Clinical Trial

Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Systemic Lupus Erythematosus

Recruiting Phase 2
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Record status
This record was last updated August 16, 2024 (before its estimated August 25, 2025 completion). Its status may not reflect the trial's current state.
Summary
This is a phase IIb, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of orelabrutinib in adult subjects with SLE who are receiving standard of care (SOC) therapy.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2023-01-17; most recent amendment 2024-08-15.
Status change: Not Yet Recruiting → Recruiting 2023-06-02
Trial Details
NCT Number NCT05688696
Lead Sponsor Beijing InnoCare Pharma Tech Co., Ltd.
Conditions Systemic Lupus Erythematosus, SLE
Enrollment 186 participants
Start Date 2023-04-29
Primary Completion 2025-08-25 (estimated)
Study Completion 2026-05-30 (estimated)
Updated on ClinicalTrials.gov 2024-08-16