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

NCT04882878 | Completed Phase 2 DMC FDA Drug

• 3 other identifiers: CR10901180202135SLE20012020-005569-14
• Study Type: interventional
• Target: 228
• Locations: 12 countries
• Sites: 86

Brief Summary

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

Conditions

Systemic Lupus Erythematosus

Keywords

Lupus; SLE; Nipocalimab; Lupus SLE

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving an Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4 Composite Response at Week 24

  SLE SRI-4 composite response is a composite of at least 4-point improvement in SLE Disease Activity Index 2000(SLEDAI-2K), no worsening in British Isles Lupus Assessment Group (BILAG), no worsening in Physician's Global Assessment of Disease Activity score (PGA) and not meeting study treatment failure criteria.

  Week 24

Secondary Outcomes (15)

• Percentage of Participants with Baseline Active Mucocutaneous Lupus Manifestations (Cutaneous Lupus Erythematosus Disease Area and Severity Index [CLASI] Activity Score >= 6) Achieving >= 50 Percent (%) Reduction in the CLASI Activity Score at Week 24

  Week 24

• Percentage of Participants with Baseline Arthritis (with at Least 4 Active Joints at Baseline) Achieving >= 50% Reduction in Active Joints at Week 24

  Week 24

• Percentage of Participants with >= 4 Point Improvement in SLE Disease Activity Index 2000 (SLEDAI-2K) at Week 24

  Week 24

• Percentage of Participants Achieving the British Isles Lupus Assessment Group (BILAG) Composite Lupus Assessment (BICLA) Response at Week 24

  Week 24

• Time to First Flare Through Week 24

  Up to Week 24

Study Arms (3)

Group 1: Placebo

PLACEBO COMPARATOR

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 \[GCs\]).

Other: Placebo; Drug: Standard-of-care treatment

Group 2: Nipocalimab Dose 1

EXPERIMENTAL

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).

Drug: Nipocalimab; Drug: Standard-of-care treatment

Group 3: Nipocalimab Dose 2

EXPERIMENTAL

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).

Drug: Nipocalimab; Drug: Standard-of-care treatment

Interventions

Placebo OTHER

Placebo will be administered intravenously.

Group 1: Placebo

Nipocalimab DRUG

Nipocalimab dose 1 and dose 2 will be administered intravenously.

Also known as: JNJ-80202135, M281

Group 2: Nipocalimab Dose 1; Group 3: Nipocalimab Dose 2

Standard-of-care treatment DRUG

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

Group 1: Placebo; Group 2: Nipocalimab Dose 1; Group 3: Nipocalimab Dose 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (86)

Valerius Medical Group & Research Center

Los Alamitos, California, 90720, United States

Location

Desert Medical Advances

Rancho Mirage, California, 92270, United States

Location

Wolverine Clinical Trials

Santa Ana, California, 92705, United States

Location

Millennium Clinical Trials LLC

Westlake Village, California, 91361, United States

Location

Bay Area Arthritis and Osteoporosis

Brandon, Florida, 33511, United States

Location

GNP Research

Cooper City, Florida, 33024, United States

Location

South Coast Research Center

Miami, Florida, 33136, United States

Location

Advanced Clinical Research of Orlando

Ocoee, Florida, 34761, United States

Location

Omega Research Consultants

Orlando, Florida, 32808, United States

Location

Millennium Research

Ormond Beach, Florida, 32174, United States

Location

North Georgia Rheumatology, PC

Lawrenceville, Georgia, 30046, United States

Location

Atlanta Research Center for Rheumatology

Marietta, Georgia, 30060, United States

Location

West County Rheumatology

St Louis, Missouri, 63131, United States

Location

DJL Clinical Research, PLLC

Charlotte, North Carolina, 28210, United States

Location

Paramount Medical Research & Consulting

Middleburg Heights, Ohio, 44130, United States

Location

Dr. Ramesh Gupta

Memphis, Tennessee, 38119, United States

Location

Arthritis and Rheumatology Research Institute

Allen, Texas, 75013, United States

Location

Precision Comprehensive Clinical Research Solutions

Colleyville, Texas, 76034, United States

Location

Southwest Rheumatology Research LLC

Mesquite, Texas, 75150, United States

Location

Epic Medical Research

Red Oak, Texas, 75154, United States

Location

Rheumatology and Pulmonary Clinic

Beckley, West Virginia, 25801, United States

Location

Centro Médico Reumatológico (OMI)

Buenos Aires, C1015ABO, Argentina

Location

Centro Privado de Medicina Familiar

Buenos Aires, C1417EYG, Argentina

Location

ARCIS Salud SRL Aprillus asistencia e investigacion

CABA, C1406AGA, Argentina

Location

Clinica Adventista Belgrano

Ciudad de Buenos Aires, C1430EGF, Argentina

Location

Hospital Italiano La Plata

La Plata, B1900, Argentina

Location

Centro de Investigaciones Medicas Mar Del Plata

Mar del Plata, B7600, Argentina

Location

Instituto de Reumatologia - Ir Medical Center S.A.

Mendoza, 5000, Argentina

Location

Centro de Investigaciones Medicas Tucuman

San Miguel de Tucumán, T4000AXL, Argentina

Location

Multiprofile Hospital for Active Treatment Plovdiv

Plovdiv, 4000, Bulgaria

Location

Diagnostic-Consultative Center (DCC) Aleksandrovska

Sofia, 1431, Bulgaria

Location

UMHAT St. Ivan Rilski

Sofia, 1612, Bulgaria

Location

Clinica de la Costa SAS

Barranquilla, 080001, Colombia

Location

Centro de Investigacion Medico Asistencial SAS - CIMEDICAL SAS

Barranquilla, 080020, Colombia

Location

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

Bogotá, 110221, Colombia

Location

Servimed S A S

Bucaramanga, Colombia

Location

IPS Preventive Care SAS

Chía, Colombia

Location

Praxis Dr. med. Beate Schwarz - Germany

Langenau, 89129, Germany

Location

Universitaetsklinikum Leipzig

Leipzig, 04103, Germany

Location

Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz

Budapest, 1023, Hungary

Location

Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz

Gyula, 5700, Hungary

Location

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

Zalaegerszeg, H-8900, Hungary

Location

National Hospital Organization Chiba East Hospital

Chiba, 260-8712, Japan

Location

National Hospital Organization Kyushu Medical Center

Fukuoka, 810 8563, Japan

Location

National Center for Global Health and Medicine Kohnodai hospital

Ichikawa, 272 8516, Japan

Location

St Marianna University Hospital

Kanagawa, 216 8511, Japan

Location

National Hospital Organization Osaka Minami Medical Center

Kawachi-Nagano, 586 8521, Japan

Location

National Hospital Organization Nagoya Medical Center

Nagoya, 460-0001, Japan

Location

Osaka Metropolitan University Hospital

Osaka, 545 8586, Japan

Location

Tohoku University Hospital

Sendai, 980 8574, Japan

Location

Osaka Medical and Pharmaceutical University Hospital

Takatsuki, 569-8686, Japan

Location

St. Luke's International Hospital

Tokyo, 104 8560, Japan

Location

Fujita Health University Hospital

Toyoake, 470-1192, Japan

Location

University of Tsukuba Hospital

Tsukuba, 305 8576, Japan

Location

Szpital Uniwersytecki Nr 2 w Bydgoszczy

Bydgoszcz, 85 168, Poland

Location

Nzoz Bif Med

Bytom, 41 902, Poland

Location

Malopolskie Badania Kliniczne Sp z o o

Krakow, 30-002, Poland

Location

Centrum Medyczne Plejady

Krakow, 30363, Poland

Location

NZOZ Lecznica MAK MED S C

Nadarzyn, 05-830, Poland

Location

Twoja Przychodnia Poznanskie Centrum Medyczne

Poznan, 60-324, Poland

Location

AI Centrum Medyczne

Poznan, 61 113, Poland

Location

Prywatna Praktyka Lekarska Prof Um Dr Hab Med Pawel Hrycaj

Poznan, 61 397, Poland

Location

Uniwersytecki Szpital Kliniczny w Rzeszowie

Rzeszów, 35-055, Poland

Location

MICS Centrum Medyczne Warszawa

Warsaw, 00-874, Poland

Location

Panorama Medical Centre

Cape Town, 7500, South Africa

Location

Excellentis Clinical trial Consultants

George, 6529, South Africa

Location

Winelands Rheumatology Centre

Stellenbosch, 7600, South Africa

Location

Hosp Univ Vall D Hebron

Barcelona, 08035, Spain

Location

Hosp. Univ. Ramon Y Cajal

Madrid, 28034, Spain

Location

Hosp. de Navarra

Pamplona, 31008, Spain

Location

Corporacio Sanitari Parc Tauli

Sabadell, 08208, Spain

Location

Hospital Clinico Universitario Lozano Blesa

Zaragoza, 50009, Spain

Location

Kaohsiung Veterans General Hospital

Kaohsiung City, 81362, Taiwan

Location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 88301, Taiwan

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

Taipei Medical University

Taipei, 11031, Taiwan

Location

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

Chernihiv, 14029, Ukraine

Location

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

Kharkiv, 61204, Ukraine

Location

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

Kyiv, 02091, Ukraine

Location

Medbud-Clinic LLC

Kyiv, 03037, Ukraine

Location

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

Kyiv, 03049, Ukraine

Location

Medical Center 'Consylium Medical'

Kyiv, 04050, Ukraine

Location

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

Odesa, 65025, Ukraine

Location

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

Poltava, 36011, Ukraine

Location

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

Vinnytsia, 21018, Ukraine

Location

Medical Center LLC 'Modern Clinic'

Zaporizhzhya, 69600, Ukraine

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 12, 2021
• Study Start: August 20, 2021
• Primary Completion: April 30, 2024
• Study Completion: December 26, 2024
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

DE (2); CO (5); PL (10); ZA (3); US (21); UA (10); JP (12); ES (5); BU (3); TW (4); AR (8); HU (3)