A Study of Nipocalimab in Adult Participants With Active Lupus Nephritis (NCT04883619) | Clinical Trial Compass
WithdrawnPhase 2
A Study of Nipocalimab in Adult Participants With Active Lupus Nephritis
Stopped: Business Decision
0Started 2026-01-15
Plain-language summary
The purpose of this study is to evaluate the efficacy of nipocalimab versus placebo in participants with active Lupus Nephritis (LN).
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Kidney biopsy documentation of International Society of Nephrology (ISN)/Renal Pathology Society (RPS) proliferative nephritis: Class III or IV (with or without concomitant Class V) within the last 6 months prior to screening or performed during screening
* Urine Protein to Creatinine Ratio (UPCR) greater than or equal to (\>=) 1.0 milligram/milligram (mg/mg) measured twice during screening
* Currently receiving prednisone equivalent dose of 1 milligram/kilogram/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 \>= 6 weeks with stable dosing \>= 2 weeks prior to first administration of study intervention
* If receiving angiotensin-converting enzyme (ACE) inhibitor/angiotensin II receptor blockers (ARB), a stable dose for at least 2 weeks prior to first administration of study intervention
* Is recommended to be up-to-date on all age-appropriate vaccinations prior to screening per routine local medical guidelines. For study participants who received locally-approved (and including emergency use-authorized) coronavirus disease 2019 (COVID-19) vaccines recently prior to study entry, follow applicable local vaccine labelling, guidelines, and standards-of-care for patients receiving immune-targeted therapy when determining an appropriate interval between vaccination and study enrolment
Exclusion Criteria:
* Comorbidit…
What they're measuring
1
Percentage of Participants Achieving Complete Renal Response (CRR)