drugset / Trial / NCT06040086

Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations

NCT06040086

Phase 3 Active not recruiting 1454 enrolled AstraZeneca
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this Phase III study is to evaluate the efficacy and safety of tozorakimab administered subcutaneously (SC) in adult participants with symptomatic COPD with a history of ≥ 2 moderate or ≥ 1 severe exacerbations of COPD in the 12 months prior to enrolment. Participants should be receiving optimised treatment with inhaled maintenance therapy (ICS/LABA/LAMA triple therapy, or dual therapy if triple is not considered appropriate) throughout at least the last 3 months prior to enrolment.

Timeline

Start
2023-09-22
Primary completion
2026-03-06
Completion
2026-05-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Tozorakimab Monoclonal antibody Subcutaneous