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

NCT04060888 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2025-02-03

No results posted yet for this study

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

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.

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
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-14
Primary Completion
2022-01-31
Completion
2026-03-31

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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 NCT04060888 on ClinicalTrials.gov