A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE-BRAVE II)
BRAVE II
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients With Systemic Lupus Erythematosus
3 other identifiers
interventional
778
15 countries
159
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2018
Typical duration for phase_3
159 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2018
CompletedStudy Start
First participant enrolled
August 2, 2018
CompletedFirst Posted
Study publicly available on registry
August 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 24, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2021
CompletedResults Posted
Study results publicly available
November 23, 2022
CompletedNovember 23, 2022
November 1, 2022
3.1 years
August 1, 2018
September 11, 2022
November 1, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response (4 mg Baricitinib)
SRI-4 response defined as 1)greater than or equal to (\>=) 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score 2)no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score and 3)no worsening in Physician Global Assessment (PGA) of Disease Activity (worsening defined as an increase of \>=0.3 from baseline on a 0-3 visual analogue scale). SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms,or laboratory parameters related to Systemic Lupus Erythematosus (SLE),divided into 9 organ systems. For each organ system A=severe disease,B=moderate disease,C=mild stable disease,D=inactive,but previously active,E=inactive and never affected. PGA assess disease activity on a visual analogue scale from 0 to 3 (1=mild, 2=moderate, 3=severe).
Week 52
Secondary Outcomes (11)
Percentage of Participants Achieving SRI-4 Response (2 mg Baricitinib)
Week 52
Percentage of Participants Achieving a Lupus Low Disease Activity State (LLDAS)
Week 52
Time to First Severe Flare
Baseline to Week 52
Percentage of Participants Whose Average Prednisone Dose Had Been Reduced by >=25% From Baseline to <=7.5 mg/Day During Weeks 40 Through 52 in Participants Receiving Greater Than 7.5 mg/Day at Baseline
Baseline, Week 40 through Week 52
Change From Baseline in Worst Pain Numeric Rating Scale (NRS)
Baseline, Week 52
- +6 more secondary outcomes
Study Arms (3)
2 milligram (mg) Baricitinib
EXPERIMENTALParticipants received one 2 mg baricitinib tablet and one placebo tablet matching 4 mg baricitinib administered orally once daily (QD) for 52 weeks.
4 mg Baricitinib
EXPERIMENTALParticipants received one 4 mg baricitinib tablet and one placebo tablet matching 2 mg baricitinib administered orally QD for 52 weeks.
Placebo
PLACEBO COMPARATORParticipants received 2 placebo tablets: one placebo tablet matching 4 mg baricitinib and one placebo tablet matching 2 mg baricitinib administered orally QD for 52 weeks.
Interventions
Administered orally.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eli Lilly and Companylead
- Incyte Corporationcollaborator
Study Sites (159)
University of Arizona Arthritis Center
Gilbert, Arizona, 85297, United States
Arizona Arthritis & Rheumatology Research
Phoenix, Arizona, 85302, United States
Arizona Arthritis & Rheumatology Associates, P. C.
Tucson, Arizona, 85704, United States
Wallace Rheumatic Studies Center
Beverly Hills, California, 90211, United States
Medvin Clinical Research - Weidmann
Covina, California, 91722, United States
Office: Dr Robin K Dore
Tustin, California, 92780, United States
Inland Rheumatology & Osteoporosis Medical Group
Upland, California, 91786, United States
Denver Arthritis Clinic - Lowry
Denver, Colorado, 80230, United States
Clinical Research of West Florida, Inc. (Clearwater)
Clearwater, Florida, 33765, United States
Millennium Research
Ormond Beach, Florida, 32174, United States
Integral Rheumatology & Immunology Specialists
Plantation, Florida, 33324, United States
Clinical Research of West Florida
Tampa, Florida, 33603, United States
Tampa Medical Group, P.A.
Tampa, Florida, 33614, United States
Emory University
Atlanta, Georgia, 30322, United States
Northside Hospital
Atlanta, Georgia, 30342, United States
North Georgia Rheumatology, PC
Lawrenceville, Georgia, 30046, United States
Arthritis Center of Lexington
Lexington, Kentucky, 40504, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21224-6801, United States
Advanced Rheumatology, PC
Lansing, Michigan, 48910, United States
Glacier View Research Institute - Endocrinology
Kalispell, Montana, 59901, United States
Innovative Health Research
Las Vegas, Nevada, 89128, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, 87102, United States
Arthritis and Osteoporosis Associates of New Mexico
Las Cruces, New Mexico, 88011, United States
St. Lawrence Health System
Canton, New York, 13617, United States
New York University Medical Center
New York, New York, 10016, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
Joint and Muscle Medical Care
Charlotte, North Carolina, 28204, United States
Box Arthritis & Rheumatology of the Carolinas, PLLC
Charlotte, North Carolina, 28210, United States
Cincinnati Rheumatic Disease Study Group
Cincinnati, Ohio, 45242, United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104, United States
Clinical Research Center of Reading,LLC
Wyomissing, Pennsylvania, 19610, United States
Articularis Healthcare d/b/a/ Low Country Rheumatology, PA
Summerville, South Carolina, 29486, United States
Eagle Medical
Crossville, Tennessee, 38555, United States
Dr. Dhiman Basu Private Practice
Colleyville, Texas, 76034, United States
Metroplex Clinical Research Center
Dallas, Texas, 75231, United States
Advanced Rheumatology of Houston
The Woodlands, Texas, 77382, United States
Clear Lake Specialties
Webster, Texas, 77598, United States
Arthritis Clinic of Northern VA, P.C.
Arlington, Virginia, 22205, United States
Spectrum Medical Inc.
Danville, Virginia, 24541, United States
Aprillus Asistencia e Investigacion - Servicio de neurologia
CABA, Buenos Aires, C1046AAQ, Argentina
DOM Centro de Reumatologia
Ciudad de Buenos Aires, Buenos Aires, C1111AAH, Argentina
Framingham Centro Medico
La Plata, Buenos Aires, B1902COS, Argentina
CER Instituto Medico
Quilmes, Buenos Aires, B1878DVC, Argentina
Instituto de Investigaciones Clinicas Quilmes
Quilmes, Buenos Aires, B1878GEG, Argentina
Comite de Etica en Investigacion - CEMIC
Buenos Aires, Ciudad Autonoma de Buenos Aire, C1431FWO, Argentina
Clinica Adventista Belgrano
CABA, Ciudad Autónoma de Buenos Aire, C1430EGF, Argentina
Sanatorio Británico
Rosario, Santa Fe Province, 2000, Argentina
Centro Medico Privado de Reumatologia
SAN M. de Tucuman, Tucumán Province, T4000AXL, Argentina
Sanatorio Guemes Cardiocirugia
Ciudad Autonoma Buenos Aires, C1181AAX, Argentina
IR Medical Center S.A. Instituto de Reumatologia
Mendoza, M5500CPH, Argentina
Clinical Research Chile SpA
Valdivia, Los Ríos Region, 5110683, Chile
Enroll SpA
Providencia, Región Metropolitana de Santia, 7500587, Chile
Clinica Alemana de Osorno
Osorno, 5290000, Chile
Sociedad Medica Del Aparato Locomotor SA
Santiago, 7510186, Chile
Prosalud y cia. Ltda.
Santiago, Chile
ReumaCen Centro Reumatologico Integral
Viña del Mar, 2570017, Chile
HPTU-El Hospital con alma Pablo Tobon Uribe
Medellín, Antioquia, Colombia
Circaribe SAS
Barranquilla, Atlántico, Colombia
Clinica de la Costa
Barranquilla, Atlántico, Colombia
Idearg S.A.S.
Bogota, Cundinamarca, Colombia
Centro Integral de Reumatologia e Inmunologia
Bogotá, Cundinamarca, Colombia
Servimed S.A.S.
Bucaramanga, Santander Department, 12345, Colombia
Centro de Medicina Interna
Cali, Valle del Cauca Department, Colombia
Preventive Care Ltdac
Chía, Colombia
CHRU Brest - Hopital Cavale Blanche
Brest, Finistère, 29609, France
Centre hospitalier universitaire de Haut Leveque
Pessac, Gironde, 33604, France
CHU Montpellier Lapeyronie Hospital
Montpellier, Hérault, 34295, France
Centre hospitalier universitaire Pellegrin
Bordeaux, 33076, France
Hopital Européen
Marseille, 13003, France
Krishna Institute of Medical Science
Hyderabad, Andhra Pradesh, 500003, India
Panchshil Hospital
Ahmedabad, Gujarat, 380005, India
CIMS Hospital Private Limited
Ahmedabad, Gujarat, 380060, India
NHL Municipal Medical College & VS General Hospital
Ahmedabad, Gujarat, 38006, India
Shree Giriraj Hospital
Rajkot, Gujarat, 360004, India
Nirmal Hospital Private Limited
Surat, Gujarat, 395002, India
Sterling Hospital
Vadodara, Gujarat, 390007, India
St. John Medical College & Hospital
Bangalore, Karnataka, 560034, India
ChanRe Rheumatology And Immunology Center And Research
Bangalore, Karnataka, 560079, India
Sushruta Multispecialty Hospital & Research Center Pvt Ltd
Hubli, Karnataka, 580021, India
Kasturba Medical College Hospital, Mangalore
Madhav Nagar, Manipal, Karnataka, 576104, India
Jasleen Hospital
Nagpur, Maharashtra, 44012, India
Synexus Affiliate - Sujata Birla Hospital & Medical Research Center
Nashik, Maharashtra, 422101, India
Fortis Escorts Hospital
Jaipur, Rajasthan, 302017, India
Azienda Ospedaliera Universitaria
Modena, MO, 41124, Italy
Azienda Ospedaliera Universitaria Pisana
Pisa, Tuscany, 56100, Italy
IRCCS Ospedale Policlinico San Martino
Genova, 16132, Italy
Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico
Milan, 20122, Italy
Azienda Policlinico Umberto I
Roma, 00161, Italy
Azienda Ospedaliera Santa Maria Della Misericordia
Udine, 33100, Italy
University of Occupational and Enviromental Health
Kitakyushu, Fukuoka, 807-8556, Japan
Hiroshima University Hospital
Hiroshima, Hiroshima, 734-8551, Japan
National Hospital Organization Asahikawa Medical Center
Asahikawa, Hokkaido, 070-8644, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648, Japan
Jp Red Cross Society Himeji Hp
Himeji, Hyōgo, 670-8540, Japan
Kobe University Hospital
Kobe, Hyōgo, 650-0017, Japan
Kagawa University Hospital
Kita-gun, Kagawa-ken, 761-0793, Japan
Tohoku University Hospital
Sendai, Miyagi, 980-8574, Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo, 113-8431, Japan
St. Lukes International Hospital
Chuo-Ku, Tokyo, 104 8560, Japan
Toho University Ohashi Med C
Meguro-ku, Tokyo, 153-8515, Japan
Showa University Hospital
Shinagawa-ku, Tokyo, 142-8666, Japan
Keio University Hospital
Shinjuku-Ku, Tokyo, 160-8582, Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, 810 8563, Japan
Hamanomachi Hospital
Fukuoka, 810-8539, Japan
Nippon Medical School Hospital
Tokyo, 113-8603, Japan
Mary Mediatrix Medical Center
Lipa, Batangas, 4217, Philippines
Cebu Doctors Hospital
Cebu City, Cebu, 6000, Philippines
Southern Philippines Medical Center
Davao City, Davao Del Norte, 8000, Philippines
Angeles University Foundation and Medical Center
Angeles City, Pampanga, 2009, Philippines
Chong Hua Medical Arts Center
Cebu City, 6000, Philippines
Makati Medical Center
Makati City, 1229, Philippines
St. Luke's Medical Center
Quenzon City, 1102, Philippines
Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o.
Wroclaw, Lower Silesian Voivodeship, 53224, Poland
Twoja Przychodnia Centrum Medyczne Nowa Sol
Nowa Sól, Lubusz Voivodeship, 67-100, Poland
Medycyna Kliniczna
Warsaw, Masovian Voivodeship, 00874, Poland
Reumatika - Centrum Reumatologii
Warsaw, Masovian Voivodeship, 02-691, Poland
Gabinet Internistyczno- Reumatologiczny Piotr Adrian Klimiuk
Bialystok, Podlaskie Voivodeship, 15-077, Poland
Zespol Poradni Specjalistycznych REUMED
Lublin, Polska, 20582, Poland
Ambulatorium Barbara Bazela
Elblag, Warminsko-Mazurki, 82300, Poland
Szpital Uniwersytecki Nr 2 w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej
Bydgoszcz, 85-168, Poland
Centrum Medyczne Pratia Katowice
Katowice, 40-081, Poland
Malopolskie Centrum Medyczne S.C.
Krakow, 30-510, Poland
Centrum Medyczne Plejady
Krakow, 30363, Poland
NZOZ Lecznica MAK-MED s.c.
Nadarzyn, 05-830, Poland
Ortopedyczno-Rehabilitacyjny Szpital Kliniczny UM w Poznaniu
Poznan, 61-545, Poland
Centrum Medyczne AMED
Warsaw, 03-291, Poland
Napoca Emergency Clinical County Hospital
Cluj-Napoca, Cluj, 40006, Romania
Craiova Emergency Clinical County Hospital
Craiova, Dolj, 200642, Romania
SC CMDTA Neomed SRL
Brasov, 500283, Romania
Spitalul Clinic Sf Maria Bucuresti
Bucharest, 011172, Romania
Spitalul Clinic "Dr. Ioan Cantacuzino"
Bucharest, 020475, Romania
SANA Medical Center
Bucharest, 11025, Romania
St. Maria Clinical Hospital
Bucharest, 11172, Romania
Spitalul Euroclinic
Bucureti, 014461, Romania
Institute of Rheumatology
Belgrade, 11000, Serbia
Military Medical Academy
Belgrade, 11000, Serbia
University Clinical Center of Serbia
Belgrade, 11000, Serbia
Institute for Treatment and Rehabilitation Niska Banja
Niška Banja, 18205, Serbia
Clinical Center of Vojvodina
Novi Sad, 21000, Serbia
Suite 509 Umhlanga Netcare Medical Centre
Umhlanga, Durban, 4319, South Africa
Charlotte Maxeke Johannesburg Academic Hospital
Parktown, Guateng, 2000, South Africa
Jakaranda Hospital
Muckleneuk, Pretoria, 0002, South Africa
Panorama Medical Centre
Cape Town, Western Cape, 7506, South Africa
Arthritis Clinical Trial Centre
Pinelands, Western Cape, 7405, South Africa
Winelands Medical Research Centre
Stellenbosch, Western Cape, 7600, South Africa
University Of Pretoria
Pretoria, 0002, South Africa
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Kyung Pook National University Hospital
Daegu, Korea, 41944, South Korea
Gachon University Gil Hospital
Incheon, Korea, 21565, South Korea
Hanyang University Medical Center
Seoul, Korea, 04763, South Korea
The Catholic University of Korea-Seoul St. Mary's Hospital
Seocho-Gu, Seoul, 06591, South Korea
Asan Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 05505, South Korea
Hospital Marina Baixa
Villajoyosa, Alicante, 03570, Spain
Hospital De Fuenlabrada
Fuenlabrada, Madrid, 28944, Spain
Hospital do Meixoeiro
Vigo, Pontevedra, 36200, Spain
Corporacion Sanitaria Parc Tauli
Sabadell, Sapin, 08208, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Corporació Sanitària Clínic
Barcelona, 8036, Spain
Hospital Quiron Infanta Luisa
Seville, 41010, Spain
Related Publications (3)
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.
PMID: 40305472DERIVEDPetri M, Bruce IN, Dorner T, Tanaka Y, Morand EF, Kalunian KC, Cardiel MH, Silk ME, Dickson CL, Meszaros G, Zhang L, Jia B, Zhao Y, McVeigh CJ, Mosca M. Baricitinib for systemic lupus erythematosus: a double-blind, randomised, placebo-controlled, phase 3 trial (SLE-BRAVE-II). Lancet. 2023 Mar 25;401(10381):1011-1019. doi: 10.1016/S0140-6736(22)02546-6. Epub 2023 Feb 24.
PMID: 36848919DERIVEDHannon 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.
PMID: 33687069DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2018
First Posted
August 6, 2018
Study Start
August 2, 2018
Primary Completion
September 24, 2021
Study Completion
October 20, 2021
Last Updated
November 23, 2022
Results First Posted
November 23, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.