for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
completion around



The primary objective of this study is to evaluate the long-term safety and tolerability of litifilimab in participants with active systemic lupus erythematosus (SLE).

The secondary objectives of this study are to evaluate the long-term effect of litifilimab on disease activity in participants with SLE, to evaluate the long-term effect of litifilimab in participants with SLE in maintaining low disease activity, to evaluate the effect of litifilimab in participants with active SLE in preventing irreversible organ damage, to assess long-term use of oral corticosteroid (OCS) with participants receiving litifilimab treatment, to assess the impact of litifilimab on participant-reported Health-Related Quality-of-Life Questionnaire (HRQoL), symptoms, and impacts of SLE, to evaluate long-term effect of litifilimab on laboratory parameters, and to evaluate immunogenicity of litifilimab.

Official Title

A Multicenter, Randomized, Dose-Blind, Phase 3 Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of Litifilimab (BIIB059) in Adult Participants With Active Systemic Lupus Erythematosus


This is an extension study for all participants who completed study 230LE303 (NCT04895241) and 230LE304 (NCT04961567) (parent phase 3 studies) through Week 52 and did not discontinue litifilimab or placebo. Eligible participants from parent phase 3 studies will be followed for up to 180 weeks.


Systemic Lupus Erythematosus (SLE), Lupus Erythematosus, Systemic Autoimmune Diseases, Connective Tissue Diseases, Immune System Diseases, Systemic Lupus Erythematosus, Litifilimab


You can join if…

Open to people ages 18 years and up

  • Participants who completed 1 of the 52-week of the double-blind placebo-controlled, parent Phase 3 studies (230LE303 (NCT04895241) and 230LE304 (NCT04961567)) on study treatments with either litifilimab or placebo to Week 48 and attended the last study assessment visit at Week 52

You CAN'T join if...

  • Early parent Phase 3 studies treatment terminators (participants who discontinued study treatment before Week 52)
  • Early parent Phase 3 studies terminators (participants who withdrew from study participation and did not complete the 52 week treatment period)
  • Participants who developed moderate-to-severe worsening of organ-specific lupus manifestations that would require a change in antimalarials and/or immunosuppressive therapy (initiation of new treatment or increase in dose above the allowed maximum dose)
  • Use of other investigational drugs or off-label drugs used to treat SLE, cutaneous lupus, or lupus nephritis during the parent Phase 3 studies

    NOTE: Other inclusion/exclusion criteria may apply.


  • University of California San Diego School of Medicine
    La Jolla California 92037-094 United States
  • Valerius Medical Group
    Los Alamitos California 90720-5403 United States


accepting new patients by invitation only
Start Date
Completion Date
Phase 3 Lupus Research Study
Study Type
Expecting 864 study participants
Last Updated