A Study of Guselkumab in Participants With Active Lupus Nephritis

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Lupus Nephritis

In brief

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

Key facts

Study ID

NCT04376827

Run by

Janssen Research & Development, LLC

People needed

33

Starts

2020-09-15

Expected to finish

2023-02-01

Last updated by the study team

2025-03-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At screening and randomization, must be receiving oral glucocorticoids at minimum prednisone equivalent dose of 10 milligrams per day (mg/day) and maximum 1 mg/kg/day or less than or equal to (<=) 60 mg/day, whichever is lower. 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 anti-double-stranded deoxyribonucleic acid (dsDNA) antibodies (>=30 international units per milliliter ([U/mL] by central laboratory test) detected at screening
• Kidney biopsy documentation of active International Society of Nephrology (ISN)/Renal Pathology Society (RPS) proliferative nephritis: Class III-IV (with or without class V membranous nephritis) 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

You may not qualify if…

• 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) or intravenously (IV) cyclophosphamide within 3 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

Where it is running

• UC San Diego — La Jolla, California, United States
• Academic Medical Research Institute — Los Angeles, California, United States
• University of Colorado Denver — Aurora, Colorado, United States
• University of Florida College of Medicine — Gainesville, Florida, United States
• NYU Langone Ambulatory Care Brooklyn Heights — Brooklyn, New York, United States
• The Feinstein Institute for Medical Research — Manhasset, New York, United States
• Med Research, Inc. — El Paso, Texas, United States
• Centro Médico Reumatológico (OMI) — Buenos Aires, Argentina
• Hospital Ramos Mejia — Caba, Argentina
• ARCIS Salud SRL Aprillus asistencia e investigacion — CABA, Argentina
• Instituto Medico Strusberg SA — Córdoba, Argentina
• Clinica Privada Velez Sarsfield — Córdoba, Argentina
• Instituto de Reumatologia - Ir Medical Center S.A. — Mendoza, Argentina
• Instituto Médico de la Fundación de Estudios Clínicos (ECLIN) — Rosario, Argentina
• Centro de Investigaciones Medicas Tucuman — San Miguel de Tucumán, Argentina
• Hospital Civil de Guadalajara Fray Antonio Alcalde — Guadalajara, Mexico
• Centro de Investigacion y Tratamiento Reumatologico S C — Mexico City, Mexico
• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran — Mexico City, Mexico
• Unidad Reumatologica las Americas S.C.P. — Mérida, Mexico
• Consultorio de Reumatologia — México, Mexico
• Unidad de Investigaciones Reumatologicas A.C — San Luis Potosí City, Mexico
• Uniwersyteckie Centrum Medyczne Klinika Nefrologii Transplantologii i Chorob Wewnetrznych — Gdansk, Poland
• Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego — Lodz, Poland
• Uniwersytecki Szpital Kliniczny we Wroclawiu — Wroclaw, Poland
• Medvin Clinical Research — Covina, California, United States

Full record on ClinicalTrials.gov

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