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

PHASE2CompletedINTERVENTIONAL
Enrollment

228

Participants

Timeline

Start Date

August 20, 2021

Primary Completion Date

April 30, 2024

Study Completion Date

December 26, 2024

Conditions
Systemic Lupus Erythematosus
Interventions
OTHER

Placebo

Placebo will be administered intravenously.

DRUG

Nipocalimab

Nipocalimab dose 1 and dose 2 will be administered intravenously.

DRUG

Standard-of-care treatment

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

Trial Locations (86)

1023

Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz, Budapest

1431

Diagnostic-Consultative Center (DCC) Aleksandrovska, Sofia

1612

UMHAT St. Ivan Rilski, Sofia

4000

Multiprofile Hospital for Active Treatment Plovdiv, Plovdiv

5000

Instituto de Reumatologia - Ir Medical Center S.A., Mendoza

5700

Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz, Gyula

6529

Excellentis Clinical trial Consultants, George

7500

Panorama Medical Centre, Cape Town

7600

Winelands Rheumatology Centre, Stellenbosch

11031

Taipei Medical University, Taipei

14029

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

21018

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

25801

Rheumatology and Pulmonary Clinic, Beckley

28034

Hosp. Univ. Ramon Y Cajal, Madrid

28210

DJL Clinical Research, PLLC, Charlotte

30046

North Georgia Rheumatology, PC, Lawrenceville

30060

Atlanta Research Center for Rheumatology, Marietta

30363

Centrum Medyczne Plejady, Krakow

31008

Hosp. de Navarra, Pamplona

32174

Millennium Research, Ormond Beach

32808

Omega Research Consultants, Orlando

33024

GNP Research, Cooper City

33136

South Coast Research Center, Miami

33511

Bay Area Arthritis and Osteoporosis, Brandon

34761

Advanced Clinical Research of Orlando, Ocoee

36011

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

38119

Dr. Ramesh Gupta, Memphis

40447

China Medical University Hospital, Taichung

44130

Paramount Medical Research & Consulting, Middleburg Heights

50009

Hospital Clinico Universitario Lozano Blesa, Zaragoza

61204

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

63131

West County Rheumatology, St Louis

65025

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

69600

Medical Center LLC 'Modern Clinic', Zaporizhzhya

75013

Arthritis and Rheumatology Research Institute, Allen

75150

Southwest Rheumatology Research LLC, Mesquite

75154

Epic Medical Research, Red Oak

76034

Precision Comprehensive Clinical Research Solutions, Colleyville

81362

Kaohsiung Veterans General Hospital, Kaohsiung City

88301

Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City

89129

Praxis Dr. med. Beate Schwarz - Germany, Langenau

90720

Valerius Medical Group & Research Center, Los Alamitos

91361

Millennium Clinical Trials LLC, Westlake Village

92270

Desert Medical Advances, Rancho Mirage

92705

Wolverine Clinical Trials, Santa Ana

110221

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

C1015ABO

Centro Médico Reumatológico (OMI), Buenos Aires

C1417EYG

Centro Privado de Medicina Familiar, Buenos Aires

C1406AGA

ARCIS Salud SRL Aprillus asistencia e investigacion, CABA

C1430EGF

Clinica Adventista Belgrano, Ciudad de Buenos Aires

B1900

Hospital Italiano La Plata, La Plata

B7600

Centro de Investigaciones Medicas Mar Del Plata, Mar del Plata

T4000AXL

Centro de Investigaciones Medicas Tucuman, San Miguel de Tucumán

080001

Clinica de la Costa SAS, Barranquilla

080020

Centro de Investigacion Medico Asistencial SAS - CIMEDICAL SAS, Barranquilla

Unknown

Servimed S A S, Bucaramanga

IPS Preventive Care SAS, Chía

04103

Universitaetsklinikum Leipzig, Leipzig

H-8900

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

260-8712

National Hospital Organization Chiba East Hospital, Chiba

810 8563

National Hospital Organization Kyushu Medical Center, Fukuoka

272 8516

National Center for Global Health and Medicine Kohnodai hospital, Ichikawa

216 8511

St Marianna University Hospital, Kanagawa

586 8521

National Hospital Organization Osaka Minami Medical Center, Kawachi-Nagano

460-0001

National Hospital Organization Nagoya Medical Center, Nagoya

545 8586

Osaka Metropolitan University Hospital, Osaka

980 8574

Tohoku University Hospital, Sendai

569-8686

Osaka Medical and Pharmaceutical University Hospital, Takatsuki

104 8560

St. Luke's International Hospital, Tokyo

470-1192

Fujita Health University Hospital, Toyoake

305 8576

University of Tsukuba Hospital, Tsukuba

85 168

Szpital Uniwersytecki Nr 2 w Bydgoszczy, Bydgoszcz

41 902

Nzoz Bif Med, Bytom

30-002

Malopolskie Badania Kliniczne Sp z o o, Krakow

05-830

NZOZ Lecznica MAK MED S C, Nadarzyn

60-324

Twoja Przychodnia Poznanskie Centrum Medyczne, Poznan

61 113

AI Centrum Medyczne, Poznan

61 397

Prywatna Praktyka Lekarska Prof Um Dr Hab Med Pawel Hrycaj, Poznan

35-055

Uniwersytecki Szpital Kliniczny w Rzeszowie, Rzeszów

00-874

MICS Centrum Medyczne Warszawa, Warsaw

08035

Hosp Univ Vall D Hebron, Barcelona

08208

Corporacio Sanitari Parc Tauli, Sabadell

02091

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

03037

Medbud-Clinic LLC, Kyiv

03049

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

04050

Medical Center 'Consylium Medical', Kyiv

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT04882878 - A Study of Nipocalimab in Adult Participants With Active Systemic Lupus Erythematosus | Biotech Hunter | Biotech Hunter