A Study of Ustekinumab in Participants with Active Systemic Lupus Erythematosus
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in ...
Lupus Erythematosus, Systemic
Intervention name : Ustekinumab INN of the intervention : Ustekinumab Dosage And administration of the intervention : Participants will receive ustekinumab approximately 6 milligram per kilogram (mg/kg) intravenously (IV) based on body weight-range at Week 0 followed by 90 mg ustekinumab subcutaneously (SC) at Week 8 and every 8 weeks (q8w) thereafter through Week 48 during double-blind period. Eligible participants who will enter the extension period will continue to receive 90 mg ustekinumab SC q8w through Week 160 Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Participants will receive matching placebo to ustekinumab IV at Week 0, followed by matching placebo to ustekinumab SC at Week 8 and q8w thereafter through Week 48 during double-blind period. Eligible participants who will enter the extension period will cross-over to receive 90 mg ustekinumab SC q8w through Week 160. Intervention name : Ustekinumab INN of the intervention : Ustekinumab Dosage And administration of the ...
Janssen Pharmaceutical K.K.
NULL
complete
16
75
BOTH
500
Phase 3
Japan, Asia except Japan, North America, South America, Europe, Africa
A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus
A Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus A Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study of Ustekinumab i ...