Status:
TERMINATED
A Study of Guselkumab in Participants With Active Lupus Nephritis
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Lupus Nephritis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy of guselkumab in participants with active lupus nephritis (LN).
Detailed Description
Guselkumab is a monoclonal antibody (mAb) that binds to human interleukin (IL)-23 with high affinity and blocks binding of extracellular IL-23 to cell surface IL-23 receptor, inhibiting IL 23 specific...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2023
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT04376827
Start Date
September 15 2020
End Date
February 1 2023
Last Update
March 30 2025
Active Locations (60)
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1
Medvin Clinical Research
Covina, California, United States, 91722
2
UC San Diego
La Jolla, California, United States, 92037
3
Academic Medical Research Institute
Los Angeles, California, United States, 90022
4
University of Colorado Denver
Aurora, Colorado, United States, 80045