A Study of Baricitinib 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
Tustin, California 92780
Principal Investigator: Robin K Dore
Phone: 714-505-5500
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Arezou Khosroshahi
Phone: 404-778-6638
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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2147 Northeast Coachman Road
Clearwater, Florida 33765
Principal Investigator: Robert W Levin
Phone: 727-466-0078
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Clearwater, FL
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Albuquerque, New Mexico
Principal Investigator: Ellen Kim
Phone: 505-224-7407
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Arlington, Virginia 22205
Principal Investigator: Philip Kempf
Phone: 70352530698
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Arlington, VA
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1000 Johnson Ferry Rd NE
Atlanta, Georgia 30342
(404) 851-8000
Principal Investigator: Paul Geo Sutej
Northside Hospital Northside Hospital-Atlanta (in Sandy Springs) opened in 1970. The original facility had 250...
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8750 Wilshire Boulevard
Beverly Hills, California 90211
Principal Investigator: Daniel Jeffrey Wallace
Phone: 13103609197
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Caba, Buenos Aires
Principal Investigator: Pablo Mannucci
Phone: 541149512763
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Charlotte, North Carolina 00000
Principal Investigator: Emily Jane Box
Phone: 704-247-9179
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Charlotte, NC
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Charlotte, North Carolina 28204
Principal Investigator: Alireza Nami
Phone: 704-248-8577
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Cincinnati, Ohio 45242
Principal Investigator: Michael Luggen
Phone: 513-558-5538
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Covina, California 91723
Principal Investigator: Samy K Metyas
Phone: 562-713-2596
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Dallas, Texas 75231
Principal Investigator: Margarita Fallena
Phone: 214-879-6737
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Danville, Virginia 24541
Principal Investigator: Sharukh D Shroff
Phone: 4347934711349
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Gilbert, Arizona 85704
Principal Investigator: Daniel E Kreutz
Phone: 480-626-6650
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
Principal Investigator: Susan Lee
Phone: 858-657-7040
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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1255 Hillrise Circle
Las Cruces, New Mexico 88011
Principal Investigator: Arthur R Snyder
Phone: 575-571-7529
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Las Vegas, Nevada 89128
Principal Investigator: George Timothy Kelly
Phone: 7023415444
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500 Medical Center Boulevard
Lawrenceville, Georgia 30046
Principal Investigator: Theresa A Ford
Phone: 770-822-1090
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Lexington, Kentucky 40504
Principal Investigator: Alexander D Brown
Phone: 859-351-5175
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Norman, Oklahoma 73069
Principal Investigator: Robert L McArthur
Phone: 405-552-9492
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Ormond Beach, Florida 32174
Principal Investigator: Michael David Kohen
Phone: 3866721985
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Phoenix, Arizona 85037
Principal Investigator: Eric A Peters
Phone: 480-626-6656
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Plantation, Florida 33324
Principal Investigator: Guillermo Valenzuela
Phone: 909-580-6320
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750 East Adams Street
Syracuse, New York 13210
Principal Investigator: Andras Perl
Phone: 315-464-4194
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5115 North Armenia Avenue
Tampa, Florida 33603
Principal Investigator: Edgard Janer
Phone: 813-870-1292
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Tampa, Florida 33614
Principal Investigator: Michael C Burnette
Phone: 813-840-3600
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7520 North Oracle Road
Tucson, Arizona 85704
Principal Investigator: Jeffrey B Loomer
Phone: 480-443-8400
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Tupelo, Mississippi 38801
Principal Investigator: Charles King
Phone: 662-377-5131
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Upland, California 91786
Principal Investigator: Antony Hou
Phone: 909-296-8700
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Webster, Texas 77598
Principal Investigator: Abdelnaser Naser Elkhalili
Phone: 2817241860
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Wyomissing, Pennsylvania 19610
Principal Investigator: Nancy J Walker
Phone: 610-375-2466
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