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
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
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:
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 giving litifilimab. The injector device is an automatic device that delivers the full dose in one injection without needing to push a plunger. Researchers will compare the safety and tolerability of the injector device and how the body reacts to it to the current prefilled syringe method. The substudy will last 3 months and will include about 120 participants.
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.
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.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other inclusion/exclusion criteria may apply.
Washington D.C., District of Columbia 20007-2113, United States
CABA, Buenos Aires C1015ABO, Argentina
San Miguel de Tucumán, Tucumán Province 4000, Argentina
San Miguel de Tucumán, Tucumán Province T4000AXL, Argentina
Ciudad Autonoma Buenos Aires, 1425, Argentina
Ciudad Autonoma Buenos Aires, C1013AAB, Argentina
Fortaleza, Ceará 60430-372, Brazil
Santo Ângelo, Mato Grosso 78020-500, Brazil
Sao Jose Rio Preto, São Paulo 15090-000, Brazil
São Bernardo do Campo, São Paulo 09715-090, Brazil
São Paulo, São Paulo 01228-200, Brazil
Shanghai, Shanghai Municipality 200001, China
Bogotá, 110221, Colombia
Toyoake-shi, Aichi-ken 470-1192, Japan
Kitakyushu-shi, Fukuoka 807-8556, Japan
Himeji-shi, Hyōgo 670-8540, Japan
Kobe, Hyōgo 650-0047, Japan
Kita-gun, Kagawa-ken 761-0793, Japan
Kawachinagano-shi, Osaka 586-8521, Japan
Osakasayama-shi, Osaka 589-8511, Japan
Itabashi-ku, Tokyo-To 173-8610, Japan
Meguro-ku, Tokyo-To 153-8515, Japan
Shinjuku-ku, Tokyo-To 162-8655, Japan
Mexico City, Mexico City 14080, Mexico
Manila, National Capital Region 1000, Philippines
Quezon City, National Capital Region 1118, Philippines
Mabalacat, Pampanga, 2023, Philippines
San Fernando City, La Union, 2500, Philippines
Bialystok, 15-707, Poland
Malbork, 82-200, Poland
Vinnytsia, 21018, Ukraine