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

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What is this study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Centre hospitalier universitaire de Liege Liege Belgium
San Camillo Forlanini Hospital Rome Italy
Vita Verum Medical Bt. Szekesfehervar Hungary
Delta Health Care S.R.L. Bucharest Romania
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
Policlinica CCBR S.R.L. Bucharest Romania
Centrul Medical Unirea S.R.L. Brasov Romania
Azienda Ospedaliera di Padova Padua Italy
Spitalul Judetean De Urgenta Sfantul Ioan Cel Nou Suceava Suceava Romania
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Universita’ Campus Bio-medico Di Roma Rome Italy
Universita’ Di Pisa Pisa Italy
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet Budapest Hungary
University Hospital Olomouc Olomouc Czechia
Universita Degli Studi Di Brescia Brescia Italy
Medicover GmbH Oldenburg In Holstein Germany
Vital Medical Center Veszprem Hungary
Utbeueamvjsz Mhquqrj Cszkxwy Gakqxwiqm Groningen The Netherlands
Ckhqisi Mfxcyaj Dk Dqxufpajom Sa Tlcvhvqhe Aobmijdye Nzvoys Sfieqj Brasov Romania
Rsurjllgnsgl sdndtp Brno-Sever Czechia
Slfovui Cphvbjfd Skxdan Timisoara Romania
Hxqhlksb Skxn Bucharest Romania
Acxingw Soissjawe Lefmyt Dy Suhngyx Salerno Italy
Mocpctgnc Mvuepze govza Munich Germany
Uvomswmzac Hhzfahkg Cnqfbav Cologne Germany
Awwqtqmjd Uit Amsterdam The Netherlands
Uktfuwvdfdrnpmcwgeyys Mbeaxilm Aqk Munster Germany
Ukxricnjix Dvewm Spimb Dq Rbem Lj Ssuihdod Rome Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
30.08.2021
Czechia Czechia
Not recruiting
30.08.2021
Germany Germany
Not recruiting
30.08.2021
Hungary Hungary
Not recruiting
30.08.2021
Italy Italy
Not recruiting
30.08.2021
Romania Romania
Not recruiting
30.08.2021
The Netherlands The Netherlands
Not recruiting
30.08.2021

Trial locations

Investigated drugs:

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

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.

Trial ID:
2023-505696-74-00
Protocol code:
230LE304
NCT ID:
NCT04961567
Trial Phase:
Therapeutic confirmatory (Phase III)

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