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A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus
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.
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.
Age
16 - 75 years
Sex
ALL
Healthy Volunteers
No
Pinnacle Research Group, LLC
Anniston, Alabama, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
Achieve Clinical Research, LLC
Vestavia Hills, Alabama, United States
Medvin Clinical Research
Covina, California, United States
Lugene Eye Institute
Glendale, California, United States
C.V. Mehta, MD Medical Corp.
Hemet, California, United States
University of California at San Diego
La Jolla, California, United States
Advanced Medical Research - Lakewood
Lakewood, California, United States
Loma Linda University
Loma Linda, California, United States
Loma Linda University Health Care
Loma Linda, California, United States
Start Date
April 16, 2018
Primary Completion Date
November 5, 2020
Completion Date
November 5, 2020
Last Updated
April 29, 2025
516
ACTUAL participants
Placebo
DRUG
Ustekinumab (approximately 6 mg/kg)
DRUG
Ustekinumab 90 mg
DRUG
Lead Sponsor
Janssen Research & Development, LLC
NCT07015983
NCT07438496
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06673043