Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov Identifier: NCT03616912
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : April 17, 2019
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

Layout table for study information
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 : May 21, 2021
Estimated Study Completion Date : May 21, 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.


Layout table for eligibility information
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): NCT03616912


Contacts
Layout table for location contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 clinicaltrials.gov@lilly.com

  Hide Study Locations
Locations
Layout table for location information
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 Recruiting
Glendale, Arizona, United States, 85306
Contact    480-626-6650      
Principal Investigator: Saima Chohan         
United States, California
St. Joseph Heritage Medical Group Recruiting
Fullerton, California, United States, 92835
Contact    714-626-8610      
Principal Investigator: Shirley W Pang         
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
Contact    203-785-2454      
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 Recruiting
Miami, Florida, United States, 33175
Contact    305-226-3933      
Principal Investigator: Francisco G Miranda         
United States, Georgia
Piedmont Healthcare 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 Recruiting
Boise, Idaho, United States, 83702
Contact    208-489-4369      
Principal Investigator: Achini Dingman         
United States, Massachusetts
Tufts Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02111
Contact    617-636-5645      
Principal Investigator: Vlad C Steven         
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, Minnesota
St. Paul Rheumatology, PA Not yet recruiting
Eagan, Minnesota, United States, 55121
Contact    651-644-4277      
Principal Investigator: Elvia G Moreta         
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 Recruiting
Brooklyn, New York, United States, 11203
Contact    718-270-1662      
Principal Investigator: Ellen M Ginzler         
Northwell Health 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
Contact    7166752500      
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         
Accurate Clinical Management LLC - BayTown Recruiting
Baytown, Texas, United States, 77521
Contact    281-851-7088      
Principal Investigator: Sabeen Najam         
Rheumatology Center of Houston Recruiting
Houston, Texas, United States, 77004
Contact    281-481-8557      
Principal Investigator: Jacqueline D Vo         
Univ of Texas Health Science Center at San Antonio Not yet recruiting
San Antonio, Texas, United States, 78229
Contact    210-567-5396      
Principal Investigator: Agustin Escalante         
United States, Washington
Swedish Medical Center Recruiting
Seattle, Washington, United States, 98122
Contact    206-386-2000      
Principal Investigator: Philip J Mease         
Australia, New South Wales
Optimus Clinical Research Recruiting
Kogarah, New South Wales, Australia, 2217
Contact    61289648186      
Principal Investigator: Paul Bird         
John Hunter Hospital Recruiting
Newcastle, New South Wales, Australia, 2305
Contact    61249214200      
Principal Investigator: Glenn Reeves         
Australia, Queensland
The Rheumatology Research Unit Sunshine Coast Recruiting
Maroochydore, Queensland, Australia, 4558
Contact    61 7 5443 1033      
Principal Investigator: Peter Nash         
Australia, Victoria
Emeritus Research Recruiting
Camberwell, Victoria, Australia, 3124
Contact    61 3 9509 6166      
Principal Investigator: Andrew Ostor         
Monash Medical Centre Recruiting
Clayton, Victoria, Australia, 3168
Contact    61395943565      
Principal Investigator: Alberta Hoi         
St Vincents Hospital Melbourne Recruiting
Fitzroy, Victoria, Australia, 3065
Contact    61394117111      
Principal Investigator: Mandana Nikpour         
Austria
Ordensklinikum Linz GmbH - Elisabethinen Recruiting
Linz, Oberösterreich, Austria, 4020
Contact    43073276760      
Principal Investigator: Norbert Thomas Sepp         
Medizinische Universität Wien - Kinder und Jugendheilkunde Recruiting
Wien, Vienna, Austria, 1090
Contact    4314040043590      
Principal Investigator: Klaus Machold         
Medizinische Universität Graz Recruiting
Graz, Austria, 8036
Contact    433163857779      
Principal Investigator: Winfried Graninger         
KH Hietzing mit neurologischem Zentrum Rosenhügel Recruiting
Wien, Austria, 1130
Contact    431801103174      
Principal Investigator: Kurt Redlich         
Belgium
Katholieke Universiteit Leuven Recruiting
Leuven, Vlaams Brabant, Belgium, 3000
Contact    3216342541      
Principal Investigator: Ellen De Langhe         
Cliniques Universitaires Saint-Luc Recruiting
Brussels, Belgium, 1200
Contact    3227643633      
Principal Investigator: Frederic Houssiau         
CHU de Liège Recruiting
Liège, Belgium, 4000
Contact    3243668310      
Principal Investigator: Christian Von Frenckell         
Brazil
SER - Serviços Especializados em Reumatologia da Bahia S/S - ME Not yet recruiting
Salvador, Bahia, Brazil, 40150-150
Contact    557130229886      
Principal Investigator: Santiago Mittermayer Barreto         
CIP-Centro Internacional de Pesquisa Not yet recruiting
Goiania, Goiás, Brazil, 74110-120
Contact    556232293280      
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. 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
First affiliated Hospital of Sun Yat-Sen University Not yet recruiting
Guangzhou, Guangdong, China, 510080
Contact    862087332200      
Principal Investigator: Niansheng Yang         
China, Heilongjiang
First Affiliated Hospital of the Harbin Medical University Not yet recruiting
Harbin, Heilongjiang, China, 150001
Contact    8645113804601998      
Principal Investigator: Zhiyi Zhang         
China, Jiangsu
Nanjing Drum Tower Hosp Affiliated Hosp of Nanjing Univ Med Recruiting
Nanjing, Jiangsu, China, 210008
Contact    8613817544696      
Principal Investigator: Lingyun Sun         
China, Jilin
China-Japan Union Hospital of Jilin University Recruiting
Changchun Shi, Jilin, China, 100853
Contact    8603578879099      
Principal Investigator: LiQi Bi         
China, Zhejiang
Second Affiliate Hospital of Zhejiang Medical University Recruiting
Hangzhou, Zhejiang, China, 310009
Contact    05717783858      
Principal Investigator: Hua-Xiang Wu         
China
Peking Union Medical College Hospital Recruiting
Beijing, China, 100730
Principal Investigator: Xiaofeng Zeng         
Shanghai Huashan Hospital Affil to Fu Dan University Recruiting
Shanghai, China, 200040
Contact    8613817544696      
Principal Investigator: Wei-Guo Wan         
China Medical University (CMU) - First Affiliated Hospital Not yet recruiting
Shenyang, China, 110001
Contact    8613840523456      
Principal Investigator: Rong Zhang         
The First Affliated Hospital of Suzhou University Recruiting
Suzhou Shi, China, 215000
Contact    86051265223637      
Principal Investigator: Jian Wu         
Tianjin Medical University General Hospital Recruiting
Tianjin, China, 300052
Contact    8613920182411      
Principal Investigator: Wei Wei         
People's Hospital of Xinjiang Uygur Autonomous Region Not yet recruiting
Urumqi, China, 830001
Contact    8613999265917      
Principal Investigator: Li-Jun Wu         
Croatia
Klinicki Bolnicki Centar Rijeka Not yet recruiting
Rijeka, Croatia, 51000
Contact    38551658187      
Principal Investigator: Srdjan Novak         
Czechia
Revmatologie s.r.o. Recruiting
Brno, Czechia, 638 00
Contact    420 545 214 556      
Principal Investigator: Leona Prochazkova         
Fakultni Nemocnice Olomouc Recruiting
Olomouc, Czechia, 775 20
Contact    420588443373      
Principal Investigator: Pavel Horak         
Arthrohelp s.r.o Recruiting
Pardubice, Czechia, 530 02
Contact    420464007686      
Principal Investigator: Zdenek Dvorak         
Vseobecna fakultni nemocnice Recruiting
Praha 2, Czechia, 128 08
Contact    420224962605      
Principal Investigator: Vladimir Tesar         
Revmatologicky ustav Recruiting
Praha 2, Czechia, 128 50
Contact    420234075338      
Principal Investigator: Dana Tegzova         
Germany
Universitätsklinikum Tübingen Not yet recruiting
Tubingen, Baden-Wurttemberg, Germany, 72076
Principal Investigator: Jörg Henes         
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
Contact    4993120140110      
Principal Investigator: Hans-Peter Tony         
Universitätsklinikum Köln Not yet recruiting
Köln, Nordrhein-Westfalen, Germany, 50937
Contact    492214783993      
Principal Investigator: David Kofler         
Universitätsmedizin der Johannes Gutenberg-Universität Mainz Not yet recruiting
Mainz, Rheinland-Pfalz, Germany, 55131
Contact    496131177340      
Principal Investigator: Andreas Schwarting         
Universität Leipzig - Universitätsklinikum Not yet recruiting
Leipzig, Sachsen, Germany, 04103
Contact    493419724710      
Principal Investigator: Ulf Wagner         
Universitätsklinikum Jena Not yet recruiting
Jena, Thüringen, Germany, 07747
Contact    '4936419324326      
Principal Investigator: Peter Oelzner         
Charité Universitätsmedizin Berlin Not yet recruiting
Berlin, Germany, 10117
Contact    4930450513012      
Principal Investigator: Falk Hiepe         
Immanuel Krankenhaus Rheuma Klinik Berlin Buch Not yet recruiting
Berlin, Germany, 13125
Contact    493920067319      
Principal Investigator: Andreas Krause         
Greece
Gen Hospital of Athens G Gennimatas Not yet recruiting
Athens, Attiki, Greece, 11527
Contact    302107768562      
Principal Investigator: Pinelope Konstantopoulou         
University General Hospital of Heraklion Not yet recruiting
Heraklion, Crete, Greece, 71110
Principal Investigator: Prodromos Sidiropoulos         
Euromedica Kyanous Stavros General Hospital Not yet recruiting
Thessaloniki, Greece, 54636
Principal Investigator: Lucas Settas         
Ippokrateio General Hospital of Thessaloniki Not yet recruiting
Thessaloniki, Greece, 54642
Contact    302313312000      
Principal Investigator: Alexandros Garyfallos         
Hungary
Bekes Megyei Pandy Kalman Korhaz Recruiting
Gyula, Bekes, Hungary, 5700
Contact    3666361833      
Principal Investigator: Tibor Martyin         
Budai Irgalmasrendi Korhaz Recruiting
Budapest, Hungary, 1027
Contact    3614388534      
Principal Investigator: Ariunaa Gantumur         
Qualiclinic Kft Recruiting
Budapest, Hungary, 1036
Contact    3612448249      
Principal Investigator: Istvan Szombathi         
Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointeze Recruiting
Budapest, Hungary, 1097
Contact    36209266272      
Principal Investigator: Janos Kadar         
Debreceni Egyetem Klinikai Kozpont Not yet recruiting
Debrecen, Hungary, 4032
Principal Investigator: Gabriella Szucs         
Pecsi Tudomanyegyetem Klinikai Kozpont Recruiting
Pecs, Hungary, 7632
Contact    3672536809      
Principal Investigator: Cecilia Varju         
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont I. Belgyogyaszati Klinika Not yet recruiting
Szeged, Hungary, 6725
Principal Investigator: Laszlo Kovacs         
Mentaház Magánorvosi Központ Kft. Recruiting
Székesfehérvár, Hungary, 8000
Contact    36204396636      
Principal Investigator: Tunde Varga         
Vital Medical Center Recruiting
Veszprem, Hungary, 8200
Contact    3688790434      
Principal Investigator: Csaba Kiss         
Israel
Carmel Medical Center Not yet recruiting
Haifa, Israel, 3436212
Contact    97248250488      
Principal Investigator: Devy Zisman         
Hadassah Medical Center Not yet recruiting
Jerusalem, Israel, 9112001
Contact    97226777317      
Principal Investigator: Dror Mevorach         
Meir Medical Center Not yet recruiting
Kfar Saba, Israel, 4428164
Contact    97297472555      
Principal Investigator: Yair Levy         
Rabin Medical Center Not yet recruiting
Petach Tikva, Israel, 4941492
Contact    97239376947      
Principal Investigator: Yair Molad         
Chaim Sheba Medical Center Not yet recruiting
Ramat Gan, Israel, 5262100
Contact    97235302060      
Principal Investigator: Nanacy Agmon-Levin         
Mexico
CIMAB S.A. de C.V. Recruiting
Torreon, Coahuila, Mexico, 27000
Contact    528717130315      
Principal Investigator: Sandra Araceli Sicsik Ayala         
Cliditer Sa de CV Recruiting
Mexico City, Distrito Federal, Mexico, 06700
Contact    5215552079761      
Principal Investigator: Gabriel Medrano         
Centro Integral en Reumatologia SA de CV Recruiting
Guadalajara, Jalisco, Mexico, 44160
Contact    526646340662      
Principal Investigator: Hilario Avila-Armengol         
Clinica en Investigación en Reumatologia y Obesidad S.C. Recruiting
Guadalajara, Jalisco, Mexico, 44650
Contact    523331200700      
Principal Investigator: Sergio Duran Barragan         
Centro de Estudios de Investigacion Metabolicos y Cardiovasc Recruiting
Guadalajara, Jalisco, Mexico, 44690
Contact    523336300946      
Principal Investigator: Ignacio Garcia de la Torre         
Centro Medico de las Americas Recruiting
Merida, Yucatan, Mexico, 97000
Contact    529999277003      
Principal Investigator: Jose A. Covarrubias         
Kohler Milstein Research, S.A. de C.V. Recruiting
Merida, Yucatan, Mexico, 97070
Principal Investigator: Jesus Abraham Simon Campos         
Cemdeicy S.C.P. Recruiting
Merida, Yucatán, Mexico, 97130
Principal Investigator: Efren Alberto Canul Novelo         
Centro de Alta Especialidad Reumatologia e Inv Potosi, S.C. Recruiting
San Luis Potosi, Mexico, 78213
Contact    524448340562      
Principal Investigator: Juan Cruz Cruz Rizo Rodriguez         
Netherlands
Vrije Universiteit Medisch Centrum Amsterdam Not yet recruiting
Amsterdam, Netherlands, 1081 HV
Contact    0204441084      
Principal Investigator: Irene Bultink         
Universitair Medisch Centrum Groningen Not yet recruiting
Groningen, Netherlands, 9713 GZ
Principal Investigator: Karina de Leeuw         
Medisch Centrum Leeuwarden, locatie Leeuwarden Not yet recruiting
Leeuwarden, Netherlands, 8934 AD
Principal Investigator: R J BOS         
Russian Federation
City Hospital # 7 Recruiting
Kazan, Russian Federation, 420103
Contact    79178617875      
Principal Investigator: Artem Vasilyev         
Russian State Medical University Recruiting
Moscow, Russian Federation, 117997
Contact    79265345912      
Principal Investigator: Ivan Gordeev         
City Clinical Hospital N1 Not yet recruiting
Moscow, Russian Federation, 119049
Principal Investigator: Evgeniya Shmidt         
Healthy Family Recruiting
Novosibirsk, Russian Federation, 630061
Contact    73833322959      
Principal Investigator: Elena Zonova         
Reafan Recruiting
Novosibirsk, Russian Federation, 630099
Contact    0073832226065      
Principal Investigator: Alexei Sizikov         
Regional Hospital - Omsk Recruiting
Omsk, Russian Federation, 644111
Contact    73812241057      
Principal Investigator: Tatiana Kropotina         
Orenburg State Medical Academy of Roszdrav Recruiting
Orenburg, Russian Federation, 460018
Contact    79068312567      
Principal Investigator: Olga Bugrova         
Ryazan State Medical University Recruiting
Ryazan, Russian Federation, 390026
Contact    74912768406      
Principal Investigator: Sergey Yakushin         
Russian Medical Military Academy n.a. S.M. Kirov Recruiting
Saint Petersburg, Russian Federation, 194044
Contact    78122718780      
Principal Investigator: Alexander Gordienko         
Departmental Hospital at Smolensk Station "rzhd" JSC Recruiting
Smolensk, Russian Federation, 214025
Contact    74812606462      
Principal Investigator: Diana Krechikova         
Switzerland
Universitätsspital Basel Recruiting
Basel, Basel Stadt, Switzerland, 4031
Contact    41615565017      
Principal Investigator: Bettina Bannert         
Kantonsspital St. Gallen Recruiting
St. Gallen, Sankt Gallen, Switzerland, 9007
Contact    41714941439      
Principal Investigator: Andrea Rubbert-Roth         
Taiwan
Chang Gung Memorial Hospital - Linkou Recruiting
Kuei Shan Hsiang, Taoyuan Hsien, Taiwan, 33305
Contact    88633281200#8812      
Principal Investigator: Yao-Fan Fang         
Buddhist Tzu-Chi General Hospital Recruiting
Dalin Township, Taiwan, 622
Contact    886526480005010      
Principal Investigator: Ning-Sheng Lai         
Chang Gung Memorial Hospital - Kaohsiung Recruiting
Kaohsiung City, Taiwan, 83301
Contact    886975056125      
Principal Investigator: Ying-Chou Chen         
Taichung Veterans General Hospital Not yet recruiting
Taichung, Taiwan, 40705
Contact    886423503285      
Principal Investigator: Yi-Hsing Chen         
Chi-Mei Medical Center Recruiting
Tainan City, Taiwan, 71004
Contact    88662812811ext57111      
Principal Investigator: Hung-An Chen         
Taipei Medical University Hospital Recruiting
Taipei City, Taiwan, 11031
Contact    886227272181      
Principal Investigator: Chi-Ching Chang         
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10002
Contact    886223123456      
Principal Investigator: Cheng-Han Wu         
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
Investigators
Layout table for investigator information
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:
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov 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: April 17, 2019
Last Verified: April 15, 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 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.

Layout table for additional information
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:
Layout table for MeSH terms
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases