[Translation] To evaluate the efficacy, safety, tolerability, and pharmacokinetics of prunalimab in subjects with rheumatic immune disease-associated hemophagocytic lymphohistiocytosis (also known as macrophage activation syndrome) and immunogenicity open-label, single-arm, multicenter clinical study
1.主要目的
第一阶段: 评价普那利单抗在MAS患者中的安全性、耐受性。
第二阶段:
评价普那利单抗在MAS患者中的有效性。
2.次要目的
第一阶段:
评价普那利单抗在MAS患者中的药代动力学特征。
评价普那利单抗在MAS患者中的免疫原性。
评价普那利单抗在MAS患者中的有效性。
第二阶段:
评价普那利单抗在MAS患者中的安全性、耐受性。
评价普那利单抗在MAS患者中的药代动力学特征。
评价普那利单抗在MAS患者中的免疫原性。
3.探索性目的
第一/第二阶段:
探索普那利单抗疗效相关的生物标志物。
[Translation] 1. Main purpose
The first stage: To evaluate the safety and tolerability of prunalimab in patients with MAS.
second stage:
To evaluate the effectiveness of prunalimab in patients with MAS.
2. Secondary purpose
The first stage:
To evaluate the pharmacokinetic characteristics of prunalimab in MAS patients.
To evaluate the immunogenicity of prunalimab in MAS patients.
To evaluate the effectiveness of prunalimab in patients with MAS.
second stage:
To evaluate the safety and tolerability of prunalimab in patients with MAS.
To evaluate the pharmacokinetic characteristics of prunalimab in MAS patients.
To evaluate the immunogenicity of prunalimab in MAS patients.
3. Exploratory purpose
Phase 1/2:
To explore the biomarkers related to the efficacy of prunalimab.