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A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus
Condition: Subacute Cutaneous Lupus Erythematosus · Chronic Cutaneous Lupus Erythematosus · Sponsor: Biogen
About this study
In this study, researchers will learn more about a study drug called litifilimab (BIIB059) 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 main objective of the study is to learn about the effect litifilimab has on lowering the activity of the skin disease. Researchers will measure symptoms and signs 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). The main questions researchers want to answer are: * How many participants have a score of 0 or 1 on the CLA-IGA-R looking at skin redness after treatment? * How many participants have their skin disease activity go down by at least 70% as measured by CLASI? 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 CLE have on the quality of life of participants using a group of questionnaires. The study will be split into 2 parts - Part A and Part B. Both parts will be done as follows: * A…
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 (315)
| Pinnacle Research Group, LLC | Anniston, Alabama, United States | — |
| UAB Center for Women's Reproductive Health | Birmingham, Alabama, United States | — |
| Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, Arizona, United States | — |
| The Regents of the University of California | La Jolla, California, United States | — |
| Dermatology Research Associates | Los Angeles, California, United States | — |
| Clinical Science Institute | Santa Monica, California, United States | — |
| Inland Rheumatology Clinical Trials, Inc. | Upland, California, United States | — |
| Denver Arthritis Clinic | Denver, Colorado, United States | — |
| Omega Research Debary, LLC | DeBary, Florida, United States | — |
| Centre for Rheumatology, Immunology and Arthritis | Fort Lauderdale, Florida, United States | — |
| University of Florida | Gainesville, Florida, United States | — |
| University of Miami Miller School of Medicine | Miami, Florida, United States | — |
+ 303 more locations — full list on the registry record.
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