NCT04060888

A Study of Ustekinumab in Chinese Participants With Active Systemic Lupus Erythematosus

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Chinese Subjects With Active Systemic Lupus Erythematosus

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Lupus Erythematosus, Systemic

Interventions

Type	Name	Description
DRUG	Ustekinumab (approximately 6 mg/kg)	Participants will receive ustekinumab approximately 6 milligram per kilogram via IV route based on body weight-range.
DRUG	Ustekinumab 90 milligram (mg)	Participants will receive 90 mg ustekinumab via SC route.
DRUG	Placebo	Participants will receive placebo matching to ustekinumab IV or SC.

Timeline

• Start date: 2020-07-14
• Primary completion: 2022-01-31
• Completion: 2026-03-31
• First posted: 2019-08-19
• Last updated: 2025-02-03