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A Study of Ustekinumab in Participants With Active Systemic Lupus Erythematosus

NCT03517722 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 516

Last updated 2025-04-29

Study results available
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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.

Conditions

  • Lupus Erythematosus, Systemic

Interventions

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.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-16
Primary Completion
2020-11-05
Completion
2020-11-05
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Bulgaria
  • Canada
  • China
  • Colombia
  • Germany
  • Hungary
  • Japan
  • Lithuania
  • Poland
  • Portugal
  • Russia
  • Serbia
  • South Africa
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03517722 on ClinicalTrials.gov