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

Use our guide to learn which trials are right for you!

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
Arlington, Virginia 22205
Principal Investigator: Philip Kempf
Phone: 70352530698
?
mi
from
Arlington, VA
Click here to add this to my saved trials
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,...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
2147 Northeast Coachman Road
Clearwater, Florida 33765
Principal Investigator: Robert W Levin
Phone: 727-466-0078
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
Albuquerque, New Mexico
Principal Investigator: Ellen Kim
Phone: 505-224-7407
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
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...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
8750 Wilshire Boulevard
Beverly Hills, California 90211
Principal Investigator: Daniel Jeffrey Wallace
Phone: 13103609197
?
mi
from
Beverly Hills, CA
Click here to add this to my saved trials
Caba, Buenos Aires
Principal Investigator: Pablo Mannucci
Phone: 541149512763
?
mi
from
Caba,
Click here to add this to my saved trials
Charlotte, North Carolina 00000
Principal Investigator: Emily Jane Box
Phone: 704-247-9179
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Charlotte, North Carolina 28204
Principal Investigator: Alireza Nami
Phone: 704-248-8577
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Cincinnati, Ohio 45242
Principal Investigator: Michael Luggen
Phone: 513-558-5538
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Covina, California 91723
Principal Investigator: Samy K Metyas
Phone: 562-713-2596
?
mi
from
Covina, CA
Click here to add this to my saved trials
Dallas, Texas 75231
Principal Investigator: Margarita Fallena
Phone: 214-879-6737
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Danville, Virginia 24541
Principal Investigator: Sharukh D Shroff
Phone: 4347934711349
?
mi
from
Danville, VA
Click here to add this to my saved trials
Gilbert, Arizona 85704
Principal Investigator: Daniel E Kreutz
Phone: 480-626-6650
?
mi
from
Gilbert, AZ
Click here to add this to my saved trials
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...
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
1255 Hillrise Circle
Las Cruces, New Mexico 88011
Principal Investigator: Arthur R Snyder
Phone: 575-571-7529
?
mi
from
Las Cruces, NM
Click here to add this to my saved trials
Las Vegas, Nevada 89128
Principal Investigator: George Timothy Kelly
Phone: 7023415444
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
500 Medical Center Boulevard
Lawrenceville, Georgia 30046
Principal Investigator: Theresa A Ford
Phone: 770-822-1090
?
mi
from
Lawrenceville, GA
Click here to add this to my saved trials
Lexington, Kentucky 40504
Principal Investigator: Alexander D Brown
Phone: 859-351-5175
?
mi
from
Lexington, KY
Click here to add this to my saved trials
Norman, Oklahoma 73069
Principal Investigator: Robert L McArthur
Phone: 405-552-9492
?
mi
from
Norman, OK
Click here to add this to my saved trials
Ormond Beach, Florida 32174
Principal Investigator: Michael David Kohen
Phone: 3866721985
?
mi
from
Ormond Beach, FL
Click here to add this to my saved trials
Phoenix, Arizona 85037
Principal Investigator: Eric A Peters
Phone: 480-626-6656
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Plantation, Florida 33324
Principal Investigator: Guillermo Valenzuela
Phone: 909-580-6320
?
mi
from
Plantation, FL
Click here to add this to my saved trials
750 East Adams Street
Syracuse, New York 13210
Principal Investigator: Andras Perl
Phone: 315-464-4194
?
mi
from
Syracuse, NY
Click here to add this to my saved trials
5115 North Armenia Avenue
Tampa, Florida 33603
Principal Investigator: Edgard Janer
Phone: 813-870-1292
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Tampa, Florida 33614
Principal Investigator: Michael C Burnette
Phone: 813-840-3600
?
mi
from
Tampa, FL
Click here to add this to my saved trials
7520 North Oracle Road
Tucson, Arizona 85704
Principal Investigator: Jeffrey B Loomer
Phone: 480-443-8400
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
Tupelo, Mississippi 38801
Principal Investigator: Charles King
Phone: 662-377-5131
?
mi
from
Tupelo, MS
Click here to add this to my saved trials
Tustin, California 92780
Principal Investigator: Robin K Dore
Phone: 714-505-5500
?
mi
from
Tustin, CA
Click here to add this to my saved trials
Upland, California 91786
Principal Investigator: Antony Hou
Phone: 909-296-8700
?
mi
from
Upland, CA
Click here to add this to my saved trials
Webster, Texas 77598
Principal Investigator: Abdelnaser Naser Elkhalili
Phone: 2817241860
?
mi
from
Webster, TX
Click here to add this to my saved trials
Wyomissing, Pennsylvania 19610
Principal Investigator: Nancy J Walker
Phone: 610-375-2466
?
mi
from
Wyomissing, PA
Click here to add this to my saved trials