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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 on Litifilimab injections for skin lupus symptom improvement.

Recruiting
18 years and older
All
Phase 2/3

This study is for adults with a skin condition called Cutaneous Lupus Erythematosus (CLE). CLE is a type of lupus that affects the skin. Some participants might also have Systemic Lupus Erythematosus (SLE), which affects the whole body. The study aims to see if a drug called litifilimab can help improve CLE symptoms. Researchers want to find out if litifilimab can reduce skin redness and disease activity. Participants will receive injections every 4 weeks. The study has two parts: the first 24 weeks where participants receive either the drug or a placebo (a fake treatment), and the second 28 weeks where everyone gets the drug.

  • Total study time can be up to 80 weeks.
  • Participants will have both blinded (unknown treatment) and open-label (known treatment) phases.
  • After the study, there’s an option for long-term follow-up or a safety check for 24 weeks.
Study details
    Subacute Cutaneous Lupus Erythematosus
    Chronic Cutaneous Lupus Erythematosus

NCT05531565

Biogen

7 March 2026

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