A Study of Lebrikizumab (LY3650150) in Adult Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
- Interventions
- Registration Number
- NCT06338995
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in adult participants with chronic rhinosinusitis and nasal polyps treated with intranasal corticosteroids. The study will last about 18 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 510
-
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.
-
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) or may require a dose change during study.
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Prior or current biologic treatment for CRSwNP and/or asthma including but not limited to omalizumab, dupilumab, mepolizumab, reslizumab, and benralizumab.
-
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.
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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).
- A nasal cavity tumor (malignant or benign).
- Evidence of fungal rhinosinusitis.
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Have anosmia from COVID or any reason other than CRSwNP.
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Participants with forced expiratory volume in 1 second (FEV1) 50% or less (of predicted normal) at screening.
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Female participant who is pregnant, breastfeeding, or is planning to become pregnant, or to breastfeed during the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lebrikizumab every 2 weeks (Q2W)/ every 4 weeks (Q4W) LY3650150 Lebrikizumab will be given as Subcutaneous (SC) injection. Participants will receive background therapy with intranasal corticosteroids (INCS). Lebrikizumab every 2 weeks (Q2W)/ every 4 weeks (Q4W) Standard therapy for INCS Lebrikizumab will be given as Subcutaneous (SC) injection. Participants will receive background therapy with intranasal corticosteroids (INCS). Lebrikizumab Q2W/every 8 weeks (Q8W) LY3650150 Lebrikizumab will be given as SC injection. Participants will receive background therapy with INCS. Lebrikizumab Q2W/every 8 weeks (Q8W) Standard therapy for INCS Lebrikizumab will be given as SC injection. Participants will receive background therapy with INCS. Placebo Q2W/Q4W Placebo Placebo will be given as SC injection. Participants will receive background therapy with INCS. Placebo Q2W/Q4W Standard therapy for INCS Placebo will be given as SC injection. Participants will receive background therapy with INCS.
- Primary Outcome Measures
Name Time Method Mean Change From Baseline (CFBL) in Participant Reported Nasal Congestion Score (NCS) Severity 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.
Mean CFBL in Endoscopic Nasal Polyp Score (NPS) 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.
- Secondary Outcome Measures
Name Time Method Mean change in Opacification of Sinuses Measured by the Lund Mackay score (LMK) 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.
Mean change in Forced Expiratory Volume in 1 Second (FEV1) 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.
Mean CFBL in Severity of Loss of Smell 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.
Mean CFBL in Postnasal Drip 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.
Trial Locations
- Locations (157)
8-2 Otemachi
🇯🇵Shizuoka, Japan
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
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
🇺🇸Saint Louis, Missouri, United States
Madison ENT & Facial Plastic Surgery
🇺🇸New York, 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
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
UZ Gent
🇧🇪Gent, Oost-Vlaanderen, Belgium
Pneumocare
🇧🇪Erpent, Belgium
Cliniques Universitaires Saint-Luc Avenue Hippocrate 10
🇧🇪Sint-Lambrechts-Woluwe, 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 First Affiliated Hospital of Bengbu Medical College
🇨🇳Bengbu, Anhui, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
Beijing Hospital
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital Of Fujian Medical University
🇨🇳FuZhou, Fujian, China
The People's Hospital of Guangxi Zhuang Autonomous Region
🇨🇳Nan Ning, Guang XI, China
Hainan General Hospital
🇨🇳Haikou, Hainan, China
Renmin Hospital of Wuhan University
🇨🇳Wu Han, Hubei, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Huai'an First People's Hospital
🇨🇳Huai'an, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Shengjing Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
First People's Hospital of Yinchuan
🇨🇳Yinchuan Shi, Ningxia, China
The First Hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China
Sichuan Provincial People's Hospital
🇨🇳Chengdu, Sichuan, China
Ningbo Medical Center Lihuili Hospital
🇨🇳Ningbo, Zhejiang, China
Beijing Tongren Hospital
🇨🇳Beijing, China
The Third Xiangya Hospital of Central South University
🇨🇳Changsha City, China
The First People's Hospital of Foshan
🇨🇳Foshan, China
Shenzhen Second People's Hospital
🇨🇳Guangdong, China
Hangzhou First People's Hospital
🇨🇳Hangzhou City, China
The first Affilliated Hospital Shandong First Medical University
🇨🇳Shandong, China
Tongji Hospital of Tongji University
🇨🇳Shanghai, China
Tianjin People's Hospital
🇨🇳Tianjin, China
Tonghua Central Hospital
🇨🇳Tonghua City, China
The 2nd Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou Avenue, 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
Universitätsklinikum Schleswig-Holstein
🇩🇪Lübeck, Schleswig-Holstein, Germany
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
HNO Praxis
🇩🇪Sachsen, Germany
Ospedale San Raffaele
🇮🇹Milano, Lombardia, Italy
AOU Careggi- University of Florence
🇮🇹Florence, Italy
AOU Federico II Via Pansini
🇮🇹Napoli, Italy
Azienda Ospedaliera Di Padova
🇮🇹Padova, Italy
Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara
🇮🇹Pisa, Italy
Fondazione Policlinico A. Gemelli IRCCS
🇮🇹Rome, Italy
ASST Brianza - Vimercate Hospital
🇮🇹Vimercate, Italy
Kimitsu Chuo Hospital
🇯🇵Kisarazu, Chiba, Japan
1-8-1, Kishinoura
🇯🇵Kitakyushu, Fukuoka, Japan
Mie University Hospital
🇯🇵Tsu, Mie, Japan
Osaka Habikino Medical Center
🇯🇵Habikino-shi, Osaka, Japan
Kansai Medical University Hospital
🇯🇵Hirakata, Osaka, Japan
Kansai Electric Power Hospital
🇯🇵Osaka-shi, Osaka, Japan
Kyosai Hospital
🇯🇵Minami-Alps, Yamanashi, Japan
University of Yamanashi Hospital
🇯🇵Chuo, Yamanshi, Japan
Toyota Memorial Hospital
🇯🇵Aichi, Japan
Clinic Kashiwanoha
🇯🇵Chiba, Japan
University of Fukui Hospital
🇯🇵Fukui, Japan
Saiseikai Fukuoka General Hospital
🇯🇵Fukuoak, Japan
Matsuda Hospital
🇯🇵Fukuoka, Japan
Kyushu University Hospital
🇯🇵Fukuoka, Japan
Hyogo Medical University Hospital
🇯🇵Hyogo, Japan
Takarazuka City Hospital
🇯🇵Hyogo, 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
3-54-2, Kotohirahommachi
🇯🇵Kumamoto, 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
Toho University Ohashi Medical Center
🇯🇵Tokyo, Japan
Nihon University Itabashi Hospital
🇯🇵Tokyo, Japan
JCHO Shimonoseki Medical center
🇯🇵Yamaguchi, Japan
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Geonggi-do, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon, Gyeonggi-do, Korea, Republic of
Pusan National University Hospital
🇰🇷Pusan, Korea, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Inje University Haeundae Paik Hospital
🇰🇷Busan, Korea, Republic of
CHA Bundang Medical Center
🇰🇷Gyeonggi-do, Korea, Republic of
SNUH - Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
SMG-SNU Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
Niepubliczny Zakład Opieki Zdrowotnej E-Vita
🇵🇱Białystok, 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
🇵🇱Poznań, Poland
Centrum Medyczne Biotamed Morawska Barbara
🇵🇱Wieliczka, Poland
EMC INSTYTUT MEDYCZNY S.A. Przychodnia
🇵🇱Wroclaw, Poland
Centrum Medyczne Oporów
🇵🇱Wroclaw, Poland
Centrum Medyczne Pratia Katowice
🇵🇱Katowice, Śląskie, Poland
Centrul Medical Unirea SRL
🇷🇴Brasov, Romania
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L
🇷🇴Brasov, Romania
Euroclinic Hospital SA
🇷🇴Bucharest, Romania
Delta Health Care S.R.L
🇷🇴Bucuresti, Romania
Cardiomed S.R.L
🇷🇴Cluj-Napoca, Romania
Centrul de Excelenta in Rinologie S.R.L
🇷🇴Dolj, Romania
Hospital Universitario Virgen de la Macarena Avenida Dr. Fedriani
🇪🇸Andalucia, Spain
Centro Médico Teknon
🇪🇸Barcelona, Spain
Hospital Universitario de Jerez
🇪🇸Cadiz, Spain
Hospital ClÃnico Universitario de Santiago
🇪🇸GalÃcia, Spain
FutureMeds DKF
🇪🇸Madrid, Spain
Hospital Universitario Fundación Jiménez DÃaz
🇪🇸Madrid, Spain
Clinica Universidad de Navarra
🇪🇸Pamplona, Spain
Taipei Medical University Shuang Ho Hospital
🇨🇳New Taipei, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Stepping Hill Hospital
🇬🇧Stockport, Cheshire, United Kingdom
Charing Cross Hospital
🇬🇧Chelsea, London, United Kingdom
Bristol Royal Infirmary University Hospitals
🇬🇧Bristol, 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