A Study of Nipocalimab in Adult Participants With Active Systemic Lupus Erythematosus

NCT ID: NCT04882878

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 228 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-20
• Study Completion Date: 2024-12-26

Brief Summary

The purpose of this study is to evaluate the efficacy of nipocalimab versus placebo in participants with active systemic lupus erythematosus (SLE).

Detailed Description

SLE is a complex, immune-mediated inflammatory disorder of unknown etiology that can affect almost any organ system and follows a waxing and waning disease course. In SLE, the immune system attacks the body cells and tissues and the resulting inflammation and tissue damage can harm the heart, joints, skin, lungs, blood vessels, liver, kidneys, and nervous system. Nipocalimab 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). Thus, nipocalimab, a FcRn antibody, has potential in treatment of SLE through lowering of pathogenic IgGs and immune complexes. The study will consist of a Screening Period (less than or equal to [<=] 6 Weeks), double-blind Treatment Period (52 Weeks), and a Follow-up Period (6 Weeks). Key safety assessments will include adverse events (AEs), serious adverse events (SAEs), adverse events of special interests (AESIs), clinical laboratory tests (hematology, chemistry, urinalysis, and lipid profile) and vital signs. The total duration of the study is up to 64 weeks.

Conditions

Systemic Lupus Erythematosus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1: Placebo

Participants will receive placebo intravenously (IV) every two weeks (q2w) through Week 50 along with standard-of-care treatments (that is, immunomodulators, antimalarial drugs and Glucocorticoids \[GCs\]).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo will be administered intravenously.

Standard-of-care treatment

Intervention Type: DRUG

Standard-of-care treatment including immunomodulators, antimalarial drugs and GCs will be administered orally.

Group 2: Nipocalimab Dose 1

Participants will receive nipocalimab dose 1 intravenously (IV) q2w through Week 50 along with standard-of-care treatments (that is, immunomodulators, antimalarial drugs and GCs).

Group Type: EXPERIMENTAL

Nipocalimab

Intervention Type: DRUG

Nipocalimab dose 1 and dose 2 will be administered intravenously.

Standard-of-care treatment

Intervention Type: DRUG

Standard-of-care treatment including immunomodulators, antimalarial drugs and GCs will be administered orally.

Group 3: Nipocalimab Dose 2

Participants will receive nipocalimab dose 2 intravenously (IV) q2w through Week 50 along with standard-of-care treatments (that is, immunomodulators, antimalarial drugs and GCs).

Group Type: EXPERIMENTAL

Nipocalimab

Intervention Type: DRUG

Nipocalimab dose 1 and dose 2 will be administered intravenously.

Standard-of-care treatment

Intervention Type: DRUG

Standard-of-care treatment including immunomodulators, antimalarial drugs and GCs will be administered orally.

Interventions

Placebo

Placebo will be administered intravenously.

Intervention Type: OTHER

Nipocalimab

Nipocalimab dose 1 and dose 2 will be administered intravenously.

Intervention Type: DRUG

Standard-of-care treatment

Standard-of-care treatment including immunomodulators, antimalarial drugs and GCs will be administered orally.

Intervention Type: DRUG

Other Intervention Names

JNJ-80202135; M281

Eligibility Criteria

Inclusion Criteria

• Has a clinical diagnosis of systemic lupus erythematosus (SLE) greater than or equal to (>=) 6 months prior to the screening visit and according to Systemic Lupus International Collaborating Clinics (SLICC)-2012 classification criteria: at least 4 criteria fulfilled, with at least 1 clinical criterion and 1 immunologic criterion
• Has at least 1 BILAG (british isles lupus assessment group) A and/or 2 BILAG B scores observed during screening
• Must have at least moderately active SLE, as defined as systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) score >= 6 at screening visit. Must also have SLEDAI 2K >= 4 for clinical features (that is, SLEDAI-2K score excluding headache and laboratory abnormalities) present at Week 0 prior to randomization
• Has a CLASI (cutaneous lupus erythematosus disease area and severity index) activity score of at least 6 (excluding diffuse non-inflammatory alopecia) or at least 4 joints with pain and signs of inflammation (active joints) at screening or at Week 0, or both
• At least 1 unequivocally positive autoantibody test including antinuclear antibodies (ANA) (>= 1:80) and/or anti-double stranded deoxyribonucleic acid (dsDNA) antibodies (level >= 75 international units/milliliter [IU/mL]) and/or anti-Smith antibodies (>120 Absorbance unit/milliliter [AU/mL]) detected during screening
• Must be receiving 1 or more of the following protocol-permitted, systemic standard-of-care treatments prior to first administration of study intervention at a stable dose: oral glucocorticoids, antimalarial or up to 2 immunomodulatory drugs

Exclusion Criteria

• Current or history of, severe, progressive, or uncontrolled renal disease, with the exception of active lupus nephritis (LN). Have severe active LN as determined by sponsor (or designee) adjudication. Control of renal disease must be documented with at least 2 measurements of proteinuria or urine protein/creatinine ratio (UPCR) over the 6 months prior to screening
• Has any unstable or progressive manifestation of SLE that is likely to warrant escalation in therapy beyond permitted background medications
• Confirmed or suspected inflammatory diseases that might confound the evaluations of efficacy
• Has a severe infection including opportunistic infections requiring parenteral anti-infectives, and/or hospitalization within 8 weeks prior to screening
• Has received a single B-cell targeting agent within 3 months prior to first administration of study intervention

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Valerius Medical Group & Research Center

Los Alamitos, California, United States

Desert Medical Advances

Rancho Mirage, California, United States

Wolverine Clinical Trials

Santa Ana, California, United States

Millennium Clinical Trials LLC

Westlake Village, California, United States

Bay Area Arthritis and Osteoporosis

Brandon, Florida, United States

GNP Research

Cooper City, Florida, United States

South Coast Research Center

Miami, Florida, United States

Advanced Clinical Research of Orlando

Ocoee, Florida, United States

Omega Research Consultants

Orlando, Florida, United States

Millennium Research

Ormond Beach, Florida, United States

North Georgia Rheumatology, PC

Lawrenceville, Georgia, United States

Atlanta Research Center for Rheumatology

Marietta, Georgia, United States

West County Rheumatology

St Louis, Missouri, United States

DJL Clinical Research, PLLC

Charlotte, North Carolina, United States

Paramount Medical Research & Consulting

Middleburg Heights, Ohio, United States

Dr. Ramesh Gupta

Memphis, Tennessee, United States

Arthritis and Rheumatology Research Institute

Allen, Texas, United States

Precision Comprehensive Clinical Research Solutions

Colleyville, Texas, United States

Southwest Rheumatology Research LLC

Mesquite, Texas, United States

Epic Medical Research

Red Oak, Texas, United States

Rheumatology and Pulmonary Clinic

Beckley, West Virginia, United States

Centro Médico Reumatológico (OMI)

Buenos Aires, , Argentina

Centro Privado de Medicina Familiar

Buenos Aires, , Argentina

ARCIS Salud SRL Aprillus asistencia e investigacion

CABA, , Argentina

Clinica Adventista Belgrano

Ciudad de Buenos Aires, , Argentina

Hospital Italiano La Plata

La Plata, , Argentina

Centro de Investigaciones Medicas Mar Del Plata

Mar del Plata, , Argentina

Instituto de Reumatologia - Ir Medical Center S.A.

Mendoza, , Argentina

Centro de Investigaciones Medicas Tucuman

San Miguel de Tucumán, , Argentina

Multiprofile Hospital for Active Treatment Plovdiv

Plovdiv, , Bulgaria

Diagnostic-Consultative Center (DCC) Aleksandrovska

Sofia, , Bulgaria

UMHAT St. Ivan Rilski

Sofia, , Bulgaria

Clinica de la Costa SAS

Barranquilla, , Colombia

Centro de Investigacion Medico Asistencial SAS - CIMEDICAL SAS

Barranquilla, , Colombia

Centro de Investigación en Reumatología y especialidades médicas S.A.S. - CIREEM S.A.S.

Bogotá, , Colombia

Servimed S A S

Bucaramanga, , Colombia

IPS Preventive Care SAS

Chía, , Colombia

Praxis Dr. med. Beate Schwarz - Germany

Langenau, , Germany

Universitaetsklinikum Leipzig

Leipzig, , Germany

Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz

Budapest, , Hungary

Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz

Gyula, , Hungary

Belvarosi Egeszseghaz Kft. (Leda-Platan Maganklinika es Sebeszeti Kozpont)

Zalaegerszeg, , Hungary

National Hospital Organization Chiba East Hospital

Chiba, , Japan

National Hospital Organization Kyushu Medical Center

Fukuoka, , Japan

National Center for Global Health and Medicine Kohnodai hospital

Ichikawa, , Japan

St Marianna University Hospital

Kanagawa, , Japan

National Hospital Organization Osaka Minami Medical Center

Kawachi-Nagano, , Japan

National Hospital Organization Nagoya Medical Center

Nagoya, , Japan

Osaka Metropolitan University Hospital

Osaka, , Japan

Tohoku University Hospital

Sendai, , Japan

Osaka Medical and Pharmaceutical University Hospital

Takatsuki, , Japan

St. Luke's International Hospital

Tokyo, , Japan

Fujita Health University Hospital

Toyoake, , Japan

University of Tsukuba Hospital

Tsukuba, , Japan

Szpital Uniwersytecki Nr 2 w Bydgoszczy

Bydgoszcz, , Poland

Nzoz Bif Med

Bytom, , Poland

Malopolskie Badania Kliniczne Sp z o o

Krakow, , Poland

Centrum Medyczne Plejady

Krakow, , Poland

NZOZ Lecznica MAK MED S C

Nadarzyn, , Poland

Twoja Przychodnia Poznanskie Centrum Medyczne

Poznan, , Poland

AI Centrum Medyczne

Poznan, , Poland

Prywatna Praktyka Lekarska Prof Um Dr Hab Med Pawel Hrycaj

Poznan, , Poland

Uniwersytecki Szpital Kliniczny w Rzeszowie

Rzeszów, , Poland

MICS Centrum Medyczne Warszawa

Warsaw, , Poland

Panorama Medical Centre

Cape Town, , South Africa

Excellentis Clinical trial Consultants

George, , South Africa

Winelands Rheumatology Centre

Stellenbosch, , South Africa

Hosp Univ Vall D Hebron

Barcelona, , Spain

Hosp. Univ. Ramon Y Cajal

Madrid, , Spain

Hosp. de Navarra

Pamplona, , Spain

Corporacio Sanitari Parc Tauli

Sabadell, , Spain

Hospital Clinico Universitario Lozano Blesa

Zaragoza, , Spain

Kaohsiung Veterans General Hospital

Kaohsiung City, , Taiwan

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

China Medical University Hospital

Taichung, , Taiwan

Taipei Medical University

Taipei, , Taiwan

Municipal Non-Profit Enterprise 'Chernihiv Regional Hospital' of Chernihiv Regional Council

Chernihiv, , Ukraine

Municipal Non-Profit Enterprise of Kharkiv Regional Council 'Regional Clinical Hospital'

Kharkiv, , Ukraine

Medical Center 'Ok Clinic' of International Institute of Clinical Research LLC

Kyiv, , Ukraine

Medbud-Clinic LLC

Kyiv, , Ukraine

Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'

Kyiv, , Ukraine

Medical Center 'Consylium Medical'

Kyiv, , Ukraine

Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council

Odesa, , Ukraine

ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil

Poltava, , Ukraine

MNPE 'Vinnytsia Regional Clinical Hospital named after M.I. Pyrogov of Vinnytsia Regional Council'

Vinnytsia, , Ukraine

Medical Center LLC 'Modern Clinic'

Zaporizhzhya, , Ukraine

Countries

United States; Argentina; Bulgaria; Colombia; Germany; Hungary; Japan; Poland; South Africa; Spain; Taiwan; Ukraine

Other Identifiers

80202135SLE2001

Identifier Type: OTHER

Identifier Source: secondary_id

2020-005569-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR109011

Identifier Type: -

Identifier Source: org_study_id