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A Study of Outcomes in Chinese Patients Treated With Anifrolumab Who Have Active Mod-severe Systemic Lupus Erythematosus

Study acronym: LOTUS
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened Trial sites expanded: 44 → 71 locations · Completion date: Aug 25, 2028 to Aug 30, 2028 · Start date changed from estimate of Sep 4, 2026 to Aug 31, 2026 · 3 more Show 6 more changesShow less
    • Trial sites expanded: 44 → 71 locations
    • Completion date: Aug 25, 2028 to Aug 30, 2028
    • Start date changed from estimate of Sep 4, 2026 to Aug 31, 2026
    • Eligibility criteria expanded, about 38 words
    • Secondary endpoints: details revised at 9 of 23 entries
    • Study description revised
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
AstraZeneca
727 trials monitored
See 61 trials at risk
Lupus (SLE)
651 trials monitored
See 25 trials at risk
This study aims to describe clinical outcomes, with focus on remission, achieved with use of anifrolumab participants with SLE on standard-of-care (as recommended by 2025 China SLE guidelines). Further, it aims to describe outcomes alongside a systematic approach to glucocorticoid (GC) tapering, in terms of effectively minimising GC use, as well as discontinuing GC use, thereby reducing GC exposure.
Trial Details
NCT Number NCT07751848
Lead Sponsor AstraZeneca
Conditions Lupus Erythematosus, Systemic
Enrollment 417 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov