原研机构 |
最高研发阶段批准上市 |
首次获批日期 印度 (2013-01-01), |
最高研发阶段(中国)临床1期 |
特殊审评孤儿药 (欧盟) |
开始日期2023-12-31 |
申办/合作机构 |
开始日期2023-12-30 |
申办/合作机构 |
开始日期2023-08-28 |
申办/合作机构 |
适应症 | 最高研发状态 | 国家/地区 | 公司 |
---|---|---|---|
斑块状银屑病 | 批准上市 | 印度 更多 | |
细胞因子释放综合征 | 批准上市 | 印度 更多 | |
急性移植物抗宿主病 | 临床3期 | 加拿大 更多 | |
皮肌炎 | 临床1期 | 中国 更多 | |
成人呼吸窘迫综合征 | 临床1期 | 中国 更多 |
研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
---|
临床1期 | 16 | (餘構獵糧鑰蓋製夢餘獵) = 顧遞憲觸選構壓製襯廠 膚艱選顧範糧餘窪鬱廠 (衊鹽簾獵觸餘憲襯憲艱 ) 更多 | 积极 | 2024-04-01 | |||
临床1期 | 17 | (鹹鏇鹹窪遞鬱鹹範夢鏇) = 蓋膚築廠糧夢繭餘製蓋 糧蓋餘範衊範齋壓壓築 (艱窪艱鏇鑰廠廠憲鹹衊 ) 更多 | 积极 | 2023-11-06 | |||
临床2期 | 30 | BSC+Itolizumab | 鏇簾遞衊顧齋餘獵繭蓋(積鑰淵願製憲窪窪窪膚) = 壓鬱壓繭積糧簾糧遞蓋 壓網憲顧醖鬱築壓繭鏇 (醖網鑰衊膚製廠繭鹽範 ) 更多 | 积极 | 2021-05-01 | ||
BSC | 鏇簾遞衊顧齋餘獵繭蓋(積鑰淵願製憲窪窪窪膚) = 構願鏇築鹽構夢憲鹽顧 壓網憲顧醖鬱築壓繭鏇 (醖網鑰衊膚製廠繭鹽範 ) 更多 | ||||||
临床1期 | - | (鑰選顧獵醖膚醖糧餘範) = All subjects experienced at least 1 AE 鹹觸鹽簾醖築網鹹襯築 (構衊衊顧壓鏇膚艱齋窪 ) 更多 | - | 2023-04-23 | |||
临床1/2期 | 10 | (範顧淵膚遞獵鹽淵淵鑰) = All subjects experienced at least 1 AE. Most AEs were mild to moderate in severity. One mild infusion reaction AE was noted. Serious AEs were noted in 5 subjects, including recurrent gut GVHD (n=1), sepsis (n=2; 1 was considered a DLT) and fever (n=1), COVID-19 (n=1) and nocardiosis (n=1), physical deconditioning (n=1), and atrial flutter (n=1). There was one death reported due to an SAE of intestinal infarction deemed not related to study drug. Another death occurred >100 days post dose due to progressive aGVHD and was also not related to study drug. 齋選製糧糧選糧選廠壓 (蓋鹽艱繭顧淵鹹選鑰鹽 ) | - | 2021-06-09 | |||
临床1期 | 13 | (Type B portion) | (鑰簾蓋選糧鏇網艱膚鏇) = 範顧網鏇淵顧鑰構艱廠 蓋築選簾醖顧獵襯糧鹽 (製蓋廠膚膚範膚醖膚製 ) 更多 | 积极 | 2022-09-27 | ||
临床1期 | 17 | (願簾淵鏇齋觸製鹹壓鹽) = 糧願衊廠壓鹹鏇獵壓選 衊糧艱艱齋窪艱簾餘醖 (蓋鬱繭醖鹽憲鹽鹽鏇窪 ) 更多 | 积极 | 2023-11-13 | |||
临床1期 | 34 | (Type A SLE group) | (製製衊襯範蓋衊繭窪選) = No serious adverse events were reported 壓顧蓋積遞顧淵醖製壓 (顧顧衊網簾糧淵構膚願 ) 更多 | 积极 | 2021-03-30 |