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

Last updated: November 21, 2024
Sponsor: AstraZeneca
Overall Status: Completed

Phase

2

Condition

Chronic Obstructive Lung Disease

Bronchiectasis

Lung Disease

Treatment

Placebo

Mitiperstat (AZD4831)

Clinical Study ID

NCT05492877
D6582C00001
2022-002441-18
  • Ages 40-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Provision of informed consent.

  • Participants must be deemed as high risk of exacerbations as defined by: >= 1moderate or severe exacerbation in the previous 24 months; or frequent productivecough; 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 informedconsent 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 ≥ 10pack-years.

  • Participants who have a documented stable regimen of triple therapy or dual therapyfor

≥ 3 months prior to enrolment.

  • Body mass index within the range 18 to 40 kg/m2 (inclusive).

Exclusion

Exclusion Criteria:

  • As judged by the investigator, any evidence of any active medical or psychiatriccondition or other reason (at SV1 [screening] and SV3 [pre-dose]) which in theinvestigator's opinion makes it undesirable for the participant to participate inthe study.

  • Current diagnosis of asthma or past diagnosis of asthma which persisted beyond theage of 25 years.

  • Clinically important pulmonary disease other than COPD.

  • Any other clinically relevant abnormal findings on physical examination, laboratorytesting including haematology, coagulation, serum chemistry, or urinalysis; or chestCT scan at screening or randomisation, which in the opinion of the investigator ormedical monitor may compromise the safety of the participant in the study orinterfere with evaluation of the study intervention or reduce the participant'sability to participate in the study.

  • History of a clinically significant infection (viral, bacterial, or fungal; definedas requiring systemic antibiotics, antiviral, or antifungal medication for > 7 days)within 4 weeks prior to SV3 (Day 1) (including unexplained diarrhoea) or clinicalsuspicion of infection at time of dosing.

Study Design

Total Participants: 381
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
November 14, 2022
Estimated Completion Date:
August 12, 2024

Study 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.

Connect with a study center

  • Research Site

    Buenos Aires, C1414AIF
    Argentina

    Site Not Available

  • Research Site

    Córdoba, X5003DCE
    Argentina

    Site Not Available

  • Research Site

    Ranelagh, 1886
    Argentina

    Site Not Available

  • Research Site

    San Fernando, B1646EBJ
    Argentina

    Site Not Available

  • Research Site

    Dupnitsa, 2602
    Bulgaria

    Site Not Available

  • Research Site

    Haskovo, 6305
    Bulgaria

    Site Not Available

  • Research Site

    Pernik, 2300
    Bulgaria

    Site Not Available

  • Research Site

    Ruse, 7000
    Bulgaria

    Site Not Available

  • Research Site

    Sofia, 1756
    Bulgaria

    Site Not Available

  • Research Site

    Stara Zagora, 6000
    Bulgaria

    Site Not Available

  • Research Site

    Vratsa, 3000
    Bulgaria

    Site Not Available

  • Research Site

    Calgary, Alberta T3B 0M3
    Canada

    Site Not Available

  • Research Site

    Montreal, Quebec H1M 1B1
    Canada

    Site Not Available

  • Research Site

    Montréal, Quebec H1M 1B1
    Canada

    Site Not Available

  • Research Site

    St Charles Borromee, Quebec J6E 2B4
    Canada

    Site Not Available

  • Research Site

    Trois-Rivières, Quebec G8T 7A1
    Canada

    Site Not Available

  • Research Site

    Quebec, G1V 4G5
    Canada

    Site Not Available

  • Research Site

    Aalborg, 9000
    Denmark

    Site Not Available

  • Research Site

    Hvidovre, 2650
    Denmark

    Site Not Available

  • Research Site

    København NV, 2400
    Denmark

    Site Not Available

  • Research Site

    Næstved, 4700
    Denmark

    Site Not Available

  • Research Site

    Odense C, 5000
    Denmark

    Site Not Available

  • Research Site

    Vejle, 7100
    Denmark

    Site Not Available

  • Research Site

    Berlin, 10119
    Germany

    Site Not Available

  • Research Site

    Frankfurt, 60596
    Germany

    Site Not Available

  • Research Site

    Frankfurt am Main, 60596
    Germany

    Site Not Available

  • Research Site

    Hamburg, 22299
    Germany

    Site Not Available

  • Research Site

    Hannover, D-30173
    Germany

    Site Not Available

  • Research Site

    Homburg, 66421
    Germany

    Site Not Available

  • Research Site

    Immenhausen, 34376
    Germany

    Site Not Available

  • Research Site

    Koblenz, 56068
    Germany

    Site Not Available

  • Research Site

    Landsberg, 86899
    Germany

    Site Not Available

  • Research Site

    Leipzig, 04299
    Germany

    Site Not Available

  • Research Site

    Marburg, 35037
    Germany

    Site Not Available

  • Research Site

    Witten, 58452
    Germany

    Site Not Available

  • Research Site

    Foggia, 71100
    Italy

    Site Not Available

  • Research Site

    Roma, 00168
    Italy

    Site Not Available

  • Research Site

    Sassari, 07100
    Italy

    Site Not Available

  • Research Site

    Siena, 53100
    Italy

    Site Not Available

  • Research Site

    Verona, 37134
    Italy

    Site Not Available

  • Research Site

    Culiacán, 80200
    Mexico

    Site Not Available

  • Research Site

    Guadalajara, 44670
    Mexico

    Site Not Available

  • Research Site

    Mexico City, 3103
    Mexico

    Site Not Available

  • Research Site

    Monterrey, 64310
    Mexico

    Site Not Available

  • Research Site

    Veracruz, 91910
    Mexico

    Site Not Available

  • Research Site

    Zapopan, 45138
    Mexico

    Site Not Available

  • Research Site

    Groningen, 9713 GH
    Netherlands

    Site Not Available

  • Research Site

    Rotterdam, 3045 PM
    Netherlands

    Site Not Available

  • Research Site

    Veldhoven, 5504 DB
    Netherlands

    Site Not Available

  • Research Site

    Bielsko-Biała, 43-300
    Poland

    Site Not Available

  • Research Site

    Chęciny, 26-060
    Poland

    Site Not Available

  • Research Site

    Karczew, 05-480
    Poland

    Site Not Available

  • Research Site

    Kraków, 31-011
    Poland

    Site Not Available

  • Research Site

    Ksawerów, 95-054
    Poland

    Site Not Available

  • Research Site

    Proszowice, 32-100
    Poland

    Site Not Available

  • Research Site

    Sosnowiec, 41-200
    Poland

    Site Not Available

  • Research Site

    Staszów, 28-200
    Poland

    Site Not Available

  • Research Site

    Szczecin, 70-111
    Poland

    Site Not Available

  • Research Site

    Trzebnica, 55-100
    Poland

    Site Not Available

  • Research Site

    Warszawa, 01-456
    Poland

    Site Not Available

  • Research Site

    Cape Town, 7700
    South Africa

    Site Not Available

  • Research Site

    Durban, 4001
    South Africa

    Site Not Available

  • Research Site

    Krugersdorp, 1739
    South Africa

    Site Not Available

  • Research Site

    Lenasia, 1827
    South Africa

    Site Not Available

  • Research Site

    Tygervalley, 7530
    South Africa

    Site Not Available

  • Research Site

    Vereeniging, 1935
    South Africa

    Site Not Available

  • Research Site

    Granada, 18014
    Spain

    Site Not Available

  • Research Site

    Madrid, 28007
    Spain

    Site Not Available

  • Research Site

    Merida, 06800
    Spain

    Site Not Available

  • Research Site

    Málaga, 29010
    Spain

    Site Not Available

  • Research Site

    Mérida, 06800
    Spain

    Site Not Available

  • Research Site

    Santander, 39008
    Spain

    Site Not Available

  • Research Site

    Adana, 01330
    Turkey

    Site Not Available

  • Research Site

    Ankara, 06620
    Turkey

    Site Not Available

  • Research Site

    Istanbul, 34854
    Turkey

    Site Not Available

  • Research Site

    Izmir, 35360
    Turkey

    Site Not Available

  • Research Site

    Mersin, 33343
    Turkey

    Site Not Available

  • Research Site

    Bradford, BD9 6RJ
    United Kingdom

    Site Not Available

  • Research Site

    Cambridge, CB2 0QQ
    United Kingdom

    Site Not Available

  • Research Site

    Cottingham, HU16 5JQ
    United Kingdom

    Site Not Available

  • Research Site

    Dundee, DD1 9SY
    United Kingdom

    Site Not Available

  • Research Site

    Glasgow, G12 0YN
    United Kingdom

    Site Not Available

  • Research Site

    London, NW3 2QG
    United Kingdom

    Site Not Available

  • Research Site

    Manchester, M8 5RB
    United Kingdom

    Site Not Available

  • Research Site

    Nottingham, NG5 1PB
    United Kingdom

    Site Not Available

  • Research Site

    Rotherham, S65 2QL
    United Kingdom

    Site Not Available

  • Research Site

    Salford, M6 8HD
    United Kingdom

    Site Not Available

  • Research Site

    Wakefield, WF1 4DG
    United Kingdom

    Site Not Available

  • Research Site

    York, YO24 3WX
    United Kingdom

    Site Not Available

  • Research Site

    Newport Beach, California 92663
    United States

    Site Not Available

  • Research Site

    Clearwater, Florida 33765
    United States

    Site Not Available

  • Research Site

    DeLand, Florida 32720
    United States

    Site Not Available

  • Research Site

    Lake Wales, Florida 33853
    United States

    Site Not Available

  • Research Site

    Miami, Florida 33186
    United States

    Site Not Available

  • Research Site

    Orlando, Florida 32825
    United States

    Site Not Available

  • Research Site

    Tampa, Florida 33606
    United States

    Site Not Available

  • Research Site

    Winter Park, Florida 32789
    United States

    Site Not Available

  • Research Site

    Chicago Ridge, Illinois 60415
    United States

    Site Not Available

  • Research Site

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Research Site

    Chesterfield, Missouri 63017
    United States

    Site Not Available

  • Research Site

    Saint Charles, Missouri 63301
    United States

    Site Not Available

  • Research Site

    New Windsor, New York 12553
    United States

    Site Not Available

  • Research Site

    Gastonia, North Carolina 28054
    United States

    Site Not Available

  • Research Site

    Kernersville, North Carolina 27284
    United States

    Site Not Available

  • Research Site

    New Bern, North Carolina 28562
    United States

    Site Not Available

  • Research Site

    Columbus, Ohio 43215
    United States

    Site Not Available

  • Research Site

    Choctaw, Oklahoma 73020
    United States

    Site Not Available

  • Research Site

    Fort Mill, South Carolina 29707
    United States

    Site Not Available

  • Research Site

    Amarillo, Texas 79106
    United States

    Site Not Available

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