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A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus

Examining Litifilimab's safety and effectiveness for lupus symptom relief.

Recruiting
18 years and older
All
Phase 3

This study looks at how safe and effective an injection called litifilimab (BIIB059) is for adults with systemic lupus erythematosus (SLE). SLE is a disease where the immune system attacks the body by mistake. Participants will continue their usual medicines like antimalarials, steroids, and immunosuppressants. The study will check if litifilimab helps reduce the disease activity and improve symptoms over 52 weeks. Researchers will use special tools to measure changes in symptoms, like the SLE Responder Index (SRI) and the Patient Global Assessment - Visual Analog Scale (PGA-VAS).

Participants will either get litifilimab or a placebo (a fake treatment with no real medicine) as injections every 4 weeks. The study is "double-blind," meaning neither the participants nor the researchers will know who is getting the real treatment. The study will have up to 22 visits and last up to 80 weeks for each participant, including a follow-up period for safety checks.

  • Duration: Up to 80 weeks with 22 visits.
  • Participants receive injections every 4 weeks.
  • Double-blind: neither researchers nor participants know who gets the real drug.
Study details
    Lupus Erythematosus
    Systemic

NCT04895241

Biogen

2 February 2025

Step 1 Get in touch with the nearest study center
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Learn more about clinical trials

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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