An Efficacy and Safety Study of Mitiperstat (AZD4831) (MPO Inhibitor) vs Placebo in the Treatment of Moderate to Severe COPD.
NCT ID: NCT05492877
Last Updated: 2025-08-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
381 participants
INTERVENTIONAL
2022-11-14
2024-08-12
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Approximately 203 participants will be randomised to receive placebo.
Placebo
Oral dosage, once daily.
Mitiperstat (AZD4831)
Approximately 203 participants will be randomised to receive mitiperstat (AZD4831).
Mitiperstat (AZD4831)
Oral dosage, once daily.
Interventions
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Mitiperstat (AZD4831)
Oral dosage, once daily.
Placebo
Oral dosage, once daily.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
80 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Newport Beach, California, United States
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Clearwater, Florida, United States
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DeLand, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Tampa, Florida, United States
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Winter Park, Florida, United States
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Chicago Ridge, Illinois, United States
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Ann Arbor, Michigan, United States
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Chesterfield, Missouri, United States
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Saint Charles, Missouri, United States
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New Windsor, New York, United States
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Gastonia, North Carolina, United States
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Kernersville, North Carolina, United States
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New Bern, North Carolina, United States
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Columbus, Ohio, United States
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Choctaw, Oklahoma, United States
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Fort Mill, South Carolina, United States
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Amarillo, Texas, United States
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Córdoba, , Argentina
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Ranelagh, , Argentina
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San Fernando, , Argentina
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Dupnitsa, , Bulgaria
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Haskovo, , Bulgaria
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Pernik, , Bulgaria
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Rousse, , Bulgaria
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Sofia, , Bulgaria
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Stara Zagora, , Bulgaria
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Stara Zagora, , Bulgaria
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Vratsa, , Bulgaria
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Calgary, Alberta, Canada
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Québec, Quebec, Canada
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Québec, Quebec, Canada
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Saint-Charles-Borromée, Quebec, Canada
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Trois-Rivières, Quebec, Canada
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Aalborg, , Denmark
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Hvidovre, , Denmark
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København NV, , Denmark
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Næstved, , Denmark
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Odense C, , Denmark
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Vejle, , Denmark
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Berlin, , Germany
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Frankfurt, , Germany
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Immenhausen, , Germany
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Koblenz, , Germany
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Landsberg, , Germany
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Leipzig, , Germany
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Marburg, , Germany
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Witten, , Germany
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Foggia, , Italy
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Roma, , Italy
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Sassari, , Italy
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Siena, , Italy
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Verona, , Italy
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Culiacán, , Mexico
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Guadalajara, , Mexico
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Monterrey, , Mexico
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Monterrey, , Mexico
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Veracruz, , Mexico
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Zapopan, , Mexico
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Groningen, , Netherlands
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Veldhoven, , Netherlands
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Bielsko-Biala, , Poland
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Chęciny, , Poland
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Karczew, , Poland
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Krakow, , Poland
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Ksawerów, , Poland
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Staszów, , Poland
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Szczecin, , Poland
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Warsaw, , Poland
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Cape Town, , South Africa
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Durban, , South Africa
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Durban, , South Africa
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Tygervalley, , South Africa
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Vereeniging, , South Africa
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Granada, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Mérida, , Spain
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Santander, , Spain
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Adana, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Mersin, , Turkey (Türkiye)
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Bradford, , United Kingdom
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Cambridge, , United Kingdom
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Cottingham, , United Kingdom
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Dundee, , United Kingdom
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Glasgow, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
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Nottingham, , United Kingdom
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Rotherham, , United Kingdom
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Wakefield, , United Kingdom
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York, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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2022-002441-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D6582C00001
Identifier Type: -
Identifier Source: org_study_id
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