A Study of Nipocalimab in Adult Participants With Active Lupus Nephritis

Last Updated August 7, 2024

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CR109008

OVERVIEW

Sexes Eligible for Study
all
Age
18+ years
Phase
phase 2
Sites
11 Sites
Status

Not yet recruiting

SUMMARY

LN is a heterogeneous autoimmune disease that includes a broad spectrum of clinical forms, ranging from those with lesions confined to the skin (cutaneous lupus erythematosus [CLE]) to others that involve one or more vital internal organs (systemic lupus erythematosus [SLE]). Renal involvement due to SLE is termed LN. Nipocalimab (also referred to as JNJ-80202135 or M281) is a fully human aglycosylated immunoglobulin (Ig) G1 monoclonal antibody designed to selectively bind, saturate, and block the IgG binding site on the endogenous neonatal fragment crystallizable receptor (FcRn). By targeting the IgG binding site on FcRn, nipocalimab is expected to block the binding and, hence, recycling of IgG into circulation, resulting in a decrease in circulating IgG antibody levels, including pathogenic IgG autoantibodies and alloantibodies. The study will consist of a screening period (less than or equal to [<=] 8 Week), double-blind treatment period (52 Week), and a safety follow-up period (6 Week). Safety assessment will include adverse events (AEs), serious adverse events (SAEs), laboratory parameters (hematology and chemistry) and vital signs. The total duration of the main study is up to 66 weeks.

CONDITIONS

Lupus Nephritis

ELIGIBILITY

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

Inclusion Criteria:

More...

DETAILS

LOCATIONS

Locations in:

United States

Country (1)	City or Province (11)	Status
United States	Mesa Arizona Arthritis & Rheumatology Research, PLLC
United States	Canyon Country Clearview Medical Research, LLC
United States	La Palma Arthritis & Osteoporosis Medical Center - La Palma
United States	Los Alamitos Valerius Medical Group & Research Center
United States	Palm Springs Respire Research, LLC
United States	DeBary Omega Research Consultants
United States	Gainesville University of Florida Health Jacksonville - Rheumatology
United States	Miami Reliant Medical Research
United States	Plantation Integral Rheumatology & Immunology Specialists
United States	El Paso Davita Clinical Research
United States	Houston Next Innovative Clinical Research

Geo Locations

33.42227, -111.82264

34.42333, -118.47203

33.8464, -118.04673

33.80307, -118.07256

33.8303, -116.54529

28.88305, -81.30868

29.65163, -82.32483

25.77427, -80.19366

26.13421, -80.23184

31.75872, -106.48693

29.76328, -95.36327

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