A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)
- Conditions
- Systemic Lupus Erythematosus
- Interventions
- Other: PlaceboDrug: Deucravacitinib
- Registration Number
- NCT05617677
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 490
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 2: Placebo Placebo - Arm 1: Deucravacitinib Deucravacitinib -
- Primary Outcome Measures
Name Time Method Proportion of participants who achieve Systemic Lupus Erythematosus Responder Index-4 [SRI(4)] response At week 52
- Secondary Outcome Measures
Name Time Method Number of participants with AEs leading to discontinuation of treatment Up to 156 weeks Number of participants with target adverse events of special interest (AESIs) Up to 156 weeks Number of participants with electrocardiogram (ECG) abnormalities Up to 156 weeks Proportion of participants who achieve British Isles Lupus Assessment Group-based Combined Lupus Assessment (BICLA) response At week 52 Proportion of participants who achieve both SRI(4) and BICLA (dual responders) At week 52 Proportion of participants taking ≤ 7.5 mg/day prednisone (or equivalent) at Week 24 with no dose increase beyond protocol-specified limits Up to 52 weeks Proportion of participants who achieve Lupus Low Disease Activity State (LLDAS) At week 52 Number of participants with adverse events (AEs) Up to 156 weeks Proportion of participants with ≥ 6 active (tender + swollen) joints at baseline who achieve at least 50% from baseline reduction in active (tender + swollen) joints At week 52 Change from baseline in patient-reported fatigue according to Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue At week 52 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 At week 52 Number of participants with serious adverse events (SAEs) Up to 156 weeks Number of participants with AEs leading to study discontinuation Up to 156 weeks Number of participants with laboratory abnormalities Up to 156 weeks Number of participants with vital sign abnormalities Up to 156 weeks
Trial Locations
- Locations (199)
Hightech Medical Services SRL-Centrul pentru Studiul Metabolismului
🇷🇴Bucharest, București, Romania
Local Institution - 0073
🇵🇹Lisbon, Portugal
Nouvelle Clinical Research
🇺🇸Cutler Bay, Florida, United States
Local Institution - 0227
🇺🇸Des Plaines, Illinois, United States
Local Institution - 0130
🇮🇪Cork, Ireland
Local Institution - 0157
🇮🇪Dublin, Ireland
Local Institution - 0172
🇮🇪Dublin, Ireland
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
The University of Arizona Arthritis Center
🇺🇸Tucson, Arizona, United States
Kaiser Permanente
🇺🇸Fontana, California, United States
Private Practice - Dr. Chandrakant V. Mehta
🇺🇸Hemet, California, United States
Arthritis & Osteoporosis Medical Center - La Palma
🇺🇸La Palma, California, United States
UCLA Clinical & Translational Research Center (CTRC)
🇺🇸Los Angeles, California, United States
Private Practice - Dr. Hans Richard Barthel
🇺🇸Santa Barbara, California, United States
Denver Arthritis Clinic
🇺🇸Denver, Colorado, United States
Yale New Haven Hospital-Smilow Cancer Center
🇺🇸New Haven, Connecticut, United States
Rheumatology Assoc. Of South Florida
🇺🇸Boca Raton, Florida, United States
University of Florida College of Medicine
🇺🇸Gainesville, Florida, United States
University of Miami Hospital and Clinics, Sylvester Cancer Center
🇺🇸Miami, Florida, United States
Omega Research Group - Orlando
🇺🇸Orlando, Florida, United States
West Broward Rheumatology Associates
🇺🇸Tamarac, Florida, United States
Genesis Clinical Research, LLC
🇺🇸Tampa, Florida, United States
Baycare Medical Group
🇺🇸Tampa, Florida, United States
Piedmont West
🇺🇸Atlanta, Georgia, United States
North Georgia Rheumatology
🇺🇸Lawrenceville, Georgia, United States
Local Institution - 0077
🇺🇸Schaumburg, Illinois, United States
Local Institution - 0108
🇺🇸Indianapolis, Indiana, United States
Lake Cumberland Rheumatology
🇺🇸New Albany, Indiana, United States
Local Institution - 0225
🇺🇸New Orleans, Louisiana, United States
Local Institution - 0006
🇺🇸Detroit, Michigan, United States
Saint Paul Rheumatology
🇺🇸Eagan, Minnesota, United States
Atlantic Health System Overlook Medical Center
🇺🇸Summit, New Jersey, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
The Feinstein Institute for Medical Research
🇺🇸Manhasset, New York, United States
NYU Langone Health
🇺🇸New York, New York, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Carolinas HealthCare System SouthPark
🇺🇸Charlotte, North Carolina, United States
Local Institution - 0003
🇺🇸Memphis, Tennessee, United States
Arthritis and Rheumatology Research Institute
🇺🇸Allen, Texas, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Local Institution - 0088
🇺🇸Fort Worth, Texas, United States
Local Institution - 0219
🇺🇸Lubbock, Texas, United States
Advanced Rheumatology of Houston - Woodlands
🇺🇸The Woodlands, Texas, United States
Carilion Clinic
🇺🇸Roanoke, Virginia, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
University of Washington Medical Center - Montlake
🇺🇸Seattle, Washington, United States
Local Institution - 0063
🇺🇸Franklin, Wisconsin, United States
Instituto De Investigaciones Clinicas Quilmes
🇦🇷Quilmes, Buenos Aires, Argentina
Fundacion Cidea
🇦🇷Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
APRILLUS Asistencia e Investigacion Clinica
🇦🇷Caba, Ciudad Autónoma De Buenos Aires, Argentina
Investigaciones Clínicas Tucumán
🇦🇷San Miguel de Tucuman, Tucumán, Argentina
Private Practice - Dr. Mariana Natalia Rivera
🇦🇷Buenos Aires, Argentina
Hospital Británico de Buenos Aires
🇦🇷Buenos Aires, Argentina
Hospital J. M. Ramos Mejía
🇦🇷Ciudad Autónoma de Buenos Aires, Argentina
Hospital Córdoba
🇦🇷Córdoba, Argentina
Santa Casa de Misericordia de Belo Horizonte
🇧🇷Belo Horizonte, Minas Gerais, Brazil
Instituto de Reumatología
🇦🇷Mendoza, Argentina
Local Institution - 0224
🇧🇷Salvador, Bahia, Brazil
Hospital Brasilia
🇧🇷Lago sul, Distrito Federal, Brazil
Cmip-Centro Mineiro de Pesquisa
🇧🇷Juiz de Fora, Minas Gerais, Brazil
Hospital Universitário Evangélico Mackenzie
🇧🇷Curitiba, Paraná, Brazil
Local Institution - 0075
🇧🇷Niteroi, Rio De Janeiro, Brazil
Hospital São Lucas da PUCRS
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Clinica Medica Bonfiglioli
🇧🇷Campinas, São Paulo, Brazil
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) - HCFMRP
🇧🇷Ribeirão Preto, São Paulo, Brazil
Hospital do Rim e Hipertensão
🇧🇷Sao Paulo, São Paulo, Brazil
Hospital de Base de São José do Rio Preto
🇧🇷São José do Rio Preto, São Paulo, Brazil
Hospital Universitário Pedro Ernesto
🇧🇷Rio de Janeiro, Brazil
Hospital das Clinicas FMUSP
🇧🇷São Paulo, Brazil
Local Institution - 0048
🇧🇷São Paulo, Brazil
Medical Center Artmed
🇧🇬Plovdiv, Bulgaria
Local Institution - 0217
🇧🇬Sofia, Bulgaria
ACIBADEM City Clinic Diagnostic-Consultative Center
🇧🇬Sofia, Bulgaria
University of Calgary, Cumming School of Medicine
🇨🇦Calgary, Alberta, Canada
Local Institution - 0160
🇨🇦Hamilton, Ontario, Canada
St. Joseph's Health Care
🇨🇦London, Ontario, Canada
Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada
Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski
🇨🇦Rimouski, Quebec, Canada
The First Afflilated Hospital of Bengbu Medical College
🇨🇳Bengbu, Anhui, China
Beijing Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
The First Affiliated hospital of Xiamen University
🇨🇳Xiamen, Fujian, China
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
ShenZhen People's Hospital
🇨🇳Shenzhen, Guangdong, China
Local Institution - 0153
🇨🇳Baoding, Hebei, China
The First Affiliated Hospital of Henan University of Science &Technology
🇨🇳Luoyang, Henan, China
The First Affiliated Hospital of Zhengzhou Universtiy
🇨🇳Zhengzhou, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Xiangya Hospital Central South University
🇨🇳Changsha, Hunan, China
ZhuZhou Central Hospital
🇨🇳Zhuzhou, Hunan, China
Local Institution - 0059
🇨🇳Baotou, Inner Mongolia, China
The Affiliated Hospital of Inner Mongolia Medical University
🇨🇳Hohhot, Inner Mongolia, China
The First People's Hospital of Changzhou
🇨🇳Changzhou, Jiangsu, China
Jiu Jiang No.1 People's Hospital
🇨🇳Jiujiang, Jiangxi, China
Local Institution - 0071
🇨🇳Nanchang, Jiangxi, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
The Second Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Jiangxi Pingxiang People's Hospital
🇨🇳Pingxiang, Jiangxi, China
The First Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Shengjing Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Local Institution - 0149
🇨🇳Jinan, Shandong, China
Ruijin Hospital Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Huashan Hospital, Fudan University
🇨🇳Shanghai, Shanghai, China
West China Hospital, Sichuan University
🇨🇳Cheng Du, Sichuan, China
Local Institution - 0053
🇨🇳Tianjin, Tianjin, China
People's Hospital of Xinjiang Uygur Autonomous Region
🇨🇳Urumqi, Xinjiang, China
The first Affiliated Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Wenzhou People's Hospital
🇨🇳Wenzhou, Zhejiang, China
Renji Hospital Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, China
Shanxi Bethune Hospital
🇨🇳Taiyuan, China
Salud SURA Industriales
🇨🇴Medellín, Antioquia, Colombia
Centro Integral de Reumatología del Caribe
🇨🇴Barranquilla, Atlántico, Colombia
Servimed EU
🇨🇴Bucaramanga, Santander, Colombia
Cireem Sas
🇨🇴Bogotá, Colombia
Hospital Universitario San Ignacio
🇨🇴Bogotá, Colombia
IPS Centro Médico Julián Coronel S.A.S
🇨🇴Cali, Colombia
Local Institution - 0058
🇨🇴Cali, Colombia
Preventive Care
🇨🇴Chía, Colombia
Local Institution - 0055
🇨🇴Medellin, Colombia
Nouvel Hôpital Civil (NHC)
🇫🇷Strasbourg, Alsace, France
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
🇫🇷Nantes, Loire-Atlantique, France
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
🇫🇷Le Kremlin-Bicêtre, France
Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau
🇫🇷Tours, France
Universitaetsklinikum Tuebingen
🇩🇪Tübingen, Baden-Württemberg, Germany
Klinikum der Ludwig-Maximilians-Universitaet Muenchen
🇩🇪Muenchen, Bayern, Germany
Universitaetsklinikum Carl Gustav Carus Dresden
🇩🇪Dresden, Sachsen, Germany
Local Institution - 0151
🇩🇪Lübeck, Schleswig-Holstein, Germany
DRK-Krankenhaus Rabenstein
🇩🇪Chemnitz, Germany
Universitaetsklinikum Erlangen
🇩🇪Erlangen, Germany
Universitaetsklinikum Koeln
🇩🇪Köln, Germany
Klinische Forschung im medizinischen Versorgungalltag GbR
🇩🇪Planegg, Germany
Tuen Mun Hospital
🇭🇰Tuen Mun, Hong Kong
Local Institution - 0213
🇮🇳Vizianagaram, Andhra Pradesh, India
Local Institution - 0200
🇮🇳Ahmedabad, Gujarat, India
Local Institution - 0208
🇮🇳Gurugram, Haryana, India
Local Institution - 0202
🇮🇳Bengaluru, Karnataka, India
Local Institution - 0222
🇮🇳Hyderabad, Telangana, India
Local Institution - 0205
🇮🇳Hyderabad, Telangana, India
Local Institution - 0119
🇮🇪Manorhamilton, Leitrim, Ireland
AOU Policlinico Umberto I
🇮🇹Roma, Lazio, Italy
Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO
🇮🇹Milano, Lombardia, Italy
Azienda Ospedaliera Universitaria Pisana
🇮🇹Pisa, Toscana, Italy
Azienda Ospedale - Università Padova
🇮🇹Padova, Veneto, Italy
Azienda Ospedaliera Spedali Civili di Brescia
🇮🇹Brescia, Italy
Local Institution - 0072
🇮🇹Milano, Italy
AOU della Campania Luigi Vanvitelli
🇮🇹Napoli, Italy
Local Institution - 0118
🇮🇹Pavia, Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma
🇮🇹Verona, Italy
Local Institution - 0102
🇰🇷Gwangju-si, Kwangju-Kwangyǒkshi, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon, Kyǒnggi-do, Korea, Republic of
The Catholic Univ. of Korea Seoul St. Mary's Hospital
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Local Institution - 0105
🇰🇷Jung-gu, Taegu-Kwangyǒkshi, Korea, Republic of
Local Institution - 0106
🇰🇷Jung-gu, Taejǒn-Kwangyǒkshi, Korea, Republic of
Hanyang University Seoul Hospital
🇰🇷Seoul, Korea, Republic of
Hospital of Lithuanian University of Health Sciences Kauno klinikos
🇱🇹Kaunas, Kauno Apskritis, Lithuania
Centro Medico del Angel
🇲🇽Mexicali, Baja California, Mexico
Boca Clinical Trials Mexico SC
🇲🇽Puebla, Mexico
Local Institution - 0027
🇲🇽Mexico City, Distrito Federal, Mexico
Instituto para el DeSarrollo Integral de la Salud S de RL de CV
🇲🇽Mexico City, Distrito Federal, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
🇲🇽Mexico City, Distrito Federal, Mexico
Clinstile, S.A. de C.V.
🇲🇽Mexico, Distrito Federal, Mexico
Hospital Aranda de La Parra
🇲🇽Leon, Guanajuato, Mexico
Local Institution - 0024
🇲🇽Zapopan, Jalisco, Mexico
Investigacion y Biomedicina de Chihuahua
🇲🇽Chihuahua, Mexico
Local Institution - 0014
🇲🇽Mexico City, Mexico
Hogar Clínica San Juan de Dios
🇵🇪Arequipa, Peru
Instituto Peruano del Hueso y la Articulación
🇵🇪Lima, Peru
Centro Medico CORPAC
🇵🇪Lima, Peru
Investigaciones Clínicas / Instituto de Ginecología y Reproducción
🇵🇪Lima, Peru
Local Institution - 0196
🇵🇱Wroclaw, Dolnośląskie, Poland
Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
Mak-Med Clinic Sp. Z O.O.
🇵🇱Nadarzyn, Mazowieckie, Poland
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji
🇵🇱Warsaw, Mazowieckie, Poland
Rheuma Medicus Sp. z o.o.
🇵🇱Warszawa, Mazowieckie, Poland
Local Institution - 0194
🇵🇱Wolomin, Mazowieckie, Poland
Centrum Medyczne Plejady
🇵🇱Krakow, Małopolskie, Poland
Medyczne Centrum Hetmańska
🇵🇱Poznan, Wielkopolskie, Poland
Local Institution - 0030
🇵🇱Poznań, Wielkopolskie, Poland
Nova Reuma Społka Partnerska
🇵🇱Bialystok, Poland
Synexus Polska Sp. z o.o. Oddzial w Poznaniu
🇵🇱Poznan, Poland
Local Institution - 0211
🇵🇱Belchatow, Łódzkie, Poland
Centrum Medyczne Pratia Katowice
🇵🇱Katowice, Śląskie, Poland
Centro Reumatologico Caguas
🇵🇷Caguas, Puerto Rico
GCM Medical Group, PSC - Hato Rey Site
🇵🇷San Juan, Puerto Rico
Hiperdia Piața Sudului
🇷🇴Bucharest, Bucureşti, Romania
Spital Clinic Sf. Maria
🇷🇴Bucharest, București, Romania
Delta Health Care
🇷🇴Bucharest, București, Romania
Spitalul Clinic Colentina
🇷🇴Bucuresti, București, Romania
CCBR Clinical Research
🇷🇴Bucuresti, București, Romania
Medisof Diagnostic SR
🇷🇴Craiova, Dolj, Romania
RK Medcenter
🇷🇴Iasi, Iași, Romania
Sc Medaudio-Optica Srl
🇷🇴Râmnicu Vâlcea, Vâlcea, Romania
Private Practice - Dr. Carina Anna Triff
🇷🇴Timisoara, Romania
Local Institution - 0207
🇸🇰Svidnik, Prešovský Kraj, Slovakia
Local Institution - 0206
🇸🇰Martin, Žilinský Kraj, Slovakia
Gazi University Health Research and Application Center Gazi Hospital
🇹🇷Ankara, Turkey
Istanbul University Cerrahpasa Medical School Internal Diseases Institute
🇹🇷Istanbul, Turkey
Kocaeli Üniversitesi
🇹🇷Kocaeli, Turkey