CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 102 enrolled
Drug / intervention
Ustekinumab IV +4 moredrug
Likely dose
Ustekinumab IV 6 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02349061
NCT02349061Phase 2Completed
CompareCT.gov

A Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus

Janssen Research & Development, LLC·interventional·Posted Jan 28, 2015·Updated Mar 24, 2020

In Brief

A Phase 2 clinical trial evaluating Ustekinumab IV, Placebo Infusion, and 3 other interventions for Lupus Erythematosus, Systemic. Completed, enrolled 102 participants across 43 sites in 9 countries.

Detailed Summary

The purpose of this study is to evaluate the efficacy of ustekinumab as measured by a reduction in disease activity for subjects with active Active Systemic Lupus Erythematosus (SLE - chronic disorder of connective tissue in which there can be skin rash, arthritis, kidney problems, and anemia, among other problems).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLupus Erythematosus, Systemic
CountriesArgentina, Australia, Germany, Hungary, Mexico, Poland, Spain, Taiwan, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 28, 2015
Enrollment StartOct 15, 2015
Primary CompletionMay 15, 2017
Study CompletionMar 13, 2019
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 11.4 years ago

Interventions

Ustekinumab IVdrug

Weight-range based dosing of approximately 6 mg/kg of ustekinumab intravenously at Week 0.

Placebo Infusiondrug

Placebo intravenously at Week 0.

Placebo SCdrug

Placebo subcutaneously at Weeks 8 and 16.

Ustekinumab SCdrug

Ustekinumab 90 mg subcutaneously every 8 weeks up to Week 40 and up to Week 104 in study extension (for eligible participants)

Concomitant Medicationother

Concomitant treatment (mycophenolate, azathioprine/6-mercaptopurine, methotrexate, hydroxychloroquine and/or chloroquine, oral corticosteroids, NSAIDs, antihypertensive medications, and topical medications) through Week 48, as well as through the study extension although tapering of corticosteroids is encouraged beyond Week 48.