drugset / Trial / NCT05166889

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

NCT05166889

Phase 3 Completed 1132 enrolled AstraZeneca
RandomizedParallel-groupTriple-blindTreatment

Summary

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

Timeline

Start
2022-01-03
Primary completion
2026-01-19
Completion
2026-03-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Tozorakimab Monoclonal antibody Subcutaneous