A Study to Learn More About the Long-Term Safety of Litifilimab (BIIB059) Injections and it's Effects on Symptoms in Adults With Systemic Lupus Erythematosus (SLE) (EMERALD)
En multisenter, randomisert, doseblind, fase 3 langsiktig utvidelsesstudie for å evaluere kontinuerlig sikkerhet og effektivitet av BIIB059 hos voksne deltakere med aktiv systemisk lupus erythematosus
In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with systemic lupus erythematosus (SLE). The study will focus on adults who have active disease and are already taking standard of care medications. These may include antimalarials, steroids, and immunosuppressants. This is an extension study of 230LE303 and 230LE304 (TOPAZ-1 and TOPAZ-2). It will include participants who completed the treatment periods of either one of those parent studies.
The main goal of the study is to learn more about the long-term safety of litifilimab in adults. The main question researchers want to answer is:
- How many participants have adverse events and serious adverse events during the study? Adverse events are health problems that may or may not be caused by the study drug.
Researchers will also learn about:
- The effect of litifilimab on controlling symptoms of SLE and lowering its activity.
- How participants' immune systems respond to litifilimab.
- The effect of litifilimab on the quality of life of participants.
The study will be done as follows:
- This study begins when the participant has finished 1 of the parent studies (either 230LE303 or 230LE304).
- Participants who were getting either a high or low dose of litifilimab in either parent study will continue getting the same doses.
- Participants who were getting the placebo in the parent studies will be randomized to get either a high or low dose of litifilimab.
- Neither the researchers nor the participants will know which doses of litifilimab the participants are getting.
- All participants will get litifilimab as injections under the skin once every 4 weeks. The treatment period will last up to 260 weeks. Participants may continue to take their standard of care medications.
- There will be a follow-up safety period that lasts up to 24 weeks.
- In total, participants will have up to 73 study visits. At these visits, the study doctor will do tests to check the participants' overall health, including the status of their SLE symptoms. They will also measure the participants' height, weight, and vital signs and collect blood and urine samples. Participants will also complete questionnaires or answer questions about how they are feeling and about their daily lives.
- Each participant will be in the study for up to 284 weeks.
Optional Substudy:
- Some participants may be invited to join an optional "substudy" after being in the main study for at least 4 months.
- This substudy will test a new injector device for delivering litifilimab. The injector device is an automatic device that delivers the full dose in 1 injection without needing to push a plunger.
- Researchers will learn more about the safety of the injector device and how the body reacts to it. This will be compared to the current prefilled syringe method.
- The substudy will last up to 3 months and will include about 120 participants.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
This is an extension study for all participants who completed study 230LE303 (NCT04895241) and 230LE304 (NCT04961567) (parent phase 3 studies) through Week 52 and did not discontinue litifilimab or placebo. Eligible participants from parent phase 3 studies will be followed for up to 284 weeks.
The primary objective of this study is to evaluate the long-term safety and tolerability of litifilimab in participants with active systemic lupus erythematosus (SLE).
The secondary objectives of this study are to evaluate the long-term effect of litifilimab on disease activity in participants with SLE, to evaluate the long-term effect of litifilimab in participants with SLE in maintaining low disease activity, to evaluate the effect of litifilimab in participants with active SLE in preventing irreversible organ damage, to assess long-term use of oral corticosteroid (OCS) with participants receiving litifilimab treatment, to assess the impact of litifilimab on participant-reported Health-Related Quality-of-Life Questionnaire (HRQoL), symptoms, and impacts of SLE, to evaluate long-term effect of litifilimab on laboratory parameters, and to evaluate immunogenicity of litifilimab.
A phase-3, randomized, dose-blind, substudy is added in this extension study for all participants who have been enrolled in the 230LE306 Phase 3 LTE study for a minimum of 4 months and have at least four remaining visits in the Phase 3 LTE study.
The primary objective of this substudy is to evaluate the safety of injector device used for administering litifilimab in participants with active SLE.
The secondary objective of this substudy is to evaluate the tolerability of injector device used for administering litifilimab in participants with active SLE.
Studietype
Registrering (Antatt)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
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Buenos Aires, Argentina, 17251900
- Hospital Italiano de La Plata
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Buenos Aires, Argentina, 3151878
- Instituto de Investigaciones Clinicas Quilmes
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Buenos Aires, Argentina, 7600
- Cenemar SRL
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Ciudad Autonoma Buenos Aires, Argentina, 1425
- Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada
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Ciudad Autonoma Buenos Aires, Argentina, C1013AAB
- STAT Research S.A.
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Córdoba, Argentina, 5000
- Sanatorio Allende
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Mendoza, Argentina, 5500
- Instituto de Reumatologia
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San Juan, Argentina, 5400
- CER San Juan Centro Polivalente de Asistencia e Inv. Clinica
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Buenos Aires
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CABA, Buenos Aires, Argentina, C1015ABO
- Organizacion Medica de Investigacion (OMI)
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Mar del Plata, Buenos Aires, Argentina, 7600
- Centro de Investigaciones Medicas Mar del Plata
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Mar del Plata, Buenos Aires, Argentina, B7600GNY
- Policlìnica Red Omip S.A - Ensayos Clinicos GC
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San Miguel, Buenos Aires, Argentina, B1663
- Centro Dermatologico Schejtman
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Ciudad Autonoma Buenos Aires
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Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina, 1425
- Centro Medico Barrio Parque
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Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina, 1406
- APRILLUS Asistencia e Investigacion
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Mendoza Province
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Villa Nueva, Mendoza Province, Argentina, CP 5519
- Consultorio Alto Dorrego
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Santa Fe Province
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Rosario, Santa Fe Province, Argentina, S2000PBJ
- Instituto CAICI
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Tucumán Province
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San Miguel de Tucumán, Tucumán Province, Argentina, T4000ICL
- Investigaciones Clinicas Tucuman
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San Miguel de Tucumán, Tucumán Province, Argentina, 4000
- Clinica Mayo de Urgencias Medicas Cruz Blanca SRL
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San Miguel de Tucumán, Tucumán Province, Argentina, T4000AXL
- Centro de Investigaciones Medicas Tucuman
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Liège, Belgia, 4000
- Centre Hospitalier Universitaire de Liege
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São Paulo, Brasil, 04037-030
- RDSS Ricardo Diaz Scientific Solution
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São Paulo, Brasil, 01228-200
- CPCLIN - Centro de Pesquisas Clinicas
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Ceará
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Fortaleza, Ceará, Brasil, 60430-372
- HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará
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Espírito Santo
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Vitória, Espírito Santo, Brasil, 29055-450
- CEDOES - Diagnóstico e Pesquisa
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Estado de Bahia
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Salvador, Estado de Bahia, Brasil, 40150-150
- Clínica SER da Bahia
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Federal District
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Brasília, Federal District, Brasil, 70200-730
- L2IP - Instituto de Pesquisas Clínicas Ltda.
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Mato Grosso
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Santo Ângelo, Mato Grosso, Brasil, 78020-500
- IPC MT Instituto de Pesquisas Clinicas do Mato Grosso
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brasil, 30150-221
- Santa Casa de Misericordia de Belo Horizonte
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Juiz de Fora, Minas Gerais, Brasil, 36010-570
- CMiP - Centro Mineiro de Pesquisa
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Paraná
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Curitiba, Paraná, Brasil, 80030-110
- CETI - Centro de Estudos em Terapias Inovadoras Ltda.
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasil, 90480-000
- LMK Serviços Médicos S/S Ltda
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Porto Alegre, Rio Grande do Sul, Brasil, 90560032
- Hospital Moinhos de Vento
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Porto Alegre, Rio Grande do Sul, Brasil, 90035-903
- Hospital de Clínicas de Porto Alegre
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São Paulo
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Sao Jose Rio Preto, São Paulo, Brasil, 15090-000
- Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
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São Bernardo do Campo, São Paulo, Brasil, 09715-090
- Centro Multidisciplinar de Estudos Clínicos - CEMEC
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São Paulo, São Paulo, Brasil, 01228-200
- CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos
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Valinhos, São Paulo, Brasil, 13271-130
- A2Z Clinical Centro Avancado de Pesquisa Clinica
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Plovdiv, Bulgaria, 4003
- UMHAT-Plovdiv AD
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Plovdiv, Bulgaria, 4002
- MC Artmed OOD
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Plovdiv, Bulgaria, 4002
- UMHAT "Pulmed" OOD
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Rousse, Bulgaria, 7002
- DCC 1 - Ruse, EOOD
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Sofia, Bulgaria, 1431
- DCC 'Alexandrovska', EOOD
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Sofia, Bulgaria, 1606
- Military Medical Academy - MHAT - Sofia
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Sofia, Bulgaria, 1463
- DCC Focus 5 - MEOH OOD
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Sofia, Bulgaria, 1612
- UMHAT 'Sv. Ivan Rilski', EAD
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Ontario
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Toronto, Ontario, Canada, M5T 2S8
- Toronto Western Hospital
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Santiago, Chile, 7500710
- BioMedica Research Group
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Santiago, Chile, 7500000
- Centro Medico Prosalud
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Santiago, Chile, 7500571
- CTR Estudios
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Santiago, Chile, 7500587
- Enroll Spa
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Valdivia, Chile, 5090000
- Clinical Research Chile SpA.
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Armenia, Colombia, 630004
- Fundacion Cardiomet CEQUIN S.A.S
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Barranquilla, Colombia, 080020
- Centro de Investigacion Medico Asistencial S.A.S
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Barranquilla, Colombia, 080020
- Clínica de la Costa S.A.S
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Bogotá, Colombia, 110221
- Centro de Investigacion en Reumatologia y Especialidades Medicas CIREEM S.A.S.
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Bucaramanga, Colombia, 680003
- Servimed S.A.S.
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Chía, Colombia, 250001
- Preventive Care Ltda
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Floridablanca, Colombia, 681004
- Fundacion Oftalmologica de Santander - FOSCAL
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Manizales, Colombia, 170004
- IPS Medicos Internistas de Caldas S.A.S.
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Medellín, Colombia, 050021
- Centro de Investigacion Clinica CIC
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Zipaquirá, Colombia, 250252
- Healthy Medical Center
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Valle del Cauca Department
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Cali, Valle del Cauca Department, Colombia, 760001
- IPS Centro Medico Julian Coronel S.A.
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City of Taguig, Filippinene, 1642
- Ospital Ng Makati
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Iloilo City, Filippinene, 5000
- The Medical City Iloilo
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Mabalacat, Pampanga, Filippinene, 2023
- The Medical City Clark
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Manila, Filippinene, 1000
- Medical Center Manila
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Manila, Filippinene, 1012
- Jose R. Reyes Memorial Medical Center
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San Fernando City, La Union, Filippinene, 2500
- Lorma Medical Center
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Batangas
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Lipa City, Batangas, Filippinene, 4217
- Mary Mediatrix Medical Center
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Davao Region
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Davao City, Davao Region, Filippinene, 8000
- Davao Doctors Hospital
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National Capital Region
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Manila, National Capital Region, Filippinene, 1000
- University of the Philippines Manila - Philippine General Hospital
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Quezon City, National Capital Region, Filippinene, 1102
- St. Luke's Medical Center
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Quezon City, National Capital Region, Filippinene, 1118
- Far Eastern University - Dr. Nicanor Reyes Medical Foundation
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Arizona
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Phoenix, Arizona, Forente stater, 85037
- Arizona Arthritis & Rheumatology Associates, P.C.
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California
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Beverly Hills, California, Forente stater, 90211
- Wallace Rheumatic Study Center
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Huntington Beach, California, Forente stater, 92648
- Care Access Research - Huntington Beach
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Mission Hills, California, Forente stater, 91345
- Providence Facey Medical Foundation
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Upland, California, Forente stater, 91786
- Inland Rheumatology Clinical Trials, Inc.
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Colorado
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Aurora, Colorado, Forente stater, 80045
- University of Colorado Denver
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District of Columbia
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Washington D.C., District of Columbia, Forente stater, 20007-2113
- Georgetown University Hospital-Medstar
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Florida
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Aventura, Florida, Forente stater, 33180
- Arthritis & Rheumatic Disease Specialties
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Avon Park, Florida, Forente stater, 33825
- Highlands Research Institute
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Clearwater, Florida, Forente stater, 33765
- Clinical Research of West Florida - Corporate
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Cooper City, Florida, Forente stater, 33024
- GNP Research at Mark Jaffe, MD
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DeBary, Florida, Forente stater, 32713
- Omega Research Consultants
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Margate, Florida, Forente stater, 33063
- Life Clinical Trials
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Orlando, Florida, Forente stater, 32819
- HMD Research, LLC
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Tampa, Florida, Forente stater, 33606
- Clinical Research of West Florida, Inc.
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Tampa, Florida, Forente stater, 33613
- AdventHealth Medical Group
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Georgia
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Gainesville, Georgia, Forente stater, 30501
- Arthritis Center of North Georgia
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Massachusetts
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Worcester, Massachusetts, Forente stater, 01655
- University of Massachusetts Chan Medical School
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Michigan
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Flint, Michigan, Forente stater, 48504
- AA MRC LLC Ahmed Arif Medical Research Center
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Rochester Hills, Michigan, Forente stater, 48307
- Precision Comprehensive Clinical Research Solutions
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Missouri
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St Louis, Missouri, Forente stater, 63119
- Saint Louis Rheumatology
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New York
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Brooklyn, New York, Forente stater, 11220
- NYU Langone Brooklyn
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North Carolina
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Charlotte, North Carolina, Forente stater, 28210
- DJL Clinical Research, PLLC
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Salisbury, North Carolina, Forente stater, 28144
- Onyx Clinical Research, LLC
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Ohio
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Cincinnati, Ohio, Forente stater, 45219
- University of Cincinnati
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Middleburg Heights, Ohio, Forente stater, 44130
- Paramount Medical Research & Consulting, LLC
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Tennessee
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Jackson, Tennessee, Forente stater, 38305
- West Tennessee Research Institute
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Memphis, Tennessee, Forente stater, 38119
- Ramesh C Gupta, MD
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Texas
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Allen, Texas, Forente stater, 75013
- Arthritis & Rheumatology Research Institute
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Austin, Texas, Forente stater, 78745
- Tekton Research - PARENT
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Baytown, Texas, Forente stater, 77521
- Accurate Clinical Research
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Colleyville, Texas, Forente stater, 76034-5913
- Precision Comprehensive Clinical Research Solution
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Houston, Texas, Forente stater, 77054
- Prolato Clinical Research Center
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Humble, Texas, Forente stater, 77338
- Accurate Clinical Research, Inc.
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Katy, Texas, Forente stater, 77450
- R and H Clinical Research
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San Antonio, Texas, Forente stater, 78215
- Sun Research Institute, LLC
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The Woodlands, Texas, Forente stater, 77382
- Advanced Rheumatology of Houston
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Washington
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Seattle, Washington, Forente stater, 98104
- Swedish Medical Center
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Drôme
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Clermont-Ferrand, Drôme, Frankrike, 63003
- CHU Clermont Ferrand - Hopital Gabriel Montpied
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Attica
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Athens, Attica, Hellas, 11521
- NNA Hospital
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Haifa, Israel, 3109601
- Rambam Health Care Campus
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Kfar Saba, Israel, 44281
- Meir Medical Center
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Ramat Gan, Israel, 5265601
- Chaim Sheba Medical Center
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Tel Aviv, Israel, 6423906
- Tel Aviv Sourasky Medical Center Pt
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Roma, Italia, 152
- Azienda Ospedaliera San Camillo Forlanini
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Aichi-ken
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Nagoya, Aichi-ken, Japan, 457-8510
- JCHO Chukyo Hospital
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Toyoake-shi, Aichi-ken, Japan, 470-1192
- Fujita Health University Hospital
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Chiba
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Chiba, Chiba, Japan, 260-8712
- NHO Chibahigashi National Hospital
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Fukuoka
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Fukuoka, Fukuoka, Japan, 810-8539
- KKR Hamanomachi Hospital
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Fukuoka, Fukuoka, Japan, 810-8563
- NHO Kyushu Medical Center
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Kitakyushu-shi, Fukuoka, Japan, 807-8556
- Hospital of the University of Occupational and Environmental Health
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Hiroshima
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Hiroshima, Hiroshima, Japan, 734-8551
- Hiroshima University Hospital
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Hokkaido
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Sapporo, Hokkaido, Japan, 060-0004
- Tonan Hospital
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Hyōgo
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Himeji-shi, Hyōgo, Japan, 670-8540
- Japanese Red Cross Society Himeji Hospital
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Kobe, Hyōgo, Japan, 650-0017
- Kobe University Hospital
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Kobe, Hyōgo, Japan, 650-0047
- Kobe City Hospital Organization Kobe City Medical Center General Hospital
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Kagawa-ken
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Kita-gun, Kagawa-ken, Japan, 761-0793
- Kagawa University Hospital
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Kagoshima-ken
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Kagoshima, Kagoshima-ken, Japan, 890-0063
- Eiraku Clinic
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Kanagawa
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Yokohama, Kanagawa, Japan, 232-0024
- Yokohama City University Medical Center
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Yokohama, Kanagawa, Japan, 245-8575
- NHO Yokohama Medical Center
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Kumamoto
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Kumamoto, Kumamoto, Japan, 861-8520
- Japanese Red Cross Kumamoto Hospital
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Osaka
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Kawachinagano-shi, Osaka, Japan, 586-8521
- NHO Osaka Minami Medical Center
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Osakasayama-shi, Osaka, Japan, 589-8511
- Kindai University Hospital
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Tokyo-To
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Meguro-ku, Tokyo-To, Japan, 153-8515
- Toho University Ohashi Medical Center
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Shinjuku-ku, Tokyo-To, Japan, 162-8655
- Center Hospital of the National Center for Global Health and Medicine
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tabashi City, Tokyo-To, Japan, 173-8610
- Nihon University Itabashi Hospital
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Changchun, Kina, 130021
- The First Hospital of Jilin University
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100053
- Xuanwu Hospital Capital Medical University
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Guangdong
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Dongguan, Guangdong, Kina, 523059
- Dongguan People's Hospital
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Guangzhou, Guangdong, Kina, 510317
- Guangdong Second Provincial General Hospital
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Guangzhou, Guangdong, Kina, 510515
- Nanfang Hospital of Southern Medical University
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Shenzhen, Guangdong, Kina, 518020
- Shenzhen People's Hospital
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Zhongshan, Guangdong, Kina, 528400
- Zhongshan TCM Hospital
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Hainan
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Haikou, Hainan, Kina, 570311
- Hainan General Hospital
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Hebei
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Shijiazhuang, Hebei, Kina, 50000
- The Second Hospital of Hebei Medical University
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Hu'nan
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Changsha, Hu'nan, Kina, 410008
- Xiangya Hospital, Central South University
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Zhuzhou, Hu'nan, Kina, 412000
- ZhuZhou Central Hospital
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Jiangsushe
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Suzhou, Jiangsushe, Kina, 215004
- The Second Affiliated Hospital of Soochow University
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Jiangxi
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Jiujiang, Jiangxi, Kina, 332000
- Jiujiang No.1 People's Hospital
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Pingxiang, Jiangxi, Kina, 337055
- Pingxiang People's Hospital
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Jilin
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Changchun, Jilin, Kina, 130021
- Jilin Province People's Hospital
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Shandong
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Binzhou, Shandong, Kina, 256603
- Binzhou Medical University Hospital
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200001
- Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch
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Zhejiang
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Ningbo, Zhejiang, Kina, 315010
- The First Affiliated Hospital of Ningbo University
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Chihuahua City, Mexico, 31000
- Investigacion y Biomedicina de Chihuahua, S.C.
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Durango, Mexico, 34080
- Centro de Investigacion y Atencion Integral Durango CIAID
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Jalisco
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Guadalajara, Jalisco, Mexico, 44650
- Clinica de Investigacion en Reumatologia y Obesidad S.C.
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Guadalajara, Jalisco, Mexico, 44950
- Centro de investigacion medica y reumatologia
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Mexico City
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Mexico City, Mexico City, Mexico, 06700
- Clinstile, S.A. de C.V.
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Mexico City, Mexico City, Mexico, 03720
- Centro de Investigacion Clínica GRAMEL S.C
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Mexico City, Mexico City, Mexico, 14080
- Instituto Nacional de Ciencias Medicas y Nutricion Dr. Salvador Zubiran
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Morelos
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Cuernavaca, Morelos, Mexico, 62448
- Consultorio Privado Dr. Miguel Cortes Hernandez
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Nuevo León
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Monterrey, Nuevo León, Mexico, 64000
- Accelerium S. de R.L. de C.V.
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Yucatán
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Mérida, Yucatán, Mexico, 97000
- Centro Peninsular de Investigacion Clinica, SCP
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Mérida, Yucatán, Mexico, 97070
- Medical Care & Research SA de CV
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Lima, Peru, LIMA 29
- HMA - Hospital Maria Auxiliadora
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Lima, Peru, LIMA 11
- Centro de Investigacion Clinica Inmunoreumatologia - ACQ Medic
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Lima, Peru, LIMA 33
- Invest Clinicas Sac Inst de Ginecologia y Reproduccion
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Bialystok, Polen, 15-707
- Nova Reuma Domysławska i Rusiłowicz, Spółka Partnerska Lekarza Reumatologa i Fizjoterapeuty
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Bydgoszcz, Polen, 87-100
- Szpital Uniwersytecki nr 2 im.dr J. Biziela
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Bytom, Polen, 41-902
- Nzoz Bif-Med
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Krakow, Polen, 30-510
- Pratia MCM Krakow
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Malbork, Polen, 82-200
- Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. z o.o.
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Poznan, Polen, 61-441
- Gabinety Lekarskie Rivermed
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Poznan, Polen, 61-397
- Prywatna Praktyka Lekarska prof Pawel Hrycaj
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Warsaw, Polen, 00-874
- MICS Centrum Medyczne Warszawa
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Warsaw, Polen, 00-719
- Przychodnia Care Access Warszawa
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Caguas, Puerto Rico, 00725
- Centro Reumatologico
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Brasov, Romania, 500283
- S.C Centrul Medical de Diagnostic si Tratament Ambulator Neomed S.R.L
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Bucharest, Romania, 14142
- S C Delta Health Care SRL
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Bucharest, Romania, 041303
- HIPERDIA SA- Centrul de Diagnostic si Tratament Hiperdia Oltenitei
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Cluj-Napoca, Romania, 400006
- Spitalul Clinic Judetean de Urgenta Cluj Napoca
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Iași, Romania, 700023
- S.C.Centrul Medical Unirea SRL
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Belgrade, Serbia, 11000
- Institute of Rheumatology
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Belgrade, Serbia, 11000
- University Clinical Center of Serbia
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Belgrade, Serbia, 11080
- Clinical Center "Bezanijska Kosa "
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Barcelona, Spania, 08035
- Hospital Universitari Vall d'Hebron
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Seville, Spania, 41010
- Hospital Quironsalud Infanta Luisa
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Castellón
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Castellon, Castellón, Spania, 12004
- Hospital General de Castellon
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Santander, Castellón, Spania, 39008
- Hospital Universitario Marques de Valdecilla
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Sevilla
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Seville, Sevilla, Spania, 41009
- Hospital Universitario Virgen Macarena
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Greater London
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London, Greater London, Storbritannia, SE1 9RT
- Guy's Hospital
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South Yorkshire
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Doncaster, South Yorkshire, Storbritannia, DN2 5LT
- Doncaster Royal Infirmary
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Staffordshire
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Cannock, Staffordshire, Storbritannia, WS11 5XY
- Cannock Chase Hospital
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Seoul, Sør -Korea, 4763
- Hanyang University Seoul Hospital
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Gyeonggi-do
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Suwon, Gyeonggi-do, Sør -Korea, 16499
- Ajou University Hospital
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Kaohsiung City, Taiwan, 833401
- Kaohsiung Chang Gung Memorial Hospital
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Taichung, Taiwan, 40201
- Chung Shan Medical University Hospital
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Brno, Tsjekkia, 63800
- Revmatologie s.r.o.
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Olomouc, Tsjekkia, 77520
- Fakultni nemocnice Olomouc
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Cherkasy, Ukraina, 18009
- CNE Cherkasy Regional Hospital of Cherkasy Regional Council,
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Ivano-Frankivsk, Ukraina, 76018
- CNE Regional Clinical Hospital of IFRC, Center of Cardiology, Rheumatology & Interventional Med.;
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Kyiv, Ukraina, 02125
- CNE Kyiv City Clinical Hospital #3
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Poltava, Ukraina, 36011
- CE M.V. Sklifosovskyi Poltava Regional Clinical Hospital of PRC
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Vinnytsia, Ukraina, 21018
- University Clinic of NPMMU, Vinnytsya (TESC). Dep of Rheumatology with therapeutic beds,
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Vinnytsia, Ukraina, 21001
- Private Small Enterprise, Medical Centre 'Pulse'
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Vinnytsia, Ukraina, 21008
- CNE M.I. Pyrohov Vinnytsia Reg Clinic Hosp, HSC Center of Rheumatol, Osteoporosis & Biologic Therapy
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Budapest, Ungarn, 1097
- Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
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Gyula, Ungarn, 5700
- Bekes Varmegyei Kozponti Korhaz
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Veszprém, Ungarn, 8200
- Vital Medical Center
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Fejér
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Székesfehérvár, Fejér, Ungarn, 8000
- Vita Verum Medical Egeszsegugyi Szolgaltato Bt.
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Key Inclusion Criteria:
- Participants who completed 1 of the 52-week of the double-blind placebo-controlled, parent Phase 3 studies (230LE303 (NCT04895241) and 230LE304 (NCT04961567)) on study treatments with either litifilimab or placebo to Week 48 and attended the last study assessment visit at Week 52.
Key Exclusion Criteria:
- Early parent Phase 3 studies treatment terminators (participants who discontinued study treatment before Week 52)
- Early parent Phase 3 studies terminators (participants who withdrew from study participation and did not complete the 52-week treatment period)
- Participants who developed moderate-to-severe worsening of organ-specific lupus manifestations that would require a change in antimalarials and/or immunosuppressive therapy (initiation of new treatment or increase in dose above the allowed maximum dose)
- Use of other investigational drugs or off-label drugs used to treat SLE, cutaneous lupus, or lupus nephritis during the parent Phase 3 studies.
NOTE: Other inclusion/exclusion criteria may apply.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Litifilimab Low Dose
Participants who are receiving background nonbiologic lupus standard of care (SOC) therapy and received litifilimab low dose, subcutaneously (SC), every 4 weeks (Q4W) during the parent Phase 3 studies (i.e. studies 230LE303 [NCT04895241] or 230LE304 [NCT04961567]) will continue to receive litifilimab low dose, SC, Q4W from Day 1 to 260 weeks with an additional dose of litifilimab-matching placebo at Week 2. Participants who are receiving background nonbiologic lupus SOC therapy and received litifilimab-matching placebo in the parent Phase 3 studies (i.e. studies 230LE303 [NCT04895241] or 230LE304 [NCT04961567]) will be randomized to receive litifilimab low dose, SC, Q4W from Day 1 to 260 weeks with an additional dose at Week 2. |
Administered as specified in the treatment arm.
Andre navn:
Administered as specified in the treatment arm.
Andre navn:
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Eksperimentell: Litifilimab High Dose
Participants who are receiving background nonbiologic lupus SOC therapy and received litifilimab high dose, SC, Q4W during the parent Phase 3 studies (i.e. studies 230LE303 [NCT04895241] or 230LE304 [NCT04961567]) will continue to receive litifilimab high dose, SC, Q4W from Day 1 to 260 weeks with an additional dose of litifilimab-matching placebo at Week 2. Participants who are receiving background nonbiologic lupus SOC therapy and received litifilimab-matching placebo in the parent Phase 3 studies (i.e. studies 230LE303 [NCT04895241] or 230LE304 [NCT04961567]) will be randomized to receive litifilimab high dose, SC, Q4W from Day 1 to 260 weeks with an additional dose at Week 2. |
Administered as specified in the treatment arm.
Andre navn:
Administered as specified in the treatment arm.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Tidsramme: Up to Week 284
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An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is an AE that started or worsened in severity after the first dose of study treatment through 28 days after the last dose of study treatment or end of study (EOS) date, whichever comes earlier. |
Up to Week 284
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Number of Participants with Serious Adverse Events (SAEs)
Tidsramme: Up to Week 284
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An SAE is any untoward medical occurrence that at any dose results in death, in the view of the Investigator, places the participant at immediate risk of death (a life threatening event), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, and is a medically important event. |
Up to Week 284
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Percentage of Participants who Achieved an Systemic Lupus Erythematosus Responder Index (SRI)-4 Response
Tidsramme: Up to Week 284
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SRI-4 is a composite endpoint defined as the following:
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Up to Week 284
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Percentage of Participants With at Least 4 Joints (Both Swollen and Tender) at Baseline who Achieved a Joint-50 Response
Tidsramme: Up to Week 284
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Joint-50 response is a 50% reduction in total active joint count from baseline. An active joint is defined as a joint with pain and signs of inflammation (e.g., tenderness, swelling or effusion). A 28-joint assessment will be performed to determine the active joint count, which is defined as the sum of tender and swollen joint counts. |
Up to Week 284
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Percentage of Participants With a Cutaneous Lupus Erythematosus Disease Area and Severity Index - Activity (CLASI-A) Score ≥10 at Baseline who Achieved a CLASI-50, CLASI-70, and CLASI-90 Response
Tidsramme: Up to Week 284
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CLASI score is used to evaluate lupus skin manifestations. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Scores for each area are assigned based on the most severe lesion within the area of interest. CLASI-A scores of 0 to 9, 10 to 20, and 21 to 70 represent disease severity of mild, moderate, and severe, respectively. CLASI-50, CLASI-70, and CLASI-90 responders are defined as ≥ 50%, ≥ 70%, and ≥ 90% improvement in CLASI-A score from baseline at the specified timepoint. |
Up to Week 284
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Percentage of Participants who Achieved a British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA) Response
Tidsramme: Up to Week 260
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BICLA is a composite endpoint defined as the following:
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Up to Week 260
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Annualized Severe Safety of Estrogens in Systemic Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index Flare Index (SFI) Flare Rate
Tidsramme: Up to Week 260
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A severe flare is defined as any of the following:
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Up to Week 260
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Percentage of Time Spent in Lupus Low Disease Activity State (LLDAS)
Tidsramme: Up to Week 284
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LLDAS is a composite endpoint defined as the following: i. SLEDAI-2K score ≤ 4, with no activity in a major organ system (renal, central nervous system, cardiopulmonary, vasculitis, fever); and ii. No new features of lupus disease activity compared with the previous assessment; and iii. SELENA-SLEDAI PGA ≤ 1; and iv. Current prednisone (or equivalent) dose ≤ 7.5 mg/day; and v. Standard maintenance doses of immunosuppressive drugs and approved biological agents. "No new features" is defined as any new SLEDAI-2K component that was not present at the previous assessment. The SELENA-SLEDAI PGA Scale ranges from 0-3, where 0 is no disease activity and 3 is maximum disease activity. "Standard maintenance doses" include drugs limited to those allowed per protocol. |
Up to Week 284
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Percentage of Participants With Sustained LLDAS
Tidsramme: Up to Week 284
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LLDAS is a composite endpoint defined as the following: i. SLEDAI-2K score ≤ 4, with no activity in a major organ system (renal, central nervous system, cardiopulmonary, vasculitis, fever); and ii. No new features of lupus disease activity compared with the previous assessment; and iii. SELENA-SLEDAI PGA ≤ 1; and iv. Current prednisone (or equivalent) dose ≤ 7.5 mg/day; and v. Standard maintenance doses of immunosuppressive drugs and approved biological agents. "No new features" is defined as any new SLEDAI-2K component that was not present at the previous assessment. The SELENA-SLEDAI PGA Scale ranges from 0-3, where 0 is no disease activity and 3 is maximum disease activity. "Standard maintenance doses" include drugs limited to those allowed per protocol. |
Up to Week 284
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Duration of Sustained LLDAS as Defined by the Number of Visits in LLDAS
Tidsramme: Up to Week 284
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LLDAS is a composite endpoint defined as the following: i. SLEDAI-2K score ≤ 4, with no activity in a major organ system (renal, central nervous system, cardiopulmonary, vasculitis, fever); and ii. No new features of lupus disease activity compared with the previous assessment; and iii. SELENA-SLEDAI PGA ≤ 1; and iv. Current prednisone (or equivalent) dose ≤ 7.5 mg/day; and v. Standard maintenance doses of immunosuppressive drugs and approved biological agents. "No new features" is defined as any new SLEDAI-2K component that was not present at the previous assessment. The SELENA-SLEDAI PGA Scale ranges from 0-3, where 0 is no disease activity and 3 is maximum disease activity. "Standard maintenance doses" include drugs limited to those allowed per protocol. |
Up to Week 284
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Annual Change From Baseline Value From the Parent Phase 3 Studies in Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) Score
Tidsramme: Up to Week 260
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SDI score is used to assess the accumulated damage in participants with SLE. It assess 12 organ systems and records damage in participants with lupus, regardless of its cause. Damage could be due to previous disease activity, medication, or intercurrent illness (such as surgery or cancer). To distinguish between active inflammation and damage, an item must be present for at least 6 months. It is assumed that persistent inflammation (for at least 6 months) would result in tissue injury and hence damage. SDI is evaluated on a scale 0-47 with higher score indicating higher damage. |
Up to Week 260
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Cumulative Exposure to OCS Over Time
Tidsramme: Up to Week 260
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Up to Week 260
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Percentage of Participants With OCS ≤7.5 mg
Tidsramme: Up to Week 260
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Up to Week 260
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Percentage of Participants With OCS ≤5 mg
Tidsramme: Up to Week 260
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Up to Week 260
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Change From Baseline in Lupus-Specific Health-Related Quality-Of-Life (LupusQoL) Score
Tidsramme: Up to Week 260
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The LupusQoL is a participant-reported, lupus-specific, HRQoL questionnaire consisting of 34 items grouped in 8 domains: physical health, pain, planning, intimate relationships, burden to others, emotional health, body image and fatigue. Participants indicate their responses on a 5-point Likert response format, where 4 = never, 3 = occasionally, 2 = a good bit of the time, 1 = most of the time, and 0 = all the time. A LupusQoL score for each domain will be reported on a 0 to 100 scale, with greater values indicating better HRQoL. |
Up to Week 260
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Change From Baseline in Short Form Health Survey-36 (SF-36) (Acute Version) Score
Tidsramme: Up to Week 156
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The SF-36 is a 36-item scale which assesses HRQoL in 8 domains: limitations in physical activities due to health problems, limitations in social activities due to physical or emotional problems, limitations in usual role activities due to physical health problems, bodily pain, general mental health (psychological distress and well-being), limitations in usual role activities due to emotional problems, vitality (energy and fatigue), general health perceptions. The SF-36 (Acute Version) form asks for participants to reply to questions (items) according to how they have felt over a specifically defined period of time. Items 1-4 primarily contribute to the physical component summary (PCS) score of the SF-36. Items 5-8 primarily contribute to the mental component summary (MCS) score of the SF-36 where higher scores indicate best health. Scores on each item are summed and averaged (range: 0=worse health to 100=best possible health). |
Up to Week 156
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Change From Baseline in European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L)
Tidsramme: Up to Week 156
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The EQ-5D is a standardized generic measure of health status developed by the European Quality of Life Group. This study uses the EQ-5D-3L version of the instrument. This instrument consists of 2 sections. The first section comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. All dimensions are measured on a 3-point scale, 1: No problems; 2: Some problems; 3: Extreme problems. The second section comprises the Visual Analogue Scale, which records the respondent's self-rated health on a vertical scale ranging from 0 to 100, lower scores indicate the worst possible health state. |
Up to Week 156
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Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score
Tidsramme: Up to Week 260
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The FACIT-Fatigue is a participant-administered HRQoL questionnaire that evaluates participant's fatigue in 5 broad categories: physical well-being, social/family well-being, emotional well-being, functional well-being and additional concerns. The level of fatigue is measured by questions assessed on a 5-point scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much). The responses for each item are added to obtain a total score which ranges from 0 to 52, with a higher score indicating less fatigue. |
Up to Week 260
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Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Score
Tidsramme: Up to Week 260
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The PHQ-9 is a participant-administered HRQoL questionnaire to screen for the presence and severity of depression. The PHQ-9 is a participant-reported outcome (PRO) that is used to measure depression in adults. It contains 9 questions, with a 2 week recall period. The PHQ-9 yields an overall severity score that can range from 0 to 27 with the following severity scores: 0-4 = none; 5-9 = mild; 10-14 = moderate; 15-19 = moderate-to-severe; and 20-27 = severe. |
Up to Week 260
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Change From Baseline in Work Productivity and Activity Impairment (WPAI):Lupus Score
Tidsramme: Up to Week 260
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WPAI questionnaire is a validated instrument to measure impairments in work and activities. The WPAI yields four types of scores: 1. Absenteeism (work time missed) 2. Presenteesism (impairment at work / reduced on-the-job effectiveness) 3. Work productivity loss (overall work impairment / absenteeism plus presenteeism) 4. Activity Impairment. Each score ranges from 0 to 100, with higher numbers indicating greater impairment and less productivity. |
Up to Week 260
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Change from Baseline in Patient Global Assessment (PtGA) Score
Tidsramme: Up to Week 260
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The PtGA is participant-administered, single-item question evaluating the impact of health and illness, with responses ranging from very poor to very well on a 100 mm VAS. The participant will consider the previous week when addressing this question. |
Up to Week 260
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Number of Participants with Clinically Relevant Abnormalities in Standard Laboratory Parameters
Tidsramme: Up to Week 284
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Standard laboratory parameters will include hematology, blood chemistry, urinalysis, and coagulation. |
Up to Week 284
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Number of Participants with Clinically Relevant Abnormalities in Electrocardiogram (ECG) Results
Tidsramme: Up to Week 260
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Up to Week 260
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Number of Participants with Antibodies to Litifilimab
Tidsramme: Up to Week 284
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Up to Week 284
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Medical Director, Biogen
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 230LE306
- 2021-006378-22 (EudraCT-nummer)
- 2023-505635-13 (Annen identifikator: EU CTIS Number)
- 2023 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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