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Efficacy and Safety Evaluation of Litifilimab in Adults with Active Systemic Lupus Erythematosus on Nonbiologic Standard of 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 litifilimab, also known by its code name BIIB059. It is a type of medication known as a recombinant monoclonal antibody, which is administered through an injection under the skin.

The purpose of the study is to evaluate how effective and safe litifilimab is in reducing the activity of SLE in adults who are already receiving standard care for lupus that does not involve biologic treatments. Participants in the study will be randomly assigned to receive either litifilimab 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 receive regular injections and attend scheduled visits to monitor their health and the effects of the treatment.

Throughout the study, various aspects of the participants’ health will be assessed, including the activity of their lupus symptoms, any changes in their joint health, and their overall quality of life. The study aims to determine if litifilimab can help reduce the symptoms of SLE and improve the well-being of those affected by this condition. Participants will be closely monitored for any side effects or adverse reactions to ensure their safety during the trial.

Who Can Join the Study?

  • You must have been diagnosed with systemic lupus erythematosus, which is a long-term disease where the body’s immune system attacks its own healthy tissues, at least 24 weeks before joining the study.
  • A doctor must confirm that your condition meets the official medical rules used to classify systemic lupus erythematosus.
  • Your disease must be considered active, meaning it is currently causing symptoms or damage in your body.
  • You must have a score of 6 or higher on a specific scale called the SLEDAI-2K, which is a tool doctors use to measure how much your disease is affecting you, excluding certain symptoms like hair loss, fever, or specific types of headaches.
  • You must also meet a specific clinical score of 4 or higher on the same SLEDAI-2K scale, which focuses on physical symptoms and excludes certain laboratory blood test results like low levels of specific proteins called complement components.
  • Your disease must affect your organs in a specific way, measured by a scale called BILAG-2004, where you must show a high level of activity in at least one organ system or a moderate level in at least two organ systems.
  • You must already be taking standard of care therapy, which refers to the regular medical treatments used to manage your condition.
  • The medications you are taking must not be biologic therapies, which are drugs made from living organisms that target specific parts of the immune system.
  • You must have started your current non-biologic treatment at least 12 weeks before the study begins.
  • You must have been on a stable dose of your current medication for at least 4 weeks before being assigned to a study group.
  • Your treatment must consist of antimalarials (medicines often used to treat malaria but also used for lupus), OCS (oral corticosteroids, which are powerful anti-inflammatory medicines), and/or a single immunosuppressant (a drug that lowers the activity of your immune system).

Who Cannot Join the Study?

  • A history of or a positive test for human immunodeficiency virus (HIV), which is a virus that attacks the body’s immune system.
  • A current infection of hepatitis C, a virus that affects the liver, confirmed by testing for both antibodies and the virus itself in the blood.
  • A current infection of hepatitis B, another virus that affects the liver, confirmed by specific blood tests.
  • Having congestive heart failure that is not well-controlled or is at a severe stage (known as New York Heart Association class III or IV), which means the heart cannot pump enough blood to meet the body’s needs.
  • Having active and severe lupus nephritis, which is inflammation of the kidneys caused by lupus, especially if standard treatments are not working or if it requires very strong medicines like IV cyclophosphamide (a strong medicine given through a vein) or high doses of corticosteroids (steroid medicines used to reduce inflammation).
  • Having high levels of protein in the urine, measured as a urine protein-creatinine ratio greater than 2.0.
  • Having severe chronic kidney disease, which is long-term damage to the kidneys, defined by a low estimated glomerular filtration rate (a measure of how well the kidneys filter waste from the blood).
  • Having any active skin conditions other than cutaneous lupus erythematosus (lupus that only affects the skin) that might make it hard to study the skin, such as psoriasis (a condition causing red, itchy skin), dermatomyositis (an inflammatory disease causing muscle weakness and skin rashes), or systemic sclerosis (a disease that hardens the skin and connective tissues).
  • A history or current diagnosis of vasculitis, which is inflammation of the blood vessels, that is not caused by lupus.
  • Having neuropsychiatric SLE, which means lupus is affecting the brain or the nervous system.
  • Using more than 20 mg per day of oral prednisone, which is a type of steroid medicine taken by mouth to reduce inflammation.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Region Vaestmanland Vasteras Sweden
Centre Hospitalier Universitaire De Bordeaux Bordeaux France

Other Sites

Site Name City Country Status
Medical Center Hera EOOD Sofia Bulgaria
Hospital Universitario Rio Hortega Valladolid Spain
Hospital Universitario Dr Peset Aleixandre Valencia Spain
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o. Nowa Sol Poland
Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o.o. Malbork Poland
Malopolskie Badania Kliniczne Sp. z o.o. Cracow Poland
Athens Naval Hospital Athens Greece
Rivermed Sp. z o.o. Poznan Poland
ReumaClinic Gabinet Reumatologiczny Dr Izabela Domysławska Bialystok Poland
Dkc 1 Ruse EOOD Ruse Bulgaria
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy Bydgoszcz Poland
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Karolinska University Hospital Solna Sweden
Centre Hospitalier Universitaire De Montpellier Montpellier France
Pratia S.A. Skorzewo Poland
University Multiprophy Hospital For Active Treatment – Plovdiv AD Plovdiv Bulgaria
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Sofia Bulgaria
NIEPUBLICZNY ZAKŁAD OPIEKI ZDROWOTNEJ BIF-MED S.C. A. Wawiernia,M. Roykiewicz,R. Roykiewicz Bytom Poland
Twoja Przychodnia Poznańskie Centrum Medyczne Sp. z o.o. Poznan Poland
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
Mjwezbncp Iipokdvubg Cmplwwtr Sicjucap Syy z offd Warsaw Poland
Chcw Aptdna Pmrxdd Sad z ollt Warsaw Poland
Hvlijsxw Ulqmcountfydg Mffimbd Dt Vjbubvubwn Santander Spain
Eke Shjunqm Sue z ohij Katowice Poland
Ublxcky Ulpzomexrq Hefzjzrn Uppsala Sweden
Medmyizr Mweuxeu Agxgswy Pleven Bulgaria
Pbeoeeoz Pfaueboh Lvsmdsxb Pkfq Dw Hxk Mvb Pqthg Hgzluk Poznan Poland
Htfxjixv Vdsb dulezsgm Barcelona Spain

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

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
25.05.2021
France France
Not recruiting
25.05.2021
Greece Greece
Not recruiting
25.05.2021
Poland Poland
Not recruiting
25.05.2021
Spain Spain
Not recruiting
25.05.2021
Sweden Sweden
Not recruiting
25.05.2021

Trial locations

Investigated drugs:

Litifilimab is an experimental medication given as an injection under the skin. It is being tested to see if it can help reduce the activity and symptoms of systemic lupus erythematosus, an autoimmune disease where the immune system attacks the body’s own tissues.

Investigated diseases:

systemic lupus erythematosus – This is a long-term condition where the body’s immune system mistakenly attacks its own healthy tissues and organs. It can cause inflammation and damage in many different parts of the body, including the skin, joints, and kidneys. The disease often progresses through periods of active symptoms followed by periods of relative calm. During active phases, people may experience widespread swelling, pain, or rashes. The way the disease affects each person can vary significantly, sometimes targeting specific organs while leaving others unaffected.

Trial ID:
2023-505695-30-00
Protocol code:
230LE303
NCT ID:
NCT04895241
Trial Phase:
Therapeutic confirmatory (Phase III)

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