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



Status:Completed
Conditions:Lupus
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:11/23/2018
Start Date:March 24, 2016
End Date:November 9, 2017

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A Randomized, Double-Blind, Placebo-Controlled, Parallel- Group, Phase 2 Study of Baricitinib in Patients With Systemic Lupus Erythematosus (SLE)

The main purpose of this study is to evaluate the efficacy and safety of the study drug known
as baricitinib in participants with systemic lupus erythematosus.


Inclusion Criteria:

- Have received a diagnosis of SLE at least 24 weeks prior to screening, meeting the
American College of Rheumatology (ACR) 1982 revised criteria OR the 2012 Systemic
Lupus Erythematosus International Collaborating Clinics (SLICC) criteria.

- Have a positive antinuclear antibody (ANA) (titer ≥1:80) and/or a positive
anti-double-stranded deoxyribonucleic acid (dsDNA) as assessed by a central laboratory
at screening.

- Have a SLEDAI-2K score ≥4 based on clinical symptoms (not including lab values) at
randomization.

- Have active arthritis and/or active rash as defined by the SLEDAI-2K at randomization.

Exclusion Criteria:

- Have active severe lupus nephritis.

- Have active severe 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.

- Are currently receiving oral corticosteroids at doses >20-milligrams per day of
prednisone (or equivalent) or have adjusted the dose of corticosteroids within 2 weeks
of planned randomization.

- Have started treatment with or adjusted the dose of nonsteroidal anti-inflammatory
drugs (NSAIDs) (for which the NSAID use is intended for treatment of signs and
symptoms of SLE) within 4 weeks of planned randomization.

- Have started treatment with or adjusted the dose of an antimalarial within 12 weeks of
planned randomization.

- Have started treatment with or adjusted the dose of an immunosuppressant within 12
weeks of planned randomization.

- Have received cyclophosphamide (or any other cytotoxic agent) within 12 weeks prior to
screening.
We found this trial at
28
sites
8750 Wilshire Boulevard
Beverly Hills, California 90211
Principal Investigator: Daniel Wallace
Phone: 310-360-9197
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Albuquerque, New Mexico
Principal Investigator: Marigene Salazar Sharma
Phone: 505-224-7407
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Allen, Texas 75013
Principal Investigator: John Lavery
Phone: 972-562-2345
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Allen, TX
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: William McCune
Phone: 734-936-5561
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Bethlehem, Pennsylvania 18017
Principal Investigator: Charles Ludivico
Phone: 610-868-1336
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Kevin Hackshaw
Phone: 614-293-4790
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Covina, California 91723
Principal Investigator: Samy Metyas
Phone: 626-869-5730
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Denver, Colorado 80230
Principal Investigator: Christopher Antolini
Phone: 303-394-2828
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El Cajon, California 92020
Principal Investigator: Arthur Mabaquiao
Phone: 619-334-4764
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Great Neck, New York 11021
Principal Investigator: Richard Furie
Phone: 516-708-2546
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La Jolla, California 92093
Principal Investigator: Susan Lee
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Miami, Florida 33175
Principal Investigator: Francisco Miranda
Phone: 305-226-3933
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Middleburg Heights, Ohio 44130
Principal Investigator: Isam Diab
Phone: 440-826-0742
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Monroe, Louisiana 71203
Principal Investigator: John Hull
Phone: 318-388-5830
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Oklahoma City, Oklahoma 73103
Principal Investigator: Mohammad Khan
Phone: 405-606-8730
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Oklahoma City, Oklahoma 73104
Principal Investigator: Aikaterini Katherine Thanou
Phone: 405-271-7805
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Overland Park, Kansas 66209
Principal Investigator: Paul Katzenstein
Phone: 913-319-7384
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Palm Desert, California 92260
Principal Investigator: Maria Greenwald
Phone: 760-341-6800
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Saint Louis, Missouri 63141
Principal Investigator: Stephen Ross
Phone: 314-567-5100
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Saint Louis, Missouri 63117
Principal Investigator: John Budd
Phone: 314-646-0688
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Shreveport, Louisiana 71130
Principal Investigator: Samina Hayat
Phone: 318-675-5592
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Tamarac, Florida 33321
Principal Investigator: Steven Kimmel
Phone: 954-545-8400
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5115 North Armenia Avenue
Tampa, Florida 33603
Principal Investigator: Edgard Janer
Phone: 813-870-1292
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Tucson, Arizona 85721
(520) 621-2211
Principal Investigator: Dominick Sudano
Phone: 520-626-3608
University of Arizona The University of Arizona is a premier, public research university. Established in...
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Tulsa, Oklahoma 74104
Principal Investigator: James McKay
Phone: 918-748-8024
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Upland, California 91786
Principal Investigator: Antony Hou
Phone: 909-982-0099
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Wyomissing, Pennsylvania 19610
Principal Investigator: Robert Griffin
Phone: 610-375-2466
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