A Long-Term Extension Study to Learn More About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus
← catalyst calendarNCT06044337 · readout in 1,042 d
Sponsored by Biogen (industry) · BIIB — their whole pipeline →.
Phase
Phase 3
Status
Enrolling by invitation
Study type
Interventional
Design
Na · None · Treatment
Enrollment
306estimated
Sites
104
Countries
Argentina, Brazil, Bulgaria +22
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 | 2023-10-03 | actual | When the study began enrolling |
| Primary completion | 2029-06-26 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2029-12-11 | estimated | The whole study's end, after follow-up |
| First posted | 2023-09-21 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-04 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Subacute Cutaneous Lupus Erythematosus
- Chronic Cutaneous Lupus Erythematosus
Intervention
- Drug: BIIB059 (litifilimab) — also filed as litifilimab
Primary outcome
what the primary-completion date above is the date OFNumber of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
measured Up to 232 weeks
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