Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus

PHASE2TerminatedINTERVENTIONAL
Enrollment

168

Participants

Timeline

Start Date

May 6, 2021

Primary Completion Date

May 22, 2023

Study Completion Date

May 22, 2023

Conditions
Active Systemic Lupus Erythematosus
Interventions
DRUG

Efavaleukin Alfa

Administered as a subcutaneous (SC) injection.

DRUG

Placebo

Administered as a subcutaneous (SC) injection.

OTHER

Standard of Care

Standard of care procedures and therapies for managing active systemic lupus erythematosus will be carried out according to each investigator's standard procedures.

Trial Locations (150)

1407

Medical Center Excelsior OOD, Sofia

1612

Medical Center Academy EOOD, Sofia

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

4031

Universitaetsspital Basel, Basel

8036

Medizinische Universitaet Graz, Graz

9007

Kantonsspital St Gallen, Sankt Gallen

10002

National Taiwan University Hospital, Taipei

10029

Icahn School of Medicine at Mount Sinai, New York

10128

Azienda Ospedaliera Ordine Mauriziano di Torino, Torino

10461

Institute for Clinical and Translation Research at Einstein and Montefiore Clinical Research Center, The Bronx

11030

Feinstein Institute for Medical Research, Manhasset

11201

New York University Langone Ambulatory Care Brooklyn Heights, Brooklyn

11521

Athens Naval Hospital, Athens

11527

Laiko General Hospital, Athens

12462

Attiko Hospital, Athens

13210

State University of New York - Upstate Medical University, Syracuse

14004

Hospital Universitario Reina Sofia, Córdoba

15213

University of Pittsburgh Medical Center Lupus Center of Excellence, Pittsburgh

15706

Hospital Clinico Universitario de Santiago, Santiago de Compostela

16499

Ajou University Hospital, Suwon-si, Gyeonggi-do

26443

Olympion Hospital-General Clinic of Patras AE, Pátrai

27599

University of North Carolina at Chapel Hill Thurston Arthritis Research Center, Chapel Hill

28204

Joint and Muscle Research Institute, Charlotte

28210

DJL Clinical Research PLLC, Charlotte

Javara, Charlotte

28211

Atrium Health Rheumatology, Charlotte

29204

Columbia Arthritis Center, PA, Columbia

29601

Piedmont Arthritis Clinic, Greenville

31059

Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil, Toulouse

31203

Centro de Investigacion Integral Medivest SC, Chihuahua City

32174

Millennium Research, Ormond Beach

33024

GNP Research, Hollywood

33100

Azienda Ospedaliero Universitaria Integrata Santa Maria della Misericordia, Udine

33180

Arthritis and Rheumatic Disease Specialties, Aventura

Life Clinical Trials, Aventura

33309

Centre for Rheumatology Immunology and Arthritis, Fort Lauderdale

33324

Integral Rheumatology and Immunology Specialists, Plantation

33614

Baycare Medical Group Inc, Tampa

33710

Suncoast Medical Clinic, St. Petersburg

34093

Istanbul Universitesi Istanbul Tip Fakultesi, Istanbul

34295

Centre Hospitalier Universitaire de Montpellier Hopital Lapeyronie, Montpellier

35128

Azienda Ospedaliera di Padova, Padua

35294

University of Alabama at Birmingham,Arthritis Clinical Intervention Program, Birmingham

37134

Centro Ricerche Cliniche, Verona

37920

University of Tennessee Medical Center, Knoxville

38001

Hospital Universitario Hospiten Rambla, Santa Cruz de Tenerife

38119

Ramesh C Gupta MD, Memphis

38305

West Tennessee Research Institute, LLC, Jackson

40002

Diagnostic-Consultative Center Sveti Georgi EOOD, Plovdiv

40201

Chung Shan Medical University Hospital, Taichung

40705

Taichung Veterans General Hospital, Taichung

41010

Hospital Infanta Luisa, Seville

42240

Western Kentucky Rheumatology PLLC, Hopkinsville

42472

Daegu Catholic Universtiy Medcial Center, Daegu

44160

Centro Integral en Reumatologia SA de CV, Guadalajara

44690

Centro de Estudios de Investigacion Basica y Clinica, Sc, Guadalajara

46026

Hospital Universitari i Politecnic La Fe, Valencia

48439

Michigan Rheumatology Group, PC - Grand Blanc Office, Grand Blanc

48910

Arthritis and Rheumatology of Michigan, Lansing

50139

Azienda Ospedaliera Universitaria Careggi, Florence

54511

Centre Hospitalier Universitaire de Nancy - Hopital de Brabois, Vandœuvre-lès-Nancy

54636

Euromedica - Kyanous Stavros, Thessaloniki

54642

Ippokrateio Hospital of Thessaloniki, Thessaloniki

54769

Phylasis Clínicas Research S. De R. L. De C. V., Cuautitlán Izcalli

60076

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

60195

Greater Chicago Specialty Physicians, Schaumburg

60637

University of Chicago, Chicago

64718

Eukarya Pharmasite sc, Monterrey

67091

Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil, Strasbourg

70605

Accurate Clinical Research, Lake Charles

71500

University Hospital of Heraklion, Heraklion

73102

Arthritis and Rheumatology Center of Oklahoma PLLC, Oklahoma City

73104

Oklahoma Medical Research Foundation, Oklahoma City

75013

Arthritis and Rheumatology Institute, Allen

75024

Trinity Universal Research Associates, LLC, Plano

76034

Precision Comprehensive Clinical Research Solutions, Colleyville

76710

Arthritis and Osteoporosis Clinic, Waco

77043

Biopharma Informatic, LLC, Houston

77084

Accurate Clinical Management, Houston

77089

Laila A Hassan, MD, PA, Houston

78229

Clinical Trials of Texas, San Antonio

University of Texas Health Science Center at San Antonio Medical Arts Research Clinic Marc, San Antonio

79902

Texas Arthritis Center PA, El Paso

80131

Università degli studi della Campania Luigi Vanvitelli, Napoli

83301

Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City

85297

Arizona Arthritis and Rheumatology Associates PC, Gilbert

85306

Arizona Arthritis And Rheumatology Associates PC, Glendale

85704

Arizona Arthritis and Rheumatology Associates PC, Tucson

90024

University of California Los Angeles, Los Angeles

92354

Loma Linda University Health Care, Loma Linda

92780

Robin K Dore MD Inc, Tustin

92868

University of California Irvine, Orange

110221

Centro de Investigacion en Reumatologia y Especialidades Medicas SAS, Bogota

Solano y Terront Servicios Medicos Ltda - Uniendo, Bogota

115522

FSBSI SRI of Rheumatology na V A Nasonova, Moscow

119435

I M Sechenov First Medical University of the MoH of RF, Moscow

150003

Center for medical consultations and research - practice, Yaroslavl

190068

Saint-Petersburg State Budget Healthcare Institution Clinical Rheumatology Hospital 25, Saint Petersburg

196066

LLC Medical Sanitary Unit №157, Saint Petersburg

420097

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

730006

Mediservis del Tolima IPS SAS, Ibagué

760035

Centro Medico Julian Coronel, Santiago de Cali

2520598

Oncocentro Apys, Viña del Mar

5111847

Sociedad de Prestaciones Medicas Intermedica Limitada, Valdivia

5311092

Corporacion de Beneficiencia Osorno, Osorno

7500010

Investigacion y Terapias Reumatologicas Innovadoras LTDA - Interin LTDA, Providencia

7500587

Enroll SpA, Providencia

7501126

Estudios Clinicos Limitada - Centro de Estudios Reumatologicos, Santiago

7510047

Sociedad de prestaciones Medicas y Paramedicas Goecke Gatica y Compania Limitada - Prosalud, Providencia

8320000

CECIM, Santiago

M5T 2S8

Toronto Western Hospital, Toronto

050034

Hospital Pablo Tobon Uribe, Medellín

080002

Centro Integral de Reumatología del Caribe Circaribe SAS, Barranquilla

Unknown

Tuen Mun Hospital, New Territories

00161

Azienda Ospedaliera Policlinico Umberto I, Roma

00168

Policlinico Universitario Agostino Gemelli, Roma

457-8510

Japan Community Healthcare Organization Chukyo Hospital, Nagoya

467-8602

Nagoya City University Hospital, Nagoya

260-8712

National Hospital Organization Chibahigashi National Hospital, Chiba

807-8556

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

734-8551

Hiroshima University Hospital, Hiroshima

060-8604

Sapporo City General Hospital, Sapporo

060-8648

Hokkaido University Hospital, Sapporo

920-8641

Kanazawa University Hospital, Kanazawa

890-0063

Eiraku Clinic, Kagoshima

890-8520

Kagoshima University Hospital, Kagoshima

216-8511

St Marianna University Hospital, Kawasaki-shi

980-8574

National University Corporation Tohoku University Tohoku University Hospital, Sendai

852-8501

Nagasaki University Hospital, Nagasaki

430-8558

Seirei Hamamatsu General Hospital, Hamamatsu

113-8431

Juntendo University 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

162-8655

Center Hospital of the National Center for Global Health and Medicine, Shinjuku-ku

06700

CITER SA de CV (Centro de Investigación y Tratamiento de las Enfermedades Reumáticas SA de CV), Mexico City

85-605

Centrum medyczne intercore sp zoo, Bydgoszcz

42-200

Centrum Medyczne Pratia Czestochowa, Częstochowa

82-200

Centrum Badan Klinicznych Wojciech Brzezicki, Malbork

05-830

NZOZ Lecznica MAK-MED sc, Nadarzyn

61-441

Gabinety Lekarskie RIVERMED, Poznan

52-210

Reumatop Grzegorz Rozumek, Karin Pistorius, Wroclaw

03080

Seoul National University Hospital, Seoul

04763

Hanyang University Seoul Hospital, Seoul

01009

Hospital Universitario Araba, Vitoria-Gasteiz

08041

Hospital de la Santa Creu i Sant Pau, Barcelona

08208

Corporacio Sanitaria Parc Tauli, Sabadell

01790

Cukurova Universitesi Balcali Hastanesi Saglik Uygulama ve Arastirma Merkezi, Adana

06100

Hacettepe Universitesi Tip Fakultesi, Ankara

07070

Akdeniz Universitesi Tip Fakultesi, Antalya

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY

NCT04680637 - Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus | Biotech Hunter | Biotech Hunter