NBCD A/S, Telefonvej 8D, 2860 Søborg, Denmark.
Sanos Clinic, Borgergade 39, 9362 Gandrup, Denmark.
Osteoarthritis Cartilage. 2024 Nov;32(11):1471-1480. doi: 10.1016/j.joca.2024.06.016. Epub 2024 Jul 1.
To evaluate the efficacy and safety of intra-articular injections of a novel aggrecan mimetic, SB-061, in subjects with knee osteoarthritis (OA).
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 Western Ontario McMaster Universities Osteoarthritis Index (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, Patient Global Assessment, and 20-meter walk test. Exploratory endpoints included structural CFB in magnetic resonance imaging entities.
A total of 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 were similar between groups. SB-061 was well-tolerated.
Intra-articular injections of SB-061 administered at baseline, Week 16, and Week 32, over one year in subjects with knee OA, were safe but did not show any statistically significant effect on knee pain nor on other symptomatic or structural entities compared to placebo.
2019-004515-31.
评估新型聚集蛋白模拟物 SB-061 关节内注射治疗膝骨关节炎（OA）患者的疗效和安全性。
这是一项随机、安慰剂对照、双盲的 II 期研究，比较了 SB-061 与安慰剂（等渗盐水）在 52 周内的关节内注射效果，分别在基线、第 16 周和第 32 周进行注射。入选标准为目标膝关节 X 线片 KL 分级 2 或 3，筛选和基线访视时 Western Ontario McMaster Universities Osteoarthritis Index（WOMAC）疼痛评分≥50 中的 20。排除存在其他膝关节疾病的患者。禁止使用镇痛药，除了急救药物。主要终点是第 8 周时 WOMAC 疼痛从基线的变化（CFB）。次要终点是 WOMAC 功能和总评分、ICOAP、患者总体评估和 20 米步行试验的 CFB。探索性终点包括磁共振成像实体的结构 CFB。
共有 288 名受试者被随机分配至 SB-061（n=145）或安慰剂（n=143）组，252 名（87.5%）完成了注射。两组基线时具有可比性。主要终点未达到，组间第 8 周 WOMAC 疼痛评分的 CFB 无显著差异，研究期间其他时间点也无显著差异。同样，次要终点和探索性终点均未显示组间有任何显著差异。组间不良事件的频率和类型相似。SB-061 耐受性良好。
在膝骨关节炎患者中，每年在基线、第 16 周和第 32 周时关节内注射 SB-061，安全，但与安慰剂相比，在膝关节疼痛或其他症状或结构实体方面均未显示出任何有统计学意义的效果。
EUDRACT 编号：2019-004515-31。
