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
← catalyst calendarNCT05352919 · readout in 1,317 d
Sponsored by Biogen (industry) · BIIB — their whole pipeline →.
Phase
Phase 3
Status
Enrolling by invitation
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
864estimated
Sites
203
Countries
Argentina, Belgium, Brazil +25
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-06-10 | actual | When the study began enrolling |
| Primary completion | 2030-03-29 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2030-03-29 | estimated | The whole study's end, after follow-up |
| First posted | 2022-04-29 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-13 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Systemic Lupus Erythematosus (SLE)
Interventions
- Drug: Litifilimab — also filed as BIIB059
- Drug: Litifilimab-matching placebo — also filed as BIIB059
Primary outcomes
what the primary-completion date above is the date OFNumber of Participants with Treatment Emergent Adverse Events (TEAEs)
measured Up to Week 180
Number of Participants with Serious Adverse Events (SAEs)
measured Up to Week 180
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