Hồ sơ nguồn sơ cấp
Mang tính quyết địnhKết quả topline
UCB/Biogen công bố kết quả tích cực giai đoạn 3 PHOENYCS GO cho dapirolizumab pegol trong SLE
The Lancet publication confirms the Phase 3 PHOENYCS GO study met its primary endpoint at Week 48, showing statistically significant BICLA response with dapirolizumab pegol plus SOC versus placebo plus SOC. These data support continued development and the ongoing confirmatory Phase 3 PHOENYCS FLY trial, which is now recruiting.
Thông tin chính
- Nộp lúc
- 05:30 1 thg 6, 2026
- Sự kiện
- Kết quả topline
- Chiều hướng
- Tích cực
- Công ty
UCBUnited Community- Tài sản
- dapirolizumab pegol
- Độ tin cậy
- Có nguồn
- tác dụng phụ nghiêm trọng
- 10.0% so với 14.8%
- tỷ lệ đáp ứng BICLA tuần 48
- 50% so với 35% (p=0.011)
Trích đoạn nguồn
UCB and Biogen Announce Publication in The Lancet of Positive Dapirolizumab Pegol (DZP) Phase 3 Study Results in Systemic Lupus Erythematosus Publication adds to previously reported findings from Phase 3 PHOENYCS GO study, demonstrating statistically significant improvement in disease activity at Week 48 with dapirolizumab pegol plus standard of care versus placebo plus standard of care Findings showed results in favor of dapirolizumab pegol plus standard of care versus placebo plus standard of care across endpoints, including multiple disease activity measures, severe flares, patient-reported outcomes, including fatigue, and glucocorticoid tapering Results support the continued development of dapirolizumab pegol; the ongoing confirmatory Phase 3 PHOENYCS FLY clinical trial is currently r