Abstract：
OBJECTIVE: To evaluate the efficacy and safety of intra-articular injections of a novel aggrecan mimetic, SB-061, in subjects with knee OA.
METHODS: This was a randomized, placebo-controlled, double-blind phase II study comparing intra-articular injections of SB-061 with placebo (isotonic saline) for 52 weeks, administered at baseline, Wk 16, and Wk 32. Eligible subjects had a KL grade of 2 or 3 on X-ray of the target knee and a WOMAC pain score ≥20 out of 50 at screening and baseline visits. Subjects having any other knee condition were excluded. Use of analgesics was prohibited, except for rescue medication. The primary endpoint was change from baseline (CFB) in WOMAC pain at Week 8. Secondary endpoints were CFB in WOMAC function and total, ICOAP, PGA, and 20-meter walk test. Exploratory endpoints included structural CFB in MRI entities.
RESULTS: 288 subjects were randomized to SB-061 (n=145) or placebo (n=143), and 252 (87.5%) completed injections. The groups were comparable at baseline. The primary endpoint was not met, as no significant difference in the CFB of the WOMAC pain score at Week 8 between groups was observed, nor at any other time point during the study. Similarly, neither of the secondary or exploratory endpoints indicated any significant difference between groups. The frequency and type of adverse events was similar between groups. SB-061 was well-tolerated.
CONCLUSIONS: Intra-articular injections of SB-061 administered at baseline, Wk 16, and Wk 32, over one year in subjects with knee OA was safe but did not show any statistically significant effect on knee pain nor on other symptomatic or structural entities compared to placebo.
UNASSIGNED: 2019-004515-31.
METHODS: This was a randomized, placebo-controlled, double-blind phase II study comparing intra-articular injections of SB-061 with placebo (isotonic saline) for 52 weeks, administered at baseline, Wk 16, and Wk 32. Eligible subjects had a KL grade of 2 or 3 on X-ray of the target knee and a WOMAC pain score ≥20 out of 50 at screening and baseline visits. Subjects having any other knee condition were excluded. Use of analgesics was prohibited, except for rescue medication. The primary endpoint was change from baseline (CFB) in WOMAC pain at Week 8. Secondary endpoints were CFB in WOMAC function and total, ICOAP, PGA, and 20-meter walk test. Exploratory endpoints included structural CFB in MRI entities.
RESULTS: 288 subjects were randomized to SB-061 (n=145) or placebo (n=143), and 252 (87.5%) completed injections. The groups were comparable at baseline. The primary endpoint was not met, as no significant difference in the CFB of the WOMAC pain score at Week 8 between groups was observed, nor at any other time point during the study. Similarly, neither of the secondary or exploratory endpoints indicated any significant difference between groups. The frequency and type of adverse events was similar between groups. SB-061 was well-tolerated.
CONCLUSIONS: Intra-articular injections of SB-061 administered at baseline, Wk 16, and Wk 32, over one year in subjects with knee OA was safe but did not show any statistically significant effect on knee pain nor on other symptomatic or structural entities compared to placebo.
UNASSIGNED: 2019-004515-31.
摘要：
目的：为了评估关节内注射新型agrican模拟物的疗效和安全性，SB-061,在患有膝关节OA的受试者中。
方法：这是一个随机的，安慰剂对照,双盲II期研究比较SB-061与安慰剂（等渗盐水）的关节内注射52周，在基线时施用，Wk16和Wk32。符合条件的受试者在目标膝盖的X射线上的KL等级为2或3，并且在筛选和基线访问时，WOMAC疼痛评分≥50分的20分。排除具有任何其他膝盖状况的受试者。禁止使用镇痛药，除了救护药物.主要终点是第8周时WOMAC疼痛相对于基线(CFB)的变化。次要终点是WOMAC功能和总的CFB，ICOAP,PGA,和20米步行测试。探索性终点包括MRI实体中的结构性CFB。
结果：288名受试者被随机分为SB-061（n=145）或安慰剂（n=143），和252（87.5%）完成注射。两组在基线时具有可比性。未达到主要终点，因为在第8周，两组之间的WOMAC疼痛评分的CFB没有显着差异，也不在研究期间的任何其他时间点。同样，次要终点或探索性终点均未显示组间存在显著差异.两组之间不良事件的频率和类型相似。SB-061耐受性良好。
结论：在基线时关节内注射SB-061，Wk16和Wk32在膝关节OA受试者中超过一年是安全的，但与安慰剂相比，对膝关节疼痛或其他症状或结构实体均未显示出任何统计学上的显着影响。
■2019-004515-31。
方法：这是一个随机的，安慰剂对照,双盲II期研究比较SB-061与安慰剂（等渗盐水）的关节内注射52周，在基线时施用，Wk16和Wk32。符合条件的受试者在目标膝盖的X射线上的KL等级为2或3，并且在筛选和基线访问时，WOMAC疼痛评分≥50分的20分。排除具有任何其他膝盖状况的受试者。禁止使用镇痛药，除了救护药物.主要终点是第8周时WOMAC疼痛相对于基线(CFB)的变化。次要终点是WOMAC功能和总的CFB，ICOAP,PGA,和20米步行测试。探索性终点包括MRI实体中的结构性CFB。
结果：288名受试者被随机分为SB-061（n=145）或安慰剂（n=143），和252（87.5%）完成注射。两组在基线时具有可比性。未达到主要终点，因为在第8周，两组之间的WOMAC疼痛评分的CFB没有显着差异，也不在研究期间的任何其他时间点。同样，次要终点或探索性终点均未显示组间存在显著差异.两组之间不良事件的频率和类型相似。SB-061耐受性良好。
结论：在基线时关节内注射SB-061，Wk16和Wk32在膝关节OA受试者中超过一年是安全的，但与安慰剂相比，对膝关节疼痛或其他症状或结构实体均未显示出任何统计学上的显着影响。
■2019-004515-31。
