EICHORCondition: Lupus Erythematosus, Systemic · Sponsor: Biogen
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.
No contact information is available for this study as per the public registry record.
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| Tilda Research Birmingham | Homewood, Alabama, United States | — |
| Wallace Rheumatic Study Center | Beverly Hills, California, United States | — |
| University of Southern California | Los Angeles, California, United States | — |
| Providence Facey Medical Foundation | Mission Hills, California, United States | — |
| University of California San Diego School of Medicine | San Diego, California, United States | — |
| SCLA Management | Thousand Oaks, California, United States | — |
| Harbor-UCLA Medical Center | Torrance, California, United States | — |
| Inland Rheumatology Clinical Trials, Inc. | Upland, California, United States | — |
| University of Colorado Anschutz Medical Campus | Aurora, Colorado, United States | — |
| Georgetown University Hospital-Medstar | Washington D.C., District of Columbia, United States | — |
| Arthritis & Rheumatic Disease Specialties | Aventura, Florida, United States | — |
| Highlands Rheumatology | Avon Park, Florida, United States | — |
+ 152 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT04895241