Active not recruitingPHASE3INTERVENTIONAL

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

This study is looking into a new medication called litifilimab (BIIB059) for adults who have active systemic lupus erythematosus (SLE) and are already taking their usual lupus medicines. The main goal is to find out if litifilimab can help reduce disease activity and improve symptoms over 52 weeks of treatment. Researchers will also carefully monitor the safety of the new drug and how participants' immune systems respond. Participants will receive either litifilimab or a dummy injection (placebo) under the skin every four weeks, and neither they nor the doctors will know which treatment they are getting. The study aims to gather important information that could potentially lead to new treatment options for people living with lupus.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Biogen

Enrolment target

562

Start

16 Jul 2021

Estimated completion

16 Mar 2027

Lupus Erythematosus, Systemic

What is this study about?

This research study is focused on understanding a new medication called litifilimab for people living with systemic lupus erythematosus, often just called lupus. Lupus is a long-term (chronic) condition where the body's immune system mistakenly attacks its own healthy tissues. This can cause a wide range of symptoms, including pain, fatigue, skin rashes, and problems with organs like the kidneys or joints.

The study aims to see if litifilimab can help reduce the activity of lupus and improve symptoms in adults who currently have active lupus, even though they are already receiving standard treatments like antimalarials, steroids, or other suppressants. Researchers will carefully track how participants' symptoms change over 52 weeks using different scoring systems, which help measure how well someone is doing with their lupus. They will also pay close attention to the safety of litifilimab and how it affects participants' overall well-being and quality of life through surveys.

By comparing litifilimab to a placebo (an injection that looks the same but contains no medicine), the study hopes to determine if this new drug is effective and safe. Finding new ways to manage lupus is very important because while current treatments help, there's always a need for more options to improve the lives of people with this condition and better control their disease.

Key takeaways

This study is testing a new medication, litifilimab, for active lupus (SLE).
It aims to see if litifilimab can improve lupus symptoms and is safe.
Participants will receive injections of either litifilimab or a placebo every 4 weeks.
You will continue to take your regular lupus medications.
The study involves up to 22 visits over approximately 80 weeks.
Researchers and participants won't know who receives the active drug.

Who may be eligible?

To be considered for this study, you would need to be an adult, aged 18 or older, who has been diagnosed with systemic lupus erythematosus (SLE) for at least 24 weeks (about 6 months) and meets specific criteria for active lupus disease as assessed by the study doctors. You would also need to be currently taking standard lupus medications, such as antimalarials, steroids, or certain immune-suppressing drugs, and these treatments should have been stable for a period before joining.

Several factors might mean you wouldn't be able to join the study. These include a history of HIV, active hepatitis C or B infections, severe herpes infections, or certain serious heart conditions that are not well-controlled. Also, if you have very serious kidney inflammation due to lupus that the study doctors believe needs different care, you wouldn't be eligible.

The research team will carry out detailed checks to ensure that the study is suitable and safe for you to take part in. This involves reviewing your medical history and performing various tests to confirm you meet all the necessary requirements and do not have any conditions that would prevent your participation.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you an adult aged 18 or over?
Have you been diagnosed with lupus (SLE) for at least 6 months?
Are you currently on standard lupus medications (e.g., antimalarials, steroids, immune suppressants)?
Do you have active lupus symptoms as determined by a doctor?
Do you *not* have HIV, active hepatitis B/C, severe herpes, or uncontrolled severe heart failure?

Answer every question to see your result.

What does participation involve?

If you join this study, after an initial health check, you will be randomly assigned to receive either a high dose of litifilimab, a low dose of litifilimab, or a placebo (a dummy injection that contains no medicine). You'll receive your assigned treatment as an injection under the skin once every 4 weeks. This treatment period will last for 52 weeks (about one year) and you will continue to take your usual lupus medications throughout.

Neither you nor the study doctors will know which treatment you are receiving – this is a standard practice in research to ensure fair and unbiased results. After the 52-week treatment period, there will be a follow-up safety period lasting up to 24 weeks. In total, you would have up to 22 study visits over approximately 80 weeks (about 1 year and 7 months). During these visits, the study team will monitor your lupus symptoms, check for any side effects, and assess your general health and immune system response. You will also complete questionnaires about your health and quality of life.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as access to a new investigational medication that might improve your lupus symptoms or help control your disease. However, it's important to remember that litifilimab is still being studied, and we don't yet know if it will be effective or if it will have side effects. There are potential risks associated with any new medication, including possible side effects from the injections or the drug itself, and these will be closely monitored by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (177)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University of Alabama at Birmingham
Verified postcode
Birmingham, United States
Arizona Arthritis & Rheumatology Associates, P.C.
Verified postcode
Glendale, United States
Care Access Research - Huntington BeachCare Access Research - Huntington Beach
Verified postcode
Huntington Beach, United States
Valerius Medical Group
Verified postcode
Los Alamitos, United States
The Practice of Medicine
Verified postcode
Los Angeles, United States
R. Srinivasan, M.D., Inc. dba Monterey Park Medical Center
Verified postcode
Monterey Park, United States
Neurovations
Verified postcode
Napa, United States
Joo-Hyung Lee MD
Verified postcode
Orange, United States
Medvin Clinical Research
Verified postcode
Whittier, United States
RASF - Clinical Research Center
Verified postcode
Boca Raton, United States
University of Florida
Verified postcode
Gainesville, United States
Vida Clinical Research
Verified postcode
Kissimmee, United States

Common questions

What is systemic lupus erythematosus (SLE)?

SLE, or lupus, is a long-term condition where your body's immune system mistakenly attacks healthy parts of your body, causing inflammation and damage.

What is a placebo?

A placebo is an inactive substance or treatment that looks exactly like the study drug but contains no real medicine. It helps researchers understand the true effect of the drug.

Will I still take my regular lupus medications during the study?

Yes, all participants will continue taking their standard lupus medications throughout the study.

How often will I need to visit the clinic?

You will have up to 22 study visits over the total study duration of about 80 weeks.

Can I leave the study if I change my mind?

Yes, your participation is voluntary, and you can withdraw from the study at any time without affecting your normal medical care.