NOT_YET_RECRUITING
Study on Nipocalimab in Adult Patients With Active Lupus Nephritis
The purpose of this study is to assess the efficacy of nipocalimab versus placebo in patients with active Lupus Nephritis (LN).
Conditions:
🦠 Lupus Nephritis
🗓️ Study Start (Actual) 15 January 2026
🗓️ Primary Completion (Estimated) 28 February 2028
✅ Study Completion (Estimated) 28 February 2028
👥 Enrollment (Estimated) 80
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Mesa, Arizona, United States
📍 Canyon Country, California, United States
📍 La Palma, California, United States
📍 Los Alamitos, California, United States
📍 Palm Springs, California, United States
📍 DeBary, Florida, United States
📍 Gainesville, Florida, United States
📍 Miami, Florida, United States
📍 Plantation, Florida, United States
📍 El Paso, Texas, United States
📍 Houston, Texas, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to 75 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 11 May 2021
  • First Submitted that Met QC Criteria 11 May 2021
  • First Posted 12 May 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 16 July 2024
  • Last Update Posted 17 July 2024
  • Last Verified July 2024