Study A01


  • 受试者分布
  • ASAS40疗效数据更新
  • 安全性

Study A01 – 16周前退出情况

Placebo 320mg/160mg 320mg/320mg 640mg/320mg 640mg/320mg Q4W Total
(N=35) (N=51) (N=28) (N=32) (N=32) (N=178)
Subjects Randomized 35 (100%) 51 (100%) 28 (100%) 32 (100%) 32 (100%) 178 (100%)
Number of Patients
Discontinued from Loading Period 5 (14.3%) 2 (3.9%) 0 0 2 (6.2%) 9 (5.1%)
Reason for Treatment Discontinuation
LOST TO FOLLOW-UP 1 (20%) 0 0 0 0 1 (11.1%)
WITHDRAWAL BY SUBJECT 3 (60%) 2 (100%) 0 0 2 (100%) 7 (77.8%)
WITHDRAWAL OF CONSENT 1 (20%) 0 0 0 0 1 (11.1%)


A01-XX 治疗组，4(2.8%)例受试者（S215004, S217008, S221004, S222003）16周前退出研究。

Study A01


  • 受试者分布
  • ASAS40疗效数据更新
  • 安全性

Study A01 Design

Part A

Part B

Study A01 – ASAS40

A01-XX暂未体现疗效上的优势
安慰剂组16周Cross后，有显著提升

Study A01 – ASAS40 – Weight亚组分析

  • 前6周，320+320较320+160，中国无差别，土耳其差别大，可能男性比例不同导致
  • 中国地区640mg暂未体现优势

Study A01


  • 受试者分布
  • ASAS40疗效数据更新
  • 安全性

Study A01 – Week 0-16 Safety – AE Overview

Placebo 320mg/160mg 320mg/320mg 640mg/320mg 640mg/320mg Q4W
(N=35) (N=51) (N=28) (N=32) (N=32)
Any TEAE 19 (54.3%) 36 (70.6%) 20 (71.4%) 24 (75.0%) 27 (84.4%)
Any TRAEs 15 (42.9%) 26 (51.0%) 11 (39.3%) 15 (46.9%) 17 (53.1%)
TE SAEs 0 1 (2.0%) 0 1 (3.1%) 2 (6.2%)
TR SAEs 0 0 0 0 1 (3.1%)
TEAE Leading to Discontinuation 0 0 0 0 0
TEAE Leading to Interruption 0 1 (2.0%) 0 1 (3.1%) 1 (3.1%)
TEAE Leading to Death 0 0 0 0 0
AESIs 0 0 0 0 1 (3.1%)

$ S217008 ，横纹肌溶解症，SAE, 首次给药后7天，‘可能相关’，痊愈
# S217008 ，肝功能检测异常，SAE, 首次给药后11天，AST为536 >10 ULN, ‘可能相关’，已痊愈

Study A01 – Safety – Liver Function

安慰剂组：S213008, 发生在Loading Period, 基线ALT, AST指标异常有临床意义，有病史：肝功能异常