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

NCT02349061 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2020-03-24

Study results available
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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).

Conditions

  • Lupus Erythematosus, Systemic

Interventions

DRUG

Ustekinumab IV

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

DRUG

Placebo Infusion

Placebo intravenously at Week 0.

DRUG

Placebo SC

Placebo subcutaneously at Weeks 8 and 16.

DRUG

Ustekinumab SC

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

OTHER

Concomitant Medication

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.

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
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2015-10-15
Primary Completion
2017-05-15
Completion
2019-03-13

Countries

  • United States
  • Argentina
  • Australia
  • Germany
  • Hungary
  • Mexico
  • Poland
  • Spain
  • Taiwan

Study Locations

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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 NCT02349061 on ClinicalTrials.gov