Clinical trial NCT05617677: A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Active Systemic Lupus Erythematosus (SLE) (POETYK SLE-1)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Systemic Lupus Erythematosus
Keywords: Autoimmune Diseases
Immune System Diseases
Connective Tissue Diseases
Immune-mediated Diseases
Active Systemic Lupus Erythematosus
Lupus
SLE
Deucravacitinib
Tyk2
POETYK
POETYK SLE
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-11-15
Enrollment: 490
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 evaluate the effectiveness and safety of deucravacitinib compared with placebo in an active moderate to severe Systemic Lupus Erythematosus (SLE) population.


Eligibility criteria: Inclusion Criteria

* Diagnosed with Systemic Lupus Erythematosus (SLE) at least 24 weeks before the screening visit.
* Meet the European Alliance of Associations for Rheumatology (EULAR)/American College of Rheumatology (ACR) 2019 classification criteria for SLE.
* One of the following: positive antinuclear antibodies (ANA) ≥ 1:80 at screening OR positive anti dsDNA OR positive anti Smith (anti Sm) as determined by the central laboratory at screening.
* Total Systemic Lupus Erythematosus Disease Activity Index-2K (SLEDAI-2K) score ≥ 6 points and clinical SLEDAI 2K score ≥ 4 points with joint involvement, and/or cutaneous vasculitis, and/or rash.
* Lupus headache, alopecia, organic brain syndrome, and mucosal ulcers must be recorded on SLEDAI 2K, if indicated, but do not count toward the points required for screening at entry.
* At least one SLE background therapy (immunosuppressant and/or antimalarial) is required for ≥ 12 weeks before the screening visit, must be at a stable dose for ≥ 8 weeks before the screening visit, and must remain stable until randomization and throughout study participation.
* Oral corticosteroid (OCS; prednisone or equivalent) background therapy is permitted but not required. For participants taking OCS, the dose must be stable for ≥ 2 weeks before the screening visit, cannot exceed 30 mg/day at screening, and must remain stable until the Week 4 visit. Participants can be on an OCS as well as an antimalarial and/or an immunosuppressant.

Exclusion Criteria

* Diagnosis of drug-induced SLE rather than idiopathic SLE.
* Other autoimmune diseases (eg, multiple sclerosis, psoriasis, inflammatory bowel disease, etc.) are excluded. Participants with type I autoimmune diabetes mellitus, thyroid autoimmune disease, Celiac disease, or secondary Sjögren's syndrome are not excluded.
* SLE overlap syndromes including, but not limited to, rheumatoid arthritis, scleroderma, and mixed connective tissue disease are excluded.
* Active or unstable lupus neuropsychiatric manifestations, including, but not limited to, any condition defined by BILAG A criteria.
* Active, severe Class III, and IV, lupus nephritis that requires or may require treatment with cytotoxic agents or high-dose CS.
* History of congenital or acquired immunodeficiency.
* Known active infection, or any major episode of infection requiring hospitalization or treatment with parenteral (intramuscular or IV) antimicrobial agents (eg, antibiotics antiviral, antifungal, or antiparasitic agents) within 30 days of randomization, or treatment with oral antimicrobial agents within 2 weeks of randomization.
* Currently on any therapy for chronic infection (eg, pneumocystis, herpes zoster, cytomegalovirus, invasive bacterial or fungal infections, or atypical mycobacteria).
* Taking more than 1 immunosuppressant at screening.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcomes:
measure: Proportion of participants who achieve Systemic Lupus Erythematosus Responder Index-4 [SRI(4)] response
timeFrame: At week 52
Secondary outcomes:
measure: Proportion of participants who achieve British Isles Lupus Assessment Group-based Combined Lupus Assessment (BICLA) response
timeFrame: At week 52
measure: Proportion of participants who achieve both SRI(4) and BICLA (dual responders)
timeFrame: At week 52
measure: Proportion of participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score ≥ 10 at baseline who achieve a CLASI response, defined as a decrease of ≥ 50% from baseline CLASI activity score
timeFrame: At week 52
measure: Proportion of participants who achieve Lupus Low Disease Activity State (LLDAS)
timeFrame: At week 52
measure: Proportion of participants taking ≤ 7.5 mg/day prednisone (or equivalent) at Week 24 with no dose increase beyond protocol-specified limits
timeFrame: Up to 52 weeks
measure: Proportion of participants with ≥ 6 active (tender + swollen) joints at baseline who achieve at least 50% from baseline reduction in active (tender + swollen) joints
timeFrame: At week 52
measure: Change from baseline in patient-reported fatigue according to Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
timeFrame: At week 52
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 156 weeks
measure: Number of participants with serious adverse events (SAEs)
timeFrame: Up to 156 weeks
measure: Number of participants with AEs leading to discontinuation of treatment
timeFrame: Up to 156 weeks
measure: Number of participants with AEs leading to study discontinuation
timeFrame: Up to 156 weeks
measure: Number of participants with target adverse events of special interest (AESIs)
timeFrame: Up to 156 weeks
measure: Number of participants with laboratory abnormalities
timeFrame: Up to 156 weeks
measure: Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to 156 weeks
measure: Number of participants with vital sign abnormalities
timeFrame: Up to 156 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Local Institution - 0229
state: Arizona
city: Phoenix
country: United States
facility: Local Institution - 0230
state: Arizona
city: Tucson
country: United States
facility: The University of Arizona Arthritis Center
state: Arizona
city: Fontana
country: United States
facility: Kaiser Permanente
state: California
city: Hemet
country: United States
facility: Private Practice - Dr. Chandrakant V. Mehta
state: California
city: La Palma
country: United States
facility: Arthritis & Osteoporosis Medical Center - La Palma
state: California
city: Los Angeles
country: United States
facility: UCLA Clinical & Translational Research Center (CTRC)
state: California
city: Santa Barbara
country: United States
facility: Private Practice - Dr. Hans Richard Barthel
state: California
city: Denver
country: United States
facility: Local Institution - 0099
state: Colorado
city: New Haven
country: United States
facility: Yale New Haven Hospital-Smilow Cancer Center
state: Connecticut
city: Boca Raton
country: United States
facility: Rheumatology Assoc. Of South Florida
state: Florida
city: Cutler Bay
country: United States
facility: Nouvelle Clinical Research
state: Florida
city: Gainesville
country: United States
facility: University of Florida College of Medicine
state: Florida
city: Miami
country: United States
facility: University of Miami Hospital and Clinics, Sylvester Cancer Center
state: Florida
city: Orlando
country: United States
facility: Omega Research Group - Orlando
state: Florida
city: Tamarac
country: United States
facility: West Broward Rheumatology Associates
state: Florida
city: Tampa
country: United States
facility: Genesis Clinical Research, LLC
state: Florida
city: Tampa
country: United States
facility: Local Institution - 0165
state: Florida
city: Atlanta
country: United States
facility: Piedmont West
state: Georgia
city: Lawrenceville
country: United States
facility: Local Institution - 0228
state: Georgia
city: Lawrenceville
country: United States
facility: Local Institution - 0234
state: Georgia
city: Lawrenceville
country: United States
facility: North Georgia Rheumatology
state: Georgia
city: Morton Grove
country: United States
facility: IBJI Morton Grove
state: Illinois
city: Schaumburg
country: United States
facility: Greater Chicago Specialty Physicians
state: Illinois
city: Indianapolis
country: United States
facility: Local Institution - 0108
state: Indiana
city: New Albany
country: United States
facility: Lake Cumberland Rheumatology
state: Indiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Detroit
country: United States
facility: Local Institution - 0006
state: Michigan
city: Eagan
country: United States
facility: Saint Paul Rheumatology
state: Minnesota
city: Summit
country: United States
facility: Atlantic Health System Overlook Medical Center
state: New Jersey
city: Bronx
country: United States
facility: Local Institution - 0159
state: New York
city: Manhasset
country: United States
facility: The Feinstein Institute for Medical Research
state: New York
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Charlotte
country: United States
facility: Carolinas HealthCare System SouthPark
state: North Carolina
city: Memphis
country: United States
facility: Local Institution - 0003
state: Tennessee
city: Allen
country: United States
facility: Arthritis and Rheumatology Research Institute
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Fort Worth
country: United States
facility: Local Institution - 0088
state: Texas
city: Lubbock
country: United States
facility: Local Institution - 0219
state: Texas
city: The Woodlands
country: United States
facility: Advanced Rheumatology of Houston - Woodlands
state: Texas
city: Roanoke
country: United States
facility: Carilion Clinic
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Seattle
country: United States
facility: Local Institution - 0139
state: Washington
city: Franklin
country: United States
facility: Local Institution - 0063
state: Wisconsin
city: Quilmes
country: Argentina
facility: Instituto De Investigaciones Clinicas Quilmes
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Fundacion Cidea
state: Ciudad Autónoma De Buenos Aires
city: Caba
country: Argentina
facility: APRILLUS Asistencia e Investigacion Clinica
state: Ciudad Autónoma De Buenos Aires
city: San Miguel de Tucuman
country: Argentina
facility: Investigaciones Clínicas Tucumán
state: Tucumán
city: Buenos Aires
country: Argentina
facility: Private Practice - Dr. Javier Gerardo Tartaglione
city: Buenos Aires
country: Argentina
facility: Hospital Británico de Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Local Institution - 0240
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Hospital J. M. Ramos Mejía
city: Córdoba
country: Argentina
facility: Hospital Córdoba
city: Mendoza
country: Argentina
facility: Instituto de Reumatología
city: Salvador
country: Brazil
facility: Local Institution - 0224
state: Bahia
city: Lago sul
country: Brazil
facility: Hospital Brasilia
state: Distrito Federal
city: Belo Horizonte
country: Brazil
facility: Santa Casa de Misericordia de Belo Horizonte
state: Minas Gerais
city: Juiz de Fora
country: Brazil
facility: Cmip-Centro Mineiro de Pesquisa
state: Minas Gerais
city: Curitiba
country: Brazil
facility: Hospital Universitário Evangélico Mackenzie
state: Paraná
city: Niteroi
country: Brazil
facility: Local Institution - 0075
state: Rio De Janeiro
city: Porto Alegre
country: Brazil
facility: Hospital São Lucas da PUCRS
state: Rio Grande Do Sul
city: Campinas
country: Brazil
facility: Clinica Medica Bonfiglioli
state: São Paulo
city: Ribeirão Preto
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) - HCFMRP
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Hospital do Rim e Hipertensão
state: São Paulo
city: São José do Rio Preto
country: Brazil
facility: Hospital de Base de São José do Rio Preto
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: Hospital Universitário Pedro Ernesto
city: São Paulo
country: Brazil
facility: Hospital das Clinicas FMUSP
city: São Paulo
country: Brazil
facility: Local Institution - 0048
city: Plovdiv
country: Bulgaria
facility: Medical Center Artmed
city: Sofia
country: Bulgaria
facility: MC Excelsior
city: Sofia
country: Bulgaria
facility: ACIBADEM City Clinic Diagnostic-Consultative Center
city: Calgary
country: Canada
facility: University of Calgary, Cumming School of Medicine
state: Alberta
city: Hamilton
country: Canada
facility: Local Institution - 0160
state: Ontario
city: London
country: Canada
facility: St. Joseph's Health Care
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Rimouski
country: Canada
facility: Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski
state: Quebec
city: Bengbu
country: China
facility: The First Afflilated Hospital of Bengbu Medical College
state: Anhui
city: Beijing
country: China
facility: Beijing Peking Union Medical College Hospital
state: Beijing
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: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guangdong
city: Shenzhen
country: China
facility: ShenZhen People's Hospital
state: Guangdong
city: Baoding
country: China
facility: Local Institution - 0153
state: Hebei
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science &Technology
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou Universtiy
state: Henan
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Zhuzhou
country: China
facility: ZhuZhou Central Hospital
state: Hunan
city: Baotou
country: China
facility: Local Institution - 0059
state: Inner Mongolia
city: Hohhot
country: China
facility: The Affiliated Hospital of Inner Mongolia Medical University
state: Inner Mongolia
city: Changzhou
country: China
facility: The First People's Hospital of Changzhou
state: Jiangsu
city: Jiujiang
country: China
facility: Jiu Jiang No.1 People's Hospital
state: Jiangxi
city: Nanchang
country: China
facility: Local Institution - 0071
state: Jiangxi
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Pingxiang
country: China
facility: Jiangxi Pingxiang People's Hospital
state: Jiangxi
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Jinan
country: China
facility: Local Institution - 0149
state: Shandong
city: Shanghai
country: China
facility: Ruijin Hospital Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University
state: Shanghai
city: Cheng Du
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Local Institution - 0053
state: Tianjin
city: Urumqi
country: China
facility: People's Hospital of Xinjiang Uygur Autonomous Region
state: Xinjiang
city: Hangzhou
country: China
facility: The first Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Wenzhou
country: China
facility: Wenzhou People's Hospital
state: Zhejiang
city: Shanghai
country: China
facility: Renji Hospital Shanghai Jiao Tong University School of Medicine
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital
city: Medellín
country: Colombia
facility: Salud SURA Industriales
state: Antioquia
city: Barranquilla
country: Colombia
facility: Centro Integral de Reumatología del Caribe
state: Atlántico
city: Bucaramanga
country: Colombia
facility: Servimed EU
state: Santander
city: Bogota
country: Colombia
facility: Hospital Universitario San Ignacio
city: Bogotá
country: Colombia
facility: Cireem Sas
city: Cali
country: Colombia
facility: IPS Centro Médico Julián Coronel S.A.S
city: Cali
country: Colombia
facility: Local Institution - 0058
city: Chia
country: Colombia
facility: Preventive Care
city: Medellin
country: Colombia
facility: Local Institution - 0055
city: Strasbourg
country: France
facility: Nouvel Hôpital Civil (NHC)
state: Alsace
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
state: Loire-Atlantique
city: Le Kremlin-Bicêtre
country: France
facility: Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
city: Tours
country: France
facility: Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau
city: Tübingen
country: Germany
facility: Universitaetsklinikum Tuebingen
state: Baden-Württemberg
city: Muenchen
country: Germany
facility: Klinikum der Ludwig-Maximilians-Universitaet Muenchen
state: Bayern
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus Dresden
state: Sachsen
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
state: Schleswig-Holstein
city: Chemnitz
country: Germany
facility: DRK-Krankenhaus Rabenstein
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen
city: Köln
country: Germany
facility: Universitaetsklinikum Koeln
city: Planegg
country: Germany
facility: Klinische Forschung im medizinischen Versorgungalltag GbR
city: Tuen Mun
country: Hong Kong
facility: Tuen Mun Hospital
city: Vizianagaram
country: India
facility: Local Institution - 0213
state: Andhra Pradesh
city: Ahmedabad
country: India
facility: Amber Clinic
state: Gujarat
city: Gurugram
country: India
facility: Medanta The Medicity
state: Haryana
city: Bengaluru
country: India
facility: ChanRe Rheumatology And Immunology Center And Research
state: Karnataka
city: Hyderabad
country: India
facility: ESIC Medical College
state: Telangana
city: Hyderabad
country: India
facility: Nizam's Institute of Medical Sciences
state: Telangana
city: Manorhamilton
country: Ireland
facility: Local Institution - 0119
state: Leitrim
city: Cork
country: Ireland
facility: Local Institution - 0130
city: Dublin
country: Ireland
facility: Local Institution - 0157
city: Dublin
country: Ireland
facility: Local Institution - 0172
city: Roma
country: Italy
facility: AOU Policlinico Umberto I
state: Lazio
city: Milano
country: Italy
facility: Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO
state: Lombardia
city: Pisa
country: Italy
facility: Azienda Ospedaliera Universitaria Pisana
state: Toscana
city: Padova
country: Italy
facility: Azienda Ospedale - Università Padova
state: Veneto
city: Brescia
country: Italy
facility: Azienda Ospedaliera Spedali Civili di Brescia
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Napoli
country: Italy
facility: AOU della Campania Luigi Vanvitelli
city: Pavia
country: Italy
facility: Local Institution - 0118
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma
city: Gwangju-si
country: Korea, Republic of
facility: Chonnam National University Hospital
state: Kwangju-Kwangyǒkshi
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Kyǒnggi-do
city: Seoul
country: Korea, Republic of
facility: The Catholic Univ. of Korea Seoul St. Mary's Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Jung-gu
country: Korea, Republic of
facility: Local Institution - 0105
state: Taegu-Kwangyǒkshi
city: Jung-gu
country: Korea, Republic of
facility: Local Institution - 0106
state: Taejǒn-Kwangyǒkshi
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kauno klinikos
state: Kauno Apskritis
city: Mexicali
country: Mexico
facility: Centro Medico del Angel
state: Baja California
city: Ciudad de México
country: Mexico
facility: Boca Clinical Trials Mexico SC
state: Distrito Federal
city: Mexico City
country: Mexico
facility: Local Institution - 0027
state: Distrito Federal
city: Mexico City
country: Mexico
facility: Instituto para el DeSarrollo Integral de la Salud S de RL de CV
state: Distrito Federal
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
state: Distrito Federal
city: Mexico
country: Mexico
facility: Clinstile, S.A. de C.V.
state: Distrito Federal
city: Leon
country: Mexico
facility: Hospital Aranda de La Parra
state: Guanajuato
city: Zapopan
country: Mexico
facility: Local Institution - 0024
state: Jalisco
city: Chihuahua
country: Mexico
facility: Investigacion y Biomedicina de Chihuahua
city: Mexico City
country: Mexico
facility: Local Institution - 0014
city: Puebla
country: Mexico
facility: Boca Clinical Trials Mexico SC
city: Chisinau
country: Moldova, Republic of
facility: Local Institution - 0237
state: Chișinău
city: Chisinau
country: Moldova, Republic of
facility: Local Institution - 0238
state: Chișinău
city: Chisinau
country: Moldova, Republic of
facility: Republican Clinical Hospital
city: Arequipa
country: Peru
facility: Hogar Clínica San Juan de Dios
city: Lima
country: Peru
facility: Instituto Peruano del Hueso y la Articulación
city: Lima
country: Peru
facility: Centro Medico CORPAC
city: Lima
country: Peru
facility: Investigaciones Clínicas / Instituto de Ginecología y Reproducción
city: Wroclaw
country: Poland
facility: Local Institution - 0196
state: Dolnośląskie
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy
state: Kujawsko-pomorskie
city: Nadarzyn
country: Poland
facility: Mak-Med Clinic Sp. Z O.O.
state: Mazowieckie
city: Warsaw
country: Poland
facility: Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji
state: Mazowieckie
city: Warszawa
country: Poland
facility: Rheuma Medicus Sp. z o.o.
state: Mazowieckie
city: Wolomin
country: Poland
facility: Local Institution - 0194
state: Mazowieckie
city: Krakow
country: Poland
facility: Centrum Medyczne Plejady
state: Małopolskie
city: Poznan
country: Poland
facility: Medyczne Centrum Hetmańska
state: Wielkopolskie
city: Poznań
country: Poland
facility: Local Institution - 0030
state: Wielkopolskie
city: Bialystok
country: Poland
facility: Nova Reuma Społka Partnerska
city: Poznan
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Poznaniu
city: Belchatow
country: Poland
facility: Local Institution - 0211
state: Łódzkie
city: Katowice
country: Poland
facility: Centrum Medyczne Pratia Katowice
state: Śląskie
city: Lisbon
country: Portugal
facility: Local Institution - 0073
city: Caguas
country: Puerto Rico
facility: Centro Reumatologico Caguas
city: San Juan
country: Puerto Rico
facility: GCM Medical Group, PSC - Hato Rey Site
city: Bucharest
country: Romania
facility: Hiperdia Piața Sudului
state: Bucureşti
city: Bucharest
country: Romania
facility: Hightech Medical Services SRL-Centrul pentru Studiul Metabolismului
state: București
city: Bucharest
country: Romania
facility: Spital Clinic Sf. Maria
state: București
city: Bucharest
country: Romania
facility: Delta Health Care
state: București
city: Bucuresti
country: Romania
facility: Spitalul Clinic Colentina
state: București
city: Bucuresti
country: Romania
facility: CCBR Clinical Research
state: București
city: Craiova
country: Romania
facility: Medisof Diagnostic SR
state: Dolj
city: Iasi
country: Romania
facility: RK Medcenter
state: Iași
city: Râmnicu Vâlcea
country: Romania
facility: Sc Medaudio-Optica Srl
state: Vâlcea
city: Timisoara
country: Romania
facility: Private Practice - Dr. Carina Anna Triff
city: Svidnik
country: Slovakia
facility: Local Institution - 0207
state: Prešovský Kraj
city: Martin
country: Slovakia
facility: Local Institution - 0206
state: Žilinský Kraj
city: Pretoria
country: South Africa
facility: Local Institution - 0232
state: GP
city: Cape Town
country: South Africa
facility: Local Institution - 0233
state: Western Cape
city: Stellenbosch
country: South Africa
facility: Local Institution - 0231
state: Western Cape
city: Ankara
country: Turkey
facility: Gazi University Health Research and Application Center Gazi Hospital
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Medical School Internal Diseases Institute
city: Kocaeli
country: Turkey
facility: Kocaeli Üniversitesi
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: