Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Efficacy Danirixin EXACT-PRO COPD Safety RD CXCR2 inhibitor EXACT-RS PK HCRU exacerbations PD
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 102
Healthy volunteers: no

Brief summary:
The aim of this First Time in Patient study is to obtain initial information on the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical efficacy of repeat daily administration of danirixin in subjects with symptomatic chronic obstructive pulmonary disease (COPD) having mild to moderate airflow limitation and are at high risk for future COPD exacerbations.

The study will be conducted in two parts. Part A will be a two week open label, single arm study in patients with COPD to obtain pharmacokinetic data and safety information of repeat dosing of danirixin in the population of interest. Approximately 10 subjects will be enrolled in Part A of the study. Progression to and dose selection for Part B will occur following review of the data collected in Part A. Part B will be a 52-week, randomized, double-blind (sponsor unblind), placebo-controlled on top of standard of care, parallel group study. Part B will evaluate several clinical efficacy assessments related to exacerbations and respiratory symptoms. Approximately 100 subjects will be enrolled with a target of 80 subjects completing 52 weeks of danirixin administration.

Detailed description:

Arms:
arm 1: Subjects will receive 50 mg danirixin twice daily (BID) orally for 14 days. If the exposure to danirixin is lower than expected, after 14 days of dosing, then the dose may be increased to 75 mg BID for Part B. arm 2: Subjects will be randomized to receive either danirixin BID or placebo BID treatment along with standard care of treatment for 52 weeks. Subjects completing Part A and meeting the eligibility criteria for Part B could also be randomized in Part B.

Interventions: intervention 1: Danirixin intervention 2: Placebo
Intervention descriptions: intervention 1: Danirixin is available as 50 or 75 mg white, film coated immediate release tablet. intervention 2: Subjects will receive danirixin matching placebo

Protocol document: