Clinical trial NCT05352919: An Extension Study to Learn More About the Long-Term Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus
Official title: A Multicenter, Randomized, Dose-Blind, Phase 3 Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of Litifilimab (BIIB059) in Adult Participants With Active Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE3
Conditions: Systemic Lupus Erythematosus (SLE)
Keywords: Lupus Erythematosus
Systemic Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2022-04-29
Enrollment: 864
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 participants 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 enroll participants who completed the treatment periods of either one of the parent studies.

The main objective of the study is to learn more about the long-term safety of litifilimab. The main question researchers want to answer is:

- How many participants have adverse events and serious adverse events? Researchers will also learn about the effect litifilimab has on controlling symptoms of SLE and lowering its activity. They will measure symptoms of SLE over time using a variety of scoring tools. These include the SLE Responder Index (SRI), the Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K), and the British Isles Lupus Activity Group-2004 (BILAG-2004), among others.

Researchers will also study how participants' immune systems respond to litifilimab. Additionally, they will measure the effect litifilimab and SLE have on the quality of life of participants using a group of questionnaires.

The study will be done as follows:

* The Week 52 visit of studies 230LE303 and 230LE304 will be Day 1 of this study.
* Participants who were receiving either a high or low dose of litifilimab in the parent studies will continue receiving the same doses.
* Participants who were receiving placebo in the parent studies will be randomized to receive either a high or low dose of litifilimab.
* All participants will receive litifilimab as injections under the skin once every 4 weeks. The treatment period will last 156 weeks. Participants will continue to take their standard of care medications.
* Neither the researchers nor the participants will know which doses of litifilimab the participants are receiving.
* There will be a follow-up safety period that lasts up to 24 weeks.
* In total, participants will have up to 47 study visits. The total study duration for participants will be up to 180 weeks.

Detailed description: 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 180 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants with Treatment Emergent Adverse Events (TEAEs)
timeFrame: Up to Week 180
measure: Number of Participants with Serious Adverse Events (SAEs)
timeFrame: Up to Week 180
Secondary outcomes:
measure: Percentage of Participants who Achieved an Systemic Lupus Erythematosus Responder Index (SRI)-4 Response
timeFrame: Up to Week 180
measure: Percentage of Participants With at Least 4 Joints (Both Swollen and Tender) at Baseline who Achieved a Joint-50 Response
timeFrame: Up to Week 180
measure: 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
timeFrame: Up to Week 180
measure: Percentage of Participants who Achieved a British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA) Response
timeFrame: Up to Week 180
measure: Annualized Severe Safety of Estrogens in Systemic Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index Flare Index (SFI) Flare Rate
timeFrame: Up to Week 156
measure: Percentage of Time Spent in Lupus Low Disease Activity State (LLDAS)
timeFrame: Up to Week 180
measure: Percentage of Participants With Sustained LLDAS
timeFrame: Up to Week 180
measure: Duration of Sustained LLDAS as Defined by the Number of Visits in LLDAS
timeFrame: Up to Week 180
measure: 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
timeFrame: Up to Week 156
measure: Cumulative Exposure to OCS Over Time
timeFrame: Up to Week 156
measure: Percentage of Participants With OCS ≤7.5 mg
timeFrame: Up to Week 156
measure: Percentage of Participants With OCS ≤5 mg
timeFrame: Up to Week 156
measure: Change From Baseline in Lupus-Specific Health-Related Quality-Of-Life (LupusQoL) Score
timeFrame: Up to Week 156
measure: Change From Baseline in Short Form Health Survey-36 (SF-36) (Acute Version) Score
timeFrame: Up to Week 156
measure: Change From Baseline in European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L)
timeFrame: Up to Week 156
measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score
timeFrame: Up to Week 156
measure: Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Score
timeFrame: Up to Week 156
measure: Change From Baseline in Work Productivity and Activity Impairment (WPAI):Lupus Score
timeFrame: Up to Week 156
measure: Change from Baseline in Patient Global Assessment (PtGA) Score
timeFrame: Up to Week 156
measure: Number of Participants with Clinically Relevant Abnormalities in Standard Laboratory Parameters
timeFrame: Up to Week 180
measure: Number of Participants with Clinically Relevant Abnormalities in Electrocardiogram (ECG) Results
timeFrame: Up to Week 156
measure: Number of Participants with Antibodies to Litifilimab
timeFrame: Up to Week 180
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Arthritis & Rheumatology Associates, P.C.
state: Arizona
city: Beverly Hills
country: United States
facility: Wallace Rheumatic Study Center
state: California
city: Huntington Beach
country: United States
facility: Care Access Research - Huntington Beach
state: California
city: Mission Hills
country: United States
facility: Providence Facey Medical Foundation
state: California
city: Upland
country: United States
facility: Inland Rheumatology Clinical Trials, Inc.
state: California
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Washington
country: United States
facility: Georgetown University Hospital-Medstar
state: District of Columbia
city: Aventura
country: United States
facility: Arthritis & Rheumatic Disease Specialties
state: Florida
city: Clearwater
country: United States
facility: Clinical Research of West Florida - Corporate
state: Florida
city: DeBary
country: United States
facility: Omega Research Consultants
state: Florida
city: Margate
country: United States
facility: Life Clinical Trials
state: Florida
city: Tampa
country: United States
facility: AdventHealth Medical Group
state: Florida
city: Gainesville
country: United States
facility: Arthritis Center of North Georgia
state: Georgia
city: Worcester
country: United States
facility: University of Massachusetts Chan Medical School
state: Massachusetts
city: Flint
country: United States
facility: AA MRC LLC Ahmed Arif Medical Research Center
state: Michigan
city: Saint Louis
country: United States
facility: Saint Louis Rheumatology
state: Missouri
city: Brooklyn
country: United States
facility: NYU Langone Brooklyn
state: New York
city: Charlotte
country: United States
facility: DJL Clinical Research, PLLC
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Middleburg Heights
country: United States
facility: Paramount Medical Research & Consulting, LLC
state: Ohio
city: Jackson
country: United States
facility: West Tennessee Research Institute
state: Tennessee
city: Memphis
country: United States
facility: Ramesh C Gupta, MD
state: Tennessee
city: Colleyville
country: United States
facility: Precision Comprehensive Clinical Research Solution
state: Texas
city: Colleyville
country: United States
facility: Precision Comprehensive Clinical Research Solutions
state: Texas
city: Humble
country: United States
facility: Accurate Clinical Research, Inc.
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute, LLC
state: Texas
city: Stafford
country: United States
facility: Accurate Clinical Research
state: Texas
city: The Woodlands
country: United States
facility: Advanced Rheumatology of Houston
state: Texas
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Mar del Plata
country: Argentina
facility: Centro de Investigaciones Medicas Mar del Plata
state: Buenos Aires
city: San Miguel
country: Argentina
facility: Centro Dermatologico Schejtman
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Centro Medico Barrio Parque
state: Ciudad Autonoma Buenos Aires
city: Rosario
country: Argentina
facility: Instituto CAICI
state: Santa Fe
city: San Miguel de Tucuman
country: Argentina
facility: Centro de Investigaciones Medicas Tucuman
state: Tucuman
city: San Miguel de Tucuman
country: Argentina
facility: Investigaciones Clinicas Tucuman
state: Tucuman
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de La Plata
city: Buenos Aires
country: Argentina
facility: Instituto de Investigaciones Clinicas Quilmes
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: STAT Research S.A.
city: Mendoza
country: Argentina
facility: Instituto de Reumatologia
city: San Juan
country: Argentina
facility: CER San Juan Centro Polivalente de Asistencia e Inv. Clinica
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire de Liege
city: Salvador
country: Brazil
facility: Clínica SER da Bahia
state: Bahia
city: Fortaleza
country: Brazil
facility: HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará
state: Ceara
city: Brasilia
country: Brazil
facility: L2IP - Instituto de Pesquisas Clínicas Ltda.
state: Distrito Federal
city: Santo Ângelo
country: Brazil
facility: IPC MT Instituto de Pesquisas Clinicas do Mato Grosso
state: Mato Grosso
city: Belo Horizonte
country: Brazil
facility: Santa Casa de Misericordia de Belo Horizonte
state: Minas Gerais
city: Juiz de Fora
country: Brazil
facility: CMiP - Centro Mineiro de Pesquisa
state: Minas Gerais
city: Curitiba
country: Brazil
facility: CETI - Centro de Estudos em Terapias Inovadoras Ltda.
state: Paraná
city: Porto Alegre
country: Brazil
facility: LMK Serviços Médicos S/S Ltda
state: Rio Grande Do Sul
city: Sao Jose Rio Preto
country: Brazil
facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
state: Sao Paulo
city: São Bernardo do Campo
country: Brazil
facility: Centro Multidisciplinar de Estudos Clínicos - CEMEC
state: Sao Paulo
city: São Paulo
country: Brazil
facility: CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos
state: Sao Paulo
city: Plovdiv
country: Bulgaria
facility: MC Artmed OOD
city: Plovdiv
country: Bulgaria
facility: UMHAT "Pulmed" OOD
city: Plovdiv
country: Bulgaria
facility: UMHAT-Plovdiv AD
city: Ruse
country: Bulgaria
facility: DCC 1 - Ruse, EOOD
city: Sofia
country: Bulgaria
facility: DCC 'Alexandrovska', EOOD
city: Sofia
country: Bulgaria
facility: DCC Focus 5 - MEOH OOD
city: Sofia
country: Bulgaria
facility: Military Medical Academy - MHAT - Sofia
city: Santiago
country: Chile
facility: Centro Medico Prosalud
city: Santiago
country: Chile
facility: CTR Estudios
city: Santiago
country: Chile
facility: Enroll Spa
city: Santiago
country: Chile
facility: BioMedica Research Group
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University
state: Beijing
city: Dongguan
country: China
facility: Dongguan People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Second Provincial General Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
city: Changsha
country: China
facility: Xiangya Hospital, Central South University
state: Hunan
city: ZhuZhou
country: China
facility: ZhuZhou Central Hospital
state: Hunan
city: Jiujiang
country: China
facility: Jiujiang No.1 People's Hospital
state: Jiangxi
city: Pingxiang
country: China
facility: Pingxiang People's Hospital
state: Jiangxi
city: Ningbo
country: China
facility: The First Affiliated Hospital of Ningbo University
state: Zhejiang
city: Changchun
country: China
facility: The First Hospital of Jilin University
city: Cali
country: Colombia
facility: IPS Centro Medico Julian Coronel S.A.
state: Valle Del Cauca
city: Barranquilla
country: Colombia
facility: Centro de Investigacion Medico Asistencial S.A.S
city: Barranquilla
country: Colombia
facility: Clínica de la Costa S.A.S
city: Bogotá
country: Colombia
facility: Centro de Investigacion en Reumatologia y Especialidades Medicas CIREEM S.A.S.
city: Bucaramanga
country: Colombia
facility: Servimed S.A.S.
city: Chia
country: Colombia
facility: Preventive Care Ltda
city: Zipaquirá
country: Colombia
facility: Healthy Medical Center
city: Brno
country: Czechia
facility: Revmatologie s.r.o.
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Clermont-Ferrand cedex 1
country: France
facility: CHU Clermont Ferrand - Hopital Gabriel Montpied
state: Drôme
city: Athens
country: Greece
facility: NNA Hospital
state: Attica
city: Szekesfehervar
country: Hungary
facility: Vita Verum Medical Egeszsegugyi Szolgaltato Bt.
state: Fejer
city: Budapest
country: Hungary
facility: Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
city: Gyula
country: Hungary
facility: Bekes Varmegyei Kozponti Korhaz
city: Veszprem
country: Hungary
facility: Vital Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Kfar- Saba
country: Israel
facility: Meir Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center Pt
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini
city: Nagoya-shi
country: Japan
facility: JCHO Chukyo Hospital
state: Aichi-Ken
city: Chiba-shi
country: Japan
facility: NHO Chibahigashi National Hospital
state: Chiba-Ken
city: Fukuoka-shi
country: Japan
facility: NHO Kyushu Medical Center
state: Fukuoka-Ken
city: Hiroshima-shi
country: Japan
facility: Hiroshima University Hospital
state: Hiroshima-Ken
city: Sapporo-shi
country: Japan
facility: Tonan Hospital
state: Hokkaido
city: Himeji-shi
country: Japan
facility: Japanese Red Cross Society Himeji Hospital
state: Hyogo-Ken
city: Kita-gun
country: Japan
facility: Kagawa University Hospital
state: Kagawa-Ken
city: Yokohama-shi
country: Japan
facility: NHO Yokohama Medical Center
state: Kanagawa-Ken
city: Kumamoto-shi
country: Japan
facility: Japanese Red Cross Kumamoto Hospital
state: Kumamoto-Ken
city: Osakasayama-shi
country: Japan
facility: Kindai University Hospital
state: Osaka-Fu
city: Itabashi-ku
country: Japan
facility: Nihon University Itabashi Hospital
state: Tokyo-To
city: Meguro-ku
country: Japan
facility: Toho University Ohashi Medical Center
state: Tokyo-To
city: Shinjuku-ku
country: Japan
facility: Center Hospital of the National Center for Global Health and Medicine
state: Tokyo-To
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
city: Ciudad de México
country: Mexico
facility: Clinstile, S.A. de C.V.
state: Distrito Federal
city: Mexico
country: Mexico
facility: Centro de Investigacion Clínica GRAMEL S.C
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Clinica de Investigacion en Reumatologia y Obesidad S.C.
state: Jalisco
city: Guadalajara
country: Mexico
facility: Centro de investigacion medica y reumatologia
state: Jalisco
city: Cuernavaca
country: Mexico
facility: Consultorio Privado Dr. Miguel Cortes Hernandez
state: Morelos
city: Merida
country: Mexico
facility: Centro Peninsular de Investigacion Clinica, SCP
state: Yucatán
city: Merida
country: Mexico
facility: Medical Care & Research SA de CV
state: Yucatán
city: Chihuahua
country: Mexico
facility: Investigacion y Biomedicina de Chihuahua, S.C.
city: Durango
country: Mexico
facility: Centro de Investigacion y Atencion Integral Durango CIAID
city: Lima
country: Peru
facility: HMA - Hospital Maria Auxiliadora
city: Lipa City
country: Philippines
facility: Mary Mediatrix Medical Center
state: Batangas
city: Davao City
country: Philippines
facility: Davao Doctors Hospital
state: Davao
city: Manila
country: Philippines
facility: University of the Philippines Manila - Philippine General Hospital
state: Metro Manila
city: Quezon City
country: Philippines
facility: Far Eastern University - Dr. Nicanor Reyes Medical Foundation
state: Metro Manila
city: Manila
country: Philippines
facility: Medical Center Manila
city: Bialystok
country: Poland
facility: Nova Reuma Domysławska i Rusiłowicz, Spółka Partnerska Lekarza Reumatologa i Fizjoterapeuty
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im.dr J. Biziela
city: Bytom
country: Poland
facility: Nzoz Bif-Med
city: Krakow
country: Poland
facility: Pratia MCM Krakow
city: Malbork
country: Poland
facility: Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. z o.o.
city: Warszawa
country: Poland
facility: MICS Centrum Medyczne Warszawa
city: Caguas
country: Puerto Rico
facility: Centro Reumatologico
city: Brasov
country: Romania
facility: S.C Centrul Medical de Diagnostic si Tratament Ambulator Neomed S.R.L
city: Bucuresti
country: Romania
facility: S C Delta Health Care SRL
city: Cluj-Napoca
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Cluj Napoca
city: Iasi
country: Romania
facility: S.C.Centrul Medical Unirea SRL
city: Belgrade
country: Serbia
facility: Institute of Rheumatology
city: Belgrade
country: Serbia
facility: University Clinical Center of Serbia
city: Belgrade
country: Serbia
facility: Clinical Center "Bezanijska Kosa "
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
state: Castellón
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Sevilla
country: Spain
facility: Hospital Quironsalud Infanta Luisa
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: London
country: United Kingdom
facility: Guy's Hospital
state: Greater London
city: Doncaster
country: United Kingdom
facility: Doncaster Royal Infirmary
state: South Yorkshire
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: