METHODS: This is a phase 2, randomised, double-blind, placebo-controlled study evaluating efficacy and safety of CC-90001 in patients with IPF (main study) and patients with PF-ILD (substudy). Both include an 8-week screening period, a 24-week treatment period, up to an 80-week active-treatment extension and a 4-week post-treatment follow-up. Patients with IPF (n=165) will be randomised 1:1:1 to receive 200 mg or 400 mg CC-90001 or placebo administered PO one time per day; up to 25 patients/arm will be permitted concomitant pirfenidone use. Forty-five patients in the PF-ILD substudy will be randomised 2:1 to receive 400 mg CC-90001 or placebo. The primary endpoint is change in per cent predicted forced vital capacity from baseline to Week 24 in patients with IPF.
BACKGROUND: This study will be conducted in accordance with Good Clinical Practice guidelines, Declaration of Helsinki principles and local ethical and legal requirements. Results will be reported in a peer-reviewed publication.
BACKGROUND: NCT03142191.
方法:这是第二阶段,随机,双盲,安慰剂对照研究评估CC-90001在IPF患者(主要研究)和PF-ILD患者(子研究)中的疗效和安全性。两者都包括8周的筛查期,24周的治疗期,延长80周的积极治疗和4周的治疗后随访。IPF患者(n=165)将被随机分为1:1:1,每天接受200mg或400mgCC-90001或安慰剂,每天服用一次PO;最多25名患者/手臂将被允许同时使用吡非尼酮。PF-ILD子研究中的45名患者将以2:1的比例随机分配,以接受400mgCC-90001或安慰剂。主要终点是IPF患者从基线到第24周的预测用力肺活量的百分比变化。
背景:这项研究将根据良好临床实践指南进行,赫尔辛基原则宣言以及当地道德和法律要求。结果将在同行评审的出版物中报告。
背景:NCT03142191。