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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

Study testing if Litifilimab injections help cutaneous lupus symptoms.

Recruiting
18 years and older
All
Phase 2/3
In this study, researchers want to find out if a drug called **litifilimab** can help improve symptoms for people with **cutaneous lupus erythematosus (CLE)**, a skin condition. The study will have two parts. In both parts, participants will either receive litifilimab or a placebo (a fake treatment that looks like the real one) as injections every 4 weeks. During the first 24 weeks, neither the doctors nor participants will know who is receiving which treatment. After this, all participants will receive litifilimab for 28 weeks. The total study will last up to 80 weeks. Researchers will measure changes in skin symptoms using special scoring tools like CLASI and CLA-IGA-R. They'll also check for any side effects and how the drug affects participants' immune systems. After the study, eligible participants can choose to join a longer study or have a safety follow-up for up to 24 weeks. **Key Points to Consider:** - The study will last up to 80 weeks, with injections every 4 weeks. - Participants will receive either the study drug or a placebo during the first 24 weeks. - There will be an option to join an extension study after the main study.
Study details
    Subacute Cutaneous Lupus Erythematosus
    Chronic Cutaneous Lupus Erythematosus

NCT05531565

Biogen

13 September 2025

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