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
NCT ID: NCT06044337
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
PHASE3
322 participants
INTERVENTIONAL
2023-10-03
2029-12-11
Brief Summary
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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 learning 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 medical 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 assess the effect litifilimab and CLE has on the quality of life of participants using a group of questionnaires. They will also study 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.
* The treatment period will last up to 104 weeks, or 2 years.
* There will be a follow-up safety period that lasts up to 24 weeks.
* In total, participants will have up to 33 study visits.
* The total study duration for participants will be up to 128 weeks.
Detailed Description
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The secondary objectives of the study are to evaluate the long-term effect of litifilimab on disease activity and the effect of litifilimab in preventing disease damage in participants with active subacute CLE and/or chronic CLE with or without systemic manifestations and refractory and/or intolerant to antimalarials; to evaluate the long-term effect of litifilimab on preventing lupus flare in participants with CLE with SLE; to assess long-term use of oral corticosteroid (OCS) in participants receiving litifilimab treatment; to assess the impact of litifilimab on participant-reported health-related quality of life (HRQoL); to evaluate long-term effect of litifilimab on laboratory parameters; to evaluate the immunogenicity and pharmacokinetics (PK) of litifilimab.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BIIB059
Participants will receive BIIB059 subcutaneously, once every 4 weeks up to Week 100.
BIIB059 (litifilimab)
Administered as specified in the treatment arm.
Interventions
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BIIB059 (litifilimab)
Administered as specified in the treatment arm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ability of the participant to understand the purpose and risks of the study, to provide informed consent, and to authorize the use of confidential health information in accordance with national and local privacy regulations.
Exclusion Criteria
* Early Part A or Part B parent study terminators \[participants who withdrew from parent study participation before Week 52 and did not complete the parent study extended treatment period (ETP)\].
* Participants who have developed any other medical diseases, conditions, or abnormalities, rendering their participation in the long-term extension (LTE) study unsuitable in the opinion of the Investigator.
18 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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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 Pennsylvania
Philadelphia, Pennsylvania, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Precision Comprehensive Clinical Research Solutions
Grapevine, Texas, United States
Centro de Investigaciones Medicas Tucuman
San Miguel de Tucumán, Tucumán Province, Argentina
APRILLUS Asistencia e Investigacion
Buenos Aires, , Argentina
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
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
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
Healthy Medical Center
Zipaquirá, Cundinamarca, Colombia
Centro de Investigacion Medico Asistencial S.A.S
Barranquilla, , Colombia
Hopital Larrey
Toulouse, Haute Garonne, 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
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
Kumamoto University Hospital
Kumamoto, Kumamoto, Japan
Tohoku University Hospital
Sendai, Miyagi, 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
Lorma Medical Center
San Fernando City, La Union, La Union, Philippines
University of the Philippines Manila - Philippine General Hospital
Manila, , Philippines
University Clinical Center of Serbia
Belgrade, , Serbia
Artromac n.o.
Košice, , Slovakia
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
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
Countries
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Other Identifiers
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2023-504863-17-00
Identifier Type: OTHER
Identifier Source: secondary_id
230LE305
Identifier Type: -
Identifier Source: org_study_id