Study Stopped
The trial was terminated prematurely as it met pre-defined criteria for futility at IA3.
Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus
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
1 other identifier
interventional
168
19 countries
150
Brief Summary
The primary objective is to evaluate the efficacy and safety of efavaleukin alfa in subjects with active systemic lupus erythematosus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2021
150 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2020
CompletedFirst Posted
Study publicly available on registry
December 23, 2020
CompletedStudy Start
First participant enrolled
May 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 22, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 22, 2023
CompletedResults Posted
Study results publicly available
June 28, 2024
CompletedJune 28, 2024
June 1, 2024
2 years
December 18, 2020
May 21, 2024
June 26, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants Who Achieved a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response at Week 52
A participant achieved an SRI-4 response if all the following criteria were met: * ≥ 4-point reduction from baseline in Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) score (scale 0-105, with higher scores indicating more disease activity). * No new British-Isles Lupus Assessment Group (BILAG) A score and no \> 1 new BILAG B organ domain scores compared with baseline. The BILAG index evaluates disease activity in 9 separate organ systems. Each of the organ systems are allocated an alphabetical score of A (most active), B (moderate activity), C (minor activity), D (stable) or E (never present). * \< 0.3-points deterioration from baseline in Physician Global Assessment (PGA) visual analogue (VAS) score (scale 0 to 3, with higher scores indicating more severe disease). Participants were considered non-responders for using more than protocol-permitted therapies.
Week 52
Secondary Outcomes (30)
Number of Participants Who Achieved a BILAG-based Composite Lupus Assessment (BICLA) Response at Week 52
Week 52
Number of Participants Who Achieved a Lupus Low Disease Activity State (LLDAS) Response at Week 52
Week 52
Number of Participants With a Reduction of Oral Corticosteroids (OCS) to ≤ 7.5 mg/Day by Week 44 and Sustained Through Week 52 in Participants With a Baseline OCS Dose ≥ 10 mg/Day
Baseline to Week 52
Number of Participants Who Achieved a SRI-4 Response at Week 24
Week 24
Number of Participants Who Achieved a BICLA Response at Week 24
Week 24
- +25 more secondary outcomes
Study Arms (4)
Placebo + Standard of Care
PLACEBO COMPARATOREfavaleukin Alfa Dose Level One + Standard of Care
EXPERIMENTALEfavaleukin Alfa Dose Level Two + Standard of Care
EXPERIMENTALEfavaleukin Alfa Dose Level Three + Standard of Care
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (150)
University of Alabama at Birmingham,Arthritis Clinical Intervention Program
Birmingham, Alabama, 35294, United States
Arizona Arthritis and Rheumatology Associates PC
Gilbert, Arizona, 85297, United States
Arizona Arthritis And Rheumatology Associates PC
Glendale, Arizona, 85306, United States
Arizona Arthritis and Rheumatology Associates PC
Tucson, Arizona, 85704, United States
Loma Linda University Health Care
Loma Linda, California, 92354, United States
University of California Los Angeles
Los Angeles, California, 90024, United States
University of California Irvine
Orange, California, 92868, United States
Robin K Dore MD Inc
Tustin, California, 92780, United States
Arthritis and Rheumatic Disease Specialties
Aventura, Florida, 33180, United States
Life Clinical Trials
Aventura, Florida, 33180, United States
Centre for Rheumatology Immunology and Arthritis
Fort Lauderdale, Florida, 33309, United States
GNP Research
Hollywood, Florida, 33024, United States
Millennium Research
Ormond Beach, Florida, 32174, United States
Integral Rheumatology and Immunology Specialists
Plantation, Florida, 33324, United States
Suncoast Medical Clinic
St. Petersburg, Florida, 33710, United States
Baycare Medical Group Inc
Tampa, Florida, 33614, United States
University of Chicago
Chicago, Illinois, 60637, United States
Greater Chicago Specialty Physicians
Schaumburg, Illinois, 60195, United States
Clinic of Robert Hozman, MD - Clinical Investigational Specialists, Inc
Skokie, Illinois, 60076, United States
Western Kentucky Rheumatology PLLC
Hopkinsville, Kentucky, 42240, United States
Accurate Clinical Research
Lake Charles, Louisiana, 70605, United States
Michigan Rheumatology Group, PC - Grand Blanc Office
Grand Blanc, Michigan, 48439, United States
Arthritis and Rheumatology of Michigan
Lansing, Michigan, 48910, United States
New York University Langone Ambulatory Care Brooklyn Heights
Brooklyn, New York, 11201, United States
Feinstein Institute for Medical Research
Manhasset, New York, 11030, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210, United States
Institute for Clinical and Translation Research at Einstein and Montefiore Clinical Research Center
The Bronx, New York, 10461, United States
University of North Carolina at Chapel Hill Thurston Arthritis Research Center
Chapel Hill, North Carolina, 27599, United States
Joint and Muscle Research Institute
Charlotte, North Carolina, 28204, United States
DJL Clinical Research PLLC
Charlotte, North Carolina, 28210, United States
Javara
Charlotte, North Carolina, 28210, United States
Atrium Health Rheumatology
Charlotte, North Carolina, 28211, United States
Arthritis and Rheumatology Center of Oklahoma PLLC
Oklahoma City, Oklahoma, 73102, United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104, United States
University of Pittsburgh Medical Center Lupus Center of Excellence
Pittsburgh, Pennsylvania, 15213, United States
Columbia Arthritis Center, PA
Columbia, South Carolina, 29204, United States
Piedmont Arthritis Clinic
Greenville, South Carolina, 29601, United States
West Tennessee Research Institute, LLC
Jackson, Tennessee, 38305, United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920, United States
Ramesh C Gupta MD
Memphis, Tennessee, 38119, United States
Arthritis and Rheumatology Institute
Allen, Texas, 75013, United States
Precision Comprehensive Clinical Research Solutions
Colleyville, Texas, 76034, United States
Texas Arthritis Center PA
El Paso, Texas, 79902, United States
Biopharma Informatic, LLC
Houston, Texas, 77043, United States
Accurate Clinical Management
Houston, Texas, 77084, United States
Laila A Hassan, MD, PA
Houston, Texas, 77089, United States
Trinity Universal Research Associates, LLC
Plano, Texas, 75024, United States
Clinical Trials of Texas
San Antonio, Texas, 78229, United States
University of Texas Health Science Center at San Antonio Medical Arts Research Clinic Marc
San Antonio, Texas, 78229, United States
Arthritis and Osteoporosis Clinic
Waco, Texas, 76710, United States
Medizinische Universitaet Graz
Graz, 8036, Austria
Diagnostic-Consultative Center Sveti Georgi EOOD
Plovdiv, 40002, Bulgaria
Medical Center Excelsior OOD
Sofia, 1407, Bulgaria
Medical Center Academy EOOD
Sofia, 1612, Bulgaria
University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD
Sofia, 1612, Bulgaria
Toronto Western Hospital
Toronto, Ontario, M5T 2S8, Canada
Investigacion y Terapias Reumatologicas Innovadoras LTDA - Interin LTDA
Providencia, Santiago Metropolitan, 7500010, Chile
Enroll SpA
Providencia, Santiago Metropolitan, 7500587, Chile
Sociedad de prestaciones Medicas y Paramedicas Goecke Gatica y Compania Limitada - Prosalud
Providencia, Santiago Metropolitan, 7510047, Chile
Corporacion de Beneficiencia Osorno
Osorno, 5311092, Chile
Estudios Clinicos Limitada - Centro de Estudios Reumatologicos
Santiago, 7501126, Chile
CECIM
Santiago, 8320000, Chile
Sociedad de Prestaciones Medicas Intermedica Limitada
Valdivia, 5111847, Chile
Oncocentro Apys
Viña del Mar, 2520598, Chile
Hospital Pablo Tobon Uribe
Medellín, Antioquia, 050034, Colombia
Centro Integral de Reumatología del Caribe Circaribe SAS
Barranquilla, Atlántico, 080002, Colombia
Centro de Investigacion en Reumatologia y Especialidades Medicas SAS
Bogota, Cundinamarca, 110221, Colombia
Solano y Terront Servicios Medicos Ltda - Uniendo
Bogota, Cundinamarca, 110221, Colombia
Mediservis del Tolima IPS SAS
Ibagué, Tolima Department, 730006, Colombia
Centro Medico Julian Coronel
Cali, Valle del Cauca Department, 760035, Colombia
Centre Hospitalier Universitaire de Montpellier Hopital Lapeyronie
Montpellier, 34295, France
Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil
Strasbourg, 67091, France
Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil
Toulouse, 31059, France
Centre Hospitalier Universitaire de Nancy - Hopital de Brabois
Vandœuvre-lès-Nancy, 54511, France
Athens Naval Hospital
Athens, 11521, Greece
Laiko General Hospital
Athens, 11527, Greece
Attiko Hospital
Athens, 12462, Greece
University Hospital of Heraklion
Heraklion, 71500, Greece
Olympion Hospital-General Clinic of Patras AE
Pátrai, 26443, Greece
Euromedica - Kyanous Stavros
Thessaloniki, 54636, Greece
Ippokrateio Hospital of Thessaloniki
Thessaloniki, 54642, Greece
Tuen Mun Hospital
New Territories, Hong Kong
Azienda Ospedaliera Universitaria Careggi
Florence, 50139, Italy
Università degli studi della Campania Luigi Vanvitelli
Napoli, 80131, Italy
Azienda Ospedaliera di Padova
Padua, 35128, Italy
Azienda Ospedaliera Policlinico Umberto I
Roma, 00161, Italy
Policlinico Universitario Agostino Gemelli
Roma, 00168, Italy
Azienda Ospedaliera Ordine Mauriziano di Torino
Torino, 10128, Italy
Azienda Ospedaliero Universitaria Integrata Santa Maria della Misericordia
Udine, 33100, Italy
Centro Ricerche Cliniche
Verona, 37134, Italy
Japan Community Healthcare Organization Chukyo Hospital
Nagoya, Aichi-ken, 457-8510, Japan
Nagoya City University Hospital
Nagoya, Aichi-ken, 467-8602, Japan
National Hospital Organization Chibahigashi National Hospital
Chiba, Chiba, 260-8712, Japan
Hospital of the University of Occupational and Environmental Health Japan
Kitakyushu-shi, Fukuoka, 807-8556, Japan
Hiroshima University Hospital
Hiroshima, Hiroshima, 734-8551, Japan
Sapporo City General Hospital
Sapporo, Hokkaido, 060-8604, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 920-8641, Japan
Eiraku Clinic
Kagoshima, Kagoshima-ken, 890-0063, Japan
Kagoshima University Hospital
Kagoshima, Kagoshima-ken, 890-8520, Japan
St Marianna University Hospital
Kawasaki-shi, Kanagawa, 216-8511, Japan
National University Corporation Tohoku University Tohoku University Hospital
Sendai, Miyagi, 980-8574, Japan
Nagasaki University Hospital
Nagasaki, Nagasaki, 852-8501, Japan
Seirei Hamamatsu General Hospital
Hamamatsu, Shizuoka, 430-8558, Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo, 113-8431, Japan
St Lukes International Hospital
Chuo-ku, Tokyo, 104-8560, Japan
National Hospital Organization Tokyo Medical Center
Meguro-ku, Tokyo, 152-8902, Japan
Keio University Hospital
Shinjuku-ku, Tokyo, 160-8582, Japan
Center Hospital of the National Center for Global Health and Medicine
Shinjuku-ku, Tokyo, 162-8655, Japan
Centro Integral en Reumatologia SA de CV
Guadalajara, Jalisco, 44160, Mexico
Centro de Estudios de Investigacion Basica y Clinica, Sc
Guadalajara, Jalisco, 44690, Mexico
CITER SA de CV (Centro de Investigación y Tratamiento de las Enfermedades Reumáticas SA de CV)
Mexico City, Mexico City, 06700, Mexico
Eukarya Pharmasite sc
Monterrey, Nuevo León, 64718, Mexico
Centro de Investigacion Integral Medivest SC
Chihuahua City, 31203, Mexico
Phylasis Clínicas Research S. De R. L. De C. V.
Cuautitlán Izcalli, 54769, Mexico
Centrum medyczne intercore sp zoo
Bydgoszcz, 85-605, Poland
Centrum Medyczne Pratia Czestochowa
Częstochowa, 42-200, Poland
Centrum Badan Klinicznych Wojciech Brzezicki
Malbork, 82-200, Poland
NZOZ Lecznica MAK-MED sc
Nadarzyn, 05-830, Poland
Gabinety Lekarskie RIVERMED
Poznan, 61-441, Poland
Reumatop Grzegorz Rozumek, Karin Pistorius
Wroclaw, 52-210, Poland
Limited liability company Scientific Research Medical Complex Your Health
Kazan', 420097, Russia
FSBSI SRI of Rheumatology na V A Nasonova
Moscow, 115522, Russia
I M Sechenov First Medical University of the MoH of RF
Moscow, 119435, Russia
Saint-Petersburg State Budget Healthcare Institution Clinical Rheumatology Hospital 25
Saint Petersburg, 190068, Russia
LLC Medical Sanitary Unit №157
Saint Petersburg, 196066, Russia
Center for medical consultations and research - practice
Yaroslavl, 150003, Russia
Daegu Catholic Universtiy Medcial Center
Daegu, 42472, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Hanyang University Seoul Hospital
Seoul, 04763, South Korea
Ajou University Hospital
Suwon-si, Gyeonggi-do, 16499, South Korea
Hospital Universitario Reina Sofia
Córdoba, Andalusia, 14004, Spain
Hospital Infanta Luisa
Seville, Andalusia, 41010, Spain
Hospital Universitario Araba
Vitoria-Gasteiz, Basque Country, 01009, Spain
Hospital Universitario Hospiten Rambla
Santa Cruz de Tenerife, Canary Islands, 38001, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, 08041, Spain
Corporacio Sanitaria Parc Tauli
Sabadell, Catalonia, 08208, Spain
Hospital Clinico Universitario de Santiago
Santiago de Compostela, Galicia, 15706, Spain
Hospital Universitari i Politecnic La Fe
Valencia, Valencia, 46026, Spain
Universitaetsspital Basel
Basel, 4031, Switzerland
Kantonsspital St Gallen
Sankt Gallen, 9007, Switzerland
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301, Taiwan
Chung Shan Medical University Hospital
Taichung, 40201, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Cukurova Universitesi Balcali Hastanesi Saglik Uygulama ve Arastirma Merkezi
Adana, 01790, Turkey (Türkiye)
Hacettepe Universitesi Tip Fakultesi
Ankara, 06100, Turkey (Türkiye)
Akdeniz Universitesi Tip Fakultesi
Antalya, 07070, Turkey (Türkiye)
Istanbul Universitesi Istanbul Tip Fakultesi
Istanbul, 34093, Turkey (Türkiye)
Related Publications (1)
Garces S, Karis E, Merrill JT, Askanase AD, Kalunian K, Mo M, Milmont CE. Improving resource utilisation in SLE drug development through innovative trial design. Lupus Sci Med. 2023 Jul;10(2):e000890. doi: 10.1136/lupus-2022-000890.
PMID: 37491104DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
This study was discontinued early due to meeting predefined futility criteria at its third interim analysis.
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2020
First Posted
December 23, 2020
Study Start
May 6, 2021
Primary Completion
May 22, 2023
Study Completion
May 22, 2023
Last Updated
June 28, 2024
Results First Posted
June 28, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- 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.
- 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.
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request