The purpose of this study is to evaluate the efficacy of ustekinumab in Chinese participants with active systemic lupus erythematosus (SLE) who have not adequately responded to one or more standard-of-care treatments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Participants will receive ustekinumab approximately 6 milligram per kilogram via IV route based on body weight-range.
Participants will receive 90 mg ustekinumab via SC route.
Participants will receive placebo matching to ustekinumab IV or SC.
Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index-4 (SRI-4) Composite Response at Week 52
SRI-4 is a composite of at least 4 point improvement in Systemic Lupus Erythematosus Disease Activity Index 2000(SLEDAI-2K), no worsening in British Isles Lupus Assessment Group (BILAG) and no worsening in Physician's Global Assessment of Disease Activity score (PGA).
Time frame: Week 52
Time to Flare
Time to flare is the duration of flare occurring at any time after the baseline will be calculated with flare defined as either 1 or more new British Isles Lupus Assessment Group (BILAG) A or 2 or more new BILAG B domain scores relative to baseline.
Time frame: Baseline up to Week 52
Percentage of Participants with an SRI-4 Composite Response at Week 24
SLE Responder Index (SRI)-4 is a composite of at least 4 point improvement in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K, no worsening in BILAG and no worsening in PGA.
Time frame: Week 24
Percentage of Participants Achieving at Least a 50% Improvement in the Number of Joints with Pain and Signs of Inflammation at Week 52
The percentage of participants achieving at least a 50 percent (%) improvement in the number of joints with pain and signs of inflammation at week 52 will be reported in participants with at least 4 affected joints at baseline.
Time frame: Week 52
Percentage of Participants Receiving Glucocorticoids at Baseline who Achieve Reduction in Glucocorticoid Dose by Week 40 and Sustain That Reduction Through Week 52
Reduction of glucocorticoid dose is defined as a reduction in average daily oral glucocorticoid dose by at least 50% (relative to the baseline dose) or reduction of average daily oral glucocorticoid dose by at least 25% (relative to the baseline dose) so that the average daily dose is reduced to less than or equal to (\<=) 7.5 milligram (mg) (prednisone or equivalent). Sustained reduction of glucocorticoid dose is defined as achieving an average daily oral glucocorticoid dose reduction between Weeks 24 and 40, and sustaining that reduction through Week 52, in those participants who, at baseline, were receiving oral glucocorticoids.
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Time frame: Baseline up to Week 52
Percentage of Participants Achieving at Least a 50% Improvement in the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score at Week 52
Percentage of participants achieving at least 50% improvement in CLASI Activity Score at Week 52 will be reported in participants with a CLASI Activity Score of 4 or greater at baseline.
Time frame: Week 52
Percentage of Participants Receiving Glucocorticoids at Baseline who Achieve Reduction in Glucocorticoid Dose by Week 40, Sustain That Reduction Through Week 52, and Achieve an SRI-4 Composite Response at Week 52
Percentage of participants receiving glucocorticoids at baseline who achieve reduction in glucocorticoid dose by Week 40, sustain that reduction through Week 52, and achieve an SRI-4 composite response at Week 52 will be reported.
Time frame: Baseline up to Week 52