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A Long-Term Extension Study to Learn More About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus
Sponsor: Biogen
Summary
In this study, researchers will learn more about a study drug called BIIB059 (litifilimab) in participants with cutaneous lupus erythematosus (CLE). The study will focus on participants who have either active subacute CLE or chronic CLE, or both. They may also have systemic lupus erythematosus (SLE). The participants did not respond to antimalarial therapy or had problems with the treatment that made it hard to continue. The study will enroll only those participants who have completed treatment with litifilimab in the parent study, 230LE301. 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 after taking litifilimab? Adverse events are unwanted health problems that may or may not be caused by the study drug. Researchers will also learn more about the effect of litifilimab on CLE. They will do this by measuring the symptoms of CLE over time using a variety of scoring tools. These include the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI), the Cutaneous Lupus Activity of Investigator's Global Assessment-Revised (CLA-IGA-R), and the SELENA-SLEDAI Flare Index (SFI). Researchers will look at how litifilimab and CLE affect the quality of life of participants using a group of questionnaires. They will also look at how litifilimab affects laboratory tests and how participants' immune systems respond to litifilimab. The study will be done as follows: * The last visit of parent study 230LE301 will be the first visit of study 230LE305. * All participants will receive litifilimab as an injection under the skin once every 4 weeks. Both researchers and participants will know the dose and identity of the study drug. * Globally, the treatment period will last up to 104 weeks, or 2 years. For participants in the United States, the treatment period may last up to 260 weeks, or 5 years * There will be a follow-up safety period that lasts up to 24 weeks. * Globally, participants will have up to 27 study visits during the treatment period. In the US, participants will have up to 66 study visits. * Globally, the total study duration for participants will be up to 128 weeks. In the US, the total study duration will be up to 284 weeks .
Official title: A Multicenter, Open-Label, Single-Arm, Phase 3, Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of BIIB059 (Litifilimab) in Adult Participants With Active Subacute Cutaneous Lupus Erythematosus and/or Chronic Cutaneous Lupus Erythematosus With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
322
Start Date
2023-10-03
Completion Date
2029-12-11
Last Updated
2026-04-08
Healthy Volunteers
No
Interventions
BIIB059 (litifilimab)
Administered as specified in the treatment arm.
Locations (100)
Arizona Arthritis & Rheumatology Research, PLLC
Phoenix, Arizona, United States
Dermatology Research Associates
Los Angeles, California, United States
Inland Rheumatology Clinical Trials, Inc.
Upland, California, United States
David Fivenson, MD, Dermatology, PLLC
Ann Arbor, Michigan, United States
Revival Research Institute, LLC
Troy, Michigan, United States
Saint Louis University
St Louis, Missouri, United States
Thurston Arthritis Research Center
Chapel Hill, North Carolina, United States
Duke Dermatology South Durham
Durham, North Carolina, United States
University of Cincinnati Health Physicians Office Dermatology
Cincinnati, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Precision Comprehensive Clinical Research Solutions
Grapevine, Texas, United States
Instituto CAICI
Rosario, Santa Fe Province, Argentina
Investigaciones Clinicas Tucuman
San Miguel de Tucumán, Tucumán Province, Argentina
Centro de Investigaciones Medicas Tucuman
San Miguel de Tucumán, Tucumán Province, Argentina
APRILLUS Asistencia e Investigacion
Buenos Aires, Argentina
Clínica SER da Bahia
Salvador, Estado de Bahia, Brazil
L2IP - Instituto de Pesquisas Clínicas Ltda.
Brasília, Federal District, Brazil
IPC MT Instituto de Pesquisas Clinicas do Mato Grosso
Santo Ângelo, Mato Grosso, Brazil
CMiP - Centro Mineiro de Pesquisa
Juiz de Fora, Minas Gerais, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Nucleo de Pesquisa Clinica do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil
CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos
São Paulo, São Paulo, Brazil
IDERJ - Instituto de Dermatologia e Estética do Brasil Ltda
Rio de Janeiro, Brazil
University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD
Sofia, Sofia City Province, Bulgaria
DCC 'Alexandrovska', EOOD
Sofia, Bulgaria
DCC Focus 5 - MEOH OOD
Sofia, Bulgaria
Laser Rejuvenation Clinics, Inc.
Calgary, Alberta, Canada
DIEX Recherche Sherbrooke Inc.
Sherbrooke, Quebec, Canada
Centro Medico SkinMed
Las Condes, Chile
CIEC - Centro Internacional de Estudios Clínicos
Santiago, Chile
Clinical Research Chile SpA
Valdivia, Chile
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Shenzhen Second People's Hospital
Shenzhen, Guangdong, China
Dongguan People's Hospital
Dongguan, Guangdongsheng, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdongsheng, China
The second Xiangya Hospital of Central South University
Changsha, Húnánsheng, China
Hospital for Skin Diseases, Chinese Academy of Medical Sciences
Nanjing, Jiangsu, China
Shanghai Skin Disease Hospital
Shanghai, Shànghaishì, China
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yun'Nan, China
Healthy Medical Center
Zipaquirá, Cundinamarca, Colombia
Centro de Investigacion Medico Asistencial S.A.S
Barranquilla, Colombia
CHU de Caen - Hopital de la Cote de Nacre
Caen, Calvados, France
Hopital Larrey
Toulouse, Haute Garonne, France
Hopital Saint Eloi
Montpellier, Herault, France
Hopital Edouard Herriot - CHU Lyon
Lyon, Rhone, France
Hopital Tenon
Paris, France
Universitaetsklinikum Erlangen
Erlangen, Bavaria, Germany
Fachklinik Bad Bentheim Dermatologie
Bad Bentheim, Lower Saxony, Germany
Klinikum Oldenburg AoeR
Oldenburg, Lower Saxony, Germany
Universitaetsklinikum Muenster
Münster, North Rhine-Westphalia, Germany
Universitaetsklinikum Carl Gustav Carus TU
Dresden, Saxony, Germany
Universitaetsklinikum Halle (Saale)
Halle, Saxony-Anhalt, Germany
Charité - Campus Charité Mitte
Berlin, Germany
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs, Hungary
Università degli studi di Firenze
Florence, Italy
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milan, Italy
JCHO Chukyo Hospital
Nagoya, Aichi-ken, Japan
NHO Nagoya Medical Center
Nagoya, Aichi-ken, Japan
University of Fukui Hospital
Yoshida-gun, Fukui, Japan
Hospital of the University of Occupational and Environmental Health
Kitakyushu-shi, Fukuoka, Japan
Kakogawa Central City Hospital
Kakogawa-shi, Hyōgo, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan
St. Marianna University Hospital
Kawasaki-shi, Kanagawa, Japan
Kumamoto University Hospital
Kumamoto, Kumamoto, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Nagasaki University Hospital
Nagasaki, Nagasaki, Japan
Niigata University Medical & Dental Hospital
Niigata, Niigata, Japan
Osaka Keisatsu Hospital
Osaka, Osaka, Japan
Teikyo University Hospital
Itabashi-ku, Tokyo-To, Japan
Clinstile, S.A. de C.V.
Mexico City, Mexico City, Mexico
Investigacion y Biomedicina de Chihuahua, S.C.
Chihuahua City, Mexico
Centro de investigacion medica y reumatologia
Guadalajara, Mexico
Mary Mediatrix Medical Center
Lipa City, Batangas, Philippines
Lorma Medical Center
San Fernando City, La Union, La Union, Philippines
St. Luke's Medical Center
Quezon City, National Capital Region (ncr), Philippines
University of the Philippines Manila - Philippine General Hospital
Manila, Philippines
Jose R. Reyes Memorial Medical Center
Manila, Philippines
Uniwersytecki Szpital Kliniczny im.Fryderyka Chopina w Rzeszowie
Rzeszów, Podkarpackie Voivodeship, Poland
Centro Hospitalar e Universitário de Coimbra, E.P.E (HUC)
Coimbra, Coimbra District, Portugal
Institute of Rheumatology_Belgrade
Belgrade, Serbia
University Clinical Center of Serbia
Belgrade, Serbia
Artromac n.o.
Košice, Slovakia
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Hanyang University Seoul Hospital
Seoul, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea
Hospital Universitario Rio Hortega
Valladolid, Cantabria, Spain
Hospital Universitario Reina Sofia
Córdoba, Córdoba, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Spain
Hospital del Mar
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitario Virgen del Rocio
Seville, Spain
Karolinska Universitetssjukhuset - Solna
Solna, Sweden
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Lucerne (Luzern), Switzerland
Kantonsspital St. Gallen
Sankt Gallen, Switzerland
Taichung Veterans General Hospital
Taichung, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Whipps Cross University Hospital
London, Greater London, United Kingdom
Queen Elizabeth Hospital
Birmingham, West Midlands, United Kingdom
Chapel Allerton Hospital
Chapel Allerton, West Yorkshire, United Kingdom