A Study of Guselkumab in Participants With Active Lupus Nephritis

• Status: Recruiting
• Trial end date: 2025-05-25
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion Criteria:

• Currently receiving prednisone equivalent dose of 1 milligram per kilogram per day (mg/kg/day) or less than or equal to (<=) 60 mg/day, whichever is lower, or less. Must be receiving prednisone equivalent of 10 mg/day or more at screening and randomization. Treated for greater than or equal to (>=) 6 weeks with stable dosing >=2 weeks before randomization

• If receiving angiotensin-converting enzyme (ACE) inhibitor/angiotensin II receptor blockers (ARB), a stable dose for at least 2 weeks prior to randomization

• Positive antinuclear antibody (ANA; >= 1:80 titer by central laboratory test) or positive anti-double-stranded deoxyribonucleic acid (dsDNA) test results at screening

• Kidney biopsy documentation of International Society of Nephrology (ISN)/Renal Pathology Society (RPS) proliferative nephritis: Class III-IV within the last 6 months prior to screening or performed during screening

• Urine Protein to Creatinine Ratio (UPCR) >= 1.0 milligram/milligram (mg/mg) assessed on 2 first morning urine void specimens during screening. These 2 specimens do not need to be on consecutive days, however, 2 samples must be tested with UPCR >= 1.0 mg/mg in a row. The UPCR requirement must be met after at least 8 weeks of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) treatment, and after stable glucocorticoid dosing is achieved at the dose intended at time of randomization

Exclusion Criteria:

• Comorbidities (other than lupus nephritis [LN], example, asthma, chronic obstructive pulmonary disease) which have required 3 or more courses of systemic glucocorticoids within the previous 12 months

• Has 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, Crohn's disease, or active Lyme disease

• Received PO (orally) cyclophosphamide within 3 months or intravenous (IV) cyclophosphamide within 6 months prior to randomization

• History of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, before screening

• History of being human immunodeficiency virus (HIV) antibody-positive, or tests positive for HIV at screening