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A Study of Guselkumab in Participants With Active Lupus Nephritis

NCT04376827 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2025-03-30

Study results available
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Summary

The purpose of this study is to evaluate the efficacy of guselkumab in participants with active lupus nephritis (LN).

Conditions

Interventions

DRUG

Guselkumab Dose 1

Participants will receive guselkumab Dose 1 via IV administration.

DRUG

Placebo

Participants will receive placebo IV at Weeks 0, 4 and 8 (that is, 3 IV doses) and placebo SC q4w from Week 12 through Week 48.

DRUG

Guselkumab Dose 2

Participants will receive guselkumab Dose 2 via SC route.

DRUG

Standard-of-care treatment

Participants will receive standard of care treatment including MMF/MPA and glucocorticoids from Week 12 through 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
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-09-15
Primary Completion
2023-02-01
Completion
2023-02-01
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Mexico
  • Poland
  • Russia
  • Spain
  • Taiwan
  • Thailand
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT04376827 on ClinicalTrials.gov