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A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus

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

NCT02349061•Janssen Research & Development, LLC

View on ClinicalTrials.gov

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).

Detailed Description

A multicenter (more than one medical research center involved in study), randomized (study drug assigned by chance), double-blind (neither the Investigator nor the participant know about the study drug), placebo-controlled, proof-of-concept study of ustekinumab in participants with active systemic lupus erythematosus. Participants will be screened to achieve all inclusion criteria and none exclusion criteria and will then receive either ustekinumab or placebo along with concomitant background medicine. Participants will be primarily assessed for response using the Systemic Lupus Erythematosus Response Index 2000 (SRI-4). Participants' safety will be assessed throughout the study.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects must have documented medical history to meet SLICC classification criteria for SLE for a minimum of 3 months prior to first dose
•At least 1 well-documented (subject file, referring physician letter, or laboratory result), unequivocally positive, documented test for autoantibodies in medical history including either of the following: ANA, and/or anti-dsDNA antibodies, and/or anti-Smith antibodies
•At least 1 unequivocally positive autoantibody test including ANA and/or anti-dsDNA antibodies and/or anti-Smith antibodies detected during screening
•At least 1 BILAG A and/or 2 BILAG B domain scores observed during screening prior to first administration of study agent
•Demonstrate active disease based on SLEDAI-2K score greater than or equal to (\>=) 6 observed during screening and assessed approximately 2 to 6 weeks prior to randomization. Must also have SLEDAI-2K score \>= 4 for clinical features (ie, SLEDAI excluding laboratory results) at Week 0 prior to the first administration of study agent
•Have received a single B cell targeting agent within 3 months prior to first study agent administration; or received more than 1 previous B cell targeting therapy including belimumab or epratuzamab within 6 months prior to first administration of the study agent; or received B cell depleting therapy (eg, rituximab) within 12 months prior to first administration of the study agent or have evidence of continued B-cell depletion following such therapy
•Have ever received ustekinumab
•Participant has a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin that has been treated with no evidence of recurrence for at least 3 months before the first study agent administration and carcinoma in situ of the cervix that has been surgically cured)

Exclusion Criteria

•Have other inflammatory diseases that might confound the evaluations of efficacy, including but not limited to rheumatoid arthritis (RA), psoriatic arthritis (PsA), RA/lupus overlap, psoriasis or active Lyme disease
•Are pregnant, nursing, or planning a pregnancy or fathering a child while enrolled in the study or within 4 months after receiving the last administration of study agent

Locations (43)

Huntsville, Alabama, United States

Beverly Hills, California, United States

Tampa, Florida, United States

Lansing, Michigan, United States

Manhasset, New York, United States

New York, New York, United States

Syracuse, New York, United States

Tulsa, Oklahoma, United States

Duncansville, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

October 15, 2015

Primary Completion Date

May 15, 2017

Completion Date

March 13, 2019

Last Updated

March 24, 2020

Enrollment

102

ACTUAL participants

Conditions

Lupus Erythematosus, Systemic

Interventions

Ustekinumab IV

DRUG

Placebo Infusion

DRUG

Placebo SC

DRUG

Ustekinumab SC

DRUG

Concomitant Medication

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 24, 2020Data synced to Clareo: March 29, 2026

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 Conditions

A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus

Inclusion Criteria

Exclusion Criteria

A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)

A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus

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Vunakizumab for the Treatment of Mild to Moderate Systemic Lupus Erythematosus

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