A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus
← catalyst calendarNCT04961567 · readout in 39 d
Sponsored by Biogen (industry) · BIIB — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
562actual
Sites
177
Countries
Argentina, Belgium, Canada +14
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 | 2021-07-16 | actual | When the study began enrolling |
| Primary completion | 2026-09-27 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-03-16 | estimated | The whole study's end, after follow-up |
| First posted | 2021-07-14 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-01-29 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Lupus Erythematosus, Systemic
Interventions
- Drug: Litifilimab — also filed as BIIB059
- Drug: Placebo
Primary outcome
what the primary-completion date above is the date OFPercentage of Participants Who Achieved a Systemic Lupus Erythematosus Responder Index of 4 (SRI-4) Response at Week 52
measured Week 52
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