A Study of Ustekinumab in Participants With Active Systemic Lupus Erythematosus



Status:Recruiting
Conditions:Lupus
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:16 - 75
Updated:3/27/2019
Start Date:April 16, 2018
End Date:June 13, 2023
Contact:Study Contact
Email:JNJ.CT@sylogent.com
Phone:844-434-4210

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A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus

The purpose of this study is to evaluate the efficacy of ustekinumab in participants with
active systemic lupus erythematosus (SLE) who have not adequately responded to one or more
standard of care treatments.

This study evaluates the efficacy, safety, and tolerability of ustekinumab in participants
with active SLE according to Systemic Lupus International Collaborating Clinics (SLICC)
criteria Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score greater
than (>=) 6, despite receiving one or more standard-of-care treatments (example,
immunomodulators, antimalarial drugs, and/or glucocorticoids). The total duration of the
study is up to 182 weeks, consisting of 3 study periods: a screening period (approximately 6
weeks), a double blind period (52 weeks), and an extension period (124 weeks). Other study
evaluations will include pharmacokinetics, immunogenicity, biomarkers and pharmacogenomic
evaluations. The safety of the participants enrolled in the study will be monitored on an
ongoing basis throughout the study.

Inclusion Criteria:

- Be male or female

- Has a documented medical history (that is, met at least 1 of the two criteria below)
that participant met the Systemic Lupus International Collaborating Clinics (SLICC)
classification criteria for systemic lupus erythematosus (SLE) at least 3 months prior
to first dose of study agent:

1. Met a total of at least 4 SLICC criteria, including at least 1 clinical and at
least 1 immunologic;

2. Has a diagnosis of lupus nephritis, confirmed by renal biopsy and at least 1 of
the following autoantibodies: antinuclear antibodies (ANA) or
anti-double-stranded deoxyribonucleic acid (anti-dsDNA)

- Has a positive test in the medical history and confirmed at screening for at least 1
of the following autoantibodies: antinuclear antibodies, anti-double-stranded
deoxyribonucleic acid, and/or anti-Smith

- Has greater than or equal to (>=) 1 British Isles Lupus Assessment Group (BILAG) A
and/or >= 2 BILAG B scores observed during screening

- Has a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity
score >=4 (excluding diffuse non-inflammatory alopecia) or >= 4 joints with pain and
signs of inflammation at screening, Week 0, or both

- Has a Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score >=6
at screening. Must also have SLEDAI-2K >= 4 for clinical features (excluding headache
and laboratory abnormalities) at Week 0

- Cannot be pregnant, nursing, intending to become pregnant, or unwilling to follow
contraception or egg/sperm donation guidelines

- Must be receiving stable doses of >=1 protocol-permitted standard of care SLE
treatment: oral glucocorticoids, anti-malarials, immunomodulators (methotrexate,
azathioprine, 6-mercaptopurine, mycophenolate mofetil, mycophenolic acid)

Exclusion Criteria:

- Has any unstable or progressive SLE manifestation (example: central nervous system
lupus, systemic vasculitis, end-stage renal disease, severe or rapidly progressive
glomerulonephritis, pulmonary hemorrhage, myocarditis) that may warrant escalation in
therapy beyond permitted background medications. Participants requiring renal
hemodialysis or peritoneal dialysis are also excluded

- Has other co-existent inflammatory diseases (example: rheumatoid arthritis, psoriasis,
psoriatic arthritis, Crohn's disease)

- Has a urinary protein to creatinine ratio of greater than (>)4 gram per gram (g/g) per
day

- Has an acute or chronic infectious illness (example: human immunodeficiency virus,
hepatitis B or C virus, tuberculosis, opportunistic infections)

- Has a history of cancer or lymphoproliferative disease within the last 5 years except
for treated and non-recurrent cutaneous basal cell carcinoma, squamous cell carcinoma,
or cervical carcinoma

- Has any condition requiring multiple courses of systemic glucocorticoids (example:
uncontrolled asthma, chronic obstructive pulmonary disease)

- Has a history of major surgery within the last month

- Has received live virus or bacterial vaccines within 16 weeks prior to first dose of
study agent or Bacille Calmette-Guerin (BCG) vaccination within 12 months of screening

- Has previously received ustekinumab

- Has received cyclophosphamide orally within 90 days or intravenously within 180 days
of screening

- Has received a single B-cell targeted therapy (e.g. belimumab) within 3 months, >1
previous B-cell targeted therapy within 6 months, or B-cell depleting therapy
(example: rituximab) within 12 months of first dose of study agent

- Has received protocol-prohibited oral or biologic immunomodulatory therapy in the last
3 months or less than (<)5 half-lives (whichever is longer) prior to first dose of
study agent

- Has received adrenocorticotropic hormone (ACTH) within 1 month prior to first dose of
study agent

- Has received epidural, intravenous, intramuscular, intraarticular, intrabursal,
intralesional glucocorticoids within 6 weeks of first dose of study agent

- Locally-delivered therapies except for ophthalmic use of cyclosporine A or topical use
of nonsteroidal anti inflammatory drugs (NSAIDs), analgesics, or high-potency
glucocorticoids (World Health Organization criteria) are prohibited
We found this trial at
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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1601 Northwest 12th Avenue
Miami, Florida 33136
(305) 243-6545
University of Miami Miller School of Medicine The University of Miami Leonard M. Miller School...
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
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Seattle, Washington 98104
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Albuquerque, New Mexico 87102
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Anniston, Alabama 36207
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Aurora, Colorado 80045
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Austin, Texas 78731
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Beckley, West Virginia 25801
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Brandon, Florida 33511
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Chapel Hill, North Carolina 27599
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Charlotte, North Carolina 28204
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Charlotte, North Carolina 28210
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
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Columbia, South Carolina 29204
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Covina, California 91723
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Decatur, Georgia 30033
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
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Eagan, Minnesota 55121
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Fort Lauderdale, Florida 33334
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
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Lake Success, New York 10075
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Loma Linda University
Loma Linda, California 92354
(909) 558-4000
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New Haven, Connecticut 06520
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New York, New York 10016
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535 E 70th St
New York, New York 10021
(212) 606-1000
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
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Palo Alto, California 94304
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3500 North Broad Street
Philadelphia, Pennsylvania 19140
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
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Stamford, Connecticut 06095
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750 East Adams Street
Syracuse, New York 13210
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5115 North Armenia Avenue
Tampa, Florida 33603
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550 Saint Charles Drive
Thousand Oaks, California 91360
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1907 Tradd Ct
Wilmington, North Carolina 28401
(910) 799-5500
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Winston-Salem, North Carolina 27157
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