Proof of Concept Study to Evaluate the Efficacy and Safety of BMS-931699 (Lulizumab) or BMS-986142 in Primary Sjögren's Syndrome



Status:Terminated
Conditions:Rheumatology
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - 70
Updated:10/6/2018
Start Date:October 18, 2016
End Date:July 24, 2017

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

A Phase II, Randomized, Multi-Center, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of BMS-931699 (Lulizumab) or BMS-986142 in Subjects With Moderate to Severe Primary Sjögren's Syndrome

The primary objective of this study is to evaluate the efficacy of treatment with either
lulizumab or BMS-986142 versus placebo in subjects with moderate to severe primary Sjögren's
syndrome as measured by the change from baseline in ESSDAI at Week 12 between active
treatment arms (lulizumab or BMS-986142, respectively) and the placebo arm.


For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com

Inclusion Criteria:

- Subjects diagnosed or classified as having moderate to severe primary Sjögren's
Syndrome based on the 2016 ACR-EULAR Sjögren's Syndrome Classification Criteria for at
least 16 weeks prior to screening

- ESSDAI ≥ 5 including disease activity (any score > 0) in at least one of the following
domains: Glandular, Articular, Hematological, Biological, Lymphadenopathy

- Positive anti-SS-A/Ro and/or anti-SS-B/La autoantibody

- Unstimulated whole saliva secretion > 0.01 ml/min

- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy
test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to
the start of study drug and must not be pregnant or breastfeeding. Male and female
subjects must be willing to adhere to protocol-mandated highly effective contraception
for the duration of the study and for the protocol-specified follow up period.
Hormone-based contraceptive methods are not permitted

Exclusion Criteria:

- Secondary Sjögren's syndrome or the presence of any other systemic autoimmune disease
(eg, RA, SLE, multiple sclerosis, vasculitis)

- Very severe primary Sjögren's syndrome or severe complications of primary Sjögren's
syndrome at the time of the screening visit

- Active systemic or latent bacterial (including tuberculosis), viral or fungal
infection, evidence of current or chronic Hepatitis B or C infection, or HIV infection

- Any significant concurrent medical condition at the time of screening or baseline
visit

- Use of methotrexate, cyclophosphamide, cyclosporine, tacrolimus, azathioprine,
mycophenolate mofetil (MMF) or leflunomide within 12 weeks of screening visit

- Previous treatment with biologics therapies either marketed or in development within 6
months prior to screening visit

- Treatment started or an unstable dose of hydroxychloroquine within 8 weeks of
screening visit

- Oral corticosteroids > 10 mg/day within 14 days of dosing (Day 1), corticosteroid
therapy ≥ 1 mg/kg during the 4 weeks preceding enrollment, or intravenous,
intramuscular or intra-articular corticosteroids within 4 weeks of screening visit

Other protocol defined inclusion/exclusion criteria could apply
We found this trial at
18
sites
Middleburg Heights, Ohio 44130
Phone: 440-826-0742
?
mi
from
Middleburg Heights, OH
Click here to add this to my saved trials
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Austin, Texas 78745
?
mi
from
Austin, TX
Click here to add this to my saved trials
Camperdown, New South Wales 2050
?
mi
from
Camperdown,
Click here to add this to my saved trials
Duncansville, Pennsylvania 16635
Phone: 814-693-0300
?
mi
from
Duncansville, PA
Click here to add this to my saved trials
Freehold, New Jersey 07728
?
mi
from
Freehold, NJ
Click here to add this to my saved trials
Fullerton, California 92835
?
mi
from
Fullerton, CA
Click here to add this to my saved trials
Jackson, Tennessee 38305
Phone: 731-633-0119
?
mi
from
Jackson, TN
Click here to add this to my saved trials
Lawrenceville, Georgia 30046
?
mi
from
Lawrenceville, GA
Click here to add this to my saved trials
Mineola, New York 11501
?
mi
from
Mineola, NY
Click here to add this to my saved trials
Orangeburg, South Carolina 29118
?
mi
from
Orangeburg, SC
Click here to add this to my saved trials
Palo Alto, California 94304
?
mi
from
Palo Alto, CA
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19102
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Sarasota, Florida 34239
?
mi
from
Sarasota, FL
Click here to add this to my saved trials
Tupelo, Mississippi 38801
?
mi
from
Tupelo, MS
Click here to add this to my saved trials
Wexford, Pennsylvania 15090
?
mi
from
Wexford, PA
Click here to add this to my saved trials
1907 Tradd Ct
Wilmington, North Carolina 28401
(910) 799-5500
PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
?
mi
from
Wilmington, NC
Click here to add this to my saved trials
Worcester, Massachusetts 01610
Phone: 508-755-0201
?
mi
from
Worcester, MA
Click here to add this to my saved trials