NCT05158387

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

A Phase III, Multicentre, Randomised, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Two Dose Regimens of Tozorakimab in Participants With Symptomatic Chronic Obstructive Pulmonary Disease (COPD) With a History of COPD Exacerbations (TITANIA)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,172 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 40 Years – 130 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
DRUG	Tozorakimab	Administered subcutaneously tozorakimab Dose 1 and placebo through Week 52.
DRUG	Tozorakimab	Administered subcutaneously tozorakimab Dose 2 through Week 52.
DRUG	Placebo	Placebo administered subcutaneously, equivalent volume to tozorakimab through week 52.

Timeline

• Start date: 2022-02-07
• Primary completion: 2026-01-19
• Completion: 2026-03-22
• First posted: 2021-12-15
• Last updated: 2026-04-16

Locations

212 sites across 20 countries: United States, Australia, Brazil, Chile, China, Colombia, France, Germany, Greece, Israel, Italy, Peru, Philippines, Poland, Puerto Rico, Romania, Russia, Taiwan, Thailand, United Kingdom

Regulatory

• FDA-regulated drug study