[Translation] A multicenter, randomized, double-blind, placebo-controlled phase II study evaluating the efficacy and safety of TollB-001 tablets in patients with systemic sclerosis.
主要目的:评价TollB-001 片在SSc 患者中的有效性。
次要目的:评价TollB-001 片在SSc 患者中的安全性、药代动力学(PK)特征及其他有效性指标。
探索性目的:评价TollB-001 片在SSc 患者中的药效动力学(PD)特征、SSc 患者中的生物标志物及皮肤超声较基线变化。
[Translation] Primary objective: To evaluate the efficacy of TollB-001 tablets in patients with SSc.
Secondary objective: To evaluate the safety, pharmacokinetic (PK) characteristics, and other efficacy endpoints of TollB-001 tablets in patients with SSc.
Exploratory objective: To evaluate the pharmacodynamic (PD) characteristics of TollB-001 tablets, biomarkers, and changes in skin ultrasound from baseline in patients with SSc.