A Study of Nipocalimab in Adult Participants With Active Lupus Nephritis

Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · May 11, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called nipocalimab for adults who have active Lupus Nephritis, a condition where the immune system causes inflammation in the kidneys. The main goal of the study is to see how effective nipocalimab is compared to a placebo, which is a treatment that looks like the real thing but contains no active medicine. The trial is not currently recruiting participants, but when it does, it will include adults aged 18 to 75 who have specific signs of kidney inflammation confirmed by a biopsy and certain protein levels in their urine.

To be eligible for the trial, participants must have been receiving a stable dose of a steroid medication (like prednisone) for at least six weeks before starting the study. They should also be up-to-date on their vaccinations. However, individuals with other serious inflammatory diseases or recent infections may not qualify. Participants can expect regular check-ins and tests to monitor their health throughout the trial. This study is essential to help find better treatments for Lupus Nephritis, which can significantly impact patients' lives.

Gender

ALL

Eligibility criteria

• 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:
• • Comorbidities (other than Lupus Nephritis, 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
• • Has received oral cyclophosphamide within 3 months or intravenous (IV) cyclophosphamide within 6 months prior to first administration of study intervention
• • Has a history of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, before screening
• • COVID-19 infection: During the 6 weeks prior to baseline, have had any of the following (a) confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (test positive), or (b) suspected SARS-CoV-2 infection (clinical features of COVID-19 without documented test results), or (c) close contact with a person with known or suspected SARS-CoV-2 infection