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Efficacy and Safety Evaluation of Litifilimab in Adults with Active Systemic Lupus Erythematosus on Standard Nonbiologic Lupus Care: A Phase 3 Randomized Controlled Trial

Fast replyInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a new treatment for Systemic Lupus Erythematosus (SLE), a chronic autoimmune disease where the immune system attacks healthy tissues, causing inflammation and damage to various parts of the body. The treatment being tested is called BIIB059, also known as litifilimab, which is a type of protein called a recombinant monoclonal antibody. This study aims to evaluate how effective and safe BIIB059 is for adults with active SLE who are already receiving standard care for lupus.

Participants in the study will receive either the BIIB059 treatment or a placebo, which looks like the treatment but does not contain the active ingredient. The study will last for about a year, during which participants will have regular check-ups to monitor their health and the activity of their lupus. The goal is to see if BIIB059 can reduce the symptoms and activity of lupus more effectively than the placebo.

Throughout the study, various aspects of the participants' health will be assessed, including their response to the treatment and any changes in their lupus symptoms. The study will also track any side effects or adverse events that may occur. This research is important for understanding whether BIIB059 can be a beneficial treatment option for people living with systemic lupus erythematosus.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Study participation and medication administration
Participation in the study involves receiving either the litifilimab injection or a placebo, which is a sterile liquid that does not contain the active medicine. the placebo is identical to the medicine except for the active ingredient.
The medicine is administered through a subcutaneous injection, which means it is injected into the fatty tissue just under the skin.
The administration occurs while continuing the current standard of care, which refers to the regular medical treatments used to manage systemic lupus erythematosus, a condition where the immune system attacks the body's own tissues.
Step 2
Monitoring and evaluation
The study continues for a duration of 52 weeks to evaluate how the medicine affects disease activity.
Various measurements are taken throughout the study, including assessments at week 16, week 24, week 40, and week 52.
Evaluations include checking for improvements in joint swelling and tenderness, skin involvement, and disease flares, which are sudden increases in symptoms.
Changes in oral corticosteroid use, which are steroid medications used to reduce inflammation, are monitored to see if the dosage can be reduced.
The effectiveness of the treatment is measured by how well symptoms are controlled and by changes in quality of life, including levels of fatigue and overall well-being.

Who can join the trial?

7 criteria

You must have been diagnosed with systemic lupus erythematosus, which is a disease where the body's immune system attacks its own healthy tissues, at least 24 weeks before the start of the study.
A doctor must confirm that your condition meets the specific classification criteria, which are the standard medical rules used to officially identify the disease.
You must have an active disease level measured by a score called SLEDAI-2K of 6 or higher, which is a tool doctors use to track how active the disease is, not counting symptoms like hair loss, fever, or specific types of headaches.
Your SLEDAI-2K score must also be 4 or higher at the start and when you are assigned to a group, not counting specific blood test results like anti-dsDNA (an antibody) or low levels of complement components (proteins in the blood that help the immune system).
You must show signs of disease activity in your organs based on a scoring system called BILAG-2004, meaning you must have a grade A in at least one organ system or a grade B in at least two organ systems.
You must be currently receiving standard of care, which means the usual medical treatments recommended for this disease, such as antimalarials, OCS (oral corticosteroids, which are medicines that reduce swelling and immune activity), or immunosuppressants (medicines that lower the activity of the immune system).
These regular treatments must have been started at least 12 weeks before the study, and your dose must have been stable for at least 4 weeks.

Who cannot join the trial?

10 criteria

Having or testing positive for HIV, which is a virus that attacks the body's immune system.
Taking more than 20 mg of oral prednisone (a type of steroid medication used to reduce inflammation) per day.
Having a current hepatitis C infection, which is a virus that affects the liver.
Having a current hepatitis B infection, which is another type of virus that causes liver inflammation.
Having a history of severe herpes, a common viral infection.
Having congestive heart failure that is not under control or is in an advanced stage, which is a condition where the heart cannot pump blood effectively.
Having severe lupus nephritis, which is a serious complication where the disease causes inflammation in the kidneys, especially if the kidneys are not functioning properly or if current standard treatments are not enough.
Having any active skin conditions, such as psoriasis or dermatomyositis, that are not caused by lupus and could make it difficult to study how the disease affects the skin.
Having a history or current diagnosis of vasculitis, which is an inflammation of the blood vessels, that is not caused by lupus.
Having neuropsychiatric SLE, which means the lupus is affecting the brain or nervous system.

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Verified sites

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Responsive
Katholieke Universiteit te Leuven
Leuven, Belgium
Responsive
Spitalul Clinic Judetean De Urgenta Cluj
Cluj Napoca, Romania
Responsive
Universita Degli Studi Di Roma La Sapienza
Rome, Italy

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Investigated drugs

Litifilimab is an injection used to help reduce disease activity in adults who have active systemic lupus erythematosus.

Litifilimab

What is already known about the treatment

Litifilimab
This medication is administered as an injection under the skin and is currently being studied in late-stage clinical trials for its effectiveness. It is primarily used to treat systemic lupus erythematosus, an immune system disorder where the body attacks its own tissues. As a monoclonal antibody, it works by attaching to specific proteins on immune cells to block the harmful inflammatory signals that cause tissue damage.
Placebo
This is a sterile liquid used for injection that contains no active medicinal ingredients and is used as a comparison in clinical studies. It is designed to look and feel identical to the study drug to ensure the results of the trial are accurate. It has no therapeutic effect and serves only to help researchers determine if the actual medication is truly effective.

Investigated diseases

systemic lupus erythematosus - This is a chronic autoimmune condition where the body's immune system mistakenly attacks its own healthy tissues and organs. It can cause inflammation and damage in various parts of the body, including the skin, joints, kidneys, blood cells, brain, heart, and lungs. The disease often progresses through periods of active symptoms known as flares, followed by periods of low disease activity. Symptoms may vary widely between individuals and can change over time. Inflammation can affect multiple systems simultaneously, leading to widespread bodily involvement.