A Study of Guselkumab in Participants With Active Lupus Nephritis

Part of paid clinical trials in Covina, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT04376827
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Guselkumab Dose 1 — DRUG
    Participants will receive guselkumab Dose 1 via IV administration.
  • Placebo — DRUG
    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.
  • Guselkumab Dose 2 — DRUG
    Participants will receive guselkumab Dose 2 via SC route.
  • Standard-of-care treatment — DRUG
    Participants will receive standard of care treatment including MMF/MPA and glucocorticoids from Week 12 through Week 48.

Study Details

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

Key Dates

Start date
Sep 15, 2020
Status verified
Mar 2025
Primary completion
Feb 1, 2023
Completion
Feb 1, 2023

Study Design

Enrollment
33 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Guselkumab+Standard of Care
    Participants will receive guselkumab Dose 1 intravenously (IV) at Weeks 0, 4 and 8 and guselkumab Dose 2 subcutaneous (SC) every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52 and have completed the Week 52 assessment may have the option to participate in the long-term extension (LTE).
  • Placebo Comparator: Placebo+Standard of Care
    Participants will receive placebo IV at Weeks 0, 4 and 8 and placebo SC q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52 and have completed the Week 52 assessment may have the option to participate in the LTE of the study.

Primary Outcome Measure

Percentage of Participants Achieving at Least 50 Percent (%) Decrease From Baseline in Proteinuria at Week 24 [ Time Frame: Week 24 ]

Locations (8)

FacilityCityStateZIPSite coordinators
Medvin Clinical ResearchCovinaCalifornia91722-
UC San DiegoLa JollaCalifornia92037-
Academic Medical Research InstituteLos AngelesCalifornia90022-
University of Colorado DenverAuroraColorado80045-
University of Florida College of MedicineGainesvilleFlorida32610-
NYU Langone Ambulatory Care Brooklyn HeightsBrooklynNew York11201-
The Feinstein Institute for Medical ResearchManhassetNew York11030-
Med Research, Inc.El PasoTexas79902-

Find similar trials in Covina, CA

By condition
Lupus (SLE)
By specialty
RheumatologyAutoimmune disease
By research site
Medvin Clinical Research· Covina, CAUC San Diego· La Jolla, CAAcademic Medical Research Institute· Los Angeles, CAUniversity of Colorado Denver· Aurora, COUniversity of Florida College of Medicine· Gainesville, FLNYU Langone Ambulatory Care Brooklyn Heights· Brooklyn, NY

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