Abstract：
BACKGROUND: Idiopathic pulmonary fibrosis (IPF) is a progressive and often fatal interstitial lung disease (ILD); other ILDs have a progressive, fibrotic phenotype (PF-ILD). Antifibrotic agents can slow but not stop disease progression in patients with IPF or PF-ILD. c-Jun N-terminal kinases (JNKs) are stress-activated protein kinases implicated in the underlying mechanisms of fibrosis, including epithelial cell death, inflammation and polarisation of profibrotic macrophages, fibroblast activation and collagen production. CC-90001, an orally administered (PO), one time per day, JNK inhibitor, is being evaluated in IPF and PF-ILD.
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.
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.
摘要：
背景：特发性肺纤维化（IPF）是一种进行性且通常致命的间质性肺病（ILD）；其他ILD具有进行性，纤维化表型（PF-ILD）。抗纤维化药物可以减缓但不能阻止IPF或PF-ILD患者的疾病进展。c-JunN末端激酶（JNKs）是应激激活的蛋白激酶，涉及纤维化的潜在机制，包括上皮细胞死亡，促纤维化巨噬细胞的炎症和极化，成纤维细胞活化和胶原蛋白生产。CC-90001，口服给药(PO)，每天一次,JNK抑制剂,正在IPF和PF-ILD中进行评估。
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。
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。
