A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus Erythematosus
- Conditions
- Systemic Lupus Erythematosus
- Interventions
- Drug: DeucravacitinibOther: Placebo
- Registration Number
- NCT05620407
- 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 1: Deucravacitinib Deucravacitinib - Arm 2: Placebo Placebo -
- 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 target adverse events of special interest (AESIs) Up to 156 weeks Number of participants with laboratory abnormalities Up to 156 weeks 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 Number of participants with AEs leading to discontinuation of treatment Up to 156 weeks Proportion of participants who achieve British Isles Lupus Assessment Group-based Combined Lupus Assessment (BICLA) response At week 52 Change from baseline in patient-reported fatigue according to Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue At week 52 Number of participants with AEs leading to study discontinuation Up to 156 weeks Proportion of participants who achieve both SRI(4) and BICLA (dual responders) At week 52 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 Number of participants with adverse events (AEs) Up to 156 weeks Number of participants with serious adverse events (SAEs) Up to 156 weeks Number of participants with electrocardiogram (ECG) abnormalities Up to 156 weeks Number of participants with vital sign abnormalities Up to 156 weeks 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 Proportion of participants who achieve Lupus Low Disease Activity State (LLDAS) At week 52
Trial Locations
- Locations (192)
Local Institution - 0033
🇧🇷Curitiba, Brazil
UCSD - Altman Clinical and Translational Research Institute (ACTRI)
🇺🇸La Jolla, California, United States
Spectrum Medical, Inc.
🇺🇸Danville, Virginia, United States
East Bay Rheumatology Medical Group, Inc
🇺🇸San Leandro, California, United States
Providence Saint John's Medical Foundation
🇺🇸Santa Monica, California, United States
Clinical Research of West Florida, Inc. (Clearwater)
🇺🇸Clearwater, Florida, United States
UF Health Deerwood Park
🇺🇸Jacksonville, Florida, United States
Life Clinical Trials
🇺🇸Margate, Florida, United States
Clinical Research Center of Pompano
🇺🇸Pompano Beach, Florida, United States
Emory University School of Medicine- Grady Campus
🇺🇸Atlanta, Georgia, United States
Atlanta Research Center for Rheumatology
🇺🇸Marietta, Georgia, United States
Local Institution - 0089
🇺🇸Orland Park, Illinois, United States
Local Institution - 0041
🇺🇸Skokie, Illinois, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
University of Massachusetts Chan Medical School
🇺🇸Worcester, Massachusetts, United States
AA Medical Research Center-Grand Blanc
🇺🇸Grand Blanc, Michigan, United States
Mayo Clinic in Rochester, Minnesota
🇺🇸Rochester, Minnesota, United States
Local Institution - 0200
🇺🇸Las Vegas, Nevada, United States
Local Institution - 0216
🇺🇸Las Vegas, Nevada, United States
The Valley Hospital, Inc.
🇺🇸Paramus, New Jersey, United States
Joseph S. and Diane H. Steinberg Ambulatory Care Center
🇺🇸Brooklyn, New York, United States
Irving Goldman Family Care Center
🇺🇸Great Neck, New York, United States
Hospital for Special Surgery
🇺🇸New York, New York, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States
Local Institution - 0178
🇺🇸Charlotte, North Carolina, United States
University of Cincinnati Medical Center
🇺🇸Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Oklahoma Medical Research Foundation
🇺🇸Oklahoma City, Oklahoma, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
West Penn Allegheny Health
🇺🇸Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
West Tennessee Research Institute
🇺🇸Jackson, Tennessee, United States
Austin Regional Clinic
🇺🇸Austin, Texas, United States
Local Institution - 0001
🇺🇸Colleyville, Texas, United States
Texas Arthritis Center
🇺🇸El Paso, Texas, United States
Biopharma Informatic, LLC
🇺🇸Katy, Texas, United States
Baylor Scott & White Medical Center - Temple
🇺🇸Temple, Texas, United States
Sanatorio Guemes
🇦🇷Ciudad de Buenos Aires, Buenos Aires, Argentina
Hospital El Cruce
🇦🇷Florencio Varela, Buenos Aires, Argentina
Hospital Italiano de La Plata
🇦🇷La Plata, Buenos Aires, Argentina
Centro de Investigacion Pergamino S.A.
🇦🇷Pergamino, Buenos Aires, Argentina
Hospital Universitario Austral
🇦🇷Pilar, Buenos Aires, Argentina
Centro Dermatológico Schejtman
🇦🇷San Miguel, Buenos Aires, Argentina
CER medical Institute
🇦🇷Quilmes, Ciudad Autónoma De Buenos Aires, Argentina
Centro de Investigaciones Médicas Tucuman
🇦🇷SAN M. DE Tucuman, Tucumán, Argentina
Centro Integral de Reumatologia
🇦🇷San Miguel de Tucumán, Tucumán, Argentina
Local Institution - 0141
🇦🇷Río Cuarto, Argentina
Liverpool Hospital
🇦🇺Liverpool, New South Wales, Australia
BJC Health
🇦🇺Paramatta, New South Wales, Australia
Rheumatology Research Unit
🇦🇺Maroochydore, Queensland, Australia
Austin Health - Repatriation Hospital
🇦🇺Ivanhoe, Victoria, Australia
RK Will Pty Ltd
🇦🇺Victoria Park, Western Australia, Australia
CEDOES
🇧🇷Vitória, Espírito Santo, Brazil
Hospital Bruno Born
🇧🇷Lajeado, Rio Grande Do Sul, Brazil
Hospital de Clinicas de Porto Alegre
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Hospital Moinhos de Vento
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos
🇧🇷Barretos, São Paulo, Brazil
Local Institution - 0095
🇧🇷Santo André, São Paulo, Brazil
Centro Multidisciplinar de Estudos Clinicos
🇧🇷Sao Bernardo do Campo, São Paulo, Brazil
Hospital São Lucas de Copacabana
🇧🇷Rio de Janeiro, Brazil
Hospital Alemao Oswaldo Cruz
🇧🇷São Paulo, Brazil
Hospital 9 De Julho
🇧🇷São Paulo, Brazil
CEPIC - Centro Paulista de Investigação Clínica
🇧🇷São Paulo, Brazil
Diagnostic Consultative Centre (DCC) - Foкus 5
🇧🇬Sofia, Sofia (stolitsa), Bulgaria
University Hospital Kaspela Clinic of Rheumatology
🇧🇬Plovdiv, Bulgaria
Diagnostic Consultative Centre 1 Ruse
🇧🇬Ruse, Bulgaria
Local Institution - 0214
🇧🇬Sofia, Bulgaria
IC La Serena Research
🇨🇱La Serena, Coquimbo, Chile
Local Institution - 0099
🇨🇱Valdivia, Los Ríos, Chile
Estudios Clinicos CTR
🇨🇱Santiago, Región Metropolitana De Santiago, Chile
Biomedica Research Group
🇨🇱Santiago, Región Metropolitana De Santiago, Chile
Estudios Clinicos Limitada
🇨🇱Santiago, Región Metropolitana De Santiago, Chile
Local Institution - 0044
🇨🇱Santiago, Región Metropolitana De Santiago, Chile
Local Institution - 0098
🇨🇱Santiago, Región Metropolitana De Santiago, Chile
Pontificia Universidad Catolica de Chile
🇨🇱Santiago, Región Metropolitana De Santiago, Chile
Clínica Ensenada
🇨🇱Santiago, Región Metropolitana De Santiago, Chile
Local Institution - 0153
🇨🇱Santiago, Chile
INREA s.r.o.
🇨🇿Ostrava, Ostrava Město, Czechia
Revmatologicky ustav
🇨🇿Praha 2, Czechia
General Hospital of Athens Hippokratio
🇬🇷Athens, Attikí (Region), Greece
General Hospital of Athens "Laiko"
🇬🇷Athens, Attikí, Greece
University General Hospital of Larissa
🇬🇷Larissa, Thessalía, Greece
Pécsi Tudományegyetem Klinikai Központ
🇭🇺Pécs, Baranya, Hungary
Békés Vármegyei Központi Kórház Pándy Kálmán Tagkórház
🇭🇺Gyula, Békés, Hungary
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
🇭🇺Szeged, Csongrád, Hungary
Vital Medical Center
🇭🇺Veszprem, Veszprém City, Hungary
Local Institution - 0197
🇮🇳New Delhi, Delhi, India
Local Institution - 0209
🇮🇳Ahmedabad, Gujarat, India
Local Institution - 0191
🇮🇳Hubli, Karnataka, India
Local Institution - 0222
🇮🇳Mysore, Karnataka, India
Christian Medical College Vellore
🇮🇳Vellore, Tamil Nadu, India
Local Institution - 0204
🇮🇳Vellore, Tamil Nadu, India
Local Institution - 0199
🇮🇳Hyderabad, Telangana, India
Local Institution - 0053
🇯🇵Nagoya, Aichi, Japan
Local Institution - 0156
🇯🇵Nagoya, Aichi, Japan
Local Institution - 0083
🇯🇵Toyoake, Aichi, Japan
Local Institution - 0086
🇯🇵Eiheiji-cho,Yoshida-gun, Fukui, Japan
University of Occupational and Enviromental Health
🇯🇵Kitakyushu, Fukuoka, Japan
National Hospital Organization Asahikawa Medical Center
🇯🇵Asahikawa, Hokkaido, Japan
Hokkaido University Hospital
🇯🇵Sapporo, Hokkaido, Japan
Kagawa University Hospital
🇯🇵Kita, Kagawa, Japan
Local Institution - 0111
🇯🇵Sagamihara, Kanagawa, Japan
Yokohama City University Hospital
🇯🇵Yokohama, Kanagawa, Japan
Tohoku University Hospital
🇯🇵Sendai-shi, Miyagi, Japan
Sasebo Chuo Hospital
🇯🇵Sasebo, Nagasaki, Japan
Saitama Medical Center
🇯🇵Kawagoe, Saitama, Japan
Local Institution - 0171
🇯🇵Shimotsuga, Tochigi, Japan
Local Institution - 0046
🇯🇵Bunkyo-ku, Tokyo, Japan
Tokyo Medical and Dental University Hospital
🇯🇵Bunkyo-ku, Tokyo, Japan
Local Institution - 0045
🇯🇵Meguro-ku, Tokyo, Japan
Local Institution - 0064
🇯🇵Shinjyuku-ku, Tokyo, Japan
Local Institution - 0226
🇯🇵Toyoma, Toyama, Japan
National Hospital Organization Chibahigashi National Hospital
🇯🇵Chiba, Japan
Local Institution - 0227
🇯🇵Fukuoka, Japan
Fukushima Medical University
🇯🇵Fukushima, Japan
Local Institution - 0167
🇯🇵Gifu, Japan
Local Institution - 0126
🇯🇵Nagasaki, Japan
Local Institution - 0131
🇯🇵Niigata, Japan
Okayama University Hospital
🇯🇵Okayama, Japan
Osaka Metropolitan University Hospital
🇯🇵Osaka, Japan
St. Luke's International Hospital
🇯🇵Tokyo, Japan
Keio university hospital
🇯🇵Tokyo, Japan
Wakayama Medical University Hospital
🇯🇵Wakayama, Japan
CIMAB SA de CV
🇲🇽Torreón, Coahuila, Mexico
Local Institution - 0015
🇲🇽Cdmx, Distrito Federal, Mexico
RM Pharma Specialists
🇲🇽Mexico city, Distrito Federal, Mexico
CAIMED Investigacion en Salud
🇲🇽Mexico City, Distrito Federal, Mexico
Centro de Investigacion Farmacologica del Bajio SC
🇲🇽Leon, Guanajuato, Mexico
Boca Clinical Trials Mexico S.C.
🇲🇽Guadajalara, Jalisco, Mexico
Investigacion Biomedica para el Desarrollo de Fármacos S.A. de C.V.
🇲🇽Zapopan, Jalisco, Mexico
PanAmerican Clinical Research - Cuernavaca
🇲🇽Cuernavaca, Morelos, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
🇲🇽Monterrey, Nuevo LEON, Mexico
Local Institution - 0096
🇲🇽Chihuahua, Mexico
IMACEN S.A de C.V.
🇲🇽Chihuahua, Mexico
Oaxaca Site Management Organization
🇲🇽Oaxaca, Mexico
Local Institution - 0100
🇵🇪Lima, Peru
Instituto Peruano del Hueso y la Articulación
🇵🇪Lima, Peru
ACQ Medic SAC - Centro de Investigación Clinica Inmunoreumatología
🇵🇪Lima, Peru
Local Institution - 0093
🇵🇪Lima, Peru
Clinica San Juan Bautista
🇵🇪Lima, Peru
Clinica Medica Cayetano Heredia
🇵🇪Lima, Peru
Local Institution - 0218
🇵🇱Wroclaw, Dolnośląskie, Poland
Zespół Poradni Specjalistycznych Reumed Filia nr 1 Wallenroda
🇵🇱Lublin, Lubelskie, Poland
Local Institution - 0219
🇵🇱Warszawa, Mazowieckie, Poland
Synexus Polska Sp. z o.o. Oddzial w Warszawie
🇵🇱Warszawa, Mazowieckie, Poland
Futuremeds Targowek
🇵🇱Warszawa, Mazowieckie, Poland
Pratia MCM Krakow
🇵🇱Kraków, Małopolskie, Poland
Ambulatorium Sp. z o.o.
🇵🇱Elbląg, Warmińsko-mazurskie, Poland
Ortopedyczno-Rehabilitacyjny Szpital Kliniczny UM w Poznaniu
🇵🇱Poznan, Wielkopolskie, Poland
Centrum Wsparcia Badań Klinicznych Pomorskiego Uniwersytetu Medycznego w Szczecinie
🇵🇱Szczecin, Poland
MICS Centrum Medyczne Warszawa
🇵🇱Warszawa, Poland
Local Institution - 0031
🇵🇱Wroclaw, Poland
SOMED CR
🇵🇱Lodz, Łódzkie, Poland
M2M Med
🇵🇱Chorzów, Śląskie, Poland
Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria
🇵🇹Lisbon, Lisboa, Portugal
Centro Hospitalar de Vila Nova de Gaia/Espinho - Unidade I
🇵🇹Bila Nova De Gaia, Portugal
Instituto Portugues de Reumatologia
🇵🇹Lisbon, Portugal
Local Institution - 0073
🇵🇹Lisbon, Portugal
Latin Clinical Trial Center
🇵🇷San Juan, Puerto Rico
Singapore General Hospital
🇸🇬Singapore, Singapore
Local Institution - 0127
🇸🇬Singapore, Singapore
Hospital de Mérida
🇪🇸Mérida, Badajoz, Spain
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Barcelona [Barcelona], Spain
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Cantabria, Spain
Hospital Universitario Reina Sofia
🇪🇸Cordoba, Madrid, Spain
Local Institution - 0110
🇪🇸Bilbo, País Vasco, Spain
Local Institution - 0055
🇪🇸Vitoria-Gasteiz, País Vasco, Spain
Hospital Quironsalud Infanta Luisa
🇪🇸Sevilla, Spain
Hospital Universitario Rio Hortega
🇪🇸Valladolid, Spain
Hospital Universitari i Politecnic La Fe
🇪🇸València, Spain
Chang Gung Memorial Hospital at Kaohsiung
🇨🇳Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
Chung Shan Medical University Hospital
🇨🇳Taichung City, Taichung, Taiwan
China Medical University Hospital
🇨🇳Taichung, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
Chi Mei Medical Center
🇨🇳Tainan City, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Local Institution - 0207
🇹🇭Bangkok, Krung Thep Maha Nakhon, Thailand
Ramathibodi Hospital
🇹🇭Bangkok, Krung Thep Maha Nakhon, Thailand
Faculty of Medicine Siriraj Hospital
🇹🇭Bangkok, Krung Thep Maha Nakhon, Thailand
Hacettepe Universite Hastaneleri
🇹🇷Ankara, Turkey
Akdeniz Universitesi Hastanesi
🇹🇷Antalya, Turkey
NCR International Hospital
🇹🇷Gaziantep, Turkey
Local Institution - 0170
🇹🇷Istanbul, Turkey
Royal Free Hospital
🇬🇧London, England, United Kingdom
King's College Hospital
🇬🇧London, Greater London, United Kingdom
Guy's & St Thomas' NHS Foundation Trust
🇬🇧London, London, City Of, United Kingdom
James Cook University Hospital
🇬🇧Central Middlesbrough, Middlesbrough, United Kingdom
Local Institution - 0092
🇬🇧Bradford, United Kingdom
Oxford University Hospitals - Nuffield Orthopaedic Centre
🇬🇧Oxford, United Kingdom