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

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
Sponsor:
Collaborator:
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)
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

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).



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

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 ClinicalTrials.gov identifier (NCT number): NCT03616964


Locations
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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
Sponsors and Collaborators
Eli Lilly and Company
Incyte Corporation
Investigators
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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 ClinicalTrials.gov Identifier (NCT Number):
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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.

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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:
SLE
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases