[Translation] A multi-center, randomized, double-blind, placebo-controlled phase III clinical study on the efficacy and safety of Hemay005 tablets in patients with Behcet's disease
主要目的:以安慰剂平行对照,评价Hemay005片治疗BD患者口腔溃疡的有效性。
次要目的:与安慰剂组相比,评价Hemay005片对活动性BD患者的疗效;与安慰剂组相比,评价Hemay005片对患者报告结局(Patient Report Outcomes,PROs)的影响;与安慰剂组相比,评价Hemay005片治疗关节炎的有效性;与安慰剂组相比,评价Hemay005片治疗胃肠白塞病的有效性;与安慰剂组相比,评价Hemay005片对生物标志物的影响;与安慰剂组相比,评价Hemay005片对眼部症状的有效性;评价Hemay005在BD患者中的群体药代动力学(PopPK)特征
安全性目的:与安慰剂组相比,评价Hemay005片治疗BD患者的安全性与耐受性。
扩展目的:评价Hemay005片对活动性BD患者疾病活动性的影响
[Translation] Main purpose: To evaluate the effectiveness of Hemay005 tablets in the treatment of oral ulcers in BD patients using placebo parallel control.
Secondary purpose: To evaluate the efficacy of Hemay005 tablets in patients with active BD compared with the placebo group; to evaluate the effect of Hemay005 tablets on patient-reported outcomes (PROs) compared with the placebo group; and to evaluate the effect of Hemay005 tablets on patient-reported outcomes (PROs) compared with the placebo group To evaluate the effectiveness of Hemay005 tablets in the treatment of arthritis; to evaluate the effectiveness of Hemay005 tablets in the treatment of gastrointestinal Behcet's disease compared to the placebo group; to evaluate the effect of Hemay005 tablets on biomarkers compared to the placebo group; To evaluate the effectiveness of Hemay005 tablets on ocular symptoms compared with the placebo group; to evaluate the population pharmacokinetics (PopPK) characteristics of Hemay005 in BD patients
Safety purpose: To evaluate the safety and tolerability of Hemay005 tablets in the treatment of BD patients compared with the placebo group.
Extension purpose: To evaluate the effect of Hemay005 tablets on disease activity in patients with active BD