NCT05492877

An Efficacy and Safety Study of Mitiperstat (AZD4831) (MPO Inhibitor) vs Placebo in the Treatment of Moderate to Severe COPD.

A Phase IIa Randomised, Double Blind, Placebo Controlled, Parallel Arm, Multi-Centre Study to Evaluate the Efficacy and Safety of Mitiperstat (AZD4831), for 12-24 Weeks, in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 381 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a research study to evaluate the efficacy and safety of the investigational drug Mitiperstat (AZD4831) in adult patients with chronic obstructive pulmonary disease.

Detailed description

Study D6582C00001 is a phase IIa randomised, double blind, placebo controlled, parallel arm study to evaluate the efficacy and safety of Mitiperstat (AZD4831) in adult participants with moderate to severe chronic obstructive pulmonary disease. Approximately 100 sites globally will participate in this study. Approximately 406 participants will be randomised to two treatment groups; Mitiperstat (AZD4831) vs placebo in a 1:1 ratio.

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
DRUG	Mitiperstat (AZD4831)	Oral dosage, once daily.
OTHER	Placebo	Oral dosage, once daily.

Timeline

• Start date: 2022-11-14
• Primary completion: 2024-08-12
• Completion: 2024-08-12
• First posted: 2022-08-09
• Last updated: 2025-08-29
• Results posted: 2025-08-29

Locations

101 sites across 14 countries: United States, Argentina, Bulgaria, Canada, Denmark, Germany, Italy, Mexico, Netherlands, Poland, South Africa, Spain, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study