Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE)

PHASE2CompletedINTERVENTIONAL
Enrollment

244

Participants

Timeline

Start Date

February 19, 2020

Primary Completion Date

July 25, 2023

Study Completion Date

July 25, 2023

Conditions
Systemic Lupus Erythematosus (SLE)
Interventions
DRUG

Rozibafusp Alfa

Rozibafusp Alfa will be presented in 5 mL glass vial

DRUG

Placebo for Rozibafusp Alfa

Placebo for Rozibafusp Alfa will be presented in 5 mL glass vial

Trial Locations (147)

1407

Medical Center Excelsior OOD, Sofia

1612

Medical Center Academy EOOD, Sofia

University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD, Sofia

1642

Instituto Medico de Alta Complejidad San Isidro, San Isidro

1784

Medical Centre Synexus Sofia EOOD, Sofia

2010

Holdsworth House Medical Practice, Sydney

4000

Multiprofile Hospital for Active Treatment Trimontium OOD, Plovdiv

4002

University Multiprofile Hospital for Active Treatment - Kaspela EOOD, Plovdiv

University Multiprofile Hospital for Active Treatment Sveti Georgi EAD, Plovdiv

4032

Debreceni Egyetem Klinikai Kozpont, Debrecen

5011

The Queen Elizabeth Hospital, Woodville South

5400

CER San Juan - Centro Polivalente de Asistencia e Investigacion Clinica, San Juan

5700

Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz, Gyula

6003

Medical Centre Synexus Sofia EOOD - Branch Stara Zagora, Stara Zagora

8000

Vita Verum Medical Bt, Székesfehérvár

10016

New York University Langone Orthopedic Center, New York

10021

Hospital For Special Surgery, New York

10032

Columbia University Medical Center, New York

11030

Feinstein Institute for Medical Research, Manhasset

11527

Laiko General Hospital, Athens

12462

Attiko Hospital, Athens

13210

SUNY Upstate Medical University, Syracuse

14033

CHU Hôpital Côte de Nacre, Caen

15006

Complexo Hospitalario Universitario A Coruña, A Coruña

17033

Penn State Milton South Hershey Medical Center, Hershey

19104

University of Pennsylvania, Philadelphia

20089

IRCCS Istituto Clinico Humanitas, Rozzano MI

20132

IRCCS Ospedale San Raffaele, Milan

21079

Centre Hospitalier Universitaire Dijon Bourgogne - Hopital Francois Mitterrand, Dijon

21100

Centro Medico del Angel SC, Mexicali

21200

Centro de Investigacion en Artritis y Osteoporosis SC, Mexicalli

21201

University of Maryland School of Medicine Division of Rheumatology, Baltimore

26504

General University Hospital of Patras Panagia i Voithia, Pátrai

28204

Joint and Muscle Research Institute, Charlotte

28210

DJL Clinical Research PLLC, Charlotte

29425

Medical University of South Carolina, Charleston

29486

Articularis Healthcare Group Inc dba Low Country Rheumatology, Summerville

30318

Piedmont Atlanta Hospital, Atlanta

30322

The Emory Clinic, Atlanta

31059

Centre Hospitalier Universitaire de Toulouse - Hopital Purpan, Toulouse

Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil, Toulouse

32610

University of Florida, Gainesville

32819

Heuer Medical Doctor Research LLC, Orlando

33014

Lakes Research LLC, Miami Lakes

33076

Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin, Bordeaux

33309

Centre for Rheumatology Immunology and Arthritis, Fort Lauderdale

33609

Southwest Florida Clinical Research Center, Tampa

33613

AdventHealth Medical Group, Tampa

35294

University of Alabama at Birmingham, Birmingham

37000

Morales Vargas Centro de Investigacion SC, León

37232

Vanderbilt University Medical Center, Nashville

41010

Hospital Infanta Luisa, Seville

42601

Keimyung University Dongsan Hospital, Daegu

44160

Centro Integral en Reumatologia SA de CV, Guadalajara

51092

Centre Hospitalier Universitaire de Reims - Hopital Robert Debre, Reims

55543

Johannes Gutenberg Universitaet Mainz, Bad Kreuznach

56126

Azienda Ospedaliera Universitaria Pisana, Pisa

59037

Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez, Lille

60076

Clinic of Robert Hozman, MD - Clinical Investigational Specialists, Inc, Skokie

67091

Centre Hospitalier Universitaire de Strasbourg - Nouvel hopital civil, Strasbourg

70121

Ochsner Clinic Foundation, New Orleans

71500

University Hospital of Heraklion, Heraklion

73102

Arthritis and Rheumatology Center of Oklahoma PLLC, Oklahoma City

74104

The Oklahoma Center for Arthritis Therapy and Research Inc, Tulsa

75007

Trinity Universal Research Associates, Inc, Carrollton

75013

Hopital Pitie-Salpetriere, Paris

75150

Southwest Rheumatology, Mesquite

77004

Rheumatic Disease Clinical Research Center LLC, Houston

78731

Austin Regional Clinic Specialty Research, Austin

80010

University of Colorado Denver, Aurora

85258

Imaging Endpoints, Scottsdale

90095

University of California Los Angeles, Los Angeles

91723

Medvin Clinical Research, Covina

92037

University of California San Diego, La Jolla

92108

TriWest Research Associates, San Diego

92335

Southern California Permanente Medical Group, Fontana

94304

Stanford University Hospitals and Clinics, Palo Alto

97000

Centro Peninsular de Investigación Clínica, Mérida

115522

FSBSI SRI of Rheumatology na V A Nasonova, Moscow

196066

LLC Medical Sanitary Unit №157, Saint Petersburg

420097

Limited liability company Scientific Research Medical Complex Your Health, Kazan'

620102

State Budget Medical Institution Sverdlovsk Regional Clinical Hospital N1, Yekaterinburg

630061

LLC Center of medicine Healthy family, Novosibirsk

630091

LLC Center of general medicine, Novosibirsk

650066

LLC Medical Center Maksimum Zdorovia, Kemerovo

650070

LLC Medical center Revma Med, Kemerovo

06519

Yale University, New Haven

C1111AAJ

Dom Centro de Reumatologia, CABA

C1426ABP

Fundacion Respirar - Centro Medico Dra De Salvo, Ciudad Autonoma de Buenos Aires

B1878GEG

Instituto de Investigaciones Clinicas Quilmes, Quilmes

C1426BOR

Hospital Militar Central - Cirujano Mayor Dr Cosme Argerich, Buenos Aires

T4000AXL

Centro Medico Privado de Reumatologia, San Miguel de Tucumán

T4000

Clinical Mayo - Clinica Mayo de Urgencias Medicas Cruz Blanca S.R.L, San Miguel de Tucumán

T2N 4N1

University of Calgary Cumming School of Medicine, Calgary

R3A 1M4

Shared Health Inc. operating the Health Sciences Centre Winnipeg, Winnipeg

G1V 3M7

Groupe de recherche en maladies osseuses Incorporated, Québec

120 00

Synexus Czech sro, Prague

128 50

Revmatologicky ustav, Prague

04103

Universitätsklinikum Leipzig AöR, Leipzig

Unknown

Tuen Mun Hospital, New Territories

00168

Policlinico Universitario Agostino Gemelli, Roma

260-8712

National Hospital Organization Chibahigashi National Hospital, Chiba

279-0021

Juntendo University Urayasu Hospital, Urayasu-shi

807-8556

Hospital of the University of Occupational and Environmental Health Japan, Kitakyushu-shi

501-1194

Gifu University Hospital, Gifu

060-8604

Sapporo City General Hospital, Sapporo

060-8648

Hokkaido University Hospital, Sapporo

650-0017

Kobe University Hospital, Kobe

920-8641

Kanazawa University Hospital, Kanazawa

980-8574

National University Corporation Tohoku University Tohoku University Hospital, Sendai

390-8621

Shinshu University Hospital, Matsumoto-shi

852-8501

Nagasaki University Hospital, Nagasaki

856-8562

National Hospital Organization Nagasaki Medical Center, Omura-shi

857-1195

Sasebo Chuo Hospital, Sasebo-shi

710-8522

Kurashiki Medical Clinic, Kurashiki-shi

700-8558

Okayama University Hospital, Okayama

430-8558

Seirei Hamamatsu General Hospital, Hamamatsu

113-8431

Juntendo University Hospital, Bunkyo-ku

113-8655

The University of Tokyo Hospital, Bunkyo-ku

104-8560

St Lukes International Hospital, Chuo-ku

152-8902

National Hospital Organization Tokyo Medical Center, Meguro-ku

160-8582

Keio University Hospital, Shinjuku-ku

06100

Centro Mexicano de Desarrollo de Estudios Clinicos, Mexico City

80-382

Synexus Polska Spzoo, Gdansk

81-537

Synexus Polska Spzoo, Gdynia

40-040

Synexus Polska Spzoo, Katowice

40-282

Silmedic Spzoo, Katowice

31-209

Tomed Tomasz Miszalski-Jamka Centrum Medyczne, Krakow

90-127

Synexus Polska Spzoo, Lodz

90-368

Somed cr, Lodz

20-049

1 Wojskowy Szpital Kliniczny z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Lublin

20-078

Clinical Best Solutions Spolka z ograniczona odpowiedzialnoscia Spolka komandytowa, Lublin

60-702

Synexus Polska Spzoo, Poznan

37-450

Sanus Szpital Specjalistyczny Spzoo, Stalowa Wola

01-737

SOMED CR, Warsaw

02-672

Synexus Polska Spolka z ograniczona odpowiedzialnoscia, Warsaw

50-088

Futuremeds spolka z ograniczona odpowiedzialnoscia, Wroclaw

50-381

Synexus Polska Spzoo, Wroclaw

2801-951

Hospital Garcia de Orta, EPE, Almada

1349-019

Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz, Lisbon

1649-035

Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria, Lisbon

4099-001

Centro Hospitalar do Porto EPE - Hospital de Santo Antonio, Porto

4200-319

Centro Hospitalar Universtario de Sao Joao, EPE, Porto

03080

Seoul National University Hospital, Seoul

07985

Ewha Womans University Mokdong Hospital, Seoul

443-380

Ajou University Hospital, Suwon-si, Gyeonggi-do

08035

Hospital Universitari Vall d Hebron, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY