Clinical Trial

Efficacy and Safety of Sirolimus in Active Systemic Lupus Erythematosus

Study acronym: SIRIUS
Active, Not Recruiting Phase 3
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Summary
This is a multi-center, double-blinded, randomized, placebo-controlled, phase 3 study to evaluate the efficacy and safety of sirolimus administered in addition to standard therapy, in patients with active SLE disease.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2020-10-03; most recent amendment 2025-09-23.
Status change: Recruiting → Active, Not Recruiting 2025-09-23
Status change: Not Yet Recruiting → Recruiting 2024-02-06
Trial Details
NCT Number NCT04582136
Lead Sponsor Chinese SLE Treatment And Research Group
Collaborators: Beijing Municipal Science & Technology Commission, North China Pharmaceutical Group Corporation
Conditions Systemic Lupus Erythematosus
Enrollment 146 participants
Start Date 2021-03-04
Primary Completion 2025-04-21 (estimated)
Study Completion 2026-01 (estimated)
Updated on ClinicalTrials.gov 2025-09-26