A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus



Status:Active, not recruiting
Conditions:Lupus
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 75
Updated:2/27/2019
Start Date:October 15, 2015
End Date:March 21, 2019

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

The purpose of this study is to evaluate the efficacy of ustekinumab as measured by a
reduction in disease activity for subjects with active Active Systemic Lupus Erythematosus
(SLE - chronic disorder of connective tissue in which there can be skin rash, arthritis,
kidney problems, and anemia, among other problems).

A multicenter (more than one medical research center involved in study), randomized (study
drug assigned by chance), double-blind (neither the Investigator nor the participant know
about the study drug), placebo-controlled, proof-of-concept study of ustekinumab in
participants with active systemic lupus erythematosus. Participants will be screened to
achieve all inclusion criteria and none exclusion criteria and will then receive either
ustekinumab or placebo along with concomitant background medicine. Participants will be
primarily assessed for response using the Systemic Lupus Erythematosus Response Index 2000
(SRI-4). Participants' safety will be assessed throughout the study.

Inclusion Criteria:

- Subjects must have documented medical history to meet SLICC classification criteria
for SLE for a minimum of 3 months prior to first dose

- At least 1 well-documented (subject file, referring physician letter, or laboratory
result), unequivocally positive, documented test for autoantibodies in medical history
including either of the following: ANA, and/or anti-dsDNA antibodies, and/or
anti-Smith antibodies

- At least 1 unequivocally positive autoantibody test including ANA and/or anti-dsDNA
antibodies and/or anti-Smith antibodies detected during screening

- At least 1 BILAG A and/or 2 BILAG B domain scores observed during screening prior to
first administration of study agent

- Demonstrate active disease based on SLEDAI-2K score greater than or equal to (>=) 6
observed during screening and assessed approximately 2 to 6 weeks prior to
randomization. Must also have SLEDAI-2K score >= 4 for clinical features (ie, SLEDAI
excluding laboratory results) at Week 0 prior to the first administration of study
agent

Exclusion Criteria:

- Have other inflammatory diseases that might confound the evaluations of efficacy,
including but not limited to rheumatoid arthritis (RA), psoriatic arthritis (PsA),
RA/lupus overlap, psoriasis or active Lyme disease

- Are pregnant, nursing, or planning a pregnancy or fathering a child while enrolled in
the study or within 4 months after receiving the last administration of study agent

- Have received systemic or topical cream/ointment preparations of cyclosporine A or
other systemic immunomodulatory agents other than those described in inclusion
criteria within the past 3 months prior to first administration of study agent

- Have received a single B cell targeting agent within 3 months prior to first study
agent administration; or received more than 1 previous B cell targeting therapy
including belimumab or epratuzamab within 6 months prior to first administration of
the study agent; or received B cell depleting therapy (eg, rituximab) within 12 months
prior to first administration of the study agent or have evidence of continued B-cell
depletion following such therapy

- Have ever received ustekinumab

- Participant has a history of malignancy within 5 years before screening (exceptions
are squamous and basal cell carcinomas of the skin that has been treated with no
evidence of recurrence for at least 3 months before the first study agent
administration and carcinoma in situ of the cervix that has been surgically cured)
We found this trial at
13
sites
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Jackson, TN
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Beverly Hills, California 90211
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Beverly Hills, CA
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Buenos Aires,
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Charleston, South Carolina 29412
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Charleston, SC
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Duncansville, Pennsylvania 16635
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Huntsville, AL
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Lansing, MI
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Manhasset, NY
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New York, NY
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Philadelphia, PA
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Syracuse, NY
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Tampa, FL
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Tulsa, OK
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