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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

Testing Litifilimab for safety and symptom relief in lupus patients.

Recruiting
18 years and older
All
Phase 3

This study is about testing a new medicine called litifilimab for people with Systemic Lupus Erythematosus (SLE). SLE is a disease where the immune system, which usually protects the body, attacks it instead. The researchers want to see if litifilimab can help reduce the symptoms of SLE. Participants in the study will continue to take their usual medications like antimalarials (drugs to prevent malaria), steroids (drugs that reduce inflammation), and immunosuppressants (drugs that lower the immune system response).

The study involves getting injections under the skin every 4 weeks for 52 weeks. Some people will get the real medicine, and others will get a placebo, which is a fake medicine that looks real. Neither the participants nor the researchers will know who is getting litifilimab. After the treatment, there will be a 24-week period to check safety. The study lasts up to 80 weeks with 22 visits in total.

  • The study lasts up to 80 weeks with 22 visits.
  • Participants will get injections every 4 weeks.
  • Participants stay on their regular SLE medications.
Study details
    Lupus Erythematosus
    Systemic

NCT04961567

Biogen

1 April 2025

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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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.

How long does a clinical trial take place?

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

Do I get compensated for taking part in clinical trials?

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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