Trial intelligence / Profile preview

TITANIA: Tozorakimab in COPD

NCT05158387Phase 3

Key facts

Status: Completed
Start: Feb 2022
Primary completion: Jan 2026
Countries: 20
Sponsor: AstraZeneca
Modality: Monoclonal Antibodies

Drugs: tozorakimab
Conditions: chronic obstructive pulmonary disease (COPD)

Overview

Phase 3, randomised, double-blind trial of tozorakimab in chronic obstructive pulmonary disease (COPD) (3 arms), sponsored by AstraZeneca. Primary endpoint: Annualized rate of moderate to severe COPD exacerbations in participants who are former smokers at 52 weeks. Started Feb 2022; status: completed.

Design

3 arms

Study design: RandomizedDouble-blind

Tozorakimab Dose 1
Tozorakimab Dose 1 administered subcutaneously
Tozorakimab Dose 2
Tozorakimab Dose 2 administered subcutaneously
Placebo
Placebo administered subcutaneously

Who it enrols

Adults >= 40 years with symptomatic COPD, history of >= 2 moderate or >= 1 severe exacerbations in the past 12 months, on optimized inhaled dual or triple therapy for >= 3 months, and smoking history of >= 10 pack-years.

Endpoints

Primary

Annualized rate of moderate to severe COPD exacerbations in participants who are former smokers52 weeks

Secondary

Annualized rate of moderate to severe COPD exacerbations in former or current smokers52 weeks
Time to first moderate to severe COPD exacerbation in former smokers52 weeks
Mean change from baseline in pre-BD, pre-dose trough FEV1 in former smokers52 weeks
Mean change from baseline in pre-BD, pre-dose trough FEV1 in the overall population52 weeks
Percentage of responders achieving MCID in E-RS:COPD total score in former smokers52 weeks
Percentage of responders achieving MCID in E-RS:COPD total score in the overall population52 weeks
Mean change from baseline in E-RS:COPD total score in former smokers52 weeks
Mean change from baseline in E-RS:COPD total score in the overall population52 weeks

Beyond the preview

Go deeper on NCT05158387.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT05158387.