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



Status:Recruiting
Conditions:Lupus
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:August 2, 2018
End Date:February 16, 2021
Contact:There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Email:clinicaltrials.gov@lilly.com
Phone:1-317-615-4559

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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).


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.
We found this trial at
32
sites
Amarillo, Texas 79124
Principal Investigator: Constantine K Saadeh
Phone: 806-352-2453
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2017 Canyon Road, Suite 41
Birmingham, Alabama 35216
(205) 757-8208
Principal Investigator: Hayes T Williams
Phone: 205-757-8212
Site Overview Achieve has two clinical research sites in Birmingham, AL. Our Birmingham sites are conveniently located...
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Principal Investigator: Vlad C Steven
Phone: 617-636-5645
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
Principal Investigator: Agustin Escalante
Phone: 210-567-5396
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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Albuquerque, New Mexico 87102
Principal Investigator: Leroy A Pacheco
Phone: 505-341-4148
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Atlanta, Georgia 30309
Principal Investigator: Wambui L Machua
Phone: 404-350-0009
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Atlanta, Georgia 30342
Principal Investigator: Stuart Handelsman
Phone: 770-226-8819
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Baytown, Texas 77521
Principal Investigator: Sabeen Najam
Phone: 281-851-7088
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Bethlehem, Pennsylvania 18017
Principal Investigator: Charles L. Ludivico
Phone: 610-868-1335
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Boise, Idaho 83702
Principal Investigator: Achini Dingman
Phone: 208-489-4369
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4641 Main Street
Bridgeport, Connecticut 06606
Principal Investigator: Geoffrey S Gladstein
Phone: 203-325-8529
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Brooklyn, New York 11203
Principal Investigator: Ellen M Ginzler
Phone: 718-270-1662
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Alexa S Meara
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Detroit, Michigan 48202
Principal Investigator: Kathleen M Maksimowicz-McKinnon
Phone: 412-648-4701
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Fullerton, California 92835
Principal Investigator: Shirley W Pang
Phone: 714-626-8610
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Glendale, Arizona 85304
Principal Investigator: Saima Chohan
Phone: 480-626-6650
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Great Neck, New York 11021
Principal Investigator: Richard Alan Furie
Phone: 5164706901
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Houston, Texas 77004
Principal Investigator: Jacqueline D Vo
Phone: 281-481-8557
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Kogarah, New South Wales 2217
Principal Investigator: Paul Bird
Phone: 61289648186
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757 Westwood Plaza
Los Angeles, California 90024
(310) 825-9111
Principal Investigator: Jennifer M Grossman
Phone: 310-206-3244
UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
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Manhasset, New York 11030
Principal Investigator: Meggan Claire Mackay
Phone: 5165623838
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Miami, Florida 33175
Principal Investigator: Francisco G Miranda
Phone: 305-226-3933
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Miami Lakes, Florida 33014
Principal Investigator: Benidecto Fernandez
Phone: 305-362-4979
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Middleburg Heights, Ohio 44130
Principal Investigator: Isam A. Diab
Phone: 440-891-9395
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Principal Investigator: Fotios Koumpouras
Phone: 203-785-2454
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Anca Askanase
Phone: 212-305-0856
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Oklahoma City, Oklahoma 73103
Principal Investigator: Mohammad Khan
Phone: 405-606-8730
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Orchard Park, New York 14127
Principal Investigator: Joseph Michael Grisanti
Phone: 7166752500
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Pittsburgh, Pennsylvania 15217
Principal Investigator: Ghaith Noaiseh
Phone: 412-648-9782
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Reno, Nevada 89503
Principal Investigator: Bryan J Wolf
Phone: 775-313-9800
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Saint Louis, Missouri 63117
Principal Investigator: John J. Budd
Phone: 314-646-0688
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Principal Investigator: Philip J Mease
Phone: 206-386-2000
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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