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ACTIVE NOT RECRUITING

NCT04961567

PHASE3

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

Sponsor: Biogen

View on ClinicalTrials.gov

Summary

In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with systemic lupus erythematosus (SLE). The study will focus on participants 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 participants 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 Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K), the British Isles Lupus Activity Group-2004 index (BILAG-2004), and the BILAG-BASED Combined Lupus Assessment (BICLA), among others. Researchers will also learn more about the safety of litifilimab. They will study how participants' immune systems respond to litifilimab. Additionally, they will measure the effect litifilimab and SLE have on the quality of life of participants using a group of questionnaires. The study will be done as follows: * After screening, participants 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 participants 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 participants will know if the participants are receiving litifilimab or placebo. * There will be a follow-up safety period that lasts up to 24 weeks. * In total, participants will have up to 22 study visits. The total study duration for participants will be up to 80 weeks.

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Litifilimab (BIIB059) in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

562

Start Date

2021-07-16

Completion Date

2027-03-16

Last Updated

2026-01-29

Healthy Volunteers

Conditions

Lupus Erythematosus, Systemic

Interventions

DRUG

Litifilimab

Administered as specified in the treatment arm.

DRUG

Placebo

Administered as specified in the treatment arm.

Key Inclusion Criteria: * Participant must be diagnosed with 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-200 (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. * Participants 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. Key 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 antibody to hepatitis 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, such as adding intravenous (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.

Locations (177)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Arizona Arthritis & Rheumatology Associates, P.C.

Glendale, Arizona, United States

Care Access Research - Huntington BeachCare Access Research - Huntington Beach

Huntington Beach, California, United States

Valerius Medical Group

Los Alamitos, California, United States

The Practice of Medicine

Los Angeles, California, United States

R. Srinivasan, M.D., Inc. dba Monterey Park Medical Center

Monterey Park, California, United States

Neurovations

Napa, California, United States

Joo-Hyung Lee MD

Orange, California, United States

Medvin Clinical Research

Whittier, California, United States

RASF - Clinical Research Center

Boca Raton, Florida, United States

University of Florida

Gainesville, Florida, United States

Vida Clinical Research

Kissimmee, Florida, United States

University of Miami Miller School of Medicine

Miami, Florida, United States

HMD Research, LLC

Orlando, Florida, United States

Clinical Research of West Florida, Inc.

Tampa, Florida, United States

The Emory Clinic Emory University

Atlanta, Georgia, United States

Jefrey Lieberman, M.D., P.C.

Decatur, Georgia, United States

Southeastern Rheumatology Alliance dba Arthritis Center of North Georgia

Gainesville, Georgia, United States

RNA America Health Sciences

Gainesville, Georgia, United States

EBGS Clinical Trials

Snellville, Georgia, United States

Rush University Medical Center

Chicago, Illinois, United States

Boston University School of Medicine

Boston, Massachusetts, United States

DM Clinical Research - Boston

Brookline, Massachusetts, United States

University of Massachusetts

Worcester, Massachusetts, United States

Saint Louis Rheumatology

St Louis, Missouri, United States

Arthritis & Osteoporosis Associates, PA

Freehold, New Jersey, United States

Arthritis and Osteoporosis Associates of New Mexico

Las Cruces, New Mexico, United States

DJL Clinical Research, PLLC

Charlotte, North Carolina, United States

Carolina Arthritis Associates

Wilmington, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

STAT Research

Dayton, Ohio, United States

Piedmont Arthritis Clinic, P.A.

Greenville, South Carolina, United States

Low Country Rheumatology, PA

Summerville, South Carolina, United States

West Tennessee Research Institute

Jackson, Tennessee, United States

Arthritis & Rheumatology Institute

Allen, Texas, United States

Office of John P. Lavery M.D., PA

Allen, Texas, United States

Tekton Research

Austin, Texas, United States

Precision Comprehensive Clinical Research Solutions

Colleyville, Texas, United States

R and H Clinical Research

Katy, Texas, United States

Prime Clinical Research

Mansfield, Texas, United States

SouthWest Rheumatology Research, LLC

Mesquite, Texas, United States

Sun Research Institute, LLC

San Antonio, Texas, United States

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Swedish Medical Center

Seattle, Washington, United States

Instituto de Investigaciones Clinicas Quilmes

Buenos Aires, Buenos Aires, Argentina

Hospital Italiano de La Plata

Buenos Aires, Buenos Aires, Argentina

Hospital General de Agudos Dr. J. M. Ramos Mejia

Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina

Centro de Investigaciones Medicas Mar del Plata

Mar del Plata, Buenos Aires, Argentina

Policlìnica Red Omip S.A - Ensayos Clinicos GC

Mar del Plata, Buenos Aires, Argentina

Centro Dermatologico Schejtman

San Miguel, Buenos Aires, Argentina

APRILLUS Asistencia e Investigacion

Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina

Instituto CAICI

Rosario, Santa Fe Province, Argentina

Clinica Mayo de Urgencias Medicas Cruz Blanca SRL

San Miguel de Tucumán, Tucumán Province, Argentina

Centro de Investigaciones Medicas Tucuman

San Miguel de Tucumán, Tucumán Province, Argentina

Investigaciones Clinicas Tucuman

San Miguel de Tucumán, Tucumán Province, Argentina

Centro Medico Barrio Parque

Buenos Aires, Argentina

Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada