Clinical trial NCT06338995: A Study of Lebrikizumab (LY3650150) in Adult Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)
Official title: A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel Group Phase 3 Efficacy and Safety Study of Lebrikizumab/ LY3650150 in Adults With Chronic Rhinosinusitis With Nasal Polyps on a Background Therapy With Intranasal Corticosteroids
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2024-04-01
Enrollment: 510
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, parallel group, placebo controlled
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

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) or may require a dose change during study.
* 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:

  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.

Primary outcomes:
measure: Mean Change From Baseline (CFBL) in Participant Reported Nasal Congestion Score (NCS) Severity
timeFrame: Baseline, Week 24
measure: Mean CFBL in Endoscopic Nasal Polyp Score (NPS)
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Mean change in Opacification of Sinuses Measured by the Lund Mackay score (LMK)
timeFrame: Baseline, Week 24
measure: Mean change in Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Baseline, Week 24
measure: Mean CFBL in Severity of Loss of Smell
timeFrame: Baseline, Week 24
measure: Mean CFBL in Postnasal Drip
timeFrame: Baseline, Week 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: AllerVie Clinical Research
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Arcadia
country: United States
facility: Keck Medicine of USC
state: California
city: Irvine
country: United States
facility: University of California, Irvine
state: California
city: Roseville
country: United States
facility: DaVinci Research LLC
state: California
city: Torrance
country: United States
facility: Breathe Clear Institute
state: California
city: Colorado Springs
country: United States
facility: Colorado ENT & Allergy
state: Colorado
city: Orlando
country: United States
facility: Orlando ENT & Allergy
state: Florida
city: Pompano Beach
country: United States
facility: NuLine Clinical Trial Center
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Boise
country: United States
facility: Treasure Valley Medical Research
state: Idaho
city: Chicago
country: United States
facility: Chicago ENT
state: Illinois
city: Mandeville
country: United States
facility: South Louisiana Ear, Nose, Throat & Facial Plastic Surgery - PPDS
state: Louisiana
city: White Marsh
country: United States
facility: Chesapeake Clinical Research, Inc.
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: New York
country: United States
facility: Madison ENT & Facial Plastic Surgery
state: New York
city: Cincinnati
country: United States
facility: UCMC
state: Ohio
city: Columbus
country: United States
facility: Optimed Research, LTD
state: Ohio
city: Bethlehem
country: United States
facility: Specialty Physician Associates
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina- Department of Otolaryngology and Head and Neck Surgery
state: South Carolina
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: University of Texas Physicians Department of Otorhinolaryngology Clinc
state: Texas
city: McKinney
country: United States
facility: Ear Nose and Throat Associates of Texas PA
state: Texas
city: San Antonio
country: United States
facility: Alamo ENT Associates
state: Texas
city: Norfolk
country: United States
facility: Eastern Virginia Medical School
state: Virginia
city: Richmond
country: United States
facility: Richmond Ear Nose and Throat
state: Virginia
city: Milwaukee
country: United States
facility: The Medical College of Wisconsin
state: Wisconsin
city: Gent
country: Belgium
facility: UZ Gent
state: Oost-Vlaanderen
city: Erpent
country: Belgium
facility: Pneumocare
city: Sint-Lambrechts-Woluwe
country: Belgium
facility: Cliniques Universitaires Saint-Luc Avenue Hippocrate 10
city: Gabrovo
country: Bulgaria
facility: Multiprofile Hospital For Active Treatment Dr Tota Venkova A
city: Pleven
country: Bulgaria
facility: Medical Center Medconsult Pleven OOD
city: Sofia
country: Bulgaria
facility: Diagnostic-Consultative Centre Ascendent EOOD
city: Sofia
country: Bulgaria
facility: Military Medical Academy - Multiprofile Hospital for Active Treatment - Sofia,
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna
city: Zagora
country: Bulgaria
facility: Multiprofile Hospital for Active treatment Trakia EOOD
city: Ontario
country: Canada
facility: St. Joseph's Hospital
city: Québec
country: Canada
facility: CSAC
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College
state: Anhui
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: FuZhou
country: China
facility: The First Affiliated Hospital Of Fujian Medical University
state: Fujian
city: Nan Ning
country: China
facility: The People's Hospital of Guangxi Zhuang Autonomous Region
state: Guang XI
city: Haikou
country: China
facility: Hainan General Hospital
state: Hainan
city: Wu Han
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology
state: Hubei
city: Huai'an
country: China
facility: Huai'an First People's Hospital
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Yinchuan Shi
country: China
facility: First People's Hospital of Yinchuan
state: Ningxia
city: Taiyuan
country: China
facility: The First Hospital of Shanxi Medical University
state: Shanxi
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
city: Ningbo
country: China
facility: Ningbo Medical Center Lihuili Hospital
state: Zhejiang
city: Beijing
country: China
facility: Beijing Tongren Hospital
city: Changsha City
country: China
facility: The Third Xiangya Hospital of Central South University
city: Foshan
country: China
facility: The First People's Hospital of Foshan
city: Guangdong
country: China
facility: Shenzhen Second People's Hospital
city: Hangzhou City
country: China
facility: Hangzhou First People's Hospital
city: Shandong
country: China
facility: The first Affilliated Hospital Shandong First Medical University
city: Shanghai
country: China
facility: Tongji Hospital of Tongji University
city: Tianjin
country: China
facility: Tianjin People's Hospital
city: Tonghua City
country: China
facility: Tonghua Central Hospital
city: Wenzhou Avenue
country: China
facility: The 2nd Affiliated Hospital of Wenzhou Medical University
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital Medicinerhuset Lungemedicinsk Forskningsenhed
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Dept. of Ear-Nose-Throat
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital Department of Respiratory Medicine
city: Køge
country: Denmark
facility: Sjællands Universitets Hospital
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Charite-Universitatsmedizin Berlin
city: Berlin
country: Germany
facility: HNO Zentrum am Kudamm
city: Dresden
country: Germany
facility: Praxis für HNO und Allergologie
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden
city: Frankfurt am Main
country: Germany
facility: IKF Pneumologie
city: Jena
country: Germany
facility: Universitätsklinikum Jena
city: Sachsen
country: Germany
facility: HNO Praxis
city: Milano
country: Italy
facility: Ospedale San Raffaele
state: Lombardia
city: Florence
country: Italy
facility: AOU Careggi- University of Florence
city: Napoli
country: Italy
facility: AOU Federico II Via Pansini
city: Padova
country: Italy
facility: Azienda Ospedaliera Di Padova
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara
city: Rome
country: Italy
facility: Fondazione Policlinico A. Gemelli IRCCS
city: Vimercate
country: Italy
facility: ASST Brianza - Vimercate Hospital
city: Kisarazu
country: Japan
facility: Kimitsu Chuo Hospital
state: Chiba
city: Kitakyushu
country: Japan
facility: 1-8-1, Kishinoura
state: Fukuoka
city: Tsu
country: Japan
facility: Mie University Hospital
state: Mie
city: Habikino-shi
country: Japan
facility: Osaka Habikino Medical Center
state: Osaka
city: Hirakata
country: Japan
facility: Kansai Medical University Hospital
state: Osaka
city: Osaka-shi
country: Japan
facility: Kansai Electric Power Hospital
state: Osaka
city: Minami-Alps
country: Japan
facility: Kyosai Hospital
state: Yamanashi
city: Chuo
country: Japan
facility: University of Yamanashi Hospital
state: Yamanshi
city: Aichi
country: Japan
facility: Toyota Memorial Hospital
city: Chiba
country: Japan
facility: Clinic Kashiwanoha
city: Fukui
country: Japan
facility: University of Fukui Hospital
city: Fukuoak
country: Japan
facility: Saiseikai Fukuoka General Hospital
city: Fukuoka
country: Japan
facility: Matsuda Hospital
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Hyogo
country: Japan
facility: Hyogo Medical University Hospital
city: Hyogo
country: Japan
facility: Takarazuka City Hospital
city: Ibaraki
country: Japan
facility: Ibaraki Prefectural Central Hospital
city: Kagoshima
country: Japan
facility: Kagoshima Kouseiren Hospital
city: Kanagawa
country: Japan
facility: Yokohama City Minato Red Cross Hospital
city: Kanagawa
country: Japan
facility: Odawara Municipal Hospital
city: Kumamoto
country: Japan
facility: 3-54-2, Kotohirahommachi
city: Miyagi
country: Japan
facility: Tohoku Medical and Pharmaceutical University Hospital
city: Nagano
country: Japan
facility: Ritsuzankai Iida Hospital
city: Niigata
country: Japan
facility: Asahioka, 1-24
city: Niigata
country: Japan
facility: Niigata University Medical & Dental Hospital
city: Osaka
country: Japan
facility: Japan Community Health care Organization Osaka Hospital
city: Shizuoka
country: Japan
facility: 8-2 Otemachi
city: Tokyo
country: Japan
facility: Toho University Ohashi Medical Center
city: Tokyo
country: Japan
facility: Nihon University Itabashi Hospital
city: Yamaguchi
country: Japan
facility: JCHO Shimonoseki Medical center
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Geonggi-do
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi-do
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
state: Korea
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: CHA Bundang Medical Center
city: Seoul
country: Korea, Republic of
facility: SNUH - Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
city: Białystok
country: Poland
facility: Niepubliczny Zakład Opieki Zdrowotnej E-Vita
city: Katowice
country: Poland
facility: Centrum Medyczne Angelius Provita
city: Kielce
country: Poland
facility: B&R Clinical Sp. z o.o
city: Krakow
country: Poland
facility: Centrum Medyczne All-Med
city: Krakow
country: Poland
facility: Centrum Medyczne Promed ul. Olszańska 5G
city: Poznań
country: Poland
facility: Specjalistyczny Niepubliczny Zakład Opieki Zdrowotnej Alergologia Plus Ośrodek Diagnostyki
city: Wieliczka
country: Poland
facility: Centrum Medyczne Biotamed Morawska Barbara
city: Wroclaw
country: Poland
facility: EMC INSTYTUT MEDYCZNY S.A. Przychodnia
city: Wroclaw
country: Poland
facility: Centrum Medyczne Oporów
city: Katowice
country: Poland
facility: Centrum Medyczne Pratia Katowice
state: Śląskie
city: Brasov
country: Romania
facility: Centrul Medical Unirea SRL
city: Brasov
country: Romania
facility: Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L
city: Brasov
country: Romania
facility: Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L
city: Bucharest
country: Romania
facility: Euroclinic Hospital SA
city: Bucuresti
country: Romania
facility: Delta Health Care S.R.L
city: Cluj-Napoca
country: Romania
facility: Cardiomed S.R.L
city: Dolj
country: Romania
facility: Centrul de Excelenta in Rinologie S.R.L
city: Andalucia
country: Spain
facility: Hospital Universitario Virgen de la Macarena Avenida Dr. Fedriani
city: Barcelona
country: Spain
facility: Centro Médico Teknon
city: Cadiz
country: Spain
facility: Hospital Universitario de Jerez
city: Galícia
country: Spain
facility: Hospital Clínico Universitario de Santiago
city: Madrid
country: Spain
facility: FutureMeds DKF
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Díaz
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
city: New Taipei
country: Taiwan
facility: Taipei Medical University Shuang Ho Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Stockport
country: United Kingdom
facility: Stepping Hill Hospital
state: Cheshire
city: Chelsea
country: United Kingdom
facility: Charing Cross Hospital
state: London
city: Bristol
country: United Kingdom
facility: Bristol Royal Infirmary University Hospitals
city: Great Yarmouth
country: United Kingdom
facility: James Paget University Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: Royal Berkshire NHS Foundation Trust
city: London
country: United Kingdom
facility: Guys and St Thomas' NHS Foundation Trust
city: Newcastle upon Tyne
country: United Kingdom
facility: Newcastle upon Tyne Hospitals NHSFT Freeman Hospital
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: