A Study of Nipocalimab in Adult Participants With Active Lupus Nephritis

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Nipocalimab in Adult Participants With Active Lupus Nephritis

The purpose of this study is to evaluate the efficacy of nipocalimab versus placebo in participants with active Lupus Nephritis (LN).

Study Overview

• Status: Not yet recruiting
• Conditions: Lupus Nephritis
• Intervention / Treatment: Other: Placebo; Drug: Standard-of-care treatment; Drug: Nipocalimab

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 2

Expanded Access

Temporarily not available outside the clinical trial. See expanded access record.

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study@its.jnj.com

Study Locations

• United States
  • Arizona
    • Mesa, Arizona, United States, 85210
      • Arizona Arthritis & Rheumatology Research, PLLC
  • California
    • Canyon Country, California, United States, 91351
      • Clearview Medical Research, LLC
    • La Palma, California, United States, 90623
      • Arthritis & Osteoporosis Medical Center - La Palma
    • Los Alamitos, California, United States, 90720
      • Valerius Medical Group & Research Center
    • Palm Springs, California, United States, 92262
      • Respire Research, LLC
  • Florida
    • DeBary, Florida, United States, 32713
      • Omega Research Consultants
    • Gainesville, Florida, United States, 32610
      • University of Florida Health Jacksonville - Rheumatology
    • Miami, Florida, United States, 33165
      • Reliant Medical Research
    • Plantation, Florida, United States, 33324
      • Integral Rheumatology & Immunology Specialists
  • Texas
    • El Paso, Texas, United States, 79925
      • DaVita Clinical Research
    • Houston, Texas, United States, 77021
      • Next Innovative Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group 1: Placebo; Participants will receive placebo intravenously (IV) every two weeks (q2w) from Week 0 through Week 50 along with standard-of-care treatment of mycophenolate mofetil (MMF) or mycophenolic acid (MPA) and glucocorticoid. Participants who will complete the assessments at Week 52 and have achieved complete renal response (CRR) may have the option to participate in the long-term extension (LTE) until unblinding of the study.	Other: Placebo; Placebo will be administered intravenously.; Drug: Standard-of-care treatment; Standard-of-care treatment including MMF or MPA and glucocorticoids will be administered intravenously through Week 52.
Experimental: Group 2: Nipocalimab Dose 1; Participants will receive nipocalimab dose 1 IV q2w from Week 0 through Week 50 along with standard-of-care treatment of MMF or MPA and glucocorticoid. Participants who will complete the assessments at Week 52 and have achieved CRR may have the option to participate in the LTE of the study.	Drug: Standard-of-care treatment; Standard-of-care treatment including MMF or MPA and glucocorticoids will be administered intravenously through Week 52.; Drug: Nipocalimab; Nipocalimab dose 1 and dose 2 will be administered intravenously.; Other Names: JNJ-80202135; M281
Experimental: Group 3: Nipocalimab Dose 2; Participants will receive nipocalimab dose 2 IV q2w from Week 0 through Week 50 along with standard-of-care treatment of MMF or MPA and glucocorticoid. Participants who will complete the assessments at Week 52 and have achieved CRR may have the option to participate in the LTE of the study.	Drug: Standard-of-care treatment; Standard-of-care treatment including MMF or MPA and glucocorticoids will be administered intravenously through Week 52.; Drug: Nipocalimab; Nipocalimab dose 1 and dose 2 will be administered intravenously.; Other Names: JNJ-80202135; M281

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Complete Renal Response (CRR)	Percentage of participants achieving complete renal response will be reported.	Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving CRR	Percentage of participants achieving CRR will be reported.	Week 24
Percentage of Participants Achieving at Least 50 Percent (%) Decrease in Proteinuria from Baseline, Week 24 and Week 52	Percentage of participants achieving at least 50% decrease in proteinuria will be reported.	Baseline, Week 24 and Week 52
Percentage of Participants Achieving a Sustained Reduction in Steroid Dose Less Than or Equal to (<=)10 milligram (mg)/day of Prednisone or Equivalent	Percentage of participants achieving a sustained reduction in steroid dose <= 10 mg/day of prednisone or equivalent will be reported.	Week 16 to Week 52
Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)	An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.	Up to Week 66
Percentage of Participants with Treatment-emergent Serious Adverse Events (TESAEs)	A serious adverse event is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. TESAEs are defined as SAEs with onset or worsening on or after date of first dose of study treatment.	Up to Week 66
Percentage of Participants with Treatment-emergent AEs Leading to Discontinuation of Study Intervention	Percentage of participants with treatment-emergent AEs leading to discontinuation of study intervention will be reported.	Up to Week 52
Percentage of Participants with Treatment-emergent Adverse Events of Special Interests (AESIs)	Percentage of participants with treatment-emergent AESIs will be reported.	Up to Week 58
Percentage of Participants with Change from Baseline in Laboratory Parameters Over Time	Percentage of participants with change from baseline in laboratory parameters (hematology and chemistry) will be reported.	Up to week 58
Percentage of Participants with Change from Baseline in Vital Sign Parameters Over Time	Percentage of participants with change from baseline in vital sign parameters (temperature, pulse/heart rate, respiratory rate, and blood pressure) will be reported.	Up to week 58
Serum Concentration of Nipocalimab Over Time	Serum concentrations of nipocalimab over time in participants receiving active study intervention will be reported.	Up to Week 58
Number of Participants with Antibodies to Nipocalimab (Anti-Drug Antibodies [ADAs] and Neutralizing Antibodies [Nabs])	Number of participants with antibodies to nipocalimab (ADAs and Nabs) in participants receiving active study intervention will be reported.	Up to Week 58

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2026
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): February 28, 2028

Study Registration Dates

• First Submitted: May 11, 2021
• First Submitted That Met QC Criteria: May 11, 2021
• First Posted (Actual): May 12, 2021

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Kidney Diseases; Urologic Diseases; Connective Tissue Diseases; Glomerulonephritis; Lupus Erythematosus, Systemic; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Nephritis; Lupus Nephritis
• Other Study ID Numbers: CR109008; 2020-005568-79 (EudraCT Number); 80202135LUN2001 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No