A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus
Condition: Lupus Erythematosus, Systemic
MeSH terms: Lupus Erythematosus, Systemic
Intervention: Ustekinumab IV; Placebo Infusion; Placebo SC; Ustekinumab SC; Concomitant Medication
Intervention description: Weight-range based dosing of approximately 6 mg/kg of ustekinumab intravenously at Week 0.; Placebo intravenously at Week 0.; Placebo subcutaneously at Weeks 8 and 16.; Ustekinumab 90 mg subcutaneously every 8 weeks up to Week 40 and up to Week 104 in study extension (for eligible participants); Concomitant treatment (mycophenolate, azathioprine/6-mercaptopurine, methotrexate, hydroxychloroquine and/or chloroquine, oral corticosteroids, NSAIDs, antihypertensive medications, and topical medications) through Week 48, as well as through the study extension although tapering of corticosteroids is encouraged beyond Week 48.
Intervention MeSH terms: Ustekinumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Systemic Lupus Erythematosus; Ustekinumab

Summary:

      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).
    

Eligibility criteria:

        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)