[Translation] A Subject-, Investigator-, and Sponsor-Blinded, Randomized, 4-Group, Placebo-Controlled Study to Investigate the Safety, Tolerability, and Efficacy of Intra-articular LNA043 Following Intra-articular Canakinumab in Patients with Knee Osteoarthritis
这是一项IIa期概念验证研究,包括4个治疗组(TA1-4),旨在确定LNA043在根据MRI确定的伴有炎症的症状性膝关节OA患者中的疗效。研究的目的包括
评估能否确定i.a. LNA043在炎症性膝关节OA患者中的疗效
评估能否通过合用抗炎药物(i.a.卡那奴单抗)克服炎症的潜在不利影响
评估i.a.卡那奴单抗在缓解疼痛及其他临床症状和改善功能方面的疗效
[Translation] This is a Phase IIa proof-of-concept study with 4 treatment arms (TA1-4) designed to determine the efficacy of LNA043 in patients with symptomatic knee OA with inflammation as determined by MRI. The objectives of the study include:
Evaluate whether the efficacy of i.a. LNA043 can be determined in patients with inflammatory knee OA
Evaluate whether the potential adverse effects of inflammation can be overcome by co-administering an anti-inflammatory drug (i.a. canakinumab)
Evaluate the efficacy of i.a. canakinumab in relieving pain and other clinical symptoms and improving function