Dataset from Randomised, Double-Blind (Sponsor Open), Placebo-Controlled, Multicentre, Dose Ranging Study to Evaluate the Efficacy and Safety of Danirixin Tablets Administered Twice Daily Compared With Placebo for 24 Weeks in Adult Participants With Chronic Obstructive Pulmonary Disease (COPD)

Danirixin (DNX) is a selective CXC chemokine receptor (CXCR2) antagonist being developed as a potential anti-inflammatory agent for the treatment of COPD. This is a Phase 2, randomized, double-blind (Sponsor Open) study. The primary objective of the study is to evaluate the clinical activity and safety of danirixin compared with placebo in participants with COPD. Following baseline assessments collected over a 7 day period participants will be randomized (1:1:1:1:1:1) to receive one of five dose strengths of danirixin (5 milligram [mg], 10 mg, 25 mg, 35 mg and 50 mg) or placebo. Study treatment will be administered orally twice daily for 24 weeks. Participants will continue with their standard of care inhaled medications (i.e. long acting bronchodilators with or without inhaled corticosteroids) while receiving study treatment. Follow up will continue up to 28 days post last dose. Approximately 700 participants will be screened with a target of 540 participants completing 24 weeks of treatment and key study assessments.

达瑞昔布（Danirixin，DNX）是一款选择性CXC趋化因子受体（CXC chemokine receptor, CXCR2）拮抗剂，目前正被开发为用于治疗慢性阻塞性肺疾病（Chronic Obstructive Pulmonary Disease，简称COPD）的潜在抗炎药物。本研究为Ⅱ期随机双盲（申办方开放）临床试验，其主要目的为评估达瑞昔布相较于安慰剂在慢性阻塞性肺疾病受试者中的临床疗效与安全性。在完成为期7天的基线评估后，受试者将按照1:1:1:1:1:1的比例被随机分组，分别接受5种剂量梯度的达瑞昔布（5mg、10mg、25mg、35mg及50mg）或安慰剂治疗。研究药物将以口服方式每日给药两次，持续治疗24周。受试者在接受研究治疗期间，可继续维持其标准吸入治疗方案，即长效支气管扩张剂联合或不联合吸入性糖皮质激素。随访将持续至末次给药后28天。本研究预计筛选约700名受试者，最终目标为纳入540名完成24周治疗及关键研究评估的受试者。