drugset / Trial / NCT06897748

A Study to Investigate Efficacy and Safety of Tozorakimab Injections Compared With Placebo in Adult Participants With Symptomatic Chronic Obstructive Pulmonary Disease (COPD) With a History of COPD Exacerbations and Elevated Eosinophils

NCT06897748

Phase 2 Completed 98 enrolled AstraZeneca
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to investigate lung function parameters, composite endpoint for exacerbations in chronic obstructive pulmonary disease (COPDCompEx), symptoms and to provide safety information after tozorakimab or placebo administrations in participants with symptomatic chronic obstructive pulmonary disease (COPD) with history of exacerbations and high blood eosinophil counts. Study details include the following: * The maximum duration of the screening/run-in period is 5 weeks. An additional unscheduled visit may be performed prior to randomization to repeat safety assessments as deemed necessary by the investigator. * Eligible patients will enter 12-week treatment (intervention) period with site visits and investigational product (IP) administration every 2 weeks. * Participants who complete a treatment period, and have not been prematurely discontinued from IP, will enter a 10-week post-intervention follow-up period. * The study duration will be 27 weeks at maximum for each participant.

Timeline

Start
2025-04-12
Primary completion
2026-04-21
Completion
2026-04-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Tozorakimab Monoclonal antibody Subcutaneous