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

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What is this study about?

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.

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 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 Study?

  • 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 Study?

  • 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.

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
CHU Gabriel-Montpied Clermont Ferrand France
Centre hospitalier universitaire de Liege Liege Belgium
Pellegrin Hospital Bordeaux France
San Camillo Forlanini Hospital Rome Italy
Delta Health Care S.R.L. Bucharest Romania
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
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
Dkc 1 Ruse EOOD Ruse Bulgaria
Nova Reuma Domyslawska I Rusilowicz Lekarza Reumatologa I Fizjoterapeuty sp.p. Bialystok Poland
Karolinska University Hospital Solna Sweden
Centrul Medical Unirea S.R.L. Brasov Romania
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy Bydgoszcz Poland
Dkc Fokus-5 Lzip OOD Sofia Bulgaria
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Centre Hospitalier Universitaire De Montpellier Montpellier France
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet Budapest Hungary
Pratia S.A. Skorzewo Poland
Hospital General Universitario De Castellon Castello De La Plana Spain
University Multiprophy Hospital For Active Treatment – Plovdiv AD Plovdiv Bulgaria
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Sofia Bulgaria
Medical Center Artmed Ltd. Plovdiv Bulgaria
University Hospital Olomouc Olomouc Czechia
NIEPUBLICZNY ZAKŁAD OPIEKI ZDROWOTNEJ BIF-MED S.C. A. Wawiernia,M. Roykiewicz,R. Roykiewicz Bytom Poland
Vital Medical Center Veszprem Hungary
Mdgbfxesr Ixefpydzqt Ccoehrws Spyjwosf Sax z owjc Warsaw Poland
Cefj Aurtur Pnrdoz Syh z ovyh Warsaw Poland
Uepitggktzdc Mqdpuwl Cqcvwnm Gypfjhruf Groningen The Netherlands
Hxafiazw Unskozmexaoua Myecmar Dh Vgaulnygvd Santander Spain
Clduyum Mzdcwsx Dp Dvqyqortyw Sb Tnmnncmwr Abvfrrusf Nfmoeb Sjszaq Brasov Romania
Rwrkxmsaomyk snbfag Brno-Sever Czechia
Vhfy Vsjyw Mqzkvpq Eofkwveumkcb Sfimbnchuvr Baf Szekesfehervar Hungary
Hyjmzalv Synz Bucharest Romania
Ptsdgejn Prwcrznx Ldtrtvmn Peod Dw Hjr Mti Psord Hbocek Poznan Poland
Uxgvcugpmj Hritzqhi Cfahaqq Cologne Germany
Uhzgntm Utmsxgwsbn Hmcksfjy Uppsala Sweden
Mkogfqzq Mxdplly Accupaf Pleven Bulgaria
Hfnfachw Vpii dsjgbntr Barcelona Spain

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
10.07.2022
Bulgaria Bulgaria
Recruiting
10.07.2022
Czechia Czechia
Recruiting
10.07.2022
France France
Not recruiting
10.07.2022
Germany Germany
Not recruiting
10.07.2022
Greece Greece
Recruiting
10.07.2022
Hungary Hungary
Recruiting
10.07.2022
Italy Italy
Recruiting
10.07.2022
Poland Poland
Recruiting
10.07.2022
Romania Romania
Recruiting
10.07.2022
Spain Spain
Recruiting
10.07.2022
Sweden Sweden
Not recruiting
10.07.2022
The Netherlands The Netherlands
Not recruiting
10.07.2022

Trial locations

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.

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 ID:
2023-505635-13-00
Protocol code:
230LE306
NCT ID:
NCT05352919
Trial Phase:
Therapeutic confirmatory (Phase III)

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