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Efficacy and Safety of Sirolimus in Active Systemic Lupus Erythematosus

Study acronym: SIRIUS
StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Phase: Phase 2 to Phase 3v3 Show 5 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Oct 31, 2024 to Apr 21, 2025
    • Study completion date: May 1, 2025 to Jan 2026
    • Study description revised
    • Site details revised at 6 of 6 sites
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 6 more changesShow less
    • Primary completion date: Nov 2021 to Oct 31, 2024
    • Start date changed from estimate of Nov 2020 to Mar 4, 2021
    • Study sites: 0 to 6
    • Study completion date: Nov 2022 to May 1, 2025
    • Eligibility criteria expanded, about 97 words
    • Secondary endpoints: details revised at 1 of 5 entries
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
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.
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
(from sponsor)		 Systemic Lupus Erythematosus
Related terms Lupus Erythematosus, Systemic
Enrollment 146 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov