Home › Trials › NCT04961567

Investigating the safety and effects of litifilimab injections for adults with systemic lupus erythematosus

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

Phase 3 Interventional Biogen · NCT04961567

This study is testing if litifilimab injections can safely help adults with active systemic lupus erythematosus feel better while they continue their usual treatments.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment540 (estimated)
Ages18 Years and up
SexAll
SponsorBiogen Industry-sponsored
Drugs / interventionscyclophosphamide, prednisone, litifilimab
Locations179 sites (Birmingham, Alabama and 178 other locations)
Trial IDNCT04961567 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the safety and efficacy of litifilimab (BIIB059) in adults diagnosed with systemic lupus erythematosus (SLE) who are currently experiencing active disease. Participants will receive either the study drug or a placebo while continuing their standard of care medications. The primary objective is to assess the improvement in SLE symptoms over a 52-week period using various scoring tools, including the SLE Responder Index and the SLE Disease Activity Index. Additionally, the study will monitor the safety profile of litifilimab throughout the treatment duration.

Who should consider this trial

Good fit: Ideal candidates include adults diagnosed with SLE who have active disease and meet specific criteria related to disease activity.

Not a fit: Patients with mild or inactive SLE may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of symptoms for patients with systemic lupus erythematosus.

How similar studies have performed: Previous studies have shown promise with similar biologic treatments for lupus, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Birmingham, Alabama and 178 other locations

+129 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Lupus Erythematosus, SystemicLupusSLECLE
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.