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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

Exploring litifilimab's safety for adults with lupus symptoms.

Recruiting
18 years and older
All
Phase 3

This study is examining the safety and effectiveness of an injection called litifilimab (BIIB059) in adults with systemic lupus erythematosus (SLE). SLE is a disease where the immune system, which normally fights germs, mistakenly attacks the body. Participants with active SLE, already on standard medications like antimalarials and steroids, will be part of this study. The researchers want to see if litifilimab can help reduce SLE symptoms over time.

Participants will be randomly given either a high or low dose of litifilimab or a placebo (a fake treatment), once every 4 weeks for 52 weeks. Nobody, including the researchers, will know if a participant is getting the real medicine or placebo. Participants will continue their regular medications. There will be a follow-up period lasting up to 24 weeks, and participants will attend up to 22 study visits over 80 weeks.

  • Study Duration: Up to 80 weeks total.
  • Study Visits: Up to 22 visits.
  • Treatment: Injections every 4 weeks; may receive a placebo.
Study details
    Lupus Erythematosus
    Systemic

NCT04895241

Biogen

13 April 2025

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

What is a clinical trial?

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

Why should I take part in a clinical trial?

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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