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

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease (COPD)

In brief

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.

Key facts

Study ID: NCT05492877
Run by: AstraZeneca
People needed: 381
Starts: 2022-11-14
Expected to finish: 2024-08-12
Last updated by the study team: 2025-08-29

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Provision of informed consent.
Participants must be deemed as high risk of exacerbations as defined by: >= 1 moderate or severe exacerbation in the previous 24 months; or frequent productive cough; or post-bronchodilator (BD) forced expiratory volume in the first second (FEV1) < 50% predicted.
Participants must be 40-80 years of age inclusive, at the time of signing informed consent form (ICF).
Participants who have a confirmed primary diagnosis of moderate to severe COPD.
Participants who are current or ex-smokers with a tobacco history of ≥ 10 pack-years.
Participants who have a documented stable regimen of triple therapy or dual therapy for
≥ 3 months prior to enrolment.
Body mass index within the range 18 to 40 kg/m2 (inclusive).

You may not qualify if…

As judged by the investigator, any evidence of any active medical or psychiatric condition or other reason (at SV1 [screening] and SV3 [pre-dose]) which in the investigator's opinion makes it undesirable for the participant to participate in the study.
Current diagnosis of asthma or past diagnosis of asthma which persisted beyond the age of 25 years.
Clinically important pulmonary disease other than COPD.
Any other clinically relevant abnormal findings on physical examination, laboratory testing including haematology, coagulation, serum chemistry, or urinalysis; or chest CT scan at screening or randomisation, which in the opinion of the investigator or medical monitor may compromise the safety of the participant in the study or interfere with evaluation of the study intervention or reduce the participant's ability to participate in the study.
History of a clinically significant infection (viral, bacterial, or fungal; defined as requiring systemic antibiotics, antiviral, or antifungal medication for > 7 days) within 4 weeks prior to SV3 (Day 1) (including unexplained diarrhoea) or clinical suspicion of infection at time of dosing.

Where it is running

Research Site — Newport Beach, California, United States
Research Site — Clearwater, Florida, United States
Research Site — DeLand, Florida, United States
Research Site — Miami, Florida, United States
Research Site — Orlando, Florida, United States
Research Site — Tampa, Florida, United States
Research Site — Winter Park, Florida, United States
Research Site — Ann Arbor, Michigan, United States
Research Site — Chesterfield, Missouri, United States
Research Site — Saint Charles, Missouri, United States
Research Site — New Windsor, New York, United States
Research Site — Gastonia, North Carolina, United States
Research Site — Kernersville, North Carolina, United States
Research Site — New Bern, North Carolina, United States
Research Site — Columbus, Ohio, United States
Research Site — Choctaw, Oklahoma, United States
Research Site — Fort Mill, South Carolina, United States
Research Site — Amarillo, Texas, United States
Research Site — Buenos Aires, Argentina
Research Site — Buenos Aires, Argentina
Research Site — Buenos Aires, Argentina
Research Site — Córdoba, Argentina
Research Site — Ranelagh, Argentina
Research Site — San Fernando, Argentina
Research Site — Chicago Ridge, Illinois, United States

Full record on ClinicalTrials.gov

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