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Evaluation of Long-Term Safety and Efficacy of Litifilimab in Adults with Active Systemic Lupus Erythematosus: A Phase 3 Multicenter, Randomized, Dose-Blind Study

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 long-term safety and effectiveness of a treatment called litifilimab, also known by its code name BIIB059. The study is specifically for adults with a condition called Systemic Lupus Erythematosus (SLE), which is an autoimmune disease where the immune system mistakenly attacks healthy tissues in the body. The treatment is administered as an injection under the skin.

The purpose of the study is to evaluate how safe and tolerable litifilimab is over an extended period. Participants in the study will receive either the active treatment or a placebo, which looks like the treatment but does not contain the active ingredient. The study will monitor participants for any side effects and assess the treatment's impact on their condition over time.

Participants will be involved in the study for a long-term period, during which they will have regular visits to the study center. These visits will include health assessments and monitoring to ensure the safety and effectiveness of the treatment. The study aims to provide valuable information on how well litifilimab works in managing symptoms of Systemic Lupus Erythematosus and its long-term safety profile.

The research process

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

  1. Step 1

    Participation in the study

    You will receive either the test medication, called litifilimab (brand name biib059), or a placebo.

    The placebo is a sterile liquid for injection that contains no active medicine and is identical to the test medication except for the active ingredient.

    The litifilimab is administered as a subcutaneous injection, which means it is injected into the layer of fat just under the skin.

  2. Step 2

    Long-term monitoring

    You will be monitored to evaluate the safety and effectiveness of the medication for systemic lupus erythematosus (an autoimmune condition where the immune system attacks the body's own tissues).

    The study tracks adverse events, which are any side effects or medical problems that occur during treatment, including serious adverse events.

    Your response to the treatment is measured through various scales, such as changes in joint swelling, skin involvement (measured by the clasí score), and disease activity levels.

    The study also monitors laboratory parameters (blood tests) and ecg results (tests that check the heart's electrical activity).

Who can join the trial?

7 criteria

  • You must have previously finished part of a specific 52-week medical study (either 230LE303 or 230LE304) where you received either the study drug or a placebo, which is a substance with no active medicine, and you must have attended your final check-up at the 52-week mark.
  • You must be able to understand why the study is being done, the potential risks involved, and give your informed consent, which means you officially agree to participate after being fully told about the study.
  • You must allow the use of your private health information according to privacy laws.
  • Women who are able to have children must agree to use very effective contraception, which is a method used to prevent pregnancy, during the study and for 18 weeks after the last dose.
  • Women who can have children must not donate eggs during the study and for at least 18 weeks after the final dose.
  • Women who are postmenopausal, meaning they have permanently stopped having monthly periods, must meet specific medical requirements, such as having no periods for 52 weeks due to natural reasons and having a specific level of FSH (a hormone that helps control the menstrual cycle) in their blood.
  • For women over 55 years old, postmenopausal status can also be confirmed if they have not had a natural period for at least 5 continuous years.

Who cannot join the trial?

10 criteria

  • People who stopped taking the treatment early in the previous Phase 3 studies, which are large-scale research tests used to confirm if a drug is safe and effective.
  • People who received live or live-attenuated vaccines, which are shots containing a weakened form of a germ, within 4 weeks before the start of the study.
  • People who used other investigational drugs, which are medicines still being tested in research, or medicines used for purposes not officially approved by regulators to treat SLE (lupus), skin lupus, or lupus nephritis (inflammation of the kidneys caused by lupus).
  • Women who are pregnant, currently breastfeeding, or plan to become pregnant during the study and for 126 days after the final dose of the study medicine.
  • People who are currently part of or planning to join another interventional clinical study, which is a research study where a person receives a specific treatment or medicine.
  • People who are unable to follow all the rules and requirements of the study.
  • People who, in the opinion of the Investigator (the main doctor in charge of the study) or the Sponsor (the company funding the research), are not suitable to join.
  • People who have developed new medical illnesses or health problems that make it unsafe or unsuitable for them to participate.
  • People whose lupus manifestations (physical signs or symptoms of the disease) have become moderately to severely worse in a specific organ, requiring a change in antimalarials (medicines used to treat malaria and certain autoimmune conditions) or immunosuppressive therapy (treatments that lower the body's immune system activity).
  • People who used prohibited concurrent medication, which refers to specific medicines that are not allowed to be taken at the same time as the study drug, during the previous research phase.
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Investigated drugs

Litifilimab is an experimental medication given as an injection under the skin. It is being studied to see how well it works and how safe it is for adults living with systemic lupus erythematosus (SLE) over a long period of time.

What is already known about the treatment

Litifilimab - This medication is an experimental injection given under the skin to treat people with systemic lupus erythematosus. It belongs to a class of drugs known as monoclonal antibodies that work by blocking a specific protein on the surface of immune cells to prevent them from causing excessive inflammation. Currently, it is being studied in late-stage clinical trials to determine its long-term safety and effectiveness in managing this autoimmune disease.

Investigated diseases

Systemic lupus erythematosus - This is a chronic condition where the body's immune system mistakenly attacks its own healthy tissues and organs. It can affect various parts of the body, including the skin, joints, kidneys, blood cells, brain, heart, and lungs. The disease often progresses through periods of active inflammation followed by periods of relative calm. During active phases, individuals may experience symptoms like fatigue, joint swelling, or skin rashes. The pattern of how the disease affects different organ systems can vary significantly from person to person. Over time, the continuous immune response can lead to cumulative damage to different bodily systems.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505635-13-00Protocol code230LE306Estimated enrolment948 patientsSponsorBiogen Idec Research Limited

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).