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NCT05352919

An Extension Study to Learn More About the Long-Term Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus

Enrolling by Invitation
PHASE3Ages 18+InterventionalTreatment
Biogen
~864 participants
Updated 2026-07-31 on ClinicalTrials.gov
What's tested:LitifilimabLitifilimab-matching placebo

At a glance

Recruiting sites
0 of 197 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Measured over Up to Week 180
+1 more outcome measured

Conditions

Systemic Lupus Erythematosus (SLE)

Explore related trials

Systemic Lupus Erythematosus

Where it's being run

197 sites across 89 states
Colombia10
Texas9
Poland9
Florida8
Bulgaria8
Argentina7
Chile5
Guangdong5

Study leadership

  • Medical Director · STUDY_DIRECTOR · Biogen

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • Number of Participants with Treatment Emergent Adverse Events (TEAEs)Up to Week 180

    An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is an AE that started or worsened in severity after the first dose of study treatment through 28 days after the last dose of study treatment or end of study (EOS) date, whichever comes earlier.

  • Number of Participants with Serious Adverse Events (SAEs)Up to Week 180

    An SAE is any untoward medical occurrence that at any dose results in death, in the view of the Investigator, places the participant at immediate risk of death (a life threatening event), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, and is a medically important event.