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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
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 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 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 lit…
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 (104)
| University of Alabama at Birmingham - (UAB) | Birmingham, Alabama, United States | — |
| Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, Arizona, United States | — |
| Dermatology Research Associates | Los Angeles, California, United States | — |
| Inland Rheumatology Clinical Trials, Inc. | Upland, California, United States | — |
| David Fivenson, MD, Dermatology, PLLC | Ann Arbor, Michigan, United States | — |
| Revival Research Institute, LLC | Troy, Michigan, United States | — |
| Saint Louis University | St Louis, Missouri, United States | — |
| Thurston Arthritis Research Center | Chapel Hill, North Carolina, United States | — |
| Duke Dermatology South Durham | Durham, North Carolina, United States | — |
| University of Cincinnati Health Physicians Office Dermatology | Cincinnati, Ohio, United States | — |
| University of Pennsylvania | Philadelphia, Pennsylvania, United States | — |
| UT Southwestern Medical Center | Dallas, Texas, United States | — |
+ 92 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06044337