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By invitation only Phase 3 NCT06044337

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

Phase 3 – large-scale trial before approval
Conditions: Subacute Cutaneous Lupus Erythematosus Chronic Cutaneous Lupus Erythematosus

Sponsor: Biogen

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Overview
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 .
Description
The primary objective of the study is to evaluate the long-term safety and tolerability BIIB059 (litifilimab) in participants who completed the parent study 230LE301 (NCT05531565) with active subacute CLE and/or chronic CLE with or without systemic manifestations and refractory and/or intolerant to antimalarial therapy. 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.
Who can participate
Key Inclusion Criteria: * Participants who completed the parent study (230LE301 \[NCT05531565\], Part A or Part B) on study treatment (received treatment through Week 48 and attended the last study assessment visit at Week 52). * 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. Key Exclusion Criteria: * Early Part A or Part B parent study (230LE301 \[NCT05531565\]) treatment terminators (participants who discontinued study treatment before Week 48). * 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. NOTE: Other protocol- defined Inclusion/Exclusion criteria may apply.
Interventions
BIIB059 (litifilimab)
DRUG
Locations 102
Argentina (4)
APRILLUS Asistencia e Investigacion
Buenos Aires
Instituto CAICI
Rosario , Santa Fe Province
Investigaciones Clinicas Tucuman
San Miguel de Tucumán , Tucumán Province
Centro de Investigaciones Medicas Tucuman
San Miguel de Tucumán , Tucumán Province
Brazil (8)
L2IP - Instituto de Pesquisas Clínicas Ltda.
Brasília , Federal District
CMiP - Centro Mineiro de Pesquisa
Juiz de Fora , Minas Gerais
Hospital de Clínicas de Porto Alegre
Porto Alegre , Rio Grande do Sul
Nucleo de Pesquisa Clinica do Rio Grande do Sul
Porto Alegre , Rio Grande do Sul
IDERJ - Instituto de Dermatologia e Estética do Brasil Ltda
Rio de Janeiro
Clínica SER da Bahia
Salvador , Estado de Bahia
IPC MT Instituto de Pesquisas Clinicas do Mato Grosso
Santo Ângelo , Mato Grosso
CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos
São Paulo , São Paulo
Bulgaria (3)
University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD
Sofia , Sofia City Province
DCC 'Alexandrovska', EOOD
Sofia
DCC Focus 5 - MEOH OOD
Sofia
Canada (2)
Laser Rejuvenation Clinics, Inc.
Calgary , Alberta
DIEX Recherche Sherbrooke Inc.
Sherbrooke , Quebec
Chile (3)
Centro Medico SkinMed
Las Condes
CIEC - Centro Internacional de Estudios Clínicos
Santiago
Clinical Research Chile SpA
Valdivia
China (8)
Beijing Tongren Hospital, Capital Medical University
Beijing , Beijing Municipality
The second Xiangya Hospital of Central South University
Changsha , Húnánsheng
Dongguan People's Hospital
Dongguan , Guangdongsheng
Nanfang Hospital of Southern Medical University
Guangzhou , Guangdongsheng
The Second Affiliated Hospital of Kunming Medical University
Kunming , Yun'Nan
Hospital for Skin Diseases, Chinese Academy of Medical Sciences
Nanjing , Jiangsu
Shanghai Skin Disease Hospital
Shanghai , Shànghaishì
Shenzhen Second People's Hospital
Shenzhen , Guangdong
Colombia (2)
Centro de Investigacion Medico Asistencial S.A.S
Barranquilla
Healthy Medical Center
Zipaquirá , Cundinamarca
France (5)
CHU de Caen - Hopital de la Cote de Nacre
Caen , Calvados
Hopital Edouard Herriot - CHU Lyon
Lyon , Rhone
Hopital Saint Eloi
Montpellier , Herault
Hopital Tenon
Paris
Hopital Larrey
Toulouse , Haute Garonne
Germany (7)
Fachklinik Bad Bentheim Dermatologie
Bad Bentheim , Lower Saxony
Charité - Campus Charité Mitte
Berlin
Universitaetsklinikum Carl Gustav Carus TU
Dresden , Saxony
Universitaetsklinikum Erlangen
Erlangen , Bavaria
Universitaetsklinikum Halle (Saale)
Halle , Saxony-Anhalt
Universitaetsklinikum Muenster
Münster , North Rhine-Westphalia
Klinikum Oldenburg AoeR
Oldenburg , Lower Saxony
Hungary (1)
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs
Italy (2)
Università degli studi di Firenze
Florence
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milan
Japan (14)
Teikyo University Hospital
Itabashi-ku , Tokyo-To
Kakogawa Central City Hospital
Kakogawa-shi , Hyōgo
Kanazawa University Hospital
Kanazawa , Ishikawa-ken
St. Marianna University Hospital
Kawasaki-shi , Kanagawa
Hospital of the University of Occupational and Environmental Health
Kitakyushu-shi , Fukuoka
Kumamoto University Hospital
Kumamoto , Kumamoto
Nagasaki University Hospital
Nagasaki , Nagasaki
JCHO Chukyo Hospital
Nagoya , Aichi-ken
NHO Nagoya Medical Center
Nagoya , Aichi-ken
Niigata University Medical & Dental Hospital
Niigata , Niigata
Osaka Keisatsu Hospital
Osaka , Osaka
Tohoku University Hospital
Sendai , Miyagi
Yokohama City University Hospital
Yokohama , Kanagawa
University of Fukui Hospital
Yoshida-gun , Fukui
Mexico (3)
Investigacion y Biomedicina de Chihuahua, S.C.
Chihuahua City
Centro de investigacion medica y reumatologia
Guadalajara
Clinstile, S.A. de C.V.
Mexico City , Mexico City
Philippines (5)
Mary Mediatrix Medical Center
Lipa City , Batangas
University of the Philippines Manila - Philippine General Hospital
Manila
Jose R. Reyes Memorial Medical Center
Manila
St. Luke's Medical Center
Quezon City , National Capital Region (ncr)
Lorma Medical Center
San Fernando City, La Union , La Union
Poland (2)
Uniwersytecki Szpital Kliniczny im.Fryderyka Chopina w Rzeszowie
Rzeszów , Podkarpackie Voivodeship
Royalderm_Warszawa
Warsaw , Masovian Voivodeship
Portugal (1)
Centro Hospitalar e Universitário de Coimbra, E.P.E (HUC)
Coimbra , Coimbra District
Serbia (2)
Institute of Rheumatology_Belgrade
Belgrade
University Clinical Center of Serbia
Belgrade
Slovakia (1)
Artromac n.o.
Košice
South Korea (3)
Severance Hospital, Yonsei University Health System
Seoul
Hanyang University Seoul Hospital
Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul
Spain (6)
Hospital del Mar
Barcelona
Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital Universitario Reina Sofia
Córdoba , Córdoba
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda , Madrid
Hospital Universitario Virgen del Rocio
Seville
Hospital Universitario Rio Hortega
Valladolid , Cantabria
Sweden (1)
Karolinska Universitetssjukhuset - Solna
Solna
Switzerland (2)
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne , Lucerne (Luzern)
Kantonsspital St. Gallen
Sankt Gallen
Taiwan (2)
Taichung Veterans General Hospital
Taichung
Taipei Veterans General Hospital
Taipei
United Kingdom (3)
Queen Elizabeth Hospital
Birmingham , West Midlands
Chapel Allerton Hospital
Chapel Allerton , West Yorkshire
Whipps Cross University Hospital
London , Greater London
United States (12)
David Fivenson, MD, Dermatology, PLLC
Ann Arbor , Michigan
Thurston Arthritis Research Center
Chapel Hill , North Carolina
University of Cincinnati Health Physicians Office Dermatology
Cincinnati , Ohio
UT Southwestern Medical Center
Dallas , Texas
Duke Dermatology South Durham
Durham , North Carolina
Precision Comprehensive Clinical Research Solutions
Grapevine , Texas
Dermatology Research Associates
Los Angeles , California
University of Pennsylvania
Philadelphia , Pennsylvania
Arizona Arthritis & Rheumatology Research, PLLC
Phoenix , Arizona
Saint Louis University
St Louis , Missouri
Revival Research Institute, LLC
Troy , Michigan
Inland Rheumatology Clinical Trials, Inc.
Upland , California
Technical details
Status
By invitation only
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
03.10.2023
Completion date
11.12.2029
Registry ID
NCT06044337
Source
clinicaltrials.gov
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