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Systemic Lupus ErythematosusPhase 3BRAVE IINCT03616964

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

A Phase 3 study testing Baricitinib in people with Systemic Lupus Erythematosus, run by Eli Lilly and Company at 159 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
Baricitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
778 participants
Where
159 sitesin 15 countries
Study dates
2 Aug 2018to 20 Oct 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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)

Who cannot join

  • 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.

Trial locations and contacts

159 sites in 15 countries.

159 sites in 15 countries

United States39 sites

  • Albuquerque Clinical Trials, Inc.

    Albuquerque, New Mexico, 87102

  • Arthritis Clinic of Northern VA, P.C.

    Arlington, Virginia, 22205

  • Emory University

    Atlanta, Georgia, 30322

  • Northside Hospital

    Atlanta, Georgia, 30342

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland, 21224-6801

  • Wallace Rheumatic Studies Center

    Beverly Hills, California, 90211

  • St. Lawrence Health System

    Canton, New York, 13617

  • Joint and Muscle Medical Care

    Charlotte, North Carolina, 28204

  • Box Arthritis & Rheumatology of the Carolinas, PLLC

    Charlotte, North Carolina, 28210

  • Cincinnati Rheumatic Disease Study Group

    Cincinnati, Ohio, 45242

  • Clinical Research of West Florida, Inc. (Clearwater)

    Clearwater, Florida, 33765

  • Dr. Dhiman Basu Private Practice

    Colleyville, Texas, 76034

  • Medvin Clinical Research - Weidmann

    Covina, California, 91722

  • Eagle Medical

    Crossville, Tennessee, 38555

  • Metroplex Clinical Research Center

    Dallas, Texas, 75231

  • Spectrum Medical Inc.

    Danville, Virginia, 24541

  • Denver Arthritis Clinic - Lowry

    Denver, Colorado, 80230

  • University of Arizona Arthritis Center

    Gilbert, Arizona, 85297

  • Glacier View Research Institute - Endocrinology

    Kalispell, Montana, 59901

  • Advanced Rheumatology, PC

    Lansing, Michigan, 48910

  • Arthritis and Osteoporosis Associates of New Mexico

    Las Cruces, New Mexico, 88011

  • Innovative Health Research

    Las Vegas, Nevada, 89128

  • North Georgia Rheumatology, PC

    Lawrenceville, Georgia, 30046

  • Arthritis Center of Lexington

    Lexington, Kentucky, 40504

  • New York University Medical Center

    New York, New York, 10016

  • Oklahoma Medical Research Foundation

    Oklahoma City, Oklahoma, 73104

  • Millennium Research

    Ormond Beach, Florida, 32174

  • Arizona Arthritis & Rheumatology Research

    Phoenix, Arizona, 85302

  • Integral Rheumatology & Immunology Specialists

    Plantation, Florida, 33324

  • Articularis Healthcare d/b/a/ Low Country Rheumatology, PA

    Summerville, South Carolina, 29486

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Clinical Research of West Florida

    Tampa, Florida, 33603

  • Tampa Medical Group, P.A.

    Tampa, Florida, 33614

  • Advanced Rheumatology of Houston

    The Woodlands, Texas, 77382

  • Arizona Arthritis & Rheumatology Associates, P. C.

    Tucson, Arizona, 85704

  • Office: Dr Robin K Dore

    Tustin, California, 92780

  • Inland Rheumatology & Osteoporosis Medical Group

    Upland, California, 91786

  • Clear Lake Specialties

    Webster, Texas, 77598

  • Clinical Research Center of Reading,LLC

    Wyomissing, Pennsylvania, 19610

Other trials in United States

Japan16 sites

  • National Hospital Organization Asahikawa Medical Center

    Asahikawa, Hokkaido, 070-8644

  • Juntendo University Hospital

    Bunkyo-ku, Tokyo, 113-8431

  • St. Lukes International Hospital

    Chuo-Ku, Tokyo, 104 8560

  • National Hospital Organization Kyushu Medical Center

    Fukuoka, 810 8563

  • Hamanomachi Hospital

    Fukuoka, 810-8539

  • Jp Red Cross Society Himeji Hp

    Himeji, Hyōgo, 670-8540

  • Hiroshima University Hospital

    Hiroshima, Hiroshima, 734-8551

  • Kagawa University Hospital

    Kita-gun, Kagawa-ken, 761-0793

  • University of Occupational and Enviromental Health

    Kitakyushu, Fukuoka, 807-8556

  • Kobe University Hospital

    Kobe, Hyōgo, 650-0017

  • Toho University Ohashi Med C

    Meguro-ku, Tokyo, 153-8515

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574

  • Showa University Hospital

    Shinagawa-ku, Tokyo, 142-8666

  • Keio University Hospital

    Shinjuku-Ku, Tokyo, 160-8582

  • Nippon Medical School Hospital

    Tokyo, 113-8603

Other trials in Japan

India14 sites

  • Panchshil Hospital

    Ahmedabad, Gujarat, 380005

  • CIMS Hospital Private Limited

    Ahmedabad, Gujarat, 380060

  • NHL Municipal Medical College & VS General Hospital

    Ahmedabad, Gujarat, 38006

  • St. John Medical College & Hospital

    Bangalore, Karnataka, 560034

  • ChanRe Rheumatology And Immunology Center And Research

    Bangalore, Karnataka, 560079

  • Sushruta Multispecialty Hospital & Research Center Pvt Ltd

    Hubli, Karnataka, 580021

  • Krishna Institute of Medical Science

    Hyderabad, Andhra Pradesh, 500003

  • Fortis Escorts Hospital

    Jaipur, Rajasthan, 302017

  • Kasturba Medical College Hospital, Mangalore

    Madhav Nagar, Manipal, Karnataka, 576104

  • Jasleen Hospital

    Nagpur, Maharashtra, 44012

  • Synexus Affiliate - Sujata Birla Hospital & Medical Research Center

    Nashik, Maharashtra, 422101

  • Shree Giriraj Hospital

    Rajkot, Gujarat, 360004

  • Nirmal Hospital Private Limited

    Surat, Gujarat, 395002

  • Sterling Hospital

    Vadodara, Gujarat, 390007

Other trials in India

Poland14 sites

  • Gabinet Internistyczno- Reumatologiczny Piotr Adrian Klimiuk

    Bialystok, Podlaskie Voivodeship, 15-077

  • Szpital Uniwersytecki Nr 2 w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej

    Bydgoszcz, 85-168

  • Ambulatorium Barbara Bazela

    Elblag, Warminsko-Mazurki, 82300

  • Centrum Medyczne Pratia Katowice

    Katowice, 40-081

  • Malopolskie Centrum Medyczne S.C.

    Krakow, 30-510

  • Centrum Medyczne Plejady

    Krakow, 30363

  • Zespol Poradni Specjalistycznych REUMED

    Lublin, Polska, 20582

  • NZOZ Lecznica MAK-MED s.c.

    Nadarzyn, 05-830

  • Twoja Przychodnia Centrum Medyczne Nowa Sol

    Nowa Sól, Lubusz Voivodeship, 67-100

  • Ortopedyczno-Rehabilitacyjny Szpital Kliniczny UM w Poznaniu

    Poznan, 61-545

  • Medycyna Kliniczna

    Warsaw, Masovian Voivodeship, 00874

  • Reumatika - Centrum Reumatologii

    Warsaw, Masovian Voivodeship, 02-691

  • Centrum Medyczne AMED

    Warsaw, 03-291

  • Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o.

    Wroclaw, Lower Silesian Voivodeship, 53224

Other trials in Poland

Argentina11 sites

  • Comite de Etica en Investigacion - CEMIC

    Buenos Aires, Ciudad Autonoma de Buenos Aire, C1431FWO

  • Aprillus Asistencia e Investigacion - Servicio de neurologia

    CABA, Buenos Aires, C1046AAQ

  • Clinica Adventista Belgrano

    CABA, Ciudad Autónoma de Buenos Aire, C1430EGF

  • Sanatorio Guemes Cardiocirugia

    Ciudad Autonoma Buenos Aires, C1181AAX

  • DOM Centro de Reumatologia

    Ciudad de Buenos Aires, Buenos Aires, C1111AAH

  • Framingham Centro Medico

    La Plata, Buenos Aires, B1902COS

  • IR Medical Center S.A. Instituto de Reumatologia

    Mendoza, M5500CPH

  • CER Instituto Medico

    Quilmes, Buenos Aires, B1878DVC

  • Instituto de Investigaciones Clinicas Quilmes

    Quilmes, Buenos Aires, B1878GEG

  • Sanatorio Británico

    Rosario, Santa Fe Province, 2000

  • Centro Medico Privado de Reumatologia

    SAN M. de Tucuman, Tucumán Province, T4000AXL

Other trials in Argentina

Colombia8 sites

  • Circaribe SAS

    Barranquilla, Atlántico

  • Clinica de la Costa

    Barranquilla, Atlántico

  • Idearg S.A.S.

    Bogota, Cundinamarca

  • Centro Integral de Reumatologia e Inmunologia

    Bogotá, Cundinamarca

  • Servimed S.A.S.

    Bucaramanga, Santander Department, 12345

  • Centro de Medicina Interna

    Cali, Valle del Cauca Department

  • Preventive Care Ltdac

    Chía

  • HPTU-El Hospital con alma Pablo Tobon Uribe

    Medellín, Antioquia

Other trials in Colombia

Romania8 sites

  • SC CMDTA Neomed SRL

    Brasov, 500283

  • Spitalul Clinic Sf Maria Bucuresti

    Bucharest, 011172

  • Spitalul Clinic "Dr. Ioan Cantacuzino"

    Bucharest, 020475

  • SANA Medical Center

    Bucharest, 11025

  • St. Maria Clinical Hospital

    Bucharest, 11172

  • Spitalul Euroclinic

    Bucureti, 014461

  • Napoca Emergency Clinical County Hospital

    Cluj-Napoca, Cluj, 40006

  • Craiova Emergency Clinical County Hospital

    Craiova, Dolj, 200642

Other trials in Romania

Philippines7 sites

  • Angeles University Foundation and Medical Center

    Angeles City, Pampanga, 2009

  • Cebu Doctors Hospital

    Cebu City, Cebu, 6000

  • Chong Hua Medical Arts Center

    Cebu City, 6000

  • Southern Philippines Medical Center

    Davao City, Davao Del Norte, 8000

  • Mary Mediatrix Medical Center

    Lipa, Batangas, 4217

  • Makati Medical Center

    Makati City, 1229

  • St. Luke's Medical Center

    Quenzon City, 1102

Other trials in Philippines

South Africa7 sites

  • Panorama Medical Centre

    Cape Town, Western Cape, 7506

  • Jakaranda Hospital

    Muckleneuk, Pretoria, 0002

  • Charlotte Maxeke Johannesburg Academic Hospital

    Parktown, Guateng, 2000

  • Arthritis Clinical Trial Centre

    Pinelands, Western Cape, 7405

  • University Of Pretoria

    Pretoria, 0002

  • Winelands Medical Research Centre

    Stellenbosch, Western Cape, 7600

  • Suite 509 Umhlanga Netcare Medical Centre

    Umhlanga, Durban, 4319

Other trials in South Africa

Spain7 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Corporació Sanitària Clínic

    Barcelona, 8036

  • Hospital De Fuenlabrada

    Fuenlabrada, Madrid, 28944

  • Corporacion Sanitaria Parc Tauli

    Sabadell, Sapin, 08208

  • Hospital Quiron Infanta Luisa

    Seville, 41010

  • Hospital do Meixoeiro

    Vigo, Pontevedra, 36200

  • Hospital Marina Baixa

    Villajoyosa, Alicante, 03570

Other trials in Spain

Chile6 sites

  • Clinica Alemana de Osorno

    Osorno, 5290000

  • Enroll SpA

    Providencia, Región Metropolitana de Santia, 7500587

  • Sociedad Medica Del Aparato Locomotor SA

    Santiago, 7510186

  • Prosalud y cia. Ltda.

    Santiago

  • Clinical Research Chile SpA

    Valdivia, Los Ríos Region, 5110683

  • ReumaCen Centro Reumatologico Integral

    Viña del Mar, 2570017

Other trials in Chile

Italy6 sites

  • IRCCS Ospedale Policlinico San Martino

    Genova, 16132

  • Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • Azienda Ospedaliera Universitaria

    Modena, MO, 41124

  • Azienda Ospedaliera Universitaria Pisana

    Pisa, Tuscany, 56100

  • Azienda Policlinico Umberto I

    Roma, 00161

  • Azienda Ospedaliera Santa Maria Della Misericordia

    Udine, 33100

Other trials in Italy

South Korea6 sites

  • Kyung Pook National University Hospital

    Daegu, Korea, 41944

  • Gachon University Gil Hospital

    Incheon, Korea, 21565

  • The Catholic University of Korea-Seoul St. Mary's Hospital

    Seocho-Gu, Seoul, 06591

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Hanyang University Medical Center

    Seoul, Korea, 04763

  • Asan Medical Center

    Seoul, Seoul-teukbyeolsi [Seoul], 05505

Other trials in South Korea

France5 sites

  • Centre hospitalier universitaire Pellegrin

    Bordeaux, 33076

  • CHRU Brest - Hopital Cavale Blanche

    Brest, Finistère, 29609

  • Hopital Européen

    Marseille, 13003

  • CHU Montpellier Lapeyronie Hospital

    Montpellier, Hérault, 34295

  • Centre hospitalier universitaire de Haut Leveque

    Pessac, Gironde, 33604

Other trials in France

Serbia5 sites

  • Institute of Rheumatology

    Belgrade, 11000

  • Military Medical Academy

    Belgrade, 11000

  • University Clinical Center of Serbia

    Belgrade, 11000

  • Institute for Treatment and Rehabilitation Niska Banja

    Niška Banja, 18205

  • Clinical Center of Vojvodina

    Novi Sad, 21000

Other trials in Serbia

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients With Systemic Lupus Erythematosus

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).

Being tested
Baricitinib, Placebo
Keywords
SLE
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BaricitinibDrug

    Also called LY3009104

    Administered orally.

  • PlaceboDrug

    Administered orally

Study groups in NCT03616964
Study groupRoleWhat they receive
2 milligram (mg) BaricitinibExperimentalParticipants received one 2 mg baricitinib tablet and one placebo tablet matching 4 mg baricitinib administered orally once daily (QD) for 52 weeks.
Receives: Drug: Baricitinib; Drug: Placebo
4 mg BaricitinibExperimentalParticipants received one 4 mg baricitinib tablet and one placebo tablet matching 2 mg baricitinib administered orally QD for 52 weeks.
Receives: Drug: Baricitinib; Drug: Placebo
PlaceboPlacebo 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Week 52

Secondary outcomes (11)

  1. Percentage of Participants Achieving SRI-4 Response (2 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).

    Measured: Week 52

  2. Percentage of Participants Achieving a Lupus Low Disease Activity State (LLDAS)

    The LLDAS is a composite measure designed to identify patients achieving a state of low disease activity. The LLDAS response criteria were: (1) SLEDAI-2K <=4, with no activity in major organ systems (CNS, vascular, renal, cardiorespiratory and constitutional); where "no activity" is defined as all items of SLEDAI-2K within these major organ systems equal to 0. (2) no new features of lupus disease activity compared to previous occurred visit, where the "new feature" is defined as any of the SLEDAI-2K 24 items changed from 0 to greater than 0; (3) PGA (scale 0-3), <=1; (4) current prednisolone (or equivalent) dose <=7.5 mg daily.

    Measured: Week 52

  3. Time to First Severe Flare

    Time to first severe flare analyzed using a Cox proportional hazards model with treatment group, baseline disease activity [Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) <10; SLEDAI-2K ≥10], baseline corticosteroid dose (<10 mg/day; ≥10 mg/day prednisone or equivalent), and region fitted as explanatory variables. Participants who did not have severe flare during the flare exposure time period were censored at the end of the flare exposure time.

    Measured: Baseline to Week 52

  4. 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

    For the analysis of steroid use, steroid dosages were converted to a prednisone equivalent in mg. A responder was defined as having a prednisone reduction by >=25% from Baseline to <=7.5 mg/day during Weeks 40 through 52.

    Measured: Baseline, Week 40 through Week 52

  5. Change From Baseline in Worst Pain Numeric Rating Scale (NRS)

    Participants assessed the worst pain in the last 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine). The average worst daily pain score was calculated as the mean of the scores over the last 7 days prior to each assessment time point. Higher score indicated severe pain. Least Squares (LS) mean was calculated using Mixed Model Repeated Measures (MMRM) analysis with treatment, baseline disease activity (total SLEDAI-2K <10; >=10), baseline corticosteroid dose (<10 mg/day; >= 10 mg/day prednisone or equivalent), region (North America, Central/South, America/Mexico, Europe, Asia Rest of World), visit (as categorical variable), baseline value, treatment-by-visit interaction, and baseline value-by-visit interaction.

    Measured: Baseline, Week 52

  6. Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Total Score

    FACIT-Fatigue score calculated according to a 13-item questionnaire that assess self reported fatigue and its impact upon daily activities and function. It uses a 5-point Likert-type scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse possible score) to 52 (best score). A higher score reflected an improvement in the participant's health status. Least Squares (LS) mean was calculated using Mixed Model Repeated Measures (MMRM) analysis with treatment, baseline disease activity (total SLEDAI-2K <10; >=10), baseline corticosteroid dose (<10 mg/day; >= 10 mg/day prednisone or equivalent), region (North America, Central/South, America/Mexico, Europe, Asia Rest of World), visit (as categorical variable), baseline value, treatment-by-visit interaction, and baseline value-by-visit interaction.

    Measured: Baseline, Week 52

  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

    The CLASI is a single-page tool that separately quantifies disease activity and damage. For the activity score, points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. The total score represents the sum of the individual scores and ranges from 0 to 70. Higher scores are awarded for more severe manifestations.

    Measured: Week 52

  8. Change From Baseline in Tender Joint Count

    The number of tender and painful joints is determined by examination of 28 joints (14 on each side) which include: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. The joints are assessed and classified as tender or not tender. LS mean was calculated using Mixed Model Repeated Measures (MMRM) analysis with treatment, baseline disease activity (total SLEDAI-2K <10; >=10), baseline corticosteroid dose (<10 mg/day; >=10 mg/day prednisone or equivalent), region (North America, Central/South America/Mexico, Europe, Asia and Rest of World), visit (as categorical variable), baseline value, treatment-by-visit interaction, and baseline value-by-visit interaction.

    Measured: Baseline, Week 52

  9. Change From Baseline in Swollen Joint Count

    The number of swollen joints is determined by examination of 28 joints (14 on each side) which include: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. The joints are assessed and classified as swollen or not swollen. LS mean was calculated using MMRM analysis with treatment, baseline disease activity (total SLEDAI-2K <10; >=10), baseline corticosteroid dose (<10 mg/day; >=10 mg/day prednisone or equivalent), region (North America, Central/South America/Mexico, Europe, Asia and Rest of World), visit (as categorical variable), baseline value, treatment-by-visit interaction, and baseline value-by-visit interaction.

    Measured: Baseline, Week 52

  10. Population Pharmacokinetics (PK): Area Under the Concentration-Time Curve for Dosing Interval of Baricitinib at Steady State (AUCtau,ss)

    AUCtau,ss reported for participants who received multiple doses of mg baricitinib was derived by a population pharmacokinetics approach.

    Measured: Week 0 (Baseline): 15 minutes (min) and 60 min postdose; Week 4: 2 to 4 hours (hr) postdose; Week 8: 4 to 6 hr postdose; Week 12 and Week 16 predose

  11. Population PK: Maximum Observed Drug Concentration at Steady State (Cmax,ss)

    PK: Maximum Concentration of Baricitinib at steady-state (Cmax,ss) was derived by a population pharmacokinetics approach.

    Measured: Week 0 (Baseline): 15 minutes (min) and 60 min postdose; Week 4: 2 to 4 hours (hr) postdose; Week 8: 4 to 6 hr postdose; Week 12 and Week 16 predose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2018
  2. Study start2 Aug 2018
  3. Primary completion24 Sep 2021
  4. Study completion20 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
778 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03616964
Sponsor's protocol ID
16677
Other IDs
I4V-MC-JAIA, 2017-005027-25, 2017
Acronym
BRAVE II
Status last verified
Nov 2022
First submitted
1 Aug 2018
Last updated
23 Nov 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 40305472

  • Petri 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.

    PubMed 36848919

  • 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.

    PubMed 33687069

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Baricitinib in people with Systemic Lupus Erythematosus, run by Eli Lilly and Company at 159 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 159 sites in United States, Japan, India, Poland, Argentina and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response (4 mg Baricitinib) (time frame: Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03616964, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2022.

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