Clinical trial NCT02349061 (phase 2, status: completed)
Conditions: lupus erythematosus, systemic
ICD codes: M32.9, M32.0, M32.11, M32.12, M32.13, M32.14, M32.8
Drugs: ustekinumab iv, placebo infusion, placebo sc, ustekinumab sc
SMILES: CC1=CC(O)=CC(C)=C1Cl, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
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)