812-0053, Japan
Kyushu University Hospital
Fukuoka, 812-8582, Japan
Osaka Habikino Medical Center
Habikino-shi, 583-8588, Japan
Kansai Medical University Hospital
Hirakata, 573-1191, Japan
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
Hokkaido, 060-0033, Japan
Hyogo Medical University Hospital
Hyōgo, 663-8131, Japan
Takarazuka City Hospital
Hyōgo, 665-0827, Japan
Ibaraki Prefectural Central Hospital
Ibaraki, Japan
Kagoshima Kouseiren Hospital
Kagoshima, 890-0062, Japan
Yokohama City Minato Red Cross Hospital
Kanagawa, 231-0801, Japan
Odawara Municipal Hospital
Kanagawa, 250-8558, Japan
Tokai University Hospital
Kanagawa, 259-1193, Japan
Kimitsu Chuo Hospital
Kisarazu, 292-8535, Japan
1-8-1, Kishinoura
Kitakyushu, 806-8501, Japan
3-54-2, Kotohirahommachi
Kumamoto, 860-0814, Japan
Kyosai Hospital
Minami-Alps, 400-0405, Japan
Tohoku Medical and Pharmaceutical University Hospital
Miyagi, Japan
Ritsuzankai Iida Hospital
Nagano, 395-0056, Japan
Asahioka, 1-24
Niigata, 940-8621, Japan
Niigata University Medical & Dental Hospital
Niigata, 951-8520, Japan
Japan Community Health care Organization Osaka Hospital
Osaka, 553-0003, Japan
Kansai Electric Power Hospital
Osaka, 553-0003, Japan
Toho University Sakura Medical Center
Sakura, 285-0841, Japan
8-2 Otemachi
Shizuoka, 420-0853, Japan
Toho University Ohashi Medical Center
Tokyo, 153-8515, Japan
Nihon University Itabashi Hospital
Tokyo, 173-0032, Japan
Mie University Hospital
Tsu, 514-8507, Japan
JCHO Shimonoseki Medical center
Yamaguchi, 750-0061, Japan
Yamaguchi University Hospital
Yamaguchi, 755-8505, Japan
Yokohama Minami Kyosai Hospital
Yokohama, 236-0037, Japan
Avenida Independencia
Aguascalientes, 20116, Mexico
Calle Pascual Orozco #2125 col. Magisterial Universidad
Chihuahua City, CP 31200, Mexico
Calle Penitenciaria
Guadalajara Jalsico, 44100, Mexico
Miguel Hidalgo 2525, Consultorio 2 Urgencias
Nuevo León, 64060, Mexico
Humboldt 302 Col. Centro
Oaxaca City, 68000, Mexico
Niepubliczny Zakład Opieki Zdrowotnej E-Vita
Bialystok, 15-879, Poland
Centrum Medyczne Pratia Katowice
Katowice, 40-081, Poland
Centrum Medyczne Angelius Provita
Katowice, 40-611, Poland
B&R Clinical Sp. z o.o
Kielce, 25-426, Poland
Centrum Medyczne All-Med
Krakow, 30-033, Poland
Centrum Medyczne Promed ul. Olszańska 5G
Krakow, 31-513, Poland
Specjalistyczny Niepubliczny Zakład Opieki Zdrowotnej Alergologia Plus Ośrodek Diagnostyki
Poznan, 60-693, Poland
WIM-PIB
Warsaw, Poland
Centrum Medyczne Biotamed Morawska Barbara
Wieliczka, 32-020, Poland
EMC INSTYTUT MEDYCZNY S.A. Przychodnia
Wroclaw, 50-220, Poland
Centrum Medyczne Oporów
Wroclaw, 52-416, Poland
Unidade Local de Saúde de Almada-Seixal, E.P.E.
Almada, Portugal
ULS da Região de Aveiro, EPE - Hospital Infante D. Pedro
Aveiro, 3814-501, Portugal
Centro Clínico Académico - Braga (2CA-Braga) (Hospital de Braga)
Braga, 4710-243, Portugal
Unidade Local de Saúde Loures-Odivelas
Loures, Portugal
ULS do Algarve, EPE - Hospital de Portimão
Seco Portimao Faro, 8500-338, Portugal
Hospital Pedro Hispano
Senhora da Hora, 4464-513, Portugal
Centrul Medical Unirea SRL
Brasov, 500091, Romania
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L
Brasov, 500450, Romania
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L
Brasov, 500450, Romania
Delta Health Care S.R.L
Bucharest, 14142, Romania
Delta Health Care S.R.L
Bucharest, 14142, Romania
Cardiomed S.R.L
Cluj-Napoca, 400015, Romania
Centrul de Excelenta in Rinologie S.R.L
Dolj, 200222, Romania
Inje University Haeundae Paik Hospital
Busan, 48108, South Korea
CHA Bundang Medical Center
Gyeonggi-do, 13496, South Korea
Pusan National University Hospital
Pusan, 49241, South Korea
Seoul National University Bundang Hospital
Seongnam-si, 13620, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
SNUH - Seoul National University Hospital
Seoul, 03080, South Korea
The Catholic University of Korea
Seoul, 06591, South Korea
Korea University Guro Hospital
Seoul, 08308, South Korea
SMG-SNU Boramae Medical Center
Seoul, 7061, South Korea
Ajou University Hospital
Suwon, 16499, South Korea
Hospital Universitario Virgen de la Macarena Avenida Dr. Fedriani
Andalucia, 41009, Spain
Centro Médico Teknon
Barcelona, 8022, Spain
Hospital Universitario de Jerez
Cadiz, 11407, Spain
Hospital Clínico Universitario de Santiago
Galícia, 15706, Spain
FutureMeds DKF
Madrid, 28002, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040, Spain
Clinica Universidad de Navarra
Pamplona, 31008, Spain
Taipei Medical University Shuang Ho Hospital
New Taipei City, 23561, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Bristol Royal Infirmary University Hospitals
Bristol, BS2 8HW, United Kingdom
Charing Cross Hospital
Chelsea, W6 8RF, United Kingdom
James Paget University Hospitals NHS Foundation Trust
Great Yarmouth, NR31 6LA, United Kingdom
Royal Berkshire NHS Foundation Trust
London, RG1 5AN, United Kingdom
Guys and St Thomas' NHS Foundation Trust
London, SE1 7EH, United Kingdom
Newcastle upon Tyne Hospitals NHSFT Freeman Hospital
Newcastle upon Tyne, NE7 7DN, United Kingdom
Stepping Hill Hospital
Stockport, SK2 7JE, United Kingdom
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double-blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2024
First Posted
April 1, 2024
Study Start
April 29, 2024
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
March 1, 2028
Last Updated
April 20, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.