Purpose

The primary objective of this study is to demonstrate efficacy of litifilimab (BIIB059) compared with placebo in participants with active systemic lupus erythematosus (SLE), who are receiving background lupus standard of care (SOC) therapy in reducing disease activity. The secondary objectives of this study are to demonstrate early onset of efficacy of litifilimab compared with placebo in participants with active SLE, who are receiving background lupus SOC therapy in reducing disease activity; to demonstrate organ-specific efficacy of litifilimab compared with placebo in participants with active SLE, who are receiving background lupus SOC therapy in reducing joint disease activity; to demonstrate effect of litifilimab compared with placebo in reducing oral corticosteroid(s) (OCS) use; to demonstrate organ-specific efficacy of litifilimab compared with placebo in participants with active SLE, who are receiving background lupus SOC therapy in reducing skin disease activity; to demonstrate efficacy of litifilimab compared with placebo in participants with active SLE, who are receiving background lupus SOC therapy in reducing occurrence of flare up to Week 52; to evaluate additional efficacy of litifilimab compared with placebo in reducing disease activity with additional disease activity measures; to evaluate the effect of litifilimab compared with placebo in reducing OCS use; to assess the difference between litifilimab and placebo on participant-reported health-related quality of life (HRQoL), symptoms, and impacts of SLE; to evaluate the safety and tolerability of litifilimab in participants with active SLE and to evaluate immunogenicity of litifilimab in participants with active SLE.

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.