New drug nipocalimab aims to tame lupus flares

NCT ID NCT04882878

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

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.

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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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