2023-506368-14-00招募中3 期
A Multicenter, Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of Dapirolizumab Pegol Treatment in Study Participants With Systemic Lupus Erythematosus
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 88
- 主要终点
- 1. Incidence of treatment-emergent adverse events (TEAEs) during the study 2. Incidence of serious treatment-emergent adverse events during the study 3. Incidence of treatment-emergent adverse events (TEAEs) leading to permanent dapirolizumab pegol discontinuation
研究概览
简要总结
Evaluate the long-term safety and tolerability of dapirolizumab pegol (DZP) treatment.
入排标准
- 年龄范围
- 0 years 至 65+ years（65+ Years, 0-17 Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •The participant could, in the opinion of the Investigator, benefit from long-term dapirolizumab pegol (DZP) treatment - The participant completed one of the parent studies within 4 weeks prior to entry to this study
排除标准
- •Study participant has any medical or psychiatric condition (including conditions due to neuropsychiatric systemic lupus erythematosus (SLE)) that, in the opinion of the Investigator, could jeopardize or would compromise the study participant’s ability to participate in this study. This includes study participants with a life-threatening condition or ongoing malignancies at the start of the study
结局指标
主要结局
1. Incidence of treatment-emergent adverse events (TEAEs) during the study 2. Incidence of serious treatment-emergent adverse events during the study 3. Incidence of treatment-emergent adverse events (TEAEs) leading to permanent dapirolizumab pegol discontinuation
1. Incidence of treatment-emergent adverse events (TEAEs) during the study 2. Incidence of serious treatment-emergent adverse events during the study 3. Incidence of treatment-emergent adverse events (TEAEs) leading to permanent dapirolizumab pegol discontinuation
次要结局
- 1. Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 24
- 2. Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 52
- 3. Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 104
- 4. Achievement of LLDAS at ≥50% of all visits
- 5. Achievement of BICLA response at Week 24
- 6. Achievement of BICLA response at Week 52
- 7. Achievement of BICLA response at Week 104
研究者
UCB Cares
Scientific
UCB Biopharma
研究点 (88)
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