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A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (BRAVE I)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03616912
Recruitment Status : Terminated (Study terminated due to insufficient evidence to support a positive benefit: risk ratio. Safety findings were consistent with previously published OLUMIANT data)
First Posted : August 6, 2018
Last Update Posted : May 13, 2022
Incyte Corporation
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The reason for this study is to see how effective and safe the study drug known as baricitinib is in participants with systemic lupus erythematosus (SLE).

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: Baricitinib Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 830 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients With Systemic Lupus Erythematosus
Actual Study Start Date : August 2, 2018
Actual Primary Completion Date : November 1, 2021
Actual Study Completion Date : March 9, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus
Drug Information available for: Baricitinib

Arm Intervention/treatment
Experimental: Baricitinib High Dose
Baricitinib administered orally. Placebo administered orally to maintain the blind.
Drug: Baricitinib
Administered orally.
Other Name: LY3009104

Drug: Placebo
Administered orally.

Experimental: Baricitinib Low Dose
Baricitinib administered orally. Placebo administered orally to maintain the blind.
Drug: Baricitinib
Administered orally.
Other Name: LY3009104

Drug: Placebo
Administered orally.

Placebo Comparator: Placebo
Placebo administered orally.
Drug: Placebo
Administered orally.

Primary Outcome Measures :
  1. Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response (High Dose) [ Time Frame: Week 52 ]
    Percentage of participants achieving SRI-4 response (high dose).

Secondary Outcome Measures :
  1. Percentage of Participants Achieving SRI-4 Response (Low Dose) [ Time Frame: Week 52 ]
    Percentage of participants achieving SRI-4 response (low dose).

  2. Percentage of Participants Achieving a Lupus Low Disease Activity State (LLDAS) [ Time Frame: Week 52 ]
    Percentage of Participants Achieving a LLDAS.

  3. Time to First Severe Flare [ Time Frame: Baseline to Week 52 ]
    Time to first severe flare.

  4. Change from Baseline in Prednisone Dose [ Time Frame: Baseline, Week 52 ]
    Change from baseline in prednisone dose.

  5. Change from Baseline in Worst Pain Numeric Rating Scale (NRS) [ Time Frame: Baseline, Week 52 ]
    Change from baseline in worst pain NRS.

  6. Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Total Score [ Time Frame: Baseline, Week 52 ]
    Change from baseline on FACIT-Fatigue total score.

  7. Percentage of Participants with Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Total Activity Score ≥10 at Baseline with ≥50% Reduction in CLASI Total Activity Score [ Time Frame: Week 52 ]
    Percentage of participants with CLASI total activity score ≥10 at baseline with ≥50% reduction in CLASI total activity score.

  8. Change from Baseline in Tender Joint Count [ Time Frame: Baseline, Week 52 ]
    Change from baseline in tender joint count.

  9. Change from Baseline in Swollen Joint Count [ Time Frame: Baseline, Week 52 ]
    Change from baseline in swollen joint count.

  10. Population Pharmacokinetics (PK): Area Under the Concentration-Time Curve of Baricitinib at Steady State (AUCτ, ss) [ Time Frame: Baseline through Week 16 ]
    PK: Area Under the Concentration-Time Curve of Baricitinib at Steady State (AUCτ, ss).

  11. Population PK: Maximum Observed Drug Concentration at Steady State (Cmax,ss) [ Time Frame: Baseline through Week 16 ]
    Population PK: Maximum Observed Drug Concentration at Steady State (Cmax,ss).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Have a clinical diagnosis of SLE at least 24 weeks prior to screening.
  • 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 severe active lupus nephritis.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03616912

Hide Hide 184 study locations
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United States, Alabama
Achieve Clinical Research, LLC
Birmingham, Alabama, United States, 35216
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Arizona Arthritis & Rheumatology Research, PLLC
Glendale, Arizona, United States, 85306
University of Arizona
Tucson, Arizona, United States, 85711
United States, California
St. Joseph Heritage Medical Group
Fullerton, California, United States, 92835
MD Medical Corporation
Hemet, California, United States, 92543
ACRC Studies
Poway, California, United States, 92064
Office: Hans R Barthel M.D.
Santa Barbara, California, United States, 93108
Medvin Clinical Research - Weidmann
Whittier, California, United States, 90602
United States, Colorado
Denver Arthritis Clinic - Lowry
Denver, Colorado, United States, 80230
United States, Connecticut
New England Research Associates
Bridgeport, Connecticut, United States, 06606
Yale University School of Medicine
New Haven, Connecticut, United States, 06519
United States, Florida
Arthritis and Rheumatic Disease
Aventura, Florida, United States, 33180
Rheumatology Associates of South Florida
Boca Raton, Florida, United States, 33486
Clinical Research of West Florida, Inc. (Clearwater)
Clearwater, Florida, United States, 33765
Arthritis and Rheumatology Center of South Florida
Margate, Florida, United States, 33063
Lakes Research, LLC
Miami Lakes, Florida, United States, 33014
Millennium Research
Ormond Beach, Florida, United States, 32174
IRIS Research and Development, LLC
Plantation, Florida, United States, 33324
ForCare Clinical Research
Tampa, Florida, United States, 33613-1244
United States, Georgia
Piedmont Healthcare
Atlanta, Georgia, United States, 30318
Atlanta Center for Clinical Research
Atlanta, Georgia, United States, 30342
United States, Idaho
St Luke's Clinic - Intermountain Orthopaedics
Boise, Idaho, United States, 83702
United States, Illinois
Rockford Orthopedic Associates
Rockford, Illinois, United States, 61114
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
Clinical Research Institute of Michigan, LLC
Saint Clair Shores, Michigan, United States, 48081
United States, Missouri
St. Louis Rheumatology
Saint Louis, Missouri, United States, 63119
United States, Montana
Glacier View Research Institute - Endocrinology
Kalispell, Montana, United States, 59901
United States, Nevada
Allied Clinical Research
Reno, Nevada, United States, 89519
United States, New Mexico
Albuquerque Center for Rheumatology
Albuquerque, New Mexico, United States, 87102
United States, New York
SUNY Health Science Center
Brooklyn, New York, United States, 11203
St. Lawrence Health System
Canton, New York, United States, 13617
Northwell Health
Great Neck, New York, United States, 11021
The Feinstein Institute for Medical Research
Manhasset, New York, United States, 11030
Columbia University Medical Center
New York, New York, United States, 10032
Buffalo Rheumatology
Orchard Park, New York, United States, 14127
United States, North Carolina
Joint and Muscle Medical Care
Charlotte, North Carolina, United States, 28204
Medication Management, LLC
Greensboro, North Carolina, United States, 27408
PMG Research of Wilmington
Wilmington, North Carolina, United States, 28401
United States, Ohio
Cincinnati Arthritis Associates
Cincinnati, Ohio, United States, 45242
The Ohio State University
Columbus, Ohio, United States, 43210
Paramount Medical Research
Middleburg Heights, Ohio, United States, 44130
United States, Oklahoma
Arthritis & Rheumatology Center of Oklahoma PLLC
Oklahoma City, Oklahoma, United States, 73102
United States, Pennsylvania
East Penn Rheumatology Associates
Bethlehem, Pennsylvania, United States, 18015
UPMC Lupus Center of Excellence
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
West Tennessee Research Institute
Jackson, Tennessee, United States, 38305
United States, Texas
Amarillo Center for Clinical Research
Amarillo, Texas, United States, 79124
Accurate Clinical Management
Baytown, Texas, United States, 77521
Dr. Dhiman Basu Private Practice
Colleyville, Texas, United States, 76034
Metroplex Clinical Research Center
Dallas, Texas, United States, 75231
Precision Comprehensive Clinical Research Solutions
Fort Worth, Texas, United States, 76107
Rheumatology Center of Houston
Houston, Texas, United States, 77004
Accurate Clinical Research
Houston, Texas, United States, 77089
Southwest Rheumatology, P.A.
Mesquite, Texas, United States, 75150
Accurate Clinical Research, Inc.
San Antonio, Texas, United States, 78229
Univ of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Arthritis Clinic Of Central Texas
San Marcos, Texas, United States, 78666
United States, Virginia
Spectrum Medical Inc.
Danville, Virginia, United States, 24541
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98122
United States, Wisconsin
Rheumatic Disease Center
Glendale, Wisconsin, United States, 53217
Australia, New South Wales
Emeritus Research
Botany, New South Wales, Australia, 2019
Australia, Queensland
The Rheumatology Research Unit Sunshine Coast
Maroochydore, Queensland, Australia, 4558
Australia, Victoria
Emeritus Research
Camberwell, Victoria, Australia, 3124
Monash Medical Centre
Clayton, Victoria, Australia, 3168
St Vincents Hospital Melbourne
Fitzroy, Victoria, Australia, 3065
Griffith University
Southport, Australia, 4215
Ordensklinikum Linz GmbH Elisabethinen
Linz, Oberösterreich, Austria, 4020
Medizinische Universität Graz
Graz, Austria, 8036
Klinik Hietzing
Wien, Austria, 1130
Cliniques Universitaires Saint-Luc
Bruxelles, Brussel, Belgium, 1200
UZ Leuven
Leuven, Vlaams Brabant, Belgium, 3000
CHU de Liège
Liège, Belgium, 4000
SER - Serviços Especializados em Reumatologia da Bahia S/S - ME
Salvador, Bahia, Brazil, 40150-150
CIP-Centro Internacional de Pesquisa
Goiania, Goiás, Brazil, 74110-120
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte, MG, Brazil, 30150-221
Centro de Estudos em Terapias Inovadoras-CETI
Curitiba, Paraná, Brazil, 80030-110
EDUMED - Educação em Saúde Ltda.
Curitiba, Paraná, Brazil, 80440-080
LMK Serviços Médicos S/S
Porto Alegre, Rio Grande Do Sul, Brazil, 90540-000
Hospital de Clinicas de Porto Alegre
Porto Alegre, RS, Brazil, 90035-003
Hospital de Clinicas UNICAMP
Campinas, SP, Brazil, 13083-970
Oncovida- Centro de Onco-Hematologia de Mato Grosso
Cuiaba, Brazil, 78043-142
Hospital Alemao Oswaldo Cruz
Sao Paulo, Brazil, 01323-903
China, Guangdong
First affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China, 510080
China, Heilongjiang
First Affiliated Hospital of the Harbin Medical University
Harbin, Heilongjiang, China, 150001
China, Henan
The First Affiliated Hospital of Zhengzhou Universtiy
Zhengzhou, Henan, China, 450000
China, Hubei
Wuhan Union Hospital
Wuhan, Hubei, China, 430022
China, Jiangsu
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China, 210000
China, Jiangxi
Jiangxi Pingxiang People's Hospital
Pingxiang, Jiangxi, China, 337055
China, Jilin
China-Japan Union Hospital of Jilin University
Changchun, Jilin, China, 100853
China, Shanghai
Zhongshan Hospital, Fudan University
Shanghai, Shanghai, China, 200032
China, Tianjin
Tianjin Medical University General Hospital
Tianjin, Tianjin, China, 300052
China, Zhejiang
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Ningbo First Hospital
Ningbo, Zhejiang, China, 315010
Peking University First Hospital
Beijing, China, 100034
Beijing Peking Union Medical College Hospital
Beijing, China, 100730
Shanghai Huashan Hospital Affil to Fu Dan University
Shanghai, China, 200040
China Medical University (CMU) - First Affiliated Hospital
Shenyang, China, 110001
The First Affliated Hospital of Soochow University
Suzhou Shi, China, 215000
People's Hospital of Xinjiang Uygur Autonomous Region
Urumqi, China, 830001
Klinicki Bolnicki Centar Rijeka
Rijeka, Croatia, 51000
University Hospital Split
Split, Croatia, 21000
Clinical Hospital Dubrava
Zagreb, Croatia, 10000
Revmatologicky ustav
Praha 2, Praha, Hlavní Mešto, Czechia, 12850
Brno, Czechia, 63800
Fakultni nemocnice Olomouc
Olomouc, Czechia, 775 20
Pardubice, Czechia, 53002
Vseobecna fakultni nemocnice
Praha 2, Czechia, 128 08
Universitätsklinikum Tübingen
Tubingen, Baden-Wurttemberg, Germany, 72076
Universitätsklinikum Freiburg
Freiburg, Baden-Württemberg, Germany, 79106
Klinikum der Universität München
München, Bayern, Germany, 80336
Universitätsklinikum Würzburg A. ö. R.
Würzburg, Bayern, Germany, 97080
Universitätsklinikum Köln
Köln, Nordrhein-Westfalen, Germany, 50937
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz
Mainz, Rheinland-Pfalz, Germany, 55131
Universitätsklinikum Carl Gustav Carus
Dresden, Sachsen, Germany, 01307
Universität Leipzig - Universitätsklinikum
Leipzig, Sachsen, Germany, 04103
Charité Universitätsmedizin Berlin Campus Buch
Berlin, Germany, 10117
Immanuel Krankenhaus Rheuma Klinik Berlin Buch
Berlin, Germany, 13125
Schlosspark Klinik
Berlin, Germany, 14059
Gen Hospital of Athens G Gennimatas
Athens, Attiki, Greece, 11527
University General Hospital of Heraklion
Heraklion, Crete, Greece, 71110
University General Hospital of Larissa
Larissa, Greece, 41110
Euromedica Kyanous Stavros General Hospital
Thessaloniki, Greece, 54636
Hippokration University Hopsital
Thessaloniki, Greece, 54642
Bekes Megyei Pandy Kalman Korhaz
Gyula, Bekes, Hungary, 5700
Vital Medical Center
Veszprem, Veszprém City, Hungary, 8200
Budai Irgalmasrendi Korhaz
Budapest, Hungary, 1027
Qualiclinic Kft
Budapest, Hungary, 1036
Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointeze
Budapest, Hungary, 1097
Debreceni Egyetem Klinikai Kozpont Reumatologiai Tanszek
Debrecen, Hungary, 4032
Debreceni Egyetem Klinikai Kozpont
Debrecen, Hungary, 4032
Pecsi Tudomanyegyetem Klinikai Kozpont
Pecs, Hungary, 7632
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont I. Belgyogyaszati Klinika
Szeged, Hungary, 6725
Vita Verum Egeszsegugyi Szolgaltato Bt
Székesfehérvár, Hungary, 8000
Meir Medical Center
Kfar Saba, Israel, 4428164
Chaim Sheba Medical Center
Ramat Gan, Israel, 5262100
Carmel Hospital
Haifa, Ḥeifā, Israel, 3436212
Torreon, Coahuila, Mexico, 27000
Hospital Angeles Lindavista
Mexico city, DF, Mexico, 07760
Cliditer Sa de CV
Mexico City, Distrito Federal, Mexico, 06700
Morales Vargas Centro de Investigacion, S.C.
Leon, Guanajuato, Mexico, 37000
Centro Integral en Reumatologia SA de CV
Guadalajara, Jalisco, Mexico, 44160
Clinica de Investigacion en Reumatologia y Obesidad S. C.
Guadalajara, Jalisco, Mexico, 44650
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares
Guadalajara, Jalisco, Mexico, 44690
Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.
Zapopan, Jalisco, Mexico, 45070
Köhler & Milstein Research
Merida, Yucatan, Mexico, 97070
Centro Peninsular de Investigacion S.C.P
Merida, Yucatán, Mexico, 97000
Cemdeicy S.C.P.
Merida, Yucatán, Mexico, 97130
Centro de Investigación y Tratamiento Reumatológico S.C
Ciudad De México, Mexico, 11850
Clinosar Mexico S.A. de C.V
Mexico City, Mexico, 06760
Centro de Alta Especialidad Reumatologia e Inv Potosi, S.C.
San Luis Potosi, Mexico, 78213
Medische Centrum Leeuwarden
Leeuwarden, Fryslân, Netherlands, 8934 AD
Vrije Universiteit Medisch Centrum Amsterdam
Amsterdam, Netherlands, 1081 HV
Russian Federation
St. Petersburg, Saint Petersburg, Russian Federation, 197372
Chelyabinsk Regional Clinical Hospital
Chelyabinsk, Russian Federation, 454076
City Hospital # 7
Kazan, Russian Federation, 420103
Regional Clinical Hospital
Kursk, Russian Federation, 305007
Russian State Medical University
Moscow, Russian Federation, 117997
City Clinical Hospital 1 named after N.I. Pirogov
Moscow, Russian Federation, 119049
Rheumatology Institute RAMS
Moscow, Russian Federation
Healthy Family
Novosibirsk, Russian Federation, 630061
Novosibirsk, Russian Federation, 630099
Institute of Cytology and Genetics of Siberian Branch of Russian Academy of Medical Sciences
Novosibirsk, Russian Federation, 630117
Regional Hospital - Omsk
Omsk, Russian Federation, 644111
Orenburg State Medical Academy of Roszdrav
Orenburg, Russian Federation, 460018
Ryazan State Medical University
Ryazan, Russian Federation, 390026
Russian Medical Military Academy n.a. S.M. Kirov
Saint Petersburg, Russian Federation, 194044
Departmental Hospital at Smolensk Station "rzhd" JSC
Smolensk, Russian Federation, 214025
Kuvatov Republican Clinical Hospital
Ufa, Russian Federation, 450005
Universitätsspital Basel
Basel, Basel Stadt, Switzerland, 4031
Cantonal Hospital St.Gallen
st.Gallen, Sankt Gallen, Switzerland, 9007
Chang Gung Memorial Hospital - Linkou
Kuei Shan Hsiang, Taoyuan Hsien, Taiwan, 33305
Hualien Tzu-Chi Hospital
Dalin Township, Taiwan, 622
Chang Gung Memorial Hospital - Kaohsiung Branch
Kaohsiung City, Taiwan, 833401
Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan, 81346
China Medical University Hospital
Taichung, Taiwan, 40447
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Chi-Mei Medical Center
Tainan City, Taiwan, 71004
National Taiwan University Hospital
Taipei, Taiwan, 10002
Taipei Medical University Hospital
Taipei, Taiwan, 110
United Kingdom
Maidstone Hospital
Maidstone, Kent, United Kingdom, ME16 9QQ
Whipps Cross University Hospital
London, Surrey, United Kingdom, E11 1NR
Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
Doncaster, United Kingdom, DN2 5LT
Guy's Hospital
London, United Kingdom, SE1 9RT
St. George's University Hospitals NHS Foundation Trust
London, United Kingdom, SW17 0QT
Sponsors and Collaborators
Eli Lilly and Company
Incyte Corporation
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Study Director: 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) Eli Lilly and Company
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Eli Lilly and Company Identifier: NCT03616912    
Other Study ID Numbers: 16676
I4V-MC-JAHZ ( Other Identifier: Eli Lilly and Company )
2017-005026-37 ( EudraCT Number )
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: May 13, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Lilly and Company:
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases