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

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
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...
?
mi
from
New York, NY
Click here to add this to my saved trials
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...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
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...
?
mi
from
Boston, MA
Click here to add this to my saved trials
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...
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Albuquerque, New Mexico 87102
Principal Investigator: Leroy A Pacheco
Phone: 505-341-4148
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Amarillo, Texas 79124
Principal Investigator: Constantine K Saadeh
Phone: 806-352-2453
?
mi
from
Amarillo, TX
Click here to add this to my saved trials
Atlanta, Georgia 30309
Principal Investigator: Wambui L Machua
Phone: 404-350-0009
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Atlanta, Georgia 30342
Principal Investigator: Stuart Handelsman
Phone: 770-226-8819
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Baytown, Texas 77521
Principal Investigator: Sabeen Najam
Phone: 281-851-7088
?
mi
from
Baytown, TX
Click here to add this to my saved trials
Bethlehem, Pennsylvania 18017
Principal Investigator: Charles L. Ludivico
Phone: 610-868-1335
?
mi
from
Bethlehem, PA
Click here to add this to my saved trials
Boise, Idaho 83702
Principal Investigator: Achini Dingman
Phone: 208-489-4369
?
mi
from
Boise, ID
Click here to add this to my saved trials
4641 Main Street
Bridgeport, Connecticut 06606
Principal Investigator: Geoffrey S Gladstein
Phone: 203-325-8529
?
mi
from
Bridgeport, CT
Click here to add this to my saved trials
Brooklyn, New York 11203
Principal Investigator: Ellen M Ginzler
Phone: 718-270-1662
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
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...
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Detroit, Michigan 48202
Principal Investigator: Kathleen M Maksimowicz-McKinnon
Phone: 412-648-4701
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Fullerton, California 92835
Principal Investigator: Shirley W Pang
Phone: 714-626-8610
?
mi
from
Fullerton, CA
Click here to add this to my saved trials
Glendale, Arizona 85304
Principal Investigator: Saima Chohan
Phone: 480-626-6650
?
mi
from
Glendale, AZ
Click here to add this to my saved trials
Great Neck, New York 11021
Principal Investigator: Richard Alan Furie
Phone: 5164706901
?
mi
from
Great Neck, NY
Click here to add this to my saved trials
Houston, Texas 77004
Principal Investigator: Jacqueline D Vo
Phone: 281-481-8557
?
mi
from
Houston, TX
Click here to add this to my saved trials
Kogarah, New South Wales 2217
Principal Investigator: Paul Bird
Phone: 61289648186
?
mi
from
Kogarah,
Click here to add this to my saved trials
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...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Manhasset, New York 11030
Principal Investigator: Meggan Claire Mackay
Phone: 5165623838
?
mi
from
Manhasset, NY
Click here to add this to my saved trials
Miami, Florida 33175
Principal Investigator: Francisco G Miranda
Phone: 305-226-3933
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami Lakes, Florida 33014
Principal Investigator: Benidecto Fernandez
Phone: 305-362-4979
?
mi
from
Miami Lakes, FL
Click here to add this to my saved trials
Middleburg Heights, Ohio 44130
Principal Investigator: Isam A. Diab
Phone: 440-891-9395
?
mi
from
Middleburg Heights, OH
Click here to add this to my saved trials
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...
?
mi
from
New Haven, CT
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73103
Principal Investigator: Mohammad Khan
Phone: 405-606-8730
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Orchard Park, New York 14127
Principal Investigator: Joseph Michael Grisanti
Phone: 7166752500
?
mi
from
Orchard Park, NY
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15217
Principal Investigator: Ghaith Noaiseh
Phone: 412-648-9782
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Reno, Nevada 89503
Principal Investigator: Bryan J Wolf
Phone: 775-313-9800
?
mi
from
Reno, NV
Click here to add this to my saved trials
Saint Louis, Missouri 63117
Principal Investigator: John J. Budd
Phone: 314-646-0688
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
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...
?
mi
from
Seattle, WA
Click here to add this to my saved trials