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A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus
Condition: Lupus Erythematosus, Systemic · Sponsor: Biogen
About this study
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. The main objective of the study is to learn about the effect litifilimab has on lowering the activity of the disease. The main question researchers want to answer is: \- How many participants have an improvement in their symptoms after 52 weeks of treatment? Researchers will answer this and other questions by measuring the 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), the British Isles Lupus Activity Group-2004 index (BILAG-2004), and the BILAG-BASED Combined Lupus Assessment (BICLA), among others. Researchers will also learn more about the safety of litifilimab. They will 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: * After screening, participants will be randomized to receive either a high or low dose of litifilimab, or placebo. A placebo looks like the study drug but contains no real medicine. * All participants will receive …
This description comes directly from the study's public registry record.
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No contact information is available for this study as per the public registry record.
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Locations (177)
| University of Alabama at Birmingham | Birmingham, Alabama, United States | — |
| Arizona Arthritis & Rheumatology Associates, P.C. | Glendale, Arizona, United States | — |
| Care Access Research - Huntington BeachCare Access Research - Huntington Beach | Huntington Beach, California, United States | — |
| Valerius Medical Group | Los Alamitos, California, United States | — |
| The Practice of Medicine | Los Angeles, California, United States | — |
| R. Srinivasan, M.D., Inc. dba Monterey Park Medical Center | Monterey Park, California, United States | — |
| Neurovations | Napa, California, United States | — |
| Joo-Hyung Lee MD | Orange, California, United States | — |
| Medvin Clinical Research | Whittier, California, United States | — |
| RASF - Clinical Research Center | Boca Raton, Florida, United States | — |
| University of Florida | Gainesville, Florida, United States | — |
| Vida Clinical Research | Kissimmee, Florida, United States | — |
+ 165 more locations — full list on the registry record.
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