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

NCT05492877

CompletedPhase 2

Sponsor: AstraZeneca

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Interventions: Mitiperstat (AZD4831), Placebo

Countries: United States, Argentina, Bulgaria, Canada, Denmark, Germany, Italy, Mexico

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.

Eligibility overview

Sex: ALL

Age: 40 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Locations (101)

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