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New drug nipocalimab aims to tame lupus flares

NCT ID NCT04882878

Disease control Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 2 trial tested nipocalimab, an intravenous drug, in 228 adults with active systemic lupus erythematosus (SLE). Participants received either nipocalimab or a placebo, alongside standard treatments. The main goal was to see if nipocalimab could reduce lupus disease activity after 24 weeks, measured by a composite index (SRI-4). The study also looked at improvements in skin symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nipocalimab (a monoclonal antibody given intravenously)
What this could lead to
If successful, nipocalimab could offer a new treatment option to help control lupus activity and reduce flares in people with active disease.
What could go wrong
This is a Phase 2 trial with a moderate number of participants. The drug may not prove effective in larger studies, and side effects are still being evaluated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

228 people

The number who actually took part.

Started

Aug 2021

Finished

Dec 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Systemic lupus erythematosus

Contacts and locations

Locations

  • AI Centrum Medyczne

    Poznan, 61 113, Poland

  • ARCIS Salud SRL Aprillus asistencia e investigacion

    CABA, C1406AGA, Argentina

  • Advanced Clinical Research of Orlando

    Ocoee, Florida, 34761, United States

  • Arthritis and Rheumatology Research Institute

    Allen, Texas, 75013, United States

  • Atlanta Research Center for Rheumatology

    Marietta, Georgia, 30060, United States

  • Bay Area Arthritis and Osteoporosis

    Brandon, Florida, 33511, United States

  • Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz

    Gyula, 5700, Hungary

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

    Zalaegerszeg, H-8900, Hungary

  • Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz

    Budapest, 1023, Hungary

  • Centro Médico Reumatológico (OMI)

    Buenos Aires, C1015ABO, Argentina

  • Centro Privado de Medicina Familiar

    Buenos Aires, C1417EYG, Argentina

  • Centro de Investigacion Medico Asistencial SAS - CIMEDICAL SAS

    Barranquilla, 080020, Colombia

  • Centro de Investigaciones Medicas Mar Del Plata

    Mar del Plata, B7600, Argentina

  • Centro de Investigaciones Medicas Tucuman

    San Miguel de Tucumán, T4000AXL, Argentina

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

    Bogotá, 110221, Colombia

  • Centrum Medyczne Plejady

    Krakow, 30363, Poland

  • China Medical University Hospital

    Taichung, 40447, Taiwan

  • Clinica Adventista Belgrano

    Ciudad de Buenos Aires, C1430EGF, Argentina

  • Clinica de la Costa SAS

    Barranquilla, 080001, Colombia

  • Corporacio Sanitari Parc Tauli

    Sabadell, 08208, Spain

  • DJL Clinical Research, PLLC

    Charlotte, North Carolina, 28210, United States

  • Desert Medical Advances

    Rancho Mirage, California, 92270, United States

  • Diagnostic-Consultative Center (DCC) Aleksandrovska

    Sofia, 1431, Bulgaria

  • Dr. Ramesh Gupta

    Memphis, Tennessee, 38119, United States

  • Epic Medical Research

    Red Oak, Texas, 75154, United States

  • Excellentis Clinical trial Consultants

    George, 6529, South Africa

  • Fujita Health University Hospital

    Toyoake, 470-1192, Japan

  • GNP Research

    Cooper City, Florida, 33024, United States

  • Hosp Univ Vall D Hebron

    Barcelona, 08035, Spain

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034, Spain

  • Hosp. de Navarra

    Pamplona, 31008, Spain

  • Hospital Clinico Universitario Lozano Blesa

    Zaragoza, 50009, Spain

  • Hospital Italiano La Plata

    La Plata, B1900, Argentina

  • IPS Preventive Care SAS

    Chía, Colombia

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

    Mendoza, 5000, Argentina

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 88301, Taiwan

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 81362, Taiwan

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

    Kyiv, 03049, Ukraine

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

    Poltava, 36011, Ukraine

  • MICS Centrum Medyczne Warszawa

    Warsaw, 00-874, Poland

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

    Vinnytsia, 21018, Ukraine

  • Malopolskie Badania Kliniczne Sp z o o

    Krakow, 30-002, Poland

  • Medbud-Clinic LLC

    Kyiv, 03037, Ukraine

  • Medical Center 'Consylium Medical'

    Kyiv, 04050, Ukraine

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

    Kyiv, 02091, Ukraine

  • Medical Center LLC 'Modern Clinic'

    Zaporizhzhya, 69600, Ukraine

  • Millennium Clinical Trials LLC

    Westlake Village, California, 91361, United States

  • Millennium Research

    Ormond Beach, Florida, 32174, United States

  • Multiprofile Hospital for Active Treatment Plovdiv

    Plovdiv, 4000, Bulgaria

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

    Chernihiv, 14029, Ukraine

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

    Kharkiv, 61204, Ukraine

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

    Odesa, 65025, Ukraine

  • NZOZ Lecznica MAK MED S C

    Nadarzyn, 05-830, Poland

  • National Center for Global Health and Medicine Kohnodai hospital

    Ichikawa, 272 8516, Japan

  • National Hospital Organization Chiba East Hospital

    Chiba, 260-8712, Japan

  • National Hospital Organization Kyushu Medical Center

    Fukuoka, 810 8563, Japan

  • National Hospital Organization Nagoya Medical Center

    Nagoya, 460-0001, Japan

  • National Hospital Organization Osaka Minami Medical Center

    Kawachi-Nagano, 586 8521, Japan

  • North Georgia Rheumatology, PC

    Lawrenceville, Georgia, 30046, United States

  • Nzoz Bif Med

    Bytom, 41 902, Poland

  • Omega Research Consultants

    Orlando, Florida, 32808, United States

  • Osaka Medical and Pharmaceutical University Hospital

    Takatsuki, 569-8686, Japan

  • Osaka Metropolitan University Hospital

    Osaka, 545 8586, Japan

  • Panorama Medical Centre

    Cape Town, 7500, South Africa

  • Paramount Medical Research & Consulting

    Middleburg Heights, Ohio, 44130, United States

  • Praxis Dr. med. Beate Schwarz - Germany

    Langenau, 89129, Germany

  • Precision Comprehensive Clinical Research Solutions

    Colleyville, Texas, 76034, United States

  • Prywatna Praktyka Lekarska Prof Um Dr Hab Med Pawel Hrycaj

    Poznan, 61 397, Poland

  • Rheumatology and Pulmonary Clinic

    Beckley, West Virginia, 25801, United States

  • Servimed S A S

    Bucaramanga, Colombia

  • South Coast Research Center

    Miami, Florida, 33136, United States

  • Southwest Rheumatology Research LLC

    Mesquite, Texas, 75150, United States

  • St Marianna University Hospital

    Kanagawa, 216 8511, Japan

  • St. Luke's International Hospital

    Tokyo, 104 8560, Japan

  • Szpital Uniwersytecki Nr 2 w Bydgoszczy

    Bydgoszcz, 85 168, Poland

  • Taipei Medical University

    Taipei, 11031, Taiwan

  • Tohoku University Hospital

    Sendai, 980 8574, Japan

  • Twoja Przychodnia Poznanskie Centrum Medyczne

    Poznan, 60-324, Poland

  • UMHAT St. Ivan Rilski

    Sofia, 1612, Bulgaria

  • Universitaetsklinikum Leipzig

    Leipzig, 04103, Germany

  • University of Tsukuba Hospital

    Tsukuba, 305 8576, Japan

  • Uniwersytecki Szpital Kliniczny w Rzeszowie

    Rzeszów, 35-055, Poland

  • Valerius Medical Group & Research Center

    Los Alamitos, California, 90720, United States

  • West County Rheumatology

    St Louis, Missouri, 63131, United States

  • Winelands Rheumatology Centre

    Stellenbosch, 7600, South Africa

  • Wolverine Clinical Trials

    Santa Ana, California, 92705, United States

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