Last updated 11 days ago
A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus
540 patients around the world
Available in Chile, Mexico, Argentina, Colombia, Brazil, Peru
Biogen
25Research sites
540Patients around the world
This study is for people with
Lupus
Systemic lupus erythematosus
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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 treatment2. Antimalarial treatment in combination with OCS and/or a single immunosuppressant3. Treatment with OCS and/or a single immunosuppressant
- 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 hepatitis B surface antigen (HBsAg) and/or total hepatitis B core antibody [anti-HBc]).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.
Sites
Centro Paulista de Investigação Clínica - CEPIC
Recruiting
SER - Serviços Especializados em Reumatologia da Bahia
Recruiting
L2IP Instituto de Pesquisas Clínicas
Recruiting
Cedoes - Pesquisa e Diagnóstico
Recruiting
Santa Casa de Misericórdia de Belo Horizonte
Recruiting
Hospital Universitário Walter Cantídio - Universidade Federal do Ceará - Fortaleza, Ceara
Recruiting
Hospital Bruno Born
Recruiting
Hospital de Clínicas de Porto Alegre - HCPA/UFRGS
Recruiting
Fundação Faculdade Regional de Medicina de São José do Rio Preto
Recruiting
CEMEC - Centro Multidisciplinar de Estudos Clínicos
Recruiting
StudyTOPAZ-1
SponsorBiogen
Study typeInterventional
Conditions
Systemic lupus erythematosus
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT04895241
