Actively Recruiting
Phase 3 Study of MIL62 Monoclonal Antibody Injection for Treating Systemic Lupus Erythematosus
Led by Beijing Mabworks Biotech Co., Ltd. · Updated on 2026-05-05
316
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying the safety and effectiveness of a drug called MIL62 compared with a placebo in adults with systemic lupus erythematosus SLE, a chronic autoimmune disease. This phase 3 clinical trial aims to better understand how well MIL62 works to reduce disease activity and improve symptoms in people diagnosed with SLE based on established classification criteria. Participants will receive MIL62 or placebo through intravenous infusions at a dose of 1000 mg on specific days Week 1 Day 1, Week 3 Day 1, Week 25 Day 1, and Week 27 Day 1. The study involves random assignment to one of these two groups, and the treatment process is double-blinded, meaning neither participants nor researchers know who receives which infusion. During the trial, participants will be monitored closely for changes in disease activity using measures like the SLE Responder Index SRI-4 at Weeks 24 and 52, urine protein levels, prednisone dose adjustments, quality of life questionnaires, and serum biomarkers related to SLE. Safety is tracked by recording adverse events and immune response markers. The trial lasts up to 52 weeks, with regular assessments to evaluate the treatments impact and participant health.
CONDITIONS
Brief Title
A Phase 3 Clinical Study of MIL62 in Systemic Lupus Erythematosus
Research Team
Z
Zhanguo Li
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