A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (BRAVE II)
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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. |
ClinicalTrials.gov Identifier: NCT03616964 |
Recruitment Status :
Active, not recruiting
First Posted : August 6, 2018
Last Update Posted : March 19, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Systemic Lupus Erythematosus | Drug: Baricitinib Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 750 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 |
Estimated Primary Completion Date : | October 15, 2021 |
Estimated Study Completion Date : | November 15, 2021 |

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 |
- 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).
- Percentage of Participants Achieving SRI-4 Response (Low Dose) [ Time Frame: Week 52 ]Percentage of participants achieving SRI-4 response (low dose).
- Percentage of Participants Achieving a Lupus Low Disease Activity State (LLDAS) [ Time Frame: Week 52 ]Percentage of Participants Achieving a LLDAS.
- Time to First Severe Flare [ Time Frame: Baseline to Week 52 ]Time to first severe flare.
- Change from Baseline in Prednisone Dose [ Time Frame: Baseline, Week 52 ]Change from baseline in prednisone dose.
- Change from Baseline in Worst Pain Numeric Rating Scale (NRS) [ Time Frame: Baseline, Week 52 ]Change from baseline in worst pain NRS.
- 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.
- 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.
- Change from Baseline in Tender Joint Count [ Time Frame: Baseline, Week 52 ]Change from baseline in tender joint count.
- Change from Baseline in Swollen Joint Count [ Time Frame: Baseline, Week 52 ]Change from baseline in swollen joint count.
- 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).
- 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).

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.
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.
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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.

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 ClinicalTrials.gov identifier (NCT number): NCT03616964

United States, Arizona | |
University of Arizona Arthritis Center | |
Gilbert, Arizona, United States, 85297 | |
Arizona Arthritis & Rheumatology Research | |
Phoenix, Arizona, United States, 85302 | |
Arizona Arthritis & Rheumatology Associates, P. C. | |
Tucson, Arizona, United States, 85704 | |
United States, California | |
Wallace Rheumatic Studies Center | |
Beverly Hills, California, United States, 90211 | |
Medvin Clinical Research - Weidmann | |
Covina, California, United States, 91722 | |
Office: Dr Robin K Dore | |
Tustin, California, United States, 92780 | |
Inland Rheumatology & Osteoporosis Medical Group | |
Upland, California, United States, 91786 | |
United States, Colorado | |
Denver Arthritis Clinic - Lowry | |
Denver, Colorado, United States, 80230 | |
United States, Florida | |
Clinical Research of West Florida | |
Clearwater, Florida, United States, 33765 | |
Millennium Research | |
Ormond Beach, Florida, United States, 32174 | |
Integral Rheumatology & Immunology Specialists | |
Plantation, Florida, United States, 33324 | |
Clinical Research of West Florida | |
Tampa, Florida, United States, 33603 | |
Tampa Medical Group, P.A. | |
Tampa, Florida, United States, 33614 | |
United States, Georgia | |
Emory University | |
Atlanta, Georgia, United States, 30322 | |
Northside Hospital | |
Atlanta, Georgia, United States, 30342 | |
North Georgia Rheumatology, PC | |
Lawrenceville, Georgia, United States, 30046 | |
United States, Kentucky | |
Arthritis Center of Lexington | |
Lexington, Kentucky, United States, 40504 | |
United States, Maryland | |
Johns Hopkins University School of Medicine | |
Baltimore, Maryland, United States, 21224-6801 | |
United States, Michigan | |
Advanced Rheumatology, PC | |
Lansing, Michigan, United States, 48910 | |
United States, Montana | |
Glacier View Research Institute - Endocrinology | |
Kalispell, Montana, United States, 59901 | |
United States, Nevada | |
Innovative Health Research | |
Las Vegas, Nevada, United States, 89128 | |
United States, New Mexico | |
Albuquerque Clinical Trials, Inc. | |
Albuquerque, New Mexico, United States, 87102 | |
Arthritis and Osteoporosis Associates of New Mexico | |
Las Cruces, New Mexico, United States, 88011 | |
United States, New York | |
St. Lawrence Health System | |
Canton, New York, United States, 13617 | |
New York University Medical Center | |
New York, New York, United States, 10016 | |
SUNY Upstate Medical University | |
Syracuse, New York, United States, 13210 | |
United States, North Carolina | |
Joint and Muscle Medical Care | |
Charlotte, North Carolina, United States, 28204 | |
Box Arthritis & Rheumatology of the Carolinas, PLLC | |
Charlotte, North Carolina, United States, 28210 | |
United States, Ohio | |
Cincinnati Rheumatic Disease Study Group | |
Cincinnati, Ohio, United States, 45242 | |
United States, Oklahoma | |
Oklahoma Medical Research Foundation | |
Oklahoma City, Oklahoma, United States, 73104 | |
United States, Pennsylvania | |
Clinical Research Center of Reading,LLC | |
Wyomissing, Pennsylvania, United States, 19610 | |
United States, South Carolina | |
Articularis Healthcare d/b/a/ Low Country Rheumatology, PA | |
Summerville, South Carolina, United States, 29486 | |
United States, Tennessee | |
Eagle Medical | |
Crossville, Tennessee, United States, 38555 | |
United States, Texas | |
Dr. Dhiman Basu Private Practice | |
Colleyville, Texas, United States, 76034 | |
Metroplex Clinical Research Center | |
Dallas, Texas, United States, 75231 | |
Advanced Rheumatology of Houston | |
The Woodlands, Texas, United States, 77382 | |
Clear Lake Specialties | |
Webster, Texas, United States, 77598 | |
United States, Virginia | |
Arthritis Clinic of Northern VA, P.C. | |
Arlington, Virginia, United States, 22205 | |
Spectrum Medical Inc. | |
Danville, Virginia, United States, 24541 | |
Argentina | |
Aprillus Asistencia e Investigacion - Servicio de neurologia | |
Caba, Buenos Aires, Argentina, C1046AAQ | |
DOM Centro de Reumatologia | |
Ciudad de Buenos Aires, Buenos Aires, Argentina, C1111AAH | |
Framingham Centro Medico | |
La Plata, Buenos Aires, Argentina, B1902COS | |
CER Instituto Medico | |
Quilmes, Buenos Aires, Argentina, B1878DVC | |
Instituto de Investigaciones Clinicas Quilmes | |
Quilmes, Buenos Aires, Argentina, B1878GEG | |
Comite de Etica en Investigacion - CEMIC | |
Buenos Aires, Ciudad Autonoma De Buenos Aire, Argentina, C1431FWO | |
Clinica Adventista Belgrano | |
Caba, Ciudad Autónoma De Buenos Aire, Argentina, C1430EGF | |
Sanatorio Británico | |
Rosario, Santa Fe, Argentina, 2000 | |
Centro Medico Privado de Reumatologia | |
SAN M. DE Tucuman, Tucumán, Argentina, T4000AXL | |
Sanatorio Guemes Cardiocirugia | |
Ciudad Autonoma Buenos Aires, Argentina, C1181AAX | |
IR Medical Center S.A. Instituto de Reumatologia | |
Mendoza, Argentina, M5500CPH | |
Chile | |
Clinical Research Chile SpA | |
Valdivia, Los Ríos, Chile, 5110683 | |
Enroll SpA | |
Providencia, Región Metropolitana De Santia, Chile, 7500587 | |
Clinica Alemana de Osorno | |
Osorno, Chile, 5290000 | |
Sociedad Medica Del Aparato Locomotor SA | |
Santiago, Chile, 7510186 | |
Prosalud y cia. Ltda. | |
Santiago, Chile | |
ReumaCen Centro Reumatologico Integral | |
Vina del Mar, Chile, 2570017 | |
Colombia | |
HPTU-El Hospital con alma Pablo Tobon Uribe | |
Medellin, Antioquia, Colombia | |
Clinica de la Costa | |
Barranquilla, Atlantico, Colombia | |
Circaribe SAS | |
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, Colombia, 12345 | |
Centro de Medicina Interna | |
Cali, Valle Del Cauca, Colombia | |
Preventive Care Ltdac | |
Chia, Colombia | |
France | |
CHRU Brest - Hopital Cavale Blanche | |
Brest Cedex, Finistère, France, 29609 | |
Centre hospitalier universitaire de Haut Leveque | |
Pessac, Gironde, France, 33604 | |
CHU Montpellier Lapeyronie Hospital | |
Montpellier, Hérault, France, 34295 | |
Centre hospitalier universitaire Pellegrin | |
Bordeaux, France, 33076 | |
Hopital Européen | |
Marseille, France, 13003 | |
India | |
Krishna Institute of Medical Science | |
Hyderabad, Andhra Pradesh, India, 500003 | |
Panchshil Hospital | |
Ahmedabad, Gujarat, India, 380005 | |
CIMS Hospital Private Limited | |
Ahmedabad, Gujarat, India, 380060 | |
NHL Municipal Medical College & VS General Hospital | |
Ahmedabad, Gujarat, India, 38006 | |
Shree Giriraj Hospital | |
Rajkot, Gujarat, India, 360004 | |
Nirmal Hospital Private Limited | |
Surat, Gujarat, India, 395002 | |
Sterling Hospital | |
Vadodara, Gujarat, India, 390007 | |
St. John Medical College & Hospital | |
Bangalore, Karnataka, India, 560034 | |
ChanRe Rheumatology And Immunology Center And Research | |
Bangalore, Karnataka, India, 560079 | |
Sushruta Multispecialty Hospital & Research Center Pvt Ltd | |
Hubli, Karnataka, India, 580021 | |
Kasturba Medical College Hospital, Mangalore | |
Madhav Nagar, Manipal, Karnataka, India, 576104 | |
Jasleen Hospital | |
Nagpur, Maharashtra, India, 44012 | |
Synexus Affiliate - Sujata Birla Hospital & Medical Research Center | |
Nashik, Maharashtra, India, 422101 | |
Fortis Escorts Hospital | |
Jaipur, Rajasthan, India, 302017 | |
Italy | |
Azienda Ospedaliera Universitaria | |
Modena, MO, Italy, 41124 | |
Azienda Ospedaliera Universitaria Pisana | |
Pisa, Toscana, Italy, 56100 | |
IRCCS Ospedale Policlinico San Martino | |
Genova, Italy, 16132 | |
Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico | |
Milano, Italy, 20122 | |
Azienda Policlinico Umberto I | |
Roma, Italy, 00161 | |
Azienda Ospedaliera Santa Maria Della Misericordia | |
Udine, Italy, 33100 | |
Japan | |
University of Occupational and Enviromental Health | |
Kitakyushu, Fukuoka, Japan, 807-8556 | |
Hiroshima University Hospital | |
Hiroshima-shi, Hiroshima-ken, Japan, 734-8551 | |
National Hospital Organization Asahikawa Medical Center | |
Asahikawa, Hokkaido, Japan, 070-8644 | |
Hokkaido University Hospital | |
Sapporo, Hokkaido, Japan, 060-8648 | |
Jp Red Cross Society Himeji Hp | |
Himeji, Hyogo, Japan, 670-8540 | |
Kobe University Hospital | |
Kobe, Hyogo, Japan, 650-0017 | |
Kagawa University Hospital | |
Kita-gun, Kagawa, Japan, 761-0793 | |
Tohoku University Hospital | |
Sendai-shi, Miyagi, Japan, 980-8574 | |
Juntendo University Hospital | |
Bunkyo-ku, Tokyo, Japan, 113-8431 | |
St. Lukes International Hospital | |
Chuo-Ku, Tokyo, Japan, 104 8560 | |
Toho University Ohashi Med C | |
Meguro-ku, Tokyo, Japan, 153-8515 | |
Showa University Hospital | |
Shinagawa-ku, Tokyo, Japan, 142-8666 | |
Keio University Hospital | |
Shinjuku-Ku, Tokyo, Japan, 160-8582 | |
National Hospital Organization Kyushu Medical Center | |
Fukuoka, Japan, 810 8563 | |
Hamanomachi Hospital | |
Fukuoka, Japan, 810-8539 | |
Nippon Medical School Hospital | |
Tokyo, Japan, 113-8603 | |
Korea, Republic of | |
Seoul National University Bundang Hospital | |
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620 | |
Kyung Pook National University Hospital | |
Daegu, Korea, Korea, Republic of, 41944 | |
Gachon University Gil Medical Center | |
Incheon, Korea, Korea, Republic of, 21565 | |
Hanyang University Medical Center | |
Seoul, Korea, Korea, Republic of, 04763 | |
The Catholic University of Korea-Seoul St. Mary's Hospital | |
Seocho-Gu, Seoul, Korea, Republic of, 06591 | |
Asan Medical Center | |
Seoul, Korea, Republic of, 05505 | |
Philippines | |
Mary Mediatrix Medical Center | |
Lipa, Batangas, Philippines, 4217 | |
Cebu Doctors Hospital | |
Cebu City, Cebu, Philippines, 6000 | |
Southern Philippines Medical Center | |
Davao, Davao Del Norte, Philippines, 8000 | |
Angeles University Foundation and Medical Center | |
Angeles City, Pampanga, Philippines, 2009 | |
Chong Hua Medical Arts Center | |
Cebu City, Philippines, 6000 | |
Makati Medical Center | |
Makati City, Philippines, 1229 | |
St. Luke's Medical Center | |
Quenzon City, Philippines, 1102 | |
Poland | |
Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o. | |
Wroclaw, Dolnoslaskie, Poland, 53224 | |
Twoja Przychodnia Centrum Medyczne Nowa Sol | |
Nowa Sol, Lubuskie, Poland, 67-100 | |
Medycyna Kliniczna | |
Warszawa, Mazowieckie, Poland, 00874 | |
Centrum Medyczne Reuma Park | |
Warszawa, Mazowieckie, Poland, 02-691 | |
Gabinet Internistyczno- Reumatologiczny Piotr Adrian Klimiuk | |
Bialystok, Podlaskie, Poland, 15-077 | |
Zespol Poradni Specjalistycznych REUMED | |
Lublin, Polska, Poland, 20582 | |
Ambulatorium Sp. z o. o. | |
Elblag, Warminsko-Mazurki, Poland, 82300 | |
Szpital Uniwersytecki Nr 2 w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej | |
Bydgoszcz, Poland, 85-168 | |
Centrum Medyczne Pratia Katowice | |
Katowice, Poland, 40-081 | |
Malopolskie Centrum Medyczne S.C. | |
Krakow, Poland, 30-510 | |
Centrum Medyczne Plejady | |
Krakow, Poland, 30363 | |
NZOZ Lecznica MAK-MED s.c. | |
Nadarzyn, Poland, 05-830 | |
Ortopedyczno-Rehabilitacyjny Szpital Kliniczny UM w Poznaniu | |
Poznan, Poland, 61-545 | |
Centrum Medyczne AMED | |
Warszawa, Poland, 03-291 | |
Romania | |
Napoca Emergency Clinical County Hospital | |
Napoca, Cluj, Romania, 40006 | |
Craiova Emergency Clinical County Hospital | |
Craiova, Dolj, Romania, 200642 | |
C.M.D.T.A. Neomed | |
Brasov, Romania, 500283 | |
SANA Medical Center | |
Bucharest, Romania, 11025 | |
St. Maria Clinical Hospital | |
Bucharest, Romania, 11172 | |
Spitalul Clinic Sf Maria Bucuresti | |
Bucuresti, Romania, 011172 | |
Spitalul Clinic "Dr. Ioan Cantacuzino" | |
Bucuresti, Romania, 020475 | |
Spitalul Euroclinic | |
Bucureti, Romania, 014461 | |
Serbia | |
Clinical Center of Serbia | |
Belgrade, Serbia, 11000 | |
Institute of Rheumatology | |
Belgrade, Serbia, 11000 | |
Military Medical Academy | |
Belgrade, Serbia, 11000 | |
Institute for Treatment and Rehabilitation Niska Banja | |
Niska Banja, Serbia, 18205 | |
Clinical Center of Vojvodina | |
Novi Sad, Serbia, 21000 | |
South Africa | |
Suite 509 Umhlanga Netcare Medical Centre | |
Umhlanga, Durban, South Africa, 4319 | |
Charlotte Maxeke Johannesburg Academic Hospital | |
Parktown, Guateng, South Africa, 2000 | |
Jakaranda Hospital | |
Muckleneuk, Pretoria, South Africa, 0002 | |
Panorama Medical Centre | |
Cape Town, Western Cape, South Africa, 7506 | |
Arthritis Clinical Trial Centre | |
Pinelands, Western Cape, South Africa, 7405 | |
Winelands Medical Research Centre | |
Stellenbosch, Western Cape, South Africa, 7600 | |
University Of Pretoria | |
Pretoria, South Africa, 0002 | |
Spain | |
Hospital Marina Baixa | |
La Vila Joiosa, Alicante, Spain, 03570 | |
Hospital De Fuenlabrada | |
Fuenlabrada, Madrid, Spain, 28944 | |
Hospital do Meixoeiro | |
Vigo, Pontevedra, Spain, 36200 | |
Corporacion Sanitaria Parc Tauli | |
Sabadell, Sapin, Spain, 08208 | |
Hospital Universitari Vall d'Hebron | |
Barcelona, Spain, 08035 | |
Corporació Sanitària Clínic | |
Barcelona, Spain, 8036 | |
Hospital Quiron Infanta Luisa | |
Sevilla, Spain, 41010 |
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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT03616964 |
Other Study ID Numbers: |
16677 I4V-MC-JAIA ( Other Identifier: Eli Lilly and Company ) 2017-005027-25 ( EudraCT Number ) |
First Posted: | August 6, 2018 Key Record Dates |
Last Update Posted: | March 19, 2021 |
Last Verified: | March 15, 2021 |
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 ClinicalStudyDataRequest.com This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement. |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
SLE |
Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |