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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03616912
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : January 15, 2019
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

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 : February 16, 2021
Estimated Study Completion Date : February 16, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

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

Drug: Placebo
Administered orally.

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

Drug: Placebo
Administered orally.

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

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

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

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

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

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

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

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

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

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

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

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

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

Information from the National Library of Medicine

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

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

Inclusion Criteria:

  • Have a clinical diagnosis of SLE at least 24 weeks prior to screening.
  • Have documentation of having met at least 4 of 11 Revised Criteria for Classification of Systemic Lupus Erythematosus according to the 1997 Update of the 1982 American College of Rheumatology (ACR) criteria for classification of SLE prior to randomization.
  • Have a positive antinuclear antibody (ANA) (titer ≥1:80) and/or a positive anti-double-stranded deoxyribonucleic acid (dsDNA), and/or a positive anti-Smith (anti-Sm) as assessed by a central laboratory during screening.
  • Have a total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥6 during screening.
  • Have a clinical SLEDAI-2K score ≥4 at randomization.
  • Have at least 1 British Isles Lupus Assessment Group (BILAG) A score or 2 BILAG B scores during screening.
  • Are receiving at least one of the following standard of care medications for SLE:

    • A single antimalarial at a stable dose for at least 8 weeks prior to screening
    • A single immunosuppressant at a stable dose for at least 8 weeks prior to screening
    • An oral corticosteroid, initiated at least 4 weeks prior to screening, at a stable dose ≤40 milligrams/day prednisone (or equivalent) for at least 2 weeks prior to screening. If the participant is not receiving an antimalarial or immunosuppressant, the dose of corticosteroid must be ≥7.5 milligrams/day prednisone (or equivalent)

Exclusion Criteria:

  • Have severe active lupus nephritis.
  • Have active central nervous system (CNS) lupus.
  • Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking investigational product or interfere with the interpretation of data.
  • Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection.
  • Have received cyclophosphamide (or any other cytotoxic agent) within 12 weeks prior to screening.

Information from the National Library of Medicine

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

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

Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

  Hide Study Locations
United States, Alabama
Achieve Clinical Research, LLC Recruiting
Birmingham, Alabama, United States, 35216
Contact    205-757-8212      
Principal Investigator: Hayes T Williams         
United States, Arizona
Arizona Arthritis & Rheumatology Research Not yet recruiting
Glendale, Arizona, United States, 85306
Contact    480-626-6650      
Principal Investigator: Saima Chohan         
United States, California
ST Joseph Heritage Medical Group Not yet recruiting
Fullerton, California, United States, 92835
Contact    714-626-8610      
Principal Investigator: Shirley W Pang         
Univ of Southern California Medical Center Not yet recruiting
Los Angeles, California, United States, 90033
Contact    323-442-1946      
Principal Investigator: William Stohl         
UCLA Medical Center Not yet recruiting
Los Angeles, California, United States, 90095
Contact    310-206-3244      
Principal Investigator: Jennifer M Grossman         
United States, Connecticut
New England Research Associates Recruiting
Bridgeport, Connecticut, United States, 06606
Contact    203-325-8529      
Principal Investigator: Geoffrey S Gladstein         
Yale University School of Medicine Not yet recruiting
New Haven, Connecticut, United States, 06519
Principal Investigator: Fotios Koumpouras         
United States, Florida
Lakes Research, LLC Recruiting
Miami Lakes, Florida, United States, 33014
Contact    305-362-4979      
Principal Investigator: Benidecto Fernandez         
New Horizon Research Center Not yet recruiting
Miami, Florida, United States, 33175
Contact    305-226-3933      
Principal Investigator: Francisco G Miranda         
United States, Georgia
Piedmont Healthcare Not yet recruiting
Atlanta, Georgia, United States, 30318
Contact    404-350-0009      
Principal Investigator: Wambui L Machua         
Atlanta Center for Clinical Research Not yet recruiting
Atlanta, Georgia, United States, 30342
Contact    770-226-8819      
Principal Investigator: Stuart Handelsman         
United States, Idaho
St Luke's Clinic - Intermountain Orthopaedics Not yet recruiting
Boise, Idaho, United States, 83702
Contact    208-489-4369      
Principal Investigator: Achini Dingman         
United States, Kentucky
DermResearch, PLLC Recruiting
Louisville, Kentucky, United States, 40217
Contact    502-456-2783      
Principal Investigator: Leon H Kircik         
United States, Maryland
The Center for Rheumatology and Bone Research Not yet recruiting
Wheaton, Maryland, United States, 20902
Contact    301-942-6610      
Principal Investigator: Paul J DeMarco         
United States, Michigan
Henry Ford Health System Not yet recruiting
Detroit, Michigan, United States, 48202
Contact    412-648-4701      
Principal Investigator: Kathleen M Maksimowicz-McKinnon         
United States, Missouri
Clayton Medical Research Recruiting
Saint Louis, Missouri, United States, 63117
Contact    314-646-0688      
Principal Investigator: John J. Budd         
United States, Nevada
Allied Clinical Research Recruiting
Reno, Nevada, United States, 89519
Contact    775-313-9800      
Principal Investigator: Bryan J Wolf         
United States, New Mexico
Albuquerque Rehabilitation & Rheumatology, PC Recruiting
Albuquerque, New Mexico, United States, 87102
Contact    505-341-4148      
Principal Investigator: Leroy A Pacheco         
United States, New York
SUNY Health Science Center Not yet recruiting
Brooklyn, New York, United States, 11203
Principal Investigator: Ellen M Ginzler         
Northwell Health Not yet recruiting
Great Neck, New York, United States, 11021
Contact    5164706901      
Principal Investigator: Richard Alan Furie         
The Feinstein Institute for Medical Research Recruiting
Manhasset, New York, United States, 11030
Contact    5165623838      
Principal Investigator: Meggan Claire Mackay         
Columbia University Medical Center Not yet recruiting
New York, New York, United States, 10032
Contact    212-305-0856      
Principal Investigator: Anca Askanase         
Buffalo Rheumatology Recruiting
Orchard Park, New York, United States, 14127
Principal Investigator: Joseph Michael Grisanti         
United States, Ohio
The Ohio State University Not yet recruiting
Columbus, Ohio, United States, 43210
Principal Investigator: Alexa S Meara         
Paramount Medical Research Recruiting
Middleburg Heights, Ohio, United States, 44130
Contact    440-891-9395      
Principal Investigator: Isam A. Diab         
United States, Oklahoma
Arthritis & Rheumatology Center of Oklahoma PLLC Recruiting
Oklahoma City, Oklahoma, United States, 73102
Contact    405-606-8730      
Principal Investigator: Mohammad Khan         
United States, Pennsylvania
East Penn Rheumatology Not yet recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact    610-868-1335      
Principal Investigator: Charles L. Ludivico         
UPMC Lupus Center of Excellence Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact    412-648-9782      
Principal Investigator: Ghaith Noaiseh         
United States, Texas
Amarillo Center for Clinical Research Recruiting
Amarillo, Texas, United States, 79124
Contact    806-352-2453      
Principal Investigator: Constantine K Saadeh         
Austin Regional Clinic Not yet recruiting
Austin, Texas, United States, 78731
Contact    737-247-7240      
Principal Investigator: Anu Chadha         
Accurate Clinical Management LLC - BayTown Recruiting
Baytown, Texas, United States, 77521
Contact    281-851-7088      
Principal Investigator: Sabeen Najam         
Rheumatology Center of Houston Not yet recruiting
Houston, Texas, United States, 77004
Contact    281-481-8557      
Principal Investigator: Jacqueline D Vo         
United States, Washington
Swedish Medical Center Not yet recruiting
Seattle, Washington, United States, 98122
Contact    206-386-2000      
Principal Investigator: Philip J Mease         
Australia, New South Wales
Optimus Clinical Research Not yet recruiting
Kogarah, New South Wales, Australia, 2217
Contact    61289648186      
Principal Investigator: Paul Bird         
John Hunter Hospital Not yet recruiting
Newcastle, New South Wales, Australia, 2305
Contact    61249214200      
Principal Investigator: Glenn Reeves         
Australia, Queensland
The Rheumatology Research Unit Sunshine Coast Not yet recruiting
Maroochydore, Queensland, Australia, 4558
Principal Investigator: Peter Nash         
Australia, Victoria
Emeritus Research Not yet recruiting
Camberwell, Victoria, Australia, 3124
Principal Investigator: Andrew Ostor         
Monash Medical Centre Not yet recruiting
Clayton, Victoria, Australia, 3168
Principal Investigator: Alberta Hoi         
St Vincents Hospital Melbourne Not yet recruiting
Fitzroy, Victoria, Australia, 3065
Contact    61394117111      
Principal Investigator: Mandana Nikpour         
Ordensklinikum Linz GmbH - Elisabethinen Not yet recruiting
Linz, Oberösterreich, Austria, 4020
Contact    43073276760      
Principal Investigator: Norbert Thomas Sepp         
Medizinische Universität Wien - Kinder und Jugendheilkunde Not yet recruiting
Wien, Vienna, Austria, 1090
Principal Investigator: Klaus Machold         
Medizinische Universität Graz Not yet recruiting
Graz, Austria, 8036
Principal Investigator: Winfried Graninger         
KH Hietzing mit neurologischem Zentrum Rosenhügel Not yet recruiting
Wien, Austria, 1130
Principal Investigator: Kurt Redlich         
Katholieke Universiteit Leuven Not yet recruiting
Leuven, Vlaams Brabant, Belgium, 3000
Principal Investigator: Ellen De Langhe         
Cliniques Universitaires Saint-Luc Not yet recruiting
Brussels, Belgium, 1200
Contact    3227643633      
Principal Investigator: Frederic Houssiau         
CHU de Liège Not yet recruiting
Liège, Belgium, 4000
Contact    3243668310      
Principal Investigator: Christian Von Frenckell         
SER - Serviços Especializados em Reumatologia da Bahia S/S - ME Not yet recruiting
Salvador, Bahia, Brazil, 40150-150
Principal Investigator: Santiago Mittermayer Barreto         
CIP-Centro Internacional de Pesquisa Not yet recruiting
Goiania, Goiás, Brazil, 74110-120
Principal Investigator: Antonio Carlos Ximenes         
Santa Casa de Misericordia de Belo Horizonte Not yet recruiting
Belo Horizonte, MG, Brazil, 30150-221
Contact    5531323140179      
Principal Investigator: Claudia Lopes Santoro Neiva         
Centro de Estudos em Terapias Inovadoras-CETI Not yet recruiting
Curitiba, Paraná, Brazil, 80030-110
Contact    554130223482      
Principal Investigator: Sebastiao C. Radominski         
EDUMED - Educação em Saúde Ltda. Not yet recruiting
Curitiba, Paraná, Brazil, 80440-080
Contact    554130496504      
Principal Investigator: Valderilio Feijo Azevedo         
LMK Serviços Médicos S/S Not yet recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90540-000
Contact    555133205057      
Principal Investigator: Mauro Waldemar Keiserman         
Hospital de Clinicas de Porto Alegre Not yet recruiting
Porto Alegre, RS, Brazil, 90035-003
Contact    55513168117      
Principal Investigator: Joao C. Brenol         
Hospital de Clinicas UNICAMP Not yet recruiting
Campinas, SP, Brazil, 13083-970
Contact    55197887342      
Principal Investigator: Simone Appenzeller         
China, Guangdong
The Third Affiliated Hospital Of Sun Yat-sen University Not yet recruiting
Guangzhou, Guangdong, China, 510630
Contact    862085516867      
Principal Investigator: Jieruo Gu         
China, Heilongjiang
First Affiliated Hospital of the Harbin Medical University Not yet recruiting
Harbin, Heilongjiang, China, 150001
Contact    8645113804601998      
Principal Investigator: Zhiyi Zhang         
China, Hunan
The Second Xiangya Hospital of Central South University Not yet recruiting
Changsha, Hunan, China, 410011
Contact    867315550254      
Principal Investigator: Fei Li         
China, Jiangsu
Nanjing Drum Tower Hosp Affiliated Hosp of Nanjing Univ Med Not yet recruiting
Nanjing, Jiangsu, China, 210008
Principal Investigator: Lingyun Sun         
China, Jilin
China-Japan Union Hospital of Jilin University Not yet recruiting
Changchun Shi, Jilin, China, 100853
Principal Investigator: LiQi Bi         
China, Shanghai
Renji Hospital Affliated to Shanghai Jiaotong University Not yet recruiting
Shanghai, Shanghai, China, 200001
Principal Investigator: Chunde Bao         
China, Zhejiang
Second Affiliate Hospital of Zhejiang Medical University Not yet recruiting
Hangzhou, Zhejiang, China, 310009
Contact    05717783858      
Principal Investigator: Hua-Xiang Wu         
China-Japan Friendship Hospital Not yet recruiting
Beijing, China, 100029
Contact    8601084205716      
Principal Investigator: Guochun Wang         
Shanghai Huashan Hospital Affil to Fu Dan University Not yet recruiting
Shanghai, China, 200040
Principal Investigator: Wei-Guo Wan         
China Medical University (CMU) - First Affiliated Hospital Not yet recruiting
Shenyang, China, 110001
Principal Investigator: Rong Zhang         
The First Affliated Hospital of Suzhou University Not yet recruiting
Suzhou Shi, China, 215000
Principal Investigator: Jian Wu         
People's Hospital of Xinjiang Uygur Autonomous Region Not yet recruiting
Urumqi, China, 830001
Principal Investigator: Li-Jun Wu         
Revmatologie s.r.o. Not yet recruiting
Brno, Czechia, 638 00
Principal Investigator: Leona Prochazkova         
Fakultni Nemocnice Olomouc Not yet recruiting
Olomouc, Czechia, 775 20
Principal Investigator: Pavel Horak         
Arthrohelp s.r.o Not yet recruiting
Pardubice, Czechia, 530 02
Contact    420464007686      
Principal Investigator: Zdenek Dvorak         
Vseobecna fakultni nemocnice Not yet recruiting
Praha 2, Czechia, 128 08
Contact    420224962605      
Principal Investigator: Vladimir Tesar         
Revmatologicky ustav Not yet recruiting
Praha 2, Czechia, 128 50
Contact    420234075338      
Principal Investigator: Dana Tegzova         
Universitätsklinikum Freiburg Not yet recruiting
Freiburg im Breisgau, Baden-Württemberg, Germany, 79106
Contact    497612707396      
Principal Investigator: Stephanie Finzel         
Universitätsklinikum Heidelberg Not yet recruiting
Heidelberg, Baden-Württemberg, Germany, 69120
Contact    496221568604      
Principal Investigator: Norbert Blank         
Klinikum der Universität München Not yet recruiting
München, Bayern, Germany, 80336
Contact    498970951      
Principal Investigator: Hendrik Schulze-Koops         
Universitätsklinikum Würzburg Not yet recruiting
Würzburg, Bayern, Germany, 97080
Principal Investigator: Hans-Peter Tony         
Universitätsklinikum Köln Not yet recruiting
Köln, Nordrhein-Westfalen, Germany, 50937
Contact    492214783993      
Principal Investigator: David Kofler         
Universität Leipzig - Universitätsklinikum Not yet recruiting
Leipzig, Sachsen, Germany, 04103
Principal Investigator: Ulf Wagner         
Universitätsklinikum Jena Not yet recruiting
Jena, Thüringen, Germany, 07747
Principal Investigator: Peter Oelzner         
Charité Universitätsmedizin Berlin Not yet recruiting
Berlin, Germany, 10117
Principal Investigator: Falk Hiepe         
Immanuel Krankenhaus Rheuma Klinik Berlin Buch Not yet recruiting
Berlin, Germany, 13125
Contact    493920067319      
Principal Investigator: Andreas Krause         
Bekes Megyei Pandy Kalman Korhaz Not yet recruiting
Gyula, Bekes, Hungary, 5700
Contact    3666361833      
Principal Investigator: Tibor Martyin         
Budai Irgalmasrendi Korhaz Not yet recruiting
Budapest, Hungary, 1027
Principal Investigator: Ariunaa Gantumur         
Qualiclinic Kft Not yet recruiting
Budapest, Hungary, 1036
Principal Investigator: Istvan Szombati         
Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointeze Not yet recruiting
Budapest, Hungary, 1097
Principal Investigator: Janos Kadar         
Pecsi Tudomanyegyetem Klinikai Kozpont Not yet recruiting
Pecs, Hungary, 7632
Principal Investigator: Cecilia Varju         
Mentaház Magánorvosi Központ Kft. Not yet recruiting
Székesfehérvár, Hungary, 8000
Principal Investigator: Tunde Varga         
Vital Medical Center Not yet recruiting
Veszprem, Hungary, 8200
Contact    3688790434      
Principal Investigator: Csaba Kiss         
CIMAB S.A. de C.V. Not yet recruiting
Torreon, Coahuila, Mexico, 27000
Principal Investigator: Sandra Araceli Sicsik Ayala         
Cliditer Sa de CV Not yet recruiting
Mexico City, Distrito Federal, Mexico, 06700
Principal Investigator: Gabriel Medrano         
Centro Integral en Reumatologia SA de CV Not yet recruiting
Guadalajara, Jalisco, Mexico, 44160
Contact    526646340662      
Principal Investigator: Hilario Avila-Armengol         
Clinica en Investigación en Reumatologia y Obesidad S.C. Not yet recruiting
Guadalajara, Jalisco, Mexico, 44650
Principal Investigator: Sergio Duran Barragan         
Centro de Estudios de Investigacion Metabolicos y Cardiovasc Not yet recruiting
Guadalajara, Jalisco, Mexico, 44690
Principal Investigator: Ignacio Garcia de la Torre         
Centro Medico de las Americas Not yet recruiting
Merida, Yucatan, Mexico, 97000
Principal Investigator: Jose A. Covarrubias         
Kohler Milstein Research, S.A. de C.V. Not yet recruiting
Merida, Yucatan, Mexico, 97070
Contact    529999204004      
Principal Investigator: Jesus Abraham Simon Campos         
Cemdeicy S.C.P. Not yet recruiting
Merida, Yucatán, Mexico, 97130
Principal Investigator: Efren Alberto Canul Novelo         
Centro de Alta Especialidad Reumatologia e Inv Potosi, S.C. Not yet recruiting
San Luis Potosi, Mexico, 78213
Contact    524448340562      
Principal Investigator: Juan Cruz Cruz Rizo Rodriguez         
Russian Federation
City Hospital # 7 Not yet recruiting
Kazan, Russian Federation, 420103
Principal Investigator: Artem Vasilyev         
SIH Kemerovo Regional Clinical Hosptial Not yet recruiting
Kemerovo, Russian Federation, 650066
Contact    73842521600      
Principal Investigator: Svetlana Smakotina         
Russian State Medical University Not yet recruiting
Moscow, Russian Federation, 117997
Principal Investigator: Ivan Gordeev         
Rheumatology Institute RAMS Not yet recruiting
Moscow, Russian Federation
Principal Investigator: Marina L Stanislav         
Healthy Family Not yet recruiting
Novosibirsk, Russian Federation, 630061
Principal Investigator: Elena Zonova         
Regional Hospital - Omsk Not yet recruiting
Omsk, Russian Federation, 644111
Principal Investigator: Tatiana Kropotina         
Orenburg State Medical Academy of Roszdrav Not yet recruiting
Orenburg, Russian Federation, 460018
Contact    79068312567      
Principal Investigator: Olga Bugrova         
Ryazan State Medical University Not yet recruiting
Ryazan, Russian Federation, 390026
Principal Investigator: Sergey Yakushin         
Russian Medical Military Academy n.a. S.M. Kirov Not yet recruiting
Saint Petersburg, Russian Federation, 194044
Principal Investigator: Alexander Gordienko         
LLC ArsVitae NorthWest Not yet recruiting
Saint-Petersburg, Russian Federation, 194223
Principal Investigator: Anton S Edin         
Departmental Hospital at Smolensk Station "rzhd" JSC Not yet recruiting
Smolensk, Russian Federation, 214025
Principal Investigator: Diana Krechikova         
Universitätsspital Basel Not yet recruiting
Basel, Basel Stadt, Switzerland, 4031
Principal Investigator: Bettina Bannert         
Kantonsspital St. Gallen Not yet recruiting
St. Gallen, Sankt Gallen, Switzerland, 9007
Principal Investigator: Andrea Rubbert-Roth         
Chang Gung Memorial Hospital - Linkou Not yet recruiting
Kuei Shan Hsiang, Taoyuan Hsien, Taiwan, 33305
Principal Investigator: Yao-Fan Fang         
Buddhist Tzu-Chi General Hospital Not yet recruiting
Dalin Township, Taiwan, 622
Principal Investigator: Ning-Sheng Lai         
Chang Gung Memorial Hospital - Kaohsiung Not yet recruiting
Kaohsiung City, Taiwan, 83301
Principal Investigator: Ying-Chou Chen         
Taichung Veterans General Hospital Not yet recruiting
Taichung, Taiwan, 40705
Principal Investigator: Yi-Hsing Chen         
Chi-Mei Medical Center Not yet recruiting
Tainan City, Taiwan, 71004
Principal Investigator: Hung-An Chen         
Taipei Medical University Hospital Not yet recruiting
Taipei City, Taiwan, 11031
Contact    886227272181      
Principal Investigator: Chi-Ching Chang         
National Taiwan University Hospital Not yet recruiting
Taipei, Taiwan, 10002
Contact    8862231245665339      
Principal Investigator: Cheng-Han Wu         
MHI Regional Clinical Hospital - Center for Emergency Med Care and Disaster Medicine Not yet recruiting
Kharkiv, Ukraine, 61058
Principal Investigator: Svitlana Trypilka         
NSC The M.D. Strazhesko Inst. of Cardiol. of the AMS of Ukr. Not yet recruiting
Kyiv, Ukraine, 03680
Principal Investigator: Oleh Bortkevych         
Medical Centre CONSILIUM MEDICAL Not yet recruiting
Kyiv, Ukraine, 04050
Contact    380442470927      
Principal Investigator: Reshotko Dmytro         
Multifield Medical Center of Odesa NMU (University Clinic#1) Not yet recruiting
Odesa, Ukraine, 65026
Contact    380487185377      
Principal Investigator: Viktoria Vasylets         
Poltava Reg.Cl.H. n.a.M.V.Sklifosovskogo, Not yet recruiting
Poltava, Ukraine, 36011
Contact    380532270539      
Principal Investigator: Vyacheslav Zhdan         
MI Ternopil University Hospital under Ternopil Not yet recruiting
Ternopil, Ukraine, 46002
Principal Investigator: Svitlana Smiyan         
Regional Clinical Hospital of A. Novak Not yet recruiting
Uzhgorod, Ukraine, 88000
Principal Investigator: Samvel Turianytsia         
Vinnytsia M.I. Pyrogov NMU Ch of internal medicine #1 Not yet recruiting
Vinnytsia, Ukraine, 21018
Principal Investigator: Mykola Stanislavchuk         
SRI of Invalid Rehabil.,Educ.Scient.Med.Complex Not yet recruiting
Vinnytsia, Ukraine, 21030
Contact    380432511269      
Principal Investigator: Sergii Shevchuk         
Regional Clinical Hospital of Zaporizhzhia Not yet recruiting
Zaporizhzhia, Ukraine, 69600
Contact    380504216492      
Principal Investigator: Dmytro Rekalov         
United Kingdom
Maidstone Hospital Not yet recruiting
Maidstone, Kent, United Kingdom, ME16 9QQ
Contact    441622225033      
Principal Investigator: Michael Batley         
Whipps Cross University Hospital Not yet recruiting
London, Surrey, United Kingdom, E11 1NR
Contact    442085395522      
Principal Investigator: Angela Pakozdi         
Guy's Hospital Not yet recruiting
London, Surrey, United Kingdom, SE1 9RT
Contact    442071885040      
Principal Investigator: David D'Cruz         
Sponsors and Collaborators
Eli Lilly and Company
Incyte Corporation
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:
Responsible Party: Eli Lilly and Company Identifier: NCT03616912     History of Changes
Other Study ID Numbers: 16676
I4V-MC-JAHZ ( Other Identifier: Eli Lilly and Company )
2017-005026-37 ( EudraCT Number )
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eli Lilly and Company:

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