A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus
NCT ID: NCT03616912
Last Updated: 2023-01-30
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
830 participants
INTERVENTIONAL
2018-08-02
2022-03-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Participants received two placebo tablets: one matching baricitinib 4 milligram (mg) and one matching baricitinib 2 mg administered orally every day (QD) for 52 weeks.
Placebo
Administered orally.
2 mg Baricitinib
Participants received one Baricitinib 2 mg tablet and one placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.
Baricitinib
Administered orally.
Placebo
Administered orally.
4 mg Baricitinib
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally every day (QD) for 52 weeks.
Baricitinib
Administered orally.
Placebo
Administered orally.
Placebo Maximum Extended Enrollment (MEE)
Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally QD for 52 weeks.
Placebo
Administered orally.
2 mg Baricitinib (MEE)
Participants received one Baricitinib 2 mg tablet and 1 placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.
Baricitinib
Administered orally.
Placebo
Administered orally.
4 mg Baricitinib (MEE)
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally every day (QD) for 52 weeks.
Baricitinib
Administered orally.
Placebo
Administered orally.
Interventions
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Baricitinib
Administered orally.
Placebo
Administered orally.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have documentation of having met at least 4 of 11 Revised Criteria for Classification of Systemic Lupus Erythematosus according to the 1997 Update of the 1982 American College of Rheumatology (ACR) criteria for classification of SLE prior to randomization.
* Have a positive antinuclear antibody (ANA) (titer ≥1:80) and/or a positive anti-double-stranded deoxyribonucleic acid (dsDNA), and/or a positive anti-Smith (anti-Sm) as assessed by a central laboratory during screening.
* Have a total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥6 during screening.
* Have a clinical SLEDAI-2K score ≥4 at randomization.
* Have at least 1 British Isles Lupus Assessment Group (BILAG) A score or 2 BILAG B scores during screening.
* Are receiving at least one of the following standard of care medications for SLE:
* A single antimalarial at a stable dose for at least 8 weeks prior to screening
* A single immunosuppressant at a stable dose for at least 8 weeks prior to screening
* An oral corticosteroid, initiated at least 4 weeks prior to screening, at a stable dose ≤40 milligrams/day prednisone (or equivalent) for at least 2 weeks prior to screening. If the participant is not receiving an antimalarial or immunosuppressant, the dose of corticosteroid must be ≥7.5 milligrams/day prednisone (or equivalent)
Exclusion Criteria
* Have active central nervous system (CNS) lupus.
* Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking investigational product or interfere with the interpretation of data.
* Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection.
* Have received cyclophosphamide (or any other cytotoxic agent) within 12 weeks prior to screening.
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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
Eli Lilly and Company
Locations
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Achieve Clinical Research, LLC
Birmingham, Alabama, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
Arizona Arthritis & Rheumatology Research, PLLC
Glendale, Arizona, United States
University of Arizona
Tucson, Arizona, United States
St. Joseph Heritage Medical Group
Fullerton, California, United States
MD Medical Corporation
Hemet, California, United States
ACRC Studies
Poway, California, United States
Office: Hans R Barthel M.D.
Santa Barbara, California, United States
Medvin Clinical Research - Weidmann
Whittier, California, United States
Denver Arthritis Clinic - Lowry
Denver, Colorado, United States
New England Research Associates
Bridgeport, Connecticut, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Arthritis and Rheumatic Disease
Aventura, Florida, United States
Rheumatology Associates of South Florida
Boca Raton, Florida, United States
Clinical Research of West Florida, Inc. (Clearwater)
Clearwater, Florida, United States
Arthritis and Rheumatology Center of South Florida
Margate, Florida, United States
Lakes Research, LLC
Miami Lakes, Florida, United States
Millennium Research
Ormond Beach, Florida, United States
IRIS Research and Development, LLC
Plantation, Florida, United States
ForCare Clinical Research
Tampa, Florida, United States
Piedmont Healthcare
Atlanta, Georgia, United States
Atlanta Center for Clinical Research
Atlanta, Georgia, United States
St Luke's Clinic - Intermountain Orthopaedics
Boise, Idaho, United States
Rockford Orthopedic Associates
Rockford, Illinois, United States
Henry Ford Health System
Detroit, Michigan, United States
Clinical Research Institute of Michigan, LLC
Saint Clair Shores, Michigan, United States
St. Louis Rheumatology
St Louis, Missouri, United States
Glacier View Research Institute - Endocrinology
Kalispell, Montana, United States
Allied Clinical Research
Reno, Nevada, United States
Albuquerque Center for Rheumatology
Albuquerque, New Mexico, United States
SUNY Health Science Center
Brooklyn, New York, United States
St. Lawrence Health System
Canton, New York, United States
Northwell Health
Great Neck, New York, United States
The Feinstein Institute for Medical Research
Manhasset, New York, United States
Columbia University Medical Center
New York, New York, United States
Buffalo Rheumatology
Orchard Park, New York, United States
Joint and Muscle Medical Care
Charlotte, North Carolina, United States
Medication Management, LLC
Greensboro, North Carolina, United States
PMG Research of Wilmington
Wilmington, North Carolina, United States
Cincinnati Arthritis Associates
Cincinnati, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Paramount Medical Research
Middleburg Heights, Ohio, United States
Arthritis & Rheumatology Center of Oklahoma PLLC
Oklahoma City, Oklahoma, United States
East Penn Rheumatology Associates
Bethlehem, Pennsylvania, United States
UPMC Lupus Center of Excellence
Pittsburgh, Pennsylvania, United States
West Tennessee Research Institute
Jackson, Tennessee, United States
Amarillo Center for Clinical Research
Amarillo, Texas, United States
Accurate Clinical Management
Baytown, Texas, United States
Dr. Dhiman Basu Private Practice
Colleyville, Texas, United States
Metroplex Clinical Research Center
Dallas, Texas, United States
Precision Comprehensive Clinical Research Solutions
Fort Worth, Texas, United States
Rheumatology Center of Houston
Houston, Texas, United States
Accurate Clinical Research
Houston, Texas, United States
Southwest Rheumatology, P.A.
Mesquite, Texas, United States
Accurate Clinical Research, Inc.
San Antonio, Texas, United States
Univ of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Arthritis Clinic Of Central Texas
San Marcos, Texas, United States
Spectrum Medical Inc.
Danville, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
Rheumatic Disease Center
Glendale, Wisconsin, United States
Emeritus Research
Botany, New South Wales, Australia
The Rheumatology Research Unit Sunshine Coast
Maroochydore, Queensland, Australia
Emeritus Research
Camberwell, Victoria, Australia
Monash Medical Centre
Clayton, Victoria, Australia
St Vincents Hospital Melbourne
Fitzroy, Victoria, Australia
Griffith University
Southport, , Australia
Ordensklinikum Linz GmbH Elisabethinen
Linz, Upper Austria, Austria
Medizinische Universität Graz
Graz, , Austria
Klinik Hietzing
Vienna, , Austria
Cliniques Universitaires Saint-Luc
Brussels, Brussels Capital, Belgium
UZ Leuven
Leuven, Vlaams Brabant, Belgium
CHU de Liège
Liège, , Belgium
SER - Serviços Especializados em Reumatologia da Bahia S/S - ME
Salvador, Estado de Bahia, Brazil
CIP-Centro Internacional de Pesquisa
Goiânia, Goiás, Brazil
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte, Minas Gerais, Brazil
Centro de Estudos em Terapias Inovadoras-CETI
Curitiba, Paraná, Brazil
EDUMED - Educação em Saúde Ltda.
Curitiba, Paraná, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
LMK Serviços Médicos S/S
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Clinicas UNICAMP
Campinas, São Paulo, Brazil
Oncovida- Centro de Onco-Hematologia de Mato Grosso
Cuiabá, , Brazil
Hospital Alemao Oswaldo Cruz
São Paulo, , Brazil
The First Affliated Hospital of Soochow University
Suzhou, China, China
First affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
First Affiliated Hospital of the Harbin Medical University
Harbin, Heilongjiang, China
The First Affiliated Hospital of Zhengzhou Universtiy
Zhengzhou, Henan, China
Wuhan Union Hospital
Wuhan, Hubei, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Jiangxi Pingxiang People's Hospital
Pingxiang, Jiangxi, China
China-Japan Union Hospital of Jilin University
Changchun, Jilin, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Ningbo First Hospital
Ningbo, Zhejiang, China
Peking University First Hospital
Beijing, , China
Beijing Peking Union Medical College Hospital
Beijing, , China
Shanghai Huashan Hospital Affil to Fu Dan University
Shanghai, , China
China Medical University (CMU) - First Affiliated Hospital
Shenyang, , China
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, , China
Klinicki Bolnicki Centar Rijeka
Rijeka, , Croatia
University Hospital Split
Split, , Croatia
Clinical Hospital Dubrava
Zagreb, , Croatia
Revmatologicky ustav
Prague, Praha, Hlavní Mešto, Czechia
Revmatologie.s.r.o.
Brno, , Czechia
Fakultni nemocnice Olomouc
Olomouc, , Czechia
ARTHROHELP s.r.o.
Pardubice, , Czechia
Vseobecna fakultni nemocnice
Prague, , Czechia
Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Universitätsklinikum Tübingen
Tübingen, Baden-Wurttemberg, Germany
Klinikum der Universität München
München, Bavaria, Germany
Universitätsklinikum Würzburg A. ö. R.
Würzburg, Bavaria, Germany
Universitätsklinikum Köln
Cologne, North Rhine-Westphalia, Germany
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz
Mainz, Rhineland-Palatinate, Germany
Universitätsklinikum Carl Gustav Carus
Dresden, Saxony, Germany
Universität Leipzig - Universitätsklinikum
Leipzig, Saxony, Germany
Charité Universitätsmedizin Berlin Campus Buch
Berlin, , Germany
Immanuel Krankenhaus Rheuma Klinik Berlin Buch
Berlin, , Germany
Schlosspark Klinik
Berlin, , Germany
Gen Hospital of Athens G Gennimatas
Athens, Attica, Greece
University General Hospital of Heraklion
Heraklion, Crete, Greece
University General Hospital of Larissa
Larissa, , Greece
Euromedica Kyanous Stavros General Hospital
Thessaloniki, , Greece
Hippokration University Hopsital
Thessaloniki, , Greece
Bekes Megyei Pandy Kalman Korhaz
Gyula, Bekes County, Hungary
Vital Medical Center
Veszprém, Veszprém City, Hungary
Budai Irgalmasrendi Korhaz
Budapest, , Hungary
Qualiclinic Kft
Budapest, , Hungary
Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointeze
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont Reumatologiai Tanszek
Debrecen, , Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs, , Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont I. Belgyogyaszati Klinika
Szeged, , Hungary
Vita Verum Egeszsegugyi Szolgaltato Bt
Székesfehérvár, , Hungary
Meir Medical Center
Kfar Saba, , Israel
Chaim Sheba Medical Center
Ramat Gan, , Israel
Carmel Hospital
Haifa, Ḥeifā, Israel
CIMAB SA de CV
Torreón, Coahuila, Mexico
Morales Vargas Centro de Investigacion, S.C.
León, Guanajuato, Mexico
Centro Integral en Reumatologia SA de CV
Guadalajara, Jalisco, Mexico
Clinica de Investigacion en Reumatologia y Obesidad S. C.
Guadalajara, Jalisco, Mexico
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares
Guadalajara, Jalisco, Mexico
Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.
Zapopan, Jalisco, Mexico
Cliditer Sa de CV
Mexico City, Mexico City, Mexico
Hospital Angeles Lindavista
Mexico City, Mexico City, Mexico
Centro Peninsular de Investigacion S.C.P
Mérida, Yucatán, Mexico
Köhler & Milstein Research
Mérida, Yucatán, Mexico
Cemdeicy S.C.P.
Mérida, Yucatán, Mexico
Clinosar Mexico S.A. de C.V
Mexico City, , Mexico
Centro de Investigación y Tratamiento Reumatológico S.C
Mexico City, , Mexico
Centro de Alta Especialidad Reumatologia e Inv Potosi, S.C.
San Luis Potosí City, , Mexico
Medische Centrum Leeuwarden
Leeuwarden, Provincie Friesland, Netherlands
Vrije Universiteit Medisch Centrum Amsterdam
Amsterdam, , Netherlands
LLC MK Med
Saint Petersburg, Sankt-Peterburg, Russia
Chelyabinsk Regional Clinical Hospital
Chelyabinsk, , Russia
City Hospital # 7
Kazan', , Russia
Regional Clinical Hospital
Kursk, , Russia
Russian State Medical University
Moscow, , Russia
City Clinical Hospital 1 named after N.I. Pirogov
Moscow, , Russia
Rheumatology Institute RAMS
Moscow, , Russia
Healthy Family
Novosibirsk, , Russia
Reafan
Novosibirsk, , Russia
Institute of Cytology and Genetics of Siberian Branch of Russian Academy of Medical Sciences
Novosibirsk, , Russia
Regional Hospital - Omsk
Omsk, , Russia
Orenburg State Medical Academy of Roszdrav
Orenburg, , Russia
Ryazan State Medical University
Ryazan, , Russia
Russian Medical Military Academy n.a. S.M. Kirov
Saint Petersburg, , Russia
Departmental Hospital at Smolensk Station "rzhd" JSC
Smolensk, , Russia
Kuvatov Republican Clinical Hospital
Ufa, , Russia
Universitätsspital Basel
Basel, Canton of Basel-City, Switzerland
Cantonal Hospital St.Gallen
Sankt Gallen, Canton of St. Gallen, Switzerland
Chang Gung Memorial Hospital - Linkou
Kuei Shan Hsiang, Taoyuan Hsien, Taiwan
Hualien Tzu-Chi Hospital
Dalin Township, , Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, , Taiwan
Chang Gung Memorial Hospital - Kaohsiung Branch
Kaohsiung City, , 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 Medical University Hospital
Taipei, , Taiwan
Maidstone Hospital
Maidstone, Kent, United Kingdom
Whipps Cross University Hospital
London, Surrey, United Kingdom
Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
Doncaster, , United Kingdom
Guy's Hospital
London, , United Kingdom
St. George's University Hospitals NHS Foundation Trust
London, , United Kingdom
Countries
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References
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Yin J, Hou Y, Wang C, Qin C. Clinical outcomes of baricitinib in patients with systemic lupus erythematosus: Pooled analysis of SLE-BRAVE-I and SLE-BRAVE-II trials. PLoS One. 2025 Apr 30;20(4):e0320179. doi: 10.1371/journal.pone.0320179. eCollection 2025.
Morand EF, Vital EM, Petri M, van Vollenhoven R, Wallace DJ, Mosca M, Furie RA, Silk ME, Dickson CL, Meszaros G, Jia B, Crowe B, de la Torre I, Dorner T. Baricitinib for systemic lupus erythematosus: a double-blind, randomised, placebo-controlled, phase 3 trial (SLE-BRAVE-I). Lancet. 2023 Mar 25;401(10381):1001-1010. doi: 10.1016/S0140-6736(22)02607-1. Epub 2023 Feb 24.
Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus
Other Identifiers
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I4V-MC-JAHZ
Identifier Type: OTHER
Identifier Source: secondary_id
2017-005026-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
16676
Identifier Type: -
Identifier Source: org_study_id
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