A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Patients Who Have Lupus

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In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in patients with systemic lupus erythematosus (SLE). The study will focus on patients who have active disease and are already taking standard of care medications. These may include antimalarials, steroids, and immunosuppressants. The main objective of the study is to learn about the effect litifilimab has on lowering the activity of the disease. The main question researchers want to answer is: - How many patients have an improvement in their symptoms after 52 weeks of treatment? Researchers will answer this and other questions by measuring the symptoms of SLE over time using a variety of scoring tools. These include the SLE Responder Index (SRI), the Lupus Disease Activity Index-2000 (SLEDAI-2K), and the Patient Global Assessment - Visual Analog Scale (PGA-VAS). Researchers will also learn more about the safety of litifilimab. They will study how patients' immune systems respond to litifilimab. Additionally, they will measure the effect litifilimab and SLE have on the quality of life of patients using a group of questionnaires. The study will be done as follows: * After screening, patients will be randomized to receive either a high or low dose of litifilimab, or placebo. A placebo looks like the study drug but contains no real medicine. * All patients will receive either litifilimab or placebo as injections under the skin once every 4 weeks. The treatment period will last 52 weeks. Participants will continue to take their standard of care medications. * Neither the researchers nor the patients will know if the patients are receiving litifilimab or placebo. * There will be a follow-up safety period that lasts up to 24 weeks. * In total, patients will have up to 22 study visits. The total study duration for patients will be up to 80 weeks.

Conditions:

Lupus Erythematosus, Systemic

Study Start (Actual) 2021-05-25

Primary Completion (Estimated) 2025-03-28

Study Completion (Estimated) 2025-09-12

Enrollment (Estimated) 540

Study Type INTERVENTIONAL

Phase PHASE3

Locations:

📍 Beverly Hills, California, United States

📍 Los Angeles, California, United States

📍 Mission Hills, California, United States

📍 San Diego, California, United States

📍 Upland, California, United States

📍 Aurora, Colorado, United States

📍 Washington, District of Columbia, United States

📍 Aventura, Florida, United States

📍 Clearwater, Florida, United States

📍 Coral Springs, Florida, United States

📍 DeBary, Florida, United States

📍 Fort Lauderdale, Florida, United States

📍 Hollywood, Florida, United States

📍 Margate, Florida, United States

📍 Miami Lakes, Florida, United States

📍 Orlando, Florida, United States

📍 Tampa, Florida, United States

📍 Flint, Michigan, United States

📍 Saint Louis, Missouri, United States

📍 Brooklyn, New York, United States

📍 New Hyde Park, New York, United States

📍 Rochester, New York, United States

📍 Syracuse, New York, United States

📍 Charlotte, North Carolina, United States

📍 Greensboro, North Carolina, United States

📍 Winston-Salem, North Carolina, United States

📍 Middleburg Heights, Ohio, United States

📍 Memphis, Tennessee, United States

📍 Nashville, Tennessee, United States

📍 Colleyville, Texas, United States

📍 Houston, Texas, United States

📍 Humble, Texas, United States

📍 Stafford, Texas, United States

📍 The Woodlands, Texas, United States

📍 Webster, Texas, United States

📍 Seattle, Washington, United States

📍 Camperdown, New South Wales, Australia

📍 Box Hill, Victoria, Australia

📍 Footscray, Victoria, Australia

📍 Murdoch, Western Australia, Australia

📍 Salvador, Bahia, Brazil

📍 Fortaleza, Ceará, Brazil

📍 Brasilia, Distrito Federal, Brazil

📍 Vitória, Espírito Santo, Brazil

📍 Cuiabá, Mato Grosso, Brazil

📍 Belo Horizonte, Minas Gerais, Brazil

📍 Juiz de Fora, Minas Gerais, Brazil

📍 Curitiba, Paraná, Brazil

📍 Lajeado, Rio Grande Do Sul, Brazil

📍 Porto Alegre, Rio Grande Do Sul, Brazil

📍 Sao Jose Rio Preto, Sao Paulo, Brazil

📍 São Bernardo do Campo, Sao Paulo, Brazil

📍 São Paulo, Sao Paulo, Brazil

📍 Plovdiv, Bulgaria

📍 Ruse, Bulgaria

📍 Sofia, Bulgaria

📍 Osorno, Chile

📍 Santiago, Chile

📍 Bordeaux, Gironde, France

📍 Montpellier Cedex 5, Herault, France

📍 Clermont-Ferrand cedex 1, Puy De Dome, France

📍 Athens, Greece

📍 Suwon, Gyeonggi-do, Korea, Republic of

📍 Busan, Korea, Republic of

📍 Incheon, Korea, Republic of

📍 Seoul, Korea, Republic of

📍 Ciudad de México, Distrito Federal, Mexico

📍 Mexico, Distrito Federal, Mexico

📍 Guadalajara, Jalisco, Mexico

📍 Cuernavaca, Morelos, Mexico

📍 Monterrey, Nuevo León, Mexico

📍 Merida, Yucatán, Mexico

📍 Chihuahua, Mexico

📍 Durango, Mexico

📍 Davao City, Philippines

📍 Iloilo, Philippines

📍 Lipa City, Philippines

📍 Mabalacat, Pampanga, Philippines

📍 Manila, Philippines

📍 Quenzon City, Philippines

📍 Quezon City, Metro Manila, Philippines

📍 Bialystok, Poland

📍 Bydgoszcz, Poland

📍 Bytom, Poland

📍 Krakow, Poland

📍 Lublin, Poland

📍 Malbork, Poland

📍 Warszawa, Poland

📍 Wroclaw, Poland

📍 Kemerovo, Russian Federation

📍 Moscow, Russian Federation

📍 Orenburg, Russian Federation

📍 Santander, Cantabria, Spain

📍 Barcelona, Spain

📍 Granada, Spain

📍 Sevilla, Spain

📍 Valencia, Spain

📍 Stockholm, Sweden

📍 Uppasala, Sweden

📍 Örebro, Sweden

📍 Kaohsiung, Taiwan

📍 Taoyuan County, Taiwan

More locations available...

Eligibility Criteria

Description

Inclusion Criteria:

* Participant must be diagnosed with systemic lupus erythematosus (SLE) at least 24 weeks prior to screening and must meet the 2019 European League Against Rheumatism (EULAR) / American College of Rheumatology (ACR) classification criteria for SLE at screening by a qualified physician.
* Participant has a modified Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) score ≥ 6 (excluding alopecia, fever, lupus-related headache, and organic brain syndrome) at screening (adjudicated).
* Participant has a modified clinical SLEDAI-2K score ≥ 4 (excluding anti-dsDNA, low complement component 3 (C3) and/or complement component 4 (C4), alopecia, fever, lupus-related headache, and organic brain syndrome) at Screening (adjudicated) and randomization.
* Participant has BILAG-2004 grade A in ≥ 1 organ system or BILAG-2004 grade B in ≥ 2 organ systems at Screening (adjudicated) and randomization.
* Participant must be treated with one of the following background nonbiologic lupus SOC therapies, initiated ≥ 12 weeks prior to Screening and at stable dose ≥ 4 weeks prior to randomization:
1. Antimalarials as stand-alone treatment
2. Antimalarial treatment in combination with OCS and/or a single immunosuppressant
3. Treatment with OCS and/or a single immunosuppressant

Exclusion Criteria:

* History of or positive test result for human immunodeficiency virus (HIV).
* Current hepatitis C infection (defined as positive hepatitis C virus (HCV) antibody and detectable HCV ribonucleic acid \[RNA\]).
* Current hepatitis B infection (defined as positive for antibody to hepatitis B surface antigen (HBsAg) and/or positive for total hepatitis antibody to B core antigen \[anti-HBc\] with positive reflex HBV DNA).
* History of severe herpes infection.
* Presence of uncontrolled or New York Heart Association class III or IV congestive heart failure.
* Active severe lupus nephritis where, in the opinion of the Investigator, protocol-specified SOC is insufficient and use of a more aggressive therapeutic approach is indicated, such as adding IV cyclophosphamide and/or high-dose IV pulse corticosteroid therapy or other treatments not permitted in the protocol is indicated; or urine protein-creatinine ratio \> 2.0 or severe chronic kidney disease (estimated glomerular filtration rate \< 30 milliliters per minute per 1.73 meter square \[mL/min/1.73 m\^2\]) calculated using the abbreviated modification of diet in renal disease equation.
* Any active skin conditions other than cutaneous lupus erythematosus (CLE) that may interfere with the study assessment of CLE such as but not limited to psoriasis, dermatomyositis, systemic sclerosis, non-LE skin lupus manifestation or drug-induced lupus.
* History or current diagnosis of a clinically significant non-SLE-related vasculitis syndrome.
* Active neuropsychiatric SLE.
* Use of oral prednisone (or equivalent) above 20 mg/day.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted2021-05-17
First Submitted that Met QC Criteria2021-05-17
First Posted2021-05-20

Study Record Updates

Last Update Submitted that Met QC Criteria2024-04-29
Last Update Posted2024-04-30
Last Verified2024-04