- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04680637
Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus
October 3, 2023 updated by: Amgen
A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy
The primary objective is to evaluate the efficacy and safety of efavaleukin alfa in subjects with active systemic lupus erythematosus.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
168
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Graz, Austria, 8036
- Medizinische Universitaet Graz
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Plovdiv, Bulgaria, 40002
- Diagnostic-Consultative Center Sveti Georgi EOOD
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Sofia, Bulgaria, 1407
- Medical Center Excelsior OOD
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Sofia, Bulgaria, 1612
- Medical Center Academy EOOD
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Sofia, Bulgaria, 1612
- University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD
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Ontario
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Toronto, Ontario, Canada, M5T 2S8
- Toronto Western Hospital
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Osorno, Chile, 5311092
- Corporacion de Beneficiencia Osorno
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Santiago, Chile, 7501126
- Estudios Clinicos Limitada - Centro de Estudios Reumatologicos
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Santiago, Chile, 8320000
- CECIM
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Valdivia, Chile, 5111847
- Sociedad de Prestaciones Medicas Intermedica Limitada
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Viña del Mar, Chile, 2520598
- Oncocentro APYS
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Santiago
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Providencia, Santiago, Chile, 7500010
- Investigacion y Terapias Reumatologicas Innovadoras LTDA - Interin LTDA
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Providencia, Santiago, Chile, 7500587
- Enroll Spa
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Providencia, Santiago, Chile, 7510047
- Sociedad de prestaciones Medicas y Paramedicas Goecke Gatica y Compania Limitada - Prosalud
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Antioquia
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Medellin, Antioquia, Colombia, 050034
- Hospital Pablo Tobón Uribe
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Atlántico
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Barranquilla, Atlántico, Colombia, 080002
- Centro Integral de Reumatología del Caribe Circaribe SAS
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Cundinamarca
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Bogota, Cundinamarca, Colombia, 110221
- Centro de Investigacion en Reumatologia y Especialidades Medicas SAS
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Bogota, Cundinamarca, Colombia, 110221
- Solano y Terront Servicios Medicos Ltda - Uniendo
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Tolima
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Ibague, Tolima, Colombia, 730006
- Mediservis del Tolima IPS SAS
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Valle Del Cauca
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Santiago de Cali, Valle Del Cauca, Colombia, 760035
- Centro Medico Julian Coronel
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Montpellier cedex 05, France, 34295
- Centre Hospitalier Universitaire de Montpellier Hopital Lapeyronie
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Strasbourg, France, 67091
- Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil
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Toulouse Cedex 9, France, 31059
- Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil
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Vandoeuvre Les Nancy Cedex, France, 54511
- Centre Hospitalier Universitaire de Nancy - Hopital de Brabois
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Athens, Greece, 11527
- Laiko General Hospital
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Athens, Greece, 11521
- Athens Naval Hospital
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Athens, Greece, 12462
- Attiko Hospital
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Heraklion, Greece, 71500
- University Hospital of Heraklion
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Patra, Greece, 26443
- Olympion Hospital-General Clinic of Patras AE
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Thessaloniki, Greece, 54636
- Euromedica - Kyanous Stavros
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Thessaloniki, Greece, 54642
- Ippokrateio Hospital of Thessaloniki
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New Territories, Hong Kong
- Tuen Mun Hospital
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Firenze, Italy, 50139
- Azienda Ospedaliera Universitaria Careggi
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Napoli, Italy, 80131
- Università degli studi della Campania Luigi Vanvitelli
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Padova, Italy, 35128
- Azienda Ospedaliera di Padova
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Roma, Italy, 00168
- Policlinico Universitario Agostino Gemelli
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Roma, Italy, 00161
- Azienda Ospedaliera Policlinico Umberto I
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Torino, Italy, 10128
- Azienda Ospedaliera Ordine Mauriziano di Torino
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Udine, Italy, 33100
- Azienda Ospedaliero Universitaria Integrata Santa Maria della Misericordia
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Verona, Italy, 37134
- Centro Ricerche Cliniche
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Aichi
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Nagoya-shi, Aichi, Japan, 467-8602
- Nagoya City University Hospital
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Nagoya-shi, Aichi, Japan, 457-8510
- Japan Community Healthcare Organization Chukyo Hospital
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Chiba
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Chiba-shi, Chiba, Japan, 260-8712
- National Hospital Organization Chibahigashi National Hospital
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Fukuoka
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Kitakyushu-shi, Fukuoka, Japan, 807-8556
- Hospital of the University of Occupational and Environmental Health Japan
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Hiroshima
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Hiroshima-shi, Hiroshima, Japan, 734-8551
- Hiroshima University Hospital
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Hokkaido
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Sapporo, Hokkaido, Japan, 060-8648
- Hokkaido University Hospital
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Sapporo-shi, Hokkaido, Japan, 060-8604
- Sapporo City General Hospital
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Ishikawa
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Kanazawa-shi, Ishikawa, Japan, 920-8641
- Kanazawa University Hospital
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Kagoshima
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Kagoshima-shi, Kagoshima, Japan, 890-8520
- Kagoshima University Hospital
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Kagoshima-shi, Kagoshima, Japan, 890-0063
- Eiraku Clinic
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Kanagawa
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Kawasaki-shi, Kanagawa, Japan, 216-8511
- St Marianna University Hospital
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Miyagi
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Sendai-shi, Miyagi, Japan, 980-8574
- National University Corporation Tohoku University Tohoku University Hospital
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Nagasaki
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Nagasaki-shi, Nagasaki, Japan, 852-8501
- Nagasaki University Hospital
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Shizuoka
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Hamamatsu-shi, Shizuoka, Japan, 430-8558
- Seirei Hamamatsu General Hospital
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Tokyo
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Bunkyo-ku, Tokyo, Japan, 113-8431
- Juntendo University Hospital
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Chuo-ku, Tokyo, Japan, 104-8560
- St Lukes International Hospital
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Meguro-ku, Tokyo, Japan, 152-8902
- National Hospital Organization Tokyo Medical Center
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Shinjuku-ku, Tokyo, Japan, 160-8582
- Keio University Hospital
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Shinjuku-ku, Tokyo, Japan, 162-8655
- Center Hospital of the National Center for Global Health and Medicine
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Daegu, Korea, Republic of, 42472
- Daegu Catholic Universtiy Medcial Center
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Seoul, Korea, Republic of, 03080
- Seoul National University Hospital
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Seoul, Korea, Republic of, 04763
- Hanyang University Seoul Hospital
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Suwon-si, Gyeonggi-do, Korea, Republic of, 16499
- Ajou University Hospital
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Chihuahua, Mexico, 31203
- Centro de Investigacion Integral Medivest SC
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Cuautitlan Izcalli, Mexico, 54769
- Phylasis Clínicas Research S. De R. L. De C. V.
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Distrito Federal
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Mexico City, Distrito Federal, Mexico, 06700
- CITER SA de CV (Centro de Investigación y Tratamiento de las Enfermedades Reumáticas SA de CV)
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Jalisco
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Guadalajara, Jalisco, Mexico, 44160
- Centro Integral en Reumatologia SA de CV
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Guadalajara, Jalisco, Mexico, 44690
- Centro de Estudios de Investigacion Basica y Clinica, Sc
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Nuevo León
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Monterrey, Nuevo León, Mexico, 64718
- Eukarya Pharmasite SC
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Bydgoszcz, Poland, 85-605
- Centrum medyczne intercore sp zoo
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Czestochowa, Poland, 42-200
- Centrum Medyczne Pratia Czestochowa
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Malbork, Poland, 82-200
- Centrum Badan Klinicznych Wojciech Brzezicki
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Nadarzyn, Poland, 05-830
- NZOZ Lecznica Mak-Med sc
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Poznan, Poland, 61-441
- Gabinety Lekarskie Rivermed
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Wroclaw, Poland, 52-210
- Reumatop Grzegorz Rozumek, Karin Pistorius
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Kazan, Russian Federation, 420097
- Limited liability company Scientific Research Medical Complex Your Health
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Moscow, Russian Federation, 115522
- FSBSI SRI of Rheumatology na V A Nasonova
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Moscow, Russian Federation, 119435
- I M Sechenov First Medical University of the MoH of RF
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Saint Petersburg, Russian Federation, 196066
- LLC Medical Sanitary Unit №157
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Saint-Petersburg, Russian Federation, 190068
- Saint-Petersburg State Budget Healthcare Institution Clinical Rheumatology Hospital 25
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Yaroslavl, Russian Federation, 150003
- Center for medical consultations and research - practice
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Andalucía
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Cordoba, Andalucía, Spain, 14004
- Hospital Universitario Reina Sofía
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Sevilla, Andalucía, Spain, 41010
- Hospital Infanta Luisa
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Canarias
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Santa Cruz de Tenerife, Canarias, Spain, 38001
- Hospital Universitario Hospiten Rambla
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Cataluña
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Barcelona, Cataluña, Spain, 08041
- Hospital de La Santa Creu i Sant Pau
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Sabadell, Cataluña, Spain, 08208
- Corporacio Sanitaria Parc Tauli
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Comunidad Valenciana
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Valencia, Comunidad Valenciana, Spain, 46026
- Hospital Universitari i Politecnic La Fe
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Galicia
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Santiago de Compostela, Galicia, Spain, 15706
- Hospital Clinico Universitario de Santiago
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País Vasco
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Vitoria, País Vasco, Spain, 01009
- Hospital Universitario Araba
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Basel, Switzerland, 4031
- Universitaetsspital Basel
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Sankt Gallen, Switzerland, 9007
- Kantonsspital St Gallen
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Kaohsiung, Taiwan, 83301
- Kaohsiung Chang Gung Memorial Hospital
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Taichung, Taiwan, 40705
- Taichung Veterans General Hospital
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Taichung, Taiwan, 40201
- Chung Shan Medical University Hospital
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Taipei, Taiwan, 10002
- National Taiwan University Hospital
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Adana, Turkey, 01790
- Cukurova Universitesi Balcali Hastanesi Saglik Uygulama ve Arastirma Merkezi
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Ankara, Turkey, 06100
- Hacettepe Universitesi Tip Fakultesi
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Antalya, Turkey, 07070
- Akdeniz Universitesi Tip Fakultesi
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Istanbul, Turkey, 34093
- Istanbul Universitesi Istanbul Tip Fakultesi
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Alabama
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Birmingham, Alabama, United States, 35294
- University of Alabama at Birmingham,Arthritis Clinical Intervention Program
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Arizona
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Gilbert, Arizona, United States, 85297
- Arizona Arthritis and Rheumatology Associates PC
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Glendale, Arizona, United States, 85306
- Arizona Arthritis and Rheumatology Associates PC
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Tucson, Arizona, United States, 85704
- Arizona Arthritis and Rheumatology Associates PC
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California
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Loma Linda, California, United States, 92354
- Loma Linda University Health Care
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Los Angeles, California, United States, 90024
- University of California Los Angeles
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Orange, California, United States, 92868
- University of California Irvine
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Tustin, California, United States, 92780
- Robin K Dore MD Inc
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Florida
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Aventura, Florida, United States, 33180
- Arthritis and Rheumatic Disease Specialties
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Aventura, Florida, United States, 33180
- Life Clinical Trials
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Fort Lauderdale, Florida, United States, 33309
- Centre for Rheumatology Immunology and Arthritis
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Hollywood, Florida, United States, 33024
- GNP Research
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Ormond Beach, Florida, United States, 32174
- Millennium Research
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Plantation, Florida, United States, 33324
- Integral Rheumatology And Immunology Specialists
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Saint Petersburg, Florida, United States, 33710
- Suncoast Medical Clinic
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Tampa, Florida, United States, 33614
- BayCare Medical Group Inc
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Illinois
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Chicago, Illinois, United States, 60637
- University of Chicago
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Schaumburg, Illinois, United States, 60195
- Greater Chicago Specialty Physicians
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Skokie, Illinois, United States, 60076
- Clinic of Robert Hozman, MD - Clinical Investigational Specialists, Inc
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Kentucky
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Hopkinsville, Kentucky, United States, 42240
- Western Kentucky Rheumatology PLLC
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Louisiana
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Lake Charles, Louisiana, United States, 70605
- Accurate Clinical Research
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Michigan
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Grand Blanc, Michigan, United States, 48439
- Michigan Rheumatology Group, PC - Grand Blanc Office
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Lansing, Michigan, United States, 48910
- Arthritis and Rheumatology of Michigan
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New York
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Bronx, New York, United States, 10461
- Institute for Clinical and Translation Research at Einstein and Montefiore Clinical Research Center
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Brooklyn, New York, United States, 11201
- New York University Langone Ambulatory Care Brooklyn Heights
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Manhasset, New York, United States, 11030
- Feinstein Institute for Medical research
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New York, New York, United States, 10029
- Icahn School of Medicine at Mount Sinai
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Syracuse, New York, United States, 13210
- State University of New York - Upstate Medical University
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- University of North Carolina at Chapel Hill Thurston Arthritis Research Center
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Charlotte, North Carolina, United States, 28204
- Joint and Muscle Research Institute
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Charlotte, North Carolina, United States, 28210
- DJL Clinical Research PLLC
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Charlotte, North Carolina, United States, 28210
- Javara
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Charlotte, North Carolina, United States, 28211
- Atrium Health Rheumatology
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- Oklahoma Medical Research Foundation
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Oklahoma City, Oklahoma, United States, 73102
- Arthritis and Rheumatology Center of Oklahoma PLLC
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh Medical Center Lupus Center of Excellence
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South Carolina
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Columbia, South Carolina, United States, 29204
- Columbia Arthritis Center, PA
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Greenville, South Carolina, United States, 29601
- Piedmont Arthritis Clinic
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Tennessee
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Jackson, Tennessee, United States, 38305
- West Tennessee Research Institute, LLC
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Knoxville, Tennessee, United States, 37920
- University of Tennessee Medical Center
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Memphis, Tennessee, United States, 38119
- Ramesh C Gupta MD
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Texas
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Allen, Texas, United States, 75013
- Arthritis and Rheumatology Institute
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Colleyville, Texas, United States, 76034
- Precision Comprehensive Clinical Research Solutions
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El Paso, Texas, United States, 79902
- Texas Arthritis Center PA
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Houston, Texas, United States, 77043
- Biopharma Informatic, LLC
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Houston, Texas, United States, 77089
- Laila A Hassan, MD, PA
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Houston, Texas, United States, 77084
- Accurate Clinical Management
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Plano, Texas, United States, 75024
- Trinity Universal Research Associates, LLC
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San Antonio, Texas, United States, 78229
- Clinical Trials of Texas
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San Antonio, Texas, United States, 78229
- University of Texas Health Science Center at San Antonio Medical Arts Research Clinic Marc
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Waco, Texas, United States, 76710
- Arthritis and Osteoporosis Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Participant has provided informed consent prior to initiation of any study specific activities/procedures.
- Participant is aged between 18 and 75.
- Fulfills classification criteria for systemic lupus erythematosus (SLE) according to the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE with antinuclear antibody ≥ 1:80 by immunofluorescence on Hep-2 cells being present at screening.
- Hybrid SLEDAI score ≥ 6 points with a "Clinical" hSLEDAI score ≥ 4 points. The "Clinical" hSLEDAI is the hSLEDAI assessment score without the inclusion of points attributable to laboratory results, including urine or immunologic parameters.
- British-Isles Lupus Assessment Group (BILAG) index score (BILAG 2004) of ≥ 1 A item or ≥ 2 B items.
- Must be taking ≥ 1 of the following SLE treatments (or regional equivalent): hydroxychloroquine, chloroquine, quinacrine, mycophenolate mofetil, azathioprine, methotrexate, dapsone, or oral calcineurin inhibitors, or OCS. A participant may enter the study on OCS alone (prednisone ≥ 10 mg/day or equivalent) only if the participant has previously documented trial of anti-malarial or immunosuppressant treatment for SLE. Participants must be on a stable dose for ≥ 8 weeks prior to screening for all antimalarials and immunosuppressants, with the exception of OCS doses which must be stable for ≥ 2 weeks prior to screening.
- For participants taking OCS, dose must be ≤ 20 mg/day of prednisone or OCS equivalent, and the dose must be stable at baseline visit and for ≥ 2 weeks prior to screening visit.
- Stability of SLE treatments: OCS and other immunosuppressants/immunomodulator agents and doses must be stable since screening visit.
- Disease activity: active disease as indicated by clinical hSLEDAI score ≥ 4 must be observed (clinical hSLEDAI score is the hSLEDAI assessment score without the inclusion of points attributable to laboratory results including urine and immunologic parameters).
Exclusion Criteria:
- Lupus nephritis if any of the following are present: urine protein creatinine ratio ≥ 2000 mg/g (or equivalent) at screening, OR requiring induction therapy currently or within 1 year prior to screening, OR histological evidence (if available) of diffuse proliferative glomerulonephritis within 12 weeks prior to screening.
- Active CNS lupus within 1 year prior to screening including, but not limited to, aseptic meningitis, ataxia, CNS vasculitis, cranial neuropathy, demyelinating syndrome, optic neuritis, psychosis, seizures, or transverse myelitis.
- Currently present or within 1 year prior to screening a diagnosis of any chronic inflammatory disease other than SLE (eg, rheumatoid arthritis) which would interfere with SLE disease assessment.
- History of any disease other than SLE that has required treatment with oral or parenteral corticosteroids for > 2 weeks within 4 months prior to screening.
- Active infection (including chronic or localized infections) for which anti-infectives are indicated currently or within 4 weeks prior to screening visit OR presence of serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to screening visit.
- Active tuberculosis or latent tuberculosis with no documented past history of adequate treatment per local standard of care.
- Positive test for tuberculosis during creening defined as: either a positive or indeterminate QuantiFERON®-TB or T-spot test OR positive purified protein derivative (PPD) (≥5 mm of induration at 48 to 72 hours after test is placed).
- Positive for hepatitis B surface antigen (HBsAg); or positive for hepatitis B core antibody (HBcAb). A history of hepatitis B vaccination without history of hepatitis B infection (ie, positive hepatitis B surface antibody (HBsAb), negative HBsAg and negative HBcAb) is allowed.
- Positive for hepatitis C antibody.
- Known history of HIV or positive HIV test at screening.
Presence of 1 or more significant concurrent medical conditions, including but not limited to the following:
- poorly controlled diabetes (hemoglobin A1C > 7) or hypertension
- symptomatic heart failure (New York Heart Association class III or IV)
- myocardial infarction or unstable angina pectoris within the past 12 months prior to screening
- severe chronic pulmonary disease requiring oxygen therapy
- multiple sclerosis or any other demyelinating disease
- Any history of malignancy with the following exceptions:
- resolved non-melanoma skin cancers > 5 years prior to screening
- resolved cervical carcinoma > 5 years prior to screening
- resolved breast ductal carcinoma in situ > 5 years of screening
- Currently receiving or had treatment with: cyclophosphamide, chlorambucil, nitrogen mustard, or any other alkylating agent within 6 months prior to screening or sirolimus within 4 weeks prior screening.
- Currently receiving or had treatment with a Janus kinase (JAK) inhibitor within 3 months or less than 5 drug half-lives (whichever is longer) prior to screening.
- Currently receiving or had treatment with an immune checkpoint inhibitor (eg, programmed death 1 [PD-1] inhibitor, programmed death ligand 1 [PD-L1] inhibitor, cytotoxic T-lymphocyte associated protein 4 [CTLA-4] inhibitor).
Note: Abatacept is not considered a CTLA-4 inhibitor and is referred to below.
- Currently receiving or had treatment within 12 months prior to screening with T-cell depleting agents (eg, antithymocyte globulin, Campath).
- Currently receiving of had treatment with an interleukin 2 (IL-2) based therapy (eg, Proleukin).
- Current or previous treatment with a biologic agent with immunosuppressive/immunomodulatory activity as follows: rituximab within 6 months prior to screening; abatacept and belimumab within the past 3 months prior to screening; other biologics within < 5 drug half lives prior to screening.
- Participants who have received intraarticular, intralesional, or intramuscular corticosteroids within 2 weeks prior to screening or intravenous corticosteroids within 6 weeks prior to screening.
- Participants who have received live vaccines within 5 weeks prior to screening, or plan to receive live vaccines during the treatment period and up to 6 weeks after the end of treatment period in the study.
- Currently receiving treatment in another investigational device or drug study.
- Ending a treatment with an investigational drug or investigational device less than 3 months or 5 half-lives from the last dose of the investigational drug (whichever is longer) at screening.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo + Standard of Care
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Administered as a subcutaneous (SC) injection.
Standard of care procedures and therapies for managing active systemic lupus erythematosus will be carried out according to each investigator's standard procedures.
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Experimental: Efavaleukin Alfa Dose Level One + Standard of Care
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Standard of care procedures and therapies for managing active systemic lupus erythematosus will be carried out according to each investigator's standard procedures.
Administered as a subcutaneous (SC) injection.
Other Names:
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Experimental: Efavaleukin Alfa Dose Level Two + Standard of Care
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Standard of care procedures and therapies for managing active systemic lupus erythematosus will be carried out according to each investigator's standard procedures.
Administered as a subcutaneous (SC) injection.
Other Names:
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Experimental: Efavaleukin Alfa Dose Level Three + Standard of Care
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Standard of care procedures and therapies for managing active systemic lupus erythematosus will be carried out according to each investigator's standard procedures.
Administered as a subcutaneous (SC) injection.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of Participants Achieving a Systemic Lupus Erythematosus Responder Index-4 (SRI-4) Response at Week 52
Time Frame: Week 52
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SRI-4 response is defined as a greater than or equal to 4-point decrease in the hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) score and no new British Isles Lupus Assessment Group (BILAG) 2004 A domain score and no greater than 1 new BILAG 2004 B scores compared with baseline; and a less than 0.3-point deterioration from baseline in Physician Global Assessment (PGA) VAS (scale 0 to 3).
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Week 52
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of Participants Achieving a British Isles Lupus Assessment Group Based Composite Lupus Assessment (BICLA) Response at Week 24 and Week 52
Time Frame: Week 24 and Week 52
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BICLA response is defined as at least 1 gradation of improvement in baseline British Isles Lupus Assessment Group (BILAG) domain scores in all body systems with moderate or severe disease activity at entry (eg, all A [severe disease] domain scores falling to B [moderate], C [mild], or D [no activity], and all B domain scores falling to C or D); no new BILAG 2004 A domain score and no greater than 1 new BILAG 2004 B domain scores compared with baseline; less than 0.3-point deterioration from baseline in Physician Global Assessment (PGA) (scale 0 to 3); and no initiation of non-protocol treatment.
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Week 24 and Week 52
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Percent of Participants Achieving a Lupus Low Disease Activity State (LLDAS) Response at Week 52
Time Frame: Week 52
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LLDAS response is defined as a hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) score ≤ 4 with no activity in major organ systems (renal, central nervous system (CNS), cardiopulmonary, vasculitis, and fever) and no haemolytic anaemia or gastrointestinal activity; no new findings of lupus disease activity compared with the previous assessment; ≤ 1-point in Physician Global Assessment (PGA) (scale 0 to 3) current prednisolone-equivalent dosage ≤ 7.5 mg/day; and standard maintenance dosages of immunosuppressive drugs and approved biologics.
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Week 52
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Percent of Participants with a Reduction of Oral Corticosteroid (OCS) to Less Than or Equal to 7.5 mg/day by Week 44 and Sustained Through Week 52 in Participants with a Baseline OCS Dose ≥ 10 mg/day
Time Frame: Week 52
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To evaluate the efficacy of efavaleukin alfa with oral corticosteroid (OCS)-tapering in subjects with SLE with inadequate response to SOC therapy.
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Week 52
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Percent of Participants Achieving a Systemic Lupus Erythematosus Responder Index-4 (SRI-4) Response at Week 24
Time Frame: Week 24
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SRI-4 response is defined as a greater than or equal to 4-point decrease in the hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) score; no new British Isles Lupus Assessment Group (BILAG) 2004 A domain score and no greater than 1 new BILAG 2004 B scores compared with baseline; and a less than 0.3-point deterioration from baseline in Physician Global Assessment (PGA) (scale 0 to 3).
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Week 24
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Percent of Participants Achieving a Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) Response at Week 24 and Week 52
Time Frame: Week 24 and Week 52
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hSLEDAI response is defined as a greater than or equal to 4-point decrease in score.
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Week 24 and Week 52
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Tender and Swollen Joint Count ≥ 50% Improvement from Baseline at Weeks 8, 12, 24, 36, and 52 in Participants with ≥ 6 Tender and Swollen Joints Involving the Hands and Wrists at Baseline
Time Frame: Baseline, Week 8, 12, 24, 36, and 52
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A 28-joint count will be used to evaluate the effect of efavaleukin alfa on additional SLE efficacy endpoints.
A total 28 joints will be scored for presence or absence of swelling.
A separated score for joints in the hands and wrists will be calculated.
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Baseline, Week 8, 12, 24, 36, and 52
|
Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) Activity Score ≥ 50% Improvement from Baseline at Week 8, 12, 24, 36, and 52 in Participants with a CLASI Activity Score ≥ 8 at Baseline
Time Frame: Baseline, Week 8, 12, 24, 36, and 52
|
To evaluate the effect of efavaleukin alfa on additional SLE efficacy endpoints.
|
Baseline, Week 8, 12, 24, 36, and 52
|
Percent of Participants who Experience a Flare
Time Frame: Week 52
|
A flare is defined as a British Isles Lupus Assessment Group (BILAG) score designation of 'worse' or 'new'.
|
Week 52
|
Change from Baseline in Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a Instrument (PROMIS Fatigue SF 7A) Fatigue Score
Time Frame: Baseline, Week 12, 24, 36, and 52
|
To describe the effect of treatment with efavaleukin alfa using patient reported outcomes.
|
Baseline, Week 12, 24, 36, and 52
|
Change from Baseline in Medical Outcomes Short Form-36 Questionnaire Score
Time Frame: Baseline, Week 12, 24, 36, and 52
|
To describe the effect of treatment with efavaleukin alfa using patient reported outcomes.
|
Baseline, Week 12, 24, 36, and 52
|
Change from Baseline in Lupus Quality of Life (QoL) Questionnaire Score
Time Frame: Baseline, Week 12, 24, 36, and 52
|
To describe the effect of treatment with efavaleukin alfa using patient reported outcomes.
|
Baseline, Week 12, 24, 36, and 52
|
Number of Participants who Experience a Treatment-Emergent Adverse Event (AE) and Serious Adverse Event (SAE)
Time Frame: Up to Week 56
|
To characterize the safety of efavaleukin alfa.
|
Up to Week 56
|
Number of Participants who Experience a Clinically Significant Change in Laboratory Values and Vital Sign Measurements
Time Frame: Up to Week 56
|
To characterize the safety of efavaleukin alfa.
|
Up to Week 56
|
Trough Serum and Sparse Postdose Serum Concentration of Efavaleukin Alfa
Time Frame: Up to Week 52
|
To characterize the pharmacokinetics (PK) of efavaleukin alfa.
|
Up to Week 52
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: MD, Amgen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 6, 2021
Primary Completion (Actual)
May 22, 2023
Study Completion (Actual)
May 22, 2023
Study Registration Dates
First Submitted
December 18, 2020
First Submitted That Met QC Criteria
December 18, 2020
First Posted (Actual)
December 23, 2020
Study Record Updates
Last Update Posted (Actual)
October 4, 2023
Last Update Submitted That Met QC Criteria
October 3, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20200234
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
IPD Sharing Time Frame
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities.
There is no end date for eligibility to submit a data sharing request for this study.
IPD Sharing Access Criteria
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s).
In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling.
Requests are reviewed by a committee of internal advisors.
If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision.
Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement.
This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis.
Further details are available at the URL below.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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