NCT03517722

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 516 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 16 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy of ustekinumab in participants with active systemic lupus erythematosus (SLE) who have not adequately responded to one or more standard of care treatments.

Detailed description

This study evaluates the efficacy, safety, and tolerability of ustekinumab in participants with active SLE according to Systemic Lupus International Collaborating Clinics (SLICC) criteria Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score greater than (\>=) 6, despite receiving one or more standard-of-care treatments (example, immunomodulators, antimalarial drugs, and/or glucocorticoids). The total duration of the study is up to 182 weeks, consisting of 3 study periods: a screening period (approximately 6 weeks), a double blind period (52 weeks), and an extension period (124 weeks). Other study evaluations will include pharmacokinetics, immunogenicity, biomarkers and pharmacogenomic evaluations. The safety of the participants enrolled in the study will be monitored on an ongoing basis throughout the study.

Conditions

• Lupus Erythematosus, Systemic

Interventions

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

Timeline

• Start date: 2018-04-16
• Primary completion: 2020-11-05
• Completion: 2020-11-05
• First posted: 2018-05-07
• Last updated: 2025-04-29
• Results posted: 2022-03-09

Locations

204 sites across 20 countries: United States, Argentina, Bulgaria, Canada, China, Colombia, Germany, Hungary, Japan, Lithuania, Poland, Portugal, Russia, Serbia, South Africa, South Korea, Spain, Taiwan, Thailand, Ukraine

Regulatory

• FDA-regulated drug study