Clinical trial NCT05946941: A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome
Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome (POETYK SjS-1)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Sjögren's Syndrome
Keywords: Deucravacitinib
Sjogren's Syndrome
BMS-986165
POETYK
Sjogren Syndrome
Sjogren-Larson Syndrome
Gougerot-Sjogren
Gougerot Sjogren Syndrome
Sjogren
Sjogren's
Sjogren Disease
Sjogren's Disease
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-07-14
Enrollment: 756
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and efficacy of two doses of Deucravacitinib in adult participants with Active Sjögren's Syndrome.


Eligibility criteria: Inclusion Criteria

* Satisfy the 2016 American College of Rheumatology/European League Against Rheumatism criteria for the classification of SjS at screening (score ≥ 4), and who have disease duration (from time of initial clinical SjS diagnosis) of at least 16 weeks prior to screening.
* Have moderate to severe SjS ESSDAI ≥ 5.
* Short duration of disease (≤ 10 years) before screening.
* A stimulated whole salivary flow (SWSF) ≥ 0.05 mililiters/minute (mL/minute).
* Positive anti-Sjögren's syndrome-associated antigen A (anti-Ro/SSA) at screening.

Exclusion Criteria

* Autoimmune disease other than SjS (for example, rheumatoid arthritis, systemic lupus erthrematosus \[SLE\], systemic sclerosis).
* Active fibromyalgia with pain symptoms or signs that would interfere with joint assessment or requiring adjustment in medication within the 3 months before screening to control symptoms; participants with fibromyalgia that is well controlled on stable treatment may otherwise be considered.
* Medical condition associated with sicca syndrome.
* Previous exposure to tyrosine kinase 2 (TYK2) inhibitors such as deucravacitinib or related compounds.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcomes:
measure: Change from baseline in European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) Score at Week 52
timeFrame: Baseline, Week 52
Secondary outcomes:
measure: Change from baseline in European League Against Rheumatism Sjögren's Syndrome Patient Reported Index (ESSPRI) Score at Week 52
timeFrame: Baseline, Week 52
measure: Number of participants with decrease in ESSPRI ≥ 1 or 15% from baseline at Week 52
timeFrame: Baseline, Week 52
measure: Number of participants with decrease in ESSDAI ≥ 3 points from baseline at Week 52
timeFrame: Baseline, Week 52
measure: Number of participants with ESSDAI < 5 at Week 52
timeFrame: Baseline, Week 52
measure: Change from baseline in ESSDAI at Week 24
timeFrame: Baseline, Week 24
measure: Change from baseline in stimulated whole salivary flow (SWSF) at Week 52
timeFrame: Baseline, Week 52
measure: Change from baseline in physician global assessment (PhGA) at Week 52
timeFrame: Baseline, Week 52
measure: Change from baseline in functional assessment of chronic illness therapy (FACIT)-fatigue at Week 52
timeFrame: Baseline, Week 52
measure: Change from baseline in ocular dryness numeric rating scale (NRS) at Week 52
timeFrame: Baseline, Week 52
measure: Change from baseline in oral dryness NRS at Week 52
timeFrame: Baseline, Week 52
measure: Change from baseline in joint/ muscle pain NRS at Week 52
timeFrame: Baseline, Week 52
measure: Number of participants with an increase of Schirmer's test ≥ 5 mm if abnormal baseline or no change of Schirmer's test to abnormal if baseline is normal
timeFrame: Baseline, Week 52
measure: Number of participants with adverse events (AEs)
timeFrame: Up to Week 160
measure: Number of participants with serious AEs (SAEs)
timeFrame: Up to Week 160
measure: Number of participants with AEs leading to discontinuation of treatment and study discontinuation
timeFrame: Up to Week 160
measure: Number of participants with AEs of special interest (AESIs)
timeFrame: Up to Week 160
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to Week 160
measure: Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to Week 156
measure: Number of participants with vital sign abnormalities
timeFrame: Up to Week 160
Other outcomes:
Locations:
city: Fullerton
country: United States
facility: Local Institution - 0228
state: California
city: La Palma
country: United States
facility: Arthritis and Osteoporosis Medical Center
state: California
city: San Francisco
country: United States
facility: UCSF Univ of California San Francisco
state: California
city: Santa Monica
country: United States
facility: Providence St. John's Health Center
state: California
city: Denver
country: United States
facility: Denver Arthritis Clinic
state: Colorado
city: Clearwater
country: United States
facility: Clinical Research of West Florida; Inc
state: Florida
city: Cooper City
country: United States
facility: GNP Research
state: Florida
city: Sarasota
country: United States
facility: Sarasota Arthritis Center
state: Florida
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Lawrenceville
country: United States
facility: Local Institution - 0229
state: Georgia
city: Skokie
country: United States
facility: Clinic of Robert Hozman/Clinical Investigation Specialists Inc.
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Hopkinsville
country: United States
facility: Local Institution - 0123
state: Kentucky
city: Baton Rouge
country: United States
facility: Ochsner Health Center - Baton Rouge
state: Louisiana
city: Monroe
country: United States
facility: Local Institution - 0125
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins Medicine - Jerome L. Greene Sjogrens Syndrome Center
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Eagan
country: United States
facility: Saint Paul Rheumatology
state: Minnesota
city: Summit
country: United States
facility: Institute for Rheumatic & Autoimmune Diseases; Overlook Medical Center
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Clinical Research Osteoporosis
state: New Mexico
city: Mineola
country: United States
facility: NYU Langone Hospital - Long Island
state: New York
city: Salisbury
country: United States
facility: Onsite Clinical Solutions
state: North Carolina
city: Corvallis
country: United States
facility: Local Institution - 0132
state: Oregon
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Jackson
country: United States
facility: Local Institution - 0022
state: Tennessee
city: Allen
country: United States
facility: Arthritis & Rheumatology Research Institute; PLLC
state: Texas
city: Katy
country: United States
facility: Local Institution - 0227
state: Texas
city: Plano
country: United States
facility: Local Institution - 0175
state: Texas
city: The Woodlands
country: United States
facility: Local Institution - 0225
state: Texas
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Spokane
country: United States
facility: Arthritis Northwest
state: Washington
city: San Isidro
country: Argentina
facility: IMAC SI
state: Alabama
city: Caba
country: Argentina
facility: Iro Research
state: Buenos Aires
city: Quilmes
country: Argentina
facility: CER Instituto Medico
state: Buenos Aires
city: San Miguel de Tucuman
country: Argentina
facility: Centro de Investigaciones Medicas Tucuman
state: Tucuman
city: Buenos Aires
country: Argentina
facility: Centro Medico del Dr Javier Tartaglione
city: Buenos Aires
country: Argentina
facility: Local Institution - 0058
city: Caba
country: Argentina
facility: IME Instituto medico Especializado
city: City of Buenos Aires
country: Argentina
facility: Centro Barrio Parque - Swiss Medical
city: Cordoba
country: Argentina
facility: Consultora Integral de Salud SRL
city: Cordoba
country: Argentina
facility: Local Institution - 0039
city: Woodville South
country: Australia
facility: The Queen Elizabeth Hospital
state: South Australia
city: Nedlands
country: Australia
facility: Local Institution - 0165
state: Western Australia
city: Graz
country: Austria
facility: Medical University of Graz
city: Wien
country: Austria
facility: Local Institution - 0087
city: Aalst
country: Belgium
facility: Local Institution - 0183
city: Gent
country: Belgium
facility: UZ Gent
city: Vitoria
country: Brazil
facility: Hospital Universitario Cassiano Antonio Moraes
state: ES
city: Juiz de Fora
country: Brazil
facility: Cmip-Centro Mineiro de Pesquisa
state: MG
city: Belo Horizonte
country: Brazil
facility: Universidade Federal de Minas Gerais (UFMG) - Faculdade de Medicina
state: Minas Gerais
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Vento
state: RS
city: Sao Paulo
country: Brazil
facility: CEPIC Centro Paulista de Investigacao Clinica
state: SP
city: Uberlandia
country: Brazil
facility: Universidade Federal de Uberlandia (UFU) - Campus Santa Monica - Centro de Pesquisa Clinica
city: Plovdiv
country: Bulgaria
facility: Local Institution - 0008
city: Sofia
country: Bulgaria
facility: ARENSIA Research Clinic MBAL Sveta Sofia
city: Vancouver
country: Canada
facility: Sjogren's Clinic at the Mary Pack Arthritis Center
state: British Columbia
city: Toronto
country: Canada
facility: University Health Network - Toronto Western Hospital
state: Ontario
city: Sherbrooke
country: Canada
facility: Diex Recherche Sherbrooke
state: Quebec
city: Trois Rivières
country: Canada
facility: Centre De Recherche Musculo-Squelettique
state: Quebec
city: Valdivia
country: Chile
facility: Clinical Research Chile SpA
state: LOS Lagos
city: Valdivia
country: Chile
facility: Local Institution - 0103
state: Los Rios
city: Santiago
country: Chile
facility: BioMedica Research Group
state: Metropolitana
city: Santiago
country: Chile
facility: Centro de Estudios Reumatologicos
state: Providencia
city: Santiago De Chlie
country: Chile
facility: Hospital Sotero del Rio
state: Region Metropolitana
city: Vina Del Mar
country: Chile
facility: CIERI
state: Valparaiso
city: Osorno
country: Chile
facility: Local Institution - 0099
city: Santiago
country: Chile
facility: Estudios Clinicos GyC
city: Santiago
country: Chile
facility: Local Institution - 0121
city: Beijing Shi
country: China
facility: Peking University First Hospital (Beida Hospital) (No.1 Hospital Affiliated to Beijing Medical University)
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital - Institute of Rheumatology and Immunology
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Chongqing
country: China
facility: Local Institution - 0096
state: Chongqing
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Peoples Hospital
state: Guangdong
city: Luoyang
country: China
facility: Local Institution - 0180
state: Henan
city: Zhengzhou
country: China
facility: 1st Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital affiliated to Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: Hunan Province People's Hospital
state: Hunan
city: Baotou Shi
country: China
facility: Local Institution - 0098
state: Inner Mongolia
city: Hohhot
country: China
facility: Local Institution - 0150
state: Inner Mongolia
city: Nanjing
country: China
facility: Nanjing Drum Tower hospital
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Medical University (NMU) - Jiangsu Province Hospital (First Affiliated Hospital)
state: Jiangsu
city: Ningbo
country: China
facility: Ningbo First Hospital
state: Jiangsu
city: Suzhou
country: China
facility: Local Institution - 0154
state: Jiangsu
city: Jiujiang
country: China
facility: Local Institution - 0163
state: Jiangxi
city: Nanchang
country: China
facility: 1st Hospital of Nanchang University
state: Jiangxi
city: Nanchang
country: China
facility: Jiangxi Provincial Peoples Hospital
state: Jiangxi
city: Pingxiang
country: China
facility: Pingxiang Peoples Hospital
state: Jiangxi
city: Xian
country: China
facility: The First Affiliated Hospital of Xian Jiaotong University
state: Shaanxi
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital;Shanxi Academy of Medical Sciences
state: Shan1xi
city: Shanghai Shi
country: China
facility: Shanghai 9th Peoples Hospital
state: Shanghai Sheng
city: Shanghai
country: China
facility: Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine -Shanghai Institute of Rheumatology
state: Shanghai
city: Shanghai
country: China
facility: Tongji University - Tongji Hospital
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital Sichuan University
state: Sichuan
city: Urumqi
country: China
facility: Xinjiang Uygur Autonomous Region People's Hospital
state: Xinjiang Sheng
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: Wenzhou Medical University (WMU) - The First Affiliated Hospital
state: Zhejiang
city: Barranquilla
country: Colombia
facility: Local Institution - 0168
state: Atlantico
city: Chica
country: Colombia
facility: Local Institution - 0043
state: Cundinamarca
city: Bogota D.C
country: Colombia
facility: Local Institution - 0037
city: Aarhus
country: Denmark
facility: Local Institution - 0186
state: Region Midt
city: Glostrup
country: Denmark
facility: Local Institution - 0006
city: Helsinki
country: Finland
facility: Local Institution - 0199
city: Kuopio
country: Finland
facility: Satucon Oy
city: Turku
country: Finland
facility: Local Institution - 0119
city: Paris
country: France
facility: Hopital de la Pitie Salpetriere
state: Cedex 13
city: Orleans
country: France
facility: Local Institution - 0072
state: Centre
city: Amiens
country: France
facility: CHU Amiens-Picardie - Site Nord Hopital Nord
city: Bordeaux
country: France
facility: CHU de Bordeaux - Hopital Saint-Andre
city: Grenoble
country: France
facility: CHU Grenoble Alpes
city: Le Havre Cedex
country: France
facility: Groupe Hospitalier du Havre (GHH) - Hopital Jacques Monod
city: Le Kremlin-Bictre
country: France
facility: CHU Hpital de Bicetre Universit Paris 11
city: Marseille
country: France
facility: Local Institution - 0078
city: Paris
country: France
facility: Hopital Saint Antoine
city: Paris
country: France
facility: Hopital Cochin
city: Munich
country: Germany
facility: Klinikum der Universitaet Muenchen LMU
state: Bayern
city: Berlin
country: Germany
facility: Charite University Hospitals
city: Freiburg
country: Germany
facility: University Hospital Freiburg
city: Hamburg
country: Germany
facility: Hamburger Rheuma Forschungszentrum 2
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen
city: Wuerzburg
country: Germany
facility: Universitaetsklinikum Wuerzburg
city: Athens
country: Greece
facility: National and Kapodistrian University of Athens NKUA - Laiko General Hospital
city: Athina
country: Greece
facility: Local Institution - 0052
city: Larissa
country: Greece
facility: Local Institution - 0108
city: Budapest, IX
country: Hungary
facility: Local Institution - 0115
state: Válassz Egy Opciót…
city: Budapest
country: Hungary
facility: Local Institution - 0113
city: Debrecen
country: Hungary
facility: Debreceni Egyetem - Orvos es Egeszsegtudomanyi Centrum (DEOEC) (University of Debrecen Medical and Health Science Center)
city: Gyula
country: Hungary
facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
state: IA
city: Kfar Sava
country: Israel
facility: Meir Medical Center
city: Brescia
country: Italy
facility: Asst Spedali Civili Di Brescia
city: Milano
country: Italy
facility: Local Institution - 0029
city: Napoli
country: Italy
facility: Università degli Studi della Campania Luigi Vanvitelli Napoli
city: Padua
country: Italy
facility: Local Institution - 0082
city: Pisa
country: Italy
facility: AOU Pisana
city: Rome
country: Italy
facility: Campus Biomedico University
city: Rome
country: Italy
facility: Local Institution - 0062
city: Udine
country: Italy
facility: Santa Maria della Misericordia
city: Nagoya-shi
country: Japan
facility: Kojunkai Daido Clinic
state: Aichi
city: Toyoake-shi
country: Japan
facility: Fujita Health University Hospital
state: Aichi
city: Kitakyushu-shi
country: Japan
facility: Hospital of the University of Occupational and Environmental Health
state: Fukuoka
city: Sapporo-shi
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: Sapporo Medical University Hospital
state: Hokkaido
city: Nishinomiya-shi
country: Japan
facility: Hyogo Medical University Hospital
state: Hyogo
city: Tsukuba City
country: Japan
facility: Tsukuba University Hospital
state: Ibaraki
city: Kahoku-gun
country: Japan
facility: Kanazawa Medical University Hospital
state: Ishikawa
city: Kanazawa-shi
country: Japan
facility: Kanazawa University Hospital
state: Ishikawa
city: Kawasaki-shi
country: Japan
facility: St.Marianna University Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: National Hospital Organization Yokohama Medical Center
state: Kanagawa
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Nagasaki-Shi
country: Japan
facility: Nagasaki University Hospital
state: Nagasaki
city: Sasebo
country: Japan
facility: Sasebo Chuo Hospital
state: Nagasaki
city: Kurashiki
country: Japan
facility: Kurashiki Medical Clinic
state: Okayama
city: Otsu
country: Japan
facility: Shiga University of Medical Science Hospital
state: Shiga
city: Hamamatsu
country: Japan
facility: Hamamatsu University Hospital
state: Shizuoka
city: Shimotsugagun
country: Japan
facility: Dokkyo Medical University Hospital
state: Tochigi
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: Institute of Science Tokyo Hospital
state: Tokyo
city: Chuo-ku
country: Japan
facility: St. Luke's International Hospital
state: Tokyo
city: Itabashi City
country: Japan
facility: Nihon University Itabashi Hospital
state: Tokyo
city: Meguro-ku
country: Japan
facility: National Hospital Organization Tokyo Medical Center
state: Tokyo
city: Meguro-ku
country: Japan
facility: Toho University Ohashi Medical Center
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Showa University East Hospital
state: Tokyo
city: Shinjuku
country: Japan
facility: Keio University Hospital
state: Tokyo
city: Seongdong-gu
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
state: Seoul
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea; Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Mexico
country: Mexico
facility: CINTRE - Centro de investigacion y tratamiento reumatologico, S.C.
state: Distrito Federal
city: Leon
country: Mexico
facility: Consultorio Medico de Reumatologia
state: Guanajuato
city: Guadalajara
country: Mexico
facility: Local Institution - 0023
state: Jalisco
city: Guadalajara
country: Mexico
facility: Centro de Estudios de Investigacion Basica y Clinica S.C.
state: Jalisco
city: Chihuahua
country: Mexico
facility: Local Institution - 0021
city: Leeuwarden
country: Netherlands
facility: Local Institution - 0046
state: Friesland
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
city: Jesus Maria
country: Peru
facility: Local Institution - 0047
state: Lima
city: Santiago de Surco
country: Peru
facility: Local Institution - 0011
state: Lima
city: Lima
country: Peru
facility: Local Institution - 0171
city: Krakow
country: Poland
facility: Centrum Medyczne PLEJADY
state: Malopolskie
city: Warszawa
country: Poland
facility: MICS Centrum Medyczne Warszawa
state: Mazowieckie
city: Warszawa
country: Poland
facility: Local Institution - 0141
state: Woj. Mazowieckie
city: Warszawa
country: Poland
facility: Local Institution - 0010
state: Woj. Mazowieckie
city: Bydgoszcz
country: Poland
facility: MICS Centrum Medyczne Bydgoszcz
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im.dr. Jana Biziela w Bydgoszczy
city: Lublin
country: Poland
facility: Etg Network
city: Poznan
country: Poland
facility: Med-Polonia Sp. zo.o.
city: Warsawa
country: Poland
facility: Reuma Park Warszawa
city: Warsaw
country: Poland
facility: FutureMeds Targowek
city: Warszawa
country: Poland
facility: Narodowy Instytut Geriatrii; Reumatologii i Rehabilitacji
city: Wroclaw
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o.
city: Wroclaw
country: Poland
facility: Dolnoslaski Szpital Specjalistyczny im. Tadeusza Marciniaka
city: Lisboa
country: Portugal
facility: Instituto Portugues de Reumatologia
city: Lisboa
country: Portugal
facility: Centro Hospitalar Universitario Lisboa Norte E.P.E. (CHULN) - Hospital de Santa Maria
city: San Juan
country: Puerto Rico
facility: GCM Medical Group, PSC - Hato Rey Site-Hato Rey
city: San Juan
country: Puerto Rico
facility: Local Institution - 0127
city: Cluj-Napoca
country: Romania
facility: ARENSIA Research Clinic Emergency County Hospital
state: Cluj
city: Brasov
country: Romania
facility: CMDTA Neomed SRL
city: Bucharest
country: Romania
facility: Arensia Research Clinic
city: Iasi
country: Romania
facility: Local Institution - 0104
city: Merida
country: Spain
facility: Hospital de Merida
state: Badajoz
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
state: Cantabria
city: La Laguna
country: Spain
facility: Hospital Universitario De Canarias - San Cristbal de La Laguna
state: Santa Cruz De Tenerife
city: A Coruna
country: Spain
facility: Local Institution - 0112
city: Santiago De Compostela
country: Spain
facility: Clinica GAIAS Santiago
city: Sevilla
country: Spain
facility: Hospital Infantaluisa
city: Gotenburg
country: Sweden
facility: Sahlgrenska University Hospital
city: Solna
country: Sweden
facility: Karolinska University Hospital
city: Basel
country: Switzerland
facility: Local Institution - 0066
state: Baden-Württemberg
city: Bern
country: Switzerland
facility: Insel Gruppe AG
city: Southwest
country: Switzerland
facility: Kantonsspital St. Gallen
city: Kaohsiung City
country: Taiwan
facility: Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital CMUH
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital (VGHTC)
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital NTUH
city: Taoyuan City
country: Taiwan
facility: Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital
city: Yenimahalle
country: Turkey
facility: Gazi University Hospital
state: Ankara
city: Ankara
country: Turkey
facility: Hacettepe University School Of Medicine
city: Antalya
country: Turkey
facility: Akdeniz University Medical Faculty
city: Istanbul
country: Turkey
facility: Local Institution - 0086
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Medical School
city: Southampton
country: United Kingdom
facility: Southampton General Hospital - University Hospital Southampton NHS Foundation Trust
state: Hampshire
city: Newcastle Upon Tyne
country: United Kingdom
facility: Local Institution - 0053
state: Tyne And Wear
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
state: West Midlands
city: Birmingham
country: United Kingdom
facility: University of Birmingham - Queen Elizabeth Hospital
city: Cannock
country: United Kingdom
facility: Cannock Chase Hospital
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: