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Purpose

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), and the Patient Global Assessment - Visual Analog Scale (PGA-VAS). 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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Litifilimab High Dose 		Participants who are receiving background nonbiologic lupus SOC therapy will receive high dose of litifilimab, subcutaneously (SC), every 4 weeks (Q4W), up to Week 48 with an additional dose at Week 2.
  • Drug: Litifilimab
    Administered as specified in the treatment arm.
    Other names:
    • BIIB059
Experimental
Litifilimab Low Dose 		Participants who are receiving background nonbiologic lupus SOC therapy will receive low dose of litifilimab, SC Q4W, up to Week 48 with an additional dose at Week 2.
  • Drug: Litifilimab
    Administered as specified in the treatment arm.
    Other names:
    • BIIB059
Placebo Comparator
Placebo 		Participants who are receiving background nonbiologic lupus SOC therapy will receive litifilimab-matching placebo, SC Q4W, up to Week 48 with an additional dose at Week 2.
  • Drug: Placebo
    Administered as specified in the treatment arm.

Recruiting Locations

The University of Texas Health
San Antonio, Texas 78229
Contact:
210-450-9800

More Details

Status
Recruiting
Sponsor
Biogen

Study Contact

US Biogen Clinical Trial Center
866-633-4636
clinicaltrials@biogen.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.