Danirixin Dose Ranging Study in Participants With Chronic Obstructive Pulmonary Disease (COPD)
Status:
Completed
Trial end date:
2018-10-05
Target enrollment:
Participant gender:
Summary
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.