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Systemic Lupus ErythematosusPhase 2NCT04882878

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

A Phase 2 study testing Nipocalimab and Standard-of-care treatment in people with Systemic Lupus Erythematosus, run by Janssen Research & Development, LLC at 86 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
Nipocalimab and Standard-of-care treatment
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
228 participants
Where
86 sitesin 12 countries
Study dates
20 Aug 2021to 26 Dec 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

86 sites in 12 countries.

86 sites in 12 countries

United States21 sites

  • Arthritis and Rheumatology Research Institute

    Allen, Texas, 75013

  • Rheumatology and Pulmonary Clinic

    Beckley, West Virginia, 25801

  • Bay Area Arthritis and Osteoporosis

    Brandon, Florida, 33511

  • DJL Clinical Research, PLLC

    Charlotte, North Carolina, 28210

  • Precision Comprehensive Clinical Research Solutions

    Colleyville, Texas, 76034

  • GNP Research

    Cooper City, Florida, 33024

  • North Georgia Rheumatology, PC

    Lawrenceville, Georgia, 30046

  • Valerius Medical Group & Research Center

    Los Alamitos, California, 90720

  • Atlanta Research Center for Rheumatology

    Marietta, Georgia, 30060

  • Dr. Ramesh Gupta

    Memphis, Tennessee, 38119

  • Southwest Rheumatology Research LLC

    Mesquite, Texas, 75150

  • South Coast Research Center

    Miami, Florida, 33136

  • Paramount Medical Research & Consulting

    Middleburg Heights, Ohio, 44130

  • Advanced Clinical Research of Orlando

    Ocoee, Florida, 34761

  • Omega Research Consultants

    Orlando, Florida, 32808

  • Millennium Research

    Ormond Beach, Florida, 32174

  • Desert Medical Advances

    Rancho Mirage, California, 92270

  • Epic Medical Research

    Red Oak, Texas, 75154

  • Wolverine Clinical Trials

    Santa Ana, California, 92705

  • West County Rheumatology

    St Louis, Missouri, 63131

  • Millennium Clinical Trials LLC

    Westlake Village, California, 91361

Other trials in United States

Japan12 sites

  • National Hospital Organization Chiba East Hospital

    Chiba, 260-8712

  • National Hospital Organization Kyushu Medical Center

    Fukuoka, 810 8563

  • National Center for Global Health and Medicine Kohnodai hospital

    Ichikawa, 272 8516

  • St Marianna University Hospital

    Kanagawa, 216 8511

  • National Hospital Organization Osaka Minami Medical Center

    Kawachi-Nagano, 586 8521

  • National Hospital Organization Nagoya Medical Center

    Nagoya, 460-0001

  • Osaka Metropolitan University Hospital

    Osaka, 545 8586

  • Tohoku University Hospital

    Sendai, 980 8574

  • Osaka Medical and Pharmaceutical University Hospital

    Takatsuki, 569-8686

  • St. Luke's International Hospital

    Tokyo, 104 8560

  • Fujita Health University Hospital

    Toyoake, 470-1192

  • University of Tsukuba Hospital

    Tsukuba, 305 8576

Other trials in Japan

Poland10 sites

  • Szpital Uniwersytecki Nr 2 w Bydgoszczy

    Bydgoszcz, 85 168

  • Nzoz Bif Med

    Bytom, 41 902

  • Malopolskie Badania Kliniczne Sp z o o

    Krakow, 30-002

  • Centrum Medyczne Plejady

    Krakow, 30363

  • NZOZ Lecznica MAK MED S C

    Nadarzyn, 05-830

  • Twoja Przychodnia Poznanskie Centrum Medyczne

    Poznan, 60-324

  • AI Centrum Medyczne

    Poznan, 61 113

  • Prywatna Praktyka Lekarska Prof Um Dr Hab Med Pawel Hrycaj

    Poznan, 61 397

  • Uniwersytecki Szpital Kliniczny w Rzeszowie

    Rzeszów, 35-055

  • MICS Centrum Medyczne Warszawa

    Warsaw, 00-874

Other trials in Poland

Ukraine10 sites

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

    Chernihiv, 14029

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

    Kharkiv, 61204

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

    Kyiv, 02091

  • Medbud-Clinic LLC

    Kyiv, 03037

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

    Kyiv, 03049

  • Medical Center 'Consylium Medical'

    Kyiv, 04050

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

    Odesa, 65025

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

    Poltava, 36011

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

    Vinnytsia, 21018

  • Medical Center LLC 'Modern Clinic'

    Zaporizhzhya, 69600

Other trials in Ukraine

Argentina8 sites

  • Centro Médico Reumatológico (OMI)

    Buenos Aires, C1015ABO

  • Centro Privado de Medicina Familiar

    Buenos Aires, C1417EYG

  • ARCIS Salud SRL Aprillus asistencia e investigacion

    CABA, C1406AGA

  • Clinica Adventista Belgrano

    Ciudad de Buenos Aires, C1430EGF

  • Hospital Italiano La Plata

    La Plata, B1900

  • Centro de Investigaciones Medicas Mar Del Plata

    Mar del Plata, B7600

  • Instituto de Reumatologia - Ir Medical Center S.A.

    Mendoza, 5000

  • Centro de Investigaciones Medicas Tucuman

    San Miguel de Tucumán, T4000AXL

Other trials in Argentina

Colombia5 sites

  • Clinica de la Costa SAS

    Barranquilla, 080001

  • Centro de Investigacion Medico Asistencial SAS - CIMEDICAL SAS

    Barranquilla, 080020

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

    Bogotá, 110221

  • Servimed S A S

    Bucaramanga

  • IPS Preventive Care SAS

    Chía

Other trials in Colombia

Spain5 sites

  • Hosp Univ Vall D Hebron

    Barcelona, 08035

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034

  • Hosp. de Navarra

    Pamplona, 31008

  • Corporacio Sanitari Parc Tauli

    Sabadell, 08208

  • Hospital Clinico Universitario Lozano Blesa

    Zaragoza, 50009

Other trials in Spain

Taiwan4 sites

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 81362

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 88301

  • China Medical University Hospital

    Taichung, 40447

  • Taipei Medical University

    Taipei, 11031

Other trials in Taiwan

Bulgaria3 sites

  • Multiprofile Hospital for Active Treatment Plovdiv

    Plovdiv, 4000

  • Diagnostic-Consultative Center (DCC) Aleksandrovska

    Sofia, 1431

  • UMHAT St. Ivan Rilski

    Sofia, 1612

Other trials in Bulgaria

Hungary3 sites

  • Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz

    Budapest, 1023

  • Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz

    Gyula, 5700

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

    Zalaegerszeg, H-8900

Other trials in Hungary

South Africa3 sites

  • Panorama Medical Centre

    Cape Town, 7500

  • Excellentis Clinical trial Consultants

    George, 6529

  • Winelands Rheumatology Centre

    Stellenbosch, 7600

Other trials in South Africa

Germany2 sites

  • Praxis Dr. med. Beate Schwarz - Germany

    Langenau, 89129

  • Universitaetsklinikum Leipzig

    Leipzig, 04103

Other trials in Germany

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Nipocalimab in Adult Participants With Active Systemic Lupus Erythematosus

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

Read the 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.

Being tested
Placebo, Nipocalimab, Standard-of-care treatment
Keywords
Lupus, SLE, Nipocalimab, Lupus SLE
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboOther

    Placebo will be administered intravenously.

  • NipocalimabDrug

    Also called JNJ-80202135, M281

    Nipocalimab dose 1 and dose 2 will be administered intravenously.

  • Standard-of-care treatmentDrug

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

Study groups in NCT04882878
Study groupRoleWhat they receive
Group 1: PlaceboPlacebo comparatorParticipants 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]).
Receives: Other: Placebo; Drug: Standard-of-care treatment
Group 2: Nipocalimab Dose 1ExperimentalParticipants will receive nipocalimab dose 1 intravenously (IV) q2w through Week 50 along with standard-of-care treatments (that is, immunomodulators, antimalarial drugs and GCs).
Receives: Drug: Nipocalimab; Drug: Standard-of-care treatment
Group 3: Nipocalimab Dose 2ExperimentalParticipants will receive nipocalimab dose 2 intravenously (IV) q2w through Week 50 along with standard-of-care treatments (that is, immunomodulators, antimalarial drugs and GCs).
Receives: Drug: Nipocalimab; Drug: Standard-of-care treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 24

Secondary outcomes (15)

  1. 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

    Percentage of participants achieving at least 50% improvement in CLASI Activity Score at Week 24 will be reported in participants with a CLASI Activity Score of 6 or greater at baseline. Cutaneous lupus disease activity and severity will be measured by the CLASI. The CLASI is an instrument to assess the disease activity and damage caused to the skin for cutaneous lupus erythematosus participants with or without systemic involvement. The CLASI consists of 2 scores; the first summarizes the activity of the disease while the second is a measure of the damage caused by the disease.

    Measured: Week 24

  2. Percentage of Participants with Baseline Arthritis (with at Least 4 Active Joints at Baseline) Achieving >= 50% Reduction in Active Joints at 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 will be reported.

    Measured: Week 24

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

    Percentage of participants achieving at least 4 point improvement in SLEDAI-2K will be reported. The SLEDAI-2K is an established, validated SLE activity index. It is based on the presence of 24 features in 9 organ systems and measures disease activity in SLE participants at the time of the visit or in the previous 30 days; the index is weighted according to the feature. Features are scored by the assessing physician if present at the time of the visit or within the last 30 days, with more severe features having higher scores, and then simply added to determine the total SLEDAI-2K score, which ranges from 0 to 105, with higher scores representing increased disease activity.

    Measured: Week 24

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

    Percentage of participants achieving BICLA Response (BILAG-2004 disease activity improvement without worsening, and without worsening of SLEDAI-2K or PGA compared to baseline) at Week 24 will be reported.

    Measured: Week 24

  5. Time to First Flare Through Week 24

    Time to first flare through Week 24, with flare defined as either 1 or more new BILAG A or 2 or more new BILAG B scores will be reported.

    Measured: Up to Week 24

  6. Percentage of Participants Achieving SRI-4 Composite Response at Week 52

    Percentage of participants achieving SRI-4 composite response at Week 52 will be reported.

    Measured: Week 52

  7. Percentage of Participants Receiving >= 10 milligram/day (mg/day) Prednisone or Equivalent at Baseline who Achieve Week 6-16 Glucocorticoid (GC) Taper Goal (at Week 16 to <= 7.5 mg/day Prednisone or Equivalent) and Maintain that Reduction Until Week 24

    Percentage of participants receiving >= 10 mg/day prednisone or equivalent at baseline who achieve Week 6-16 GC taper goal (at Week 16 to <= 7.5 mg/day prednisone or equivalent) and maintain that reduction until Week 24 will be reported.

    Measured: Up to Week 24

  8. Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) Through Week 58

    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.

    Measured: Up to Week 58

  9. Percentage of Participants with Treatment-emergent Serious Adverse Events (SAEs) Through Week 58

    SAE 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. Treatment-emergent SAEs are defined as SAEs with onset or worsening on or after date of first dose of study treatment.

    Measured: Up to Week 58

  10. Percentage of Participants with Treatment-emergent Adverse Events of Special interests (AESIs) Through Week 58

    Percentage of participants with treatment-emergent AESIs will be reported. Treatment-emergent adverse events associated with the following situations are considered as AESIs: infections that are severe or require intravenous anti-infective or operative/invasive intervention, hypoalbuminemia with albumin less than (<) 20 gram/liter (g/L) (<2.0 gram/deciliter [g/dL]).

    Measured: Up to Week 58

  11. Percentage of Participants with Treatment-emergent AEs leading to treatment discontinuation Through Week 58

    Percentage of participants with treatment-emergent AEs leading to discontinuation of study intervention will be reported.

    Measured: Up to Week 58

  12. Number of Participants with Change from Baseline in Laboratory Parameters Over Time

    Number of participants with change from baseline in laboratory parameters (hematology, chemistry, urinalysis and lipid profile) over time will be reported.

    Measured: Up to Week 58

  13. Number of Participants with Change from Baseline in Vital Signs Parameters Over Time

    Number of participants with change from baseline in vital sign parameters (temperature, pulse/heart rate, respiratory rate, and blood pressure) will be reported.

    Measured: Up to Week 58

  14. Serum Concentration of Nipocalimab Over Time

    Serum concentrations of nipocalimab over time in participants receiving active study intervention will be reported.

    Measured: Up to Week 58

  15. 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.

    Measured: Up to Week 58

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2021
  2. Study start20 Aug 2021
  3. Primary completion30 Apr 2024
  4. Study completion26 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
228 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04882878
Sponsor's protocol ID
CR109011
Other IDs
80202135SLE2001, 2020-005569-14
Status last verified
Dec 2025
First submitted
7 May 2021
Last updated
8 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nipocalimab and Standard-of-care treatment in people with Systemic Lupus Erythematosus, run by Janssen Research & Development, LLC at 86 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in United States, Japan, Poland, Ukraine, Argentina and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving an Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4 Composite Response at Week 24 (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04882878.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.

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