Anifrolumab Asian PhIII Efficacy Study for Systemic Lupus Erythematosus (SLE)
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Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
277actual
Sites
65
Countries
China, Hong Kong, Philippines +3
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 | 2021-09-13 | actual | When the study began enrolling |
| Primary completion | 2025-04-07 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-06-10 | actual | The whole study's end, after follow-up |
| First posted | 2021-06-18 | actual | When this record first appeared on the registry |
| Results posted | 2026-05-20 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-05-20 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Active Systemic Lupus Erythematosus
Interventions
- Biological: Anifrolumab
- Drug: placebo
Primary outcome
what the primary-completion date above is the date OFDifference in Proportion of Participants Who Are Responders Between Anifrolumab and Placebo
measured Week 52
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2025-05-19 · 11.3 MB · Prot_000.pdf
Statistical Analysis Planposted 2025-05-16 · 4.7 MB · SAP_001.pdf
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