Clinical trial NCT04060888 (phase 3, status: withdrawn)
Conditions: lupus erythematosus, systemic
ICD codes: M32.9, M32.0, M32.11, M32.12, M32.13, M32.14, M32.8
Drugs: ustekinumab (approximately 6 mg/kg), ustekinumab 90 milligram (mg), placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Reason stopped: 
    pre-planned ia (global study) showed lack of efficacy in this indication. no new safety signals
    observed, findings consistent with known profile.
  
Eligibility criteria:

        Inclusion Criteria:

          -  Had 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)

          -  Have 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

          -  Have at least 1 British Isles Lupus Assessment Group (BILAG) A and/or 2 BILAG B scores
             observed during screening

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

          -  Have a Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score
             greater than or equal to [>=] 6 at screening. Must also have SLEDAI-2K >= 4 for
             clinical features (excluding headache and laboratory abnormalities) at Week 0

        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 inflammatory diseases that might confound the evaluations of efficacy
             (including but not limited to rheumatoid arthritis, psoriasis, psoriatic arthritis,
             Crohn's disease)

          -  Has urinary protein level of greater than (>) 4 gram per day (g/day) or
             protein/creatinine ratio estimating >4g/day equivalent proteinuria

          -  Has known allergies, hypersensitivity, or intolerance to ustekinumab or its excipients

          -  Has a known history of lymphoproliferative disease, including lymphoma, or signs and
             symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy
             of unusual size or location, clinically significant splenomegaly, or history of
             monoclonal gammopathy of undetermined significance