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
Upland, California 91786
Principal Investigator: Antony Hou
Phone: 909-982-0099
20
mi
from 91732
Upland, CA
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Albuquerque, New Mexico
Principal Investigator: Marigene Salazar Sharma
Phone: 505-224-7407
649
mi
from 91732
Albuquerque, NM
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Allen, Texas 75013
Principal Investigator: John Lavery
Phone: 972-562-2345
1228
mi
from 91732
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...
1932
mi
from 91732
Ann Arbor, MI
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Bethlehem, Pennsylvania 18017
Principal Investigator: Charles Ludivico
Phone: 610-868-1336
2185
mi
from 91732
Bethlehem, PA
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8750 Wilshire Boulevard
Beverly Hills, California 90211
Principal Investigator: Daniel Wallace
Phone: 310-360-9197
21
mi
from 91732
Beverly Hills, CA
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?
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from 91732
Ciudad Autonoma De Buenos Aire,
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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...
1959
mi
from 91732
Columbus, OH
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Covina, California 91723
Principal Investigator: Samy Metyas
Phone: 626-869-5730
7
mi
from 91732
Covina, CA
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Denver, Colorado 80230
Principal Investigator: Christopher Antolini
Phone: 303-394-2828
822
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from 91732
Denver, CO
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El Cajon, California 92020
Principal Investigator: Arthur Mabaquiao
Phone: 619-334-4764
106
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from 91732
El Cajon, CA
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Great Neck, New York 11021
Principal Investigator: Richard Furie
Phone: 516-708-2546
2446
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from 91732
Great Neck, NY
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La Jolla, California 92093
Principal Investigator: Susan Lee
93
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from 91732
La Jolla, CA
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Miami, Florida 33175
Principal Investigator: Francisco Miranda
Phone: 305-226-3933
2320
mi
from 91732
Miami, FL
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Middleburg Heights, Ohio 44130
Principal Investigator: Isam Diab
Phone: 440-826-0742
2025
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from 91732
Middleburg Heights, OH
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Monroe, Louisiana 71203
Principal Investigator: John Hull
Phone: 318-388-5830
1499
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from 91732
Monroe, LA
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Oklahoma City, Oklahoma 73103
Principal Investigator: Mohammad Khan
Phone: 405-606-8730
1164
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from 91732
Oklahoma City, OK
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Oklahoma City, Oklahoma 73104
Principal Investigator: Aikaterini Katherine Thanou
Phone: 405-271-7805
1165
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from 91732
Oklahoma City, OK
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Overland Park, Kansas 66209
Principal Investigator: Paul Katzenstein
Phone: 913-319-7384
1336
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from 91732
Overland Park, KS
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Palm Desert, California 92260
Principal Investigator: Maria Greenwald
Phone: 760-341-6800
96
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from 91732
Palm Desert, CA
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Saint Louis, Missouri 63141
Principal Investigator: Stephen Ross
Phone: 314-567-5100
1558
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from 91732
Saint Louis, MO
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Saint Louis, Missouri 63117
Principal Investigator: John Budd
Phone: 314-646-0688
1566
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from 91732
Saint Louis, MO
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Shreveport, Louisiana 71130
Principal Investigator: Samina Hayat
Phone: 318-675-5592
1400
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from 91732
Shreveport, LA
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Tamarac, Florida 33321
Principal Investigator: Steven Kimmel
Phone: 954-545-8400
2306
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from 91732
Tamarac, FL
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5115 North Armenia Avenue
Tampa, Florida 33603
Principal Investigator: Edgard Janer
Phone: 813-870-1292
2133
mi
from 91732
Tampa, FL
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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...
427
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from 91732
Tucson, AZ
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Tulsa, Oklahoma 74104
Principal Investigator: James McKay
Phone: 918-748-8024
1250
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from 91732
Tulsa, OK
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Wyomissing, Pennsylvania 19610
Principal Investigator: Robert Griffin
Phone: 610-375-2466
2331
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from 91732
Wyomissing, PA
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