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

NCT05492877 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: D6582C000012022-002441-18
• Study Type: interventional
• Target: 381
• Locations: 14 countries
• Sites: 101

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Mitiperstat; AZD4831; Myeloperoxidase; MPO; Myeloperoxidase inhibitor; COPD; Chronic Obstructive Pulmonary Disease; Lung function

Outcome Measures

Primary Outcomes (1)

• To Evaluate the Effect of Mitiperstat (AZD4831) as Compared to Placebo on the Time to First COPD Composite Exacerbation (CompEx) Event in Patients With Moderate to Severe COPD.

  COPDCompEx is a composite endpoint of exacerbations and events defined from participant e-Diaries and peak expiratory flow (PEF). COPDCompEx defined exacerbations included episodes leading to one or more of the following: hospitalization, emergency room visit, treatment with systemic corticosteroids (injected and/or oral), or treatment with antibiotics. Diary COPDCompEx events are defined by threshold and slope criteria being met for \>= 2 consecutive days using the following diary and home spirometry variables: overall symptom rating, night-time awakenings due to symptoms, reliever medication use, PEF. COPDCompEx also includes patient withdrawals for treatment failure.

  From baseline to up to 24 weeks

Secondary Outcomes (8)

• To Assess the PK of Mitiperstat (AZD4831) in Patients With Moderate to Severe COPD

  At week 12

• To Assess the Pharmacokinetics (PK) of Mitiperstat (AZD4831) in Patients With Moderate to Severe COPD.

  At week 12

• To Evaluate the Effect of Mitiperstat (AZD4831) as Compared to Placebo on the Time to First Moderate or Severe Exacerbation.

  From baseline to up to week 24

• To Assess the Effects of Mitiperstat (AZD4831) as Compared to Placebo on Post-bronchodilator (BD) Forced Expiratory Volume in the First Second (FEV1) in Patients With Moderate to Severe COPD.

  From baseline to week 12

• To Assess the Effect of Mitiperstat (AZD4831) Compared to Placebo on Respiratory Symptoms in Patients With Moderate to Severe COPD.

  From baseline to week 12 and week 24

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Approximately 203 participants will be randomised to receive placebo.

Other: Placebo

Mitiperstat (AZD4831)

EXPERIMENTAL

Approximately 203 participants will be randomised to receive mitiperstat (AZD4831).

Drug: Mitiperstat (AZD4831)

Interventions

Mitiperstat (AZD4831) DRUG

Oral dosage, once daily.

Mitiperstat (AZD4831)

Placebo OTHER

Oral dosage, once daily.

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (101)

Research Site

Newport Beach, California, 92663, United States

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Clearwater, Florida, 33765, United States

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DeLand, Florida, 32720, United States

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Miami, Florida, 33186, United States

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Orlando, Florida, 32825, United States

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Tampa, Florida, 33606, United States

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Winter Park, Florida, 32789, United States

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Chicago Ridge, Illinois, 60415, United States

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Ann Arbor, Michigan, 48109, United States

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Chesterfield, Missouri, 63017, United States

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Saint Charles, Missouri, 63301, United States

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New Windsor, New York, 12553, United States

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Gastonia, North Carolina, 28054, United States

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Kernersville, North Carolina, 27284, United States

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New Bern, North Carolina, 28562, United States

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Columbus, Ohio, 43215, United States

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Choctaw, Oklahoma, 73020, United States

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Fort Mill, South Carolina, 29707, United States

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Amarillo, Texas, 79106, United States

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Buenos Aires, C1121ABE, Argentina

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Buenos Aires, C1414AIF, Argentina

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Buenos Aires, C1425BEN, Argentina

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Córdoba, X5003DCE, Argentina

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Ranelagh, 1886, Argentina

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San Fernando, B1646EBJ, Argentina

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Dupnitsa, 2602, Bulgaria

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Haskovo, 6305, Bulgaria

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Pernik, 2300, Bulgaria

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Rousse, 7000, Bulgaria

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Sofia, 1756, Bulgaria

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Stara Zagora, 6000, Bulgaria

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Stara Zagora, 6003, Bulgaria

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Vratsa, 3000, Bulgaria

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Calgary, Alberta, T3B 0M3, Canada

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Québec, Quebec, G1V 4G5, Canada

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Québec, Quebec, G3K 2P8, Canada

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Saint-Charles-Borromée, Quebec, J6E 2B4, Canada

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Trois-Rivières, Quebec, G8T 7A1, Canada

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Aalborg, 9000, Denmark

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Hvidovre, 2650, Denmark

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København NV, 2400, Denmark

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Næstved, 4700, Denmark

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Odense C, 5000, Denmark

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Vejle, 7100, Denmark

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Berlin, 10119, Germany

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Frankfurt, 60596, Germany

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Immenhausen, 34376, Germany

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Koblenz, 56068, Germany

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Landsberg, 86899, Germany

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Leipzig, 04299, Germany

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Marburg, 35037, Germany

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Witten, 58452, Germany

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Foggia, 71100, Italy

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Roma, 00168, Italy

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Sassari, 07100, Italy

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Siena, 53100, Italy

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Verona, 37134, Italy

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Culiacán, 80200, Mexico

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Guadalajara, 44670, Mexico

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Monterrey, 64310, Mexico

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Monterrey, 64465, Mexico

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Veracruz, 91910, Mexico

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Zapopan, 45138, Mexico

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Groningen, 9713 GH, Netherlands

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Veldhoven, 5504 DB, Netherlands

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Bielsko-Biala, 43-300, Poland

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Chęciny, 26-060, Poland

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Karczew, 05-480, Poland

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Krakow, 31-011, Poland

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Ksawerów, 95-054, Poland

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Staszów, 28-200, Poland

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Szczecin, 70-111, Poland

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Warsaw, 01-456, Poland

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Cape Town, 7700, South Africa

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Durban, 4001, South Africa

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Durban, 4093, South Africa

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Tygervalley, 7530, South Africa

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Vereeniging, 1935, South Africa

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Granada, 18014, Spain

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Madrid, 28007, Spain

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Málaga, 29010, Spain

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Mérida, 06800, Spain

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Santander, 39008, Spain

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Adana, 01330, Turkey (Türkiye)

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Ankara, 06620, Turkey (Türkiye)

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Istanbul, 34854, Turkey (Türkiye)

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Istanbul, 34890, Turkey (Türkiye)

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Izmir, 35360, Turkey (Türkiye)

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Mersin, 33343, Turkey (Türkiye)

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Bradford, BD9 6RJ, United Kingdom

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Cambridge, CB2 0QQ, United Kingdom

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Cottingham, HU16 5JQ, United Kingdom

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Dundee, DD1 9SY, United Kingdom

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Glasgow, G12 0YN, United Kingdom

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London, EC1M 6BQ, United Kingdom

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London, NW3 2QG, United Kingdom

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Manchester, M8 5RB, United Kingdom

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Nottingham, NG5 1PB, United Kingdom

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Rotherham, S65 2QL, United Kingdom

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Wakefield, WF1 4DG, United Kingdom

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York, YO24 3WX, United Kingdom

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Related Links

• D6582C00001 CSR Synopsis
• D6582C00001 CSP Redacted
• D6582C00001 SAP

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

AZD4831

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Global Clinical Lead
• Organization: AstraZeneca Clinical Study Information Center

information.center@astrazeneca.com

+1-877-240-9479

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomised to receive either Mitiperstat (AZD4831) or placebo.

Study Record Dates

• First Submitted: July 22, 2022
• First Posted: August 9, 2022
• Study Start: November 14, 2022
• Primary Completion: August 12, 2024
• Study Completion: August 12, 2024
• Last Updated: August 29, 2025
• Results First Posted: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

DK (6); ZA (5); DE (8); NL (2); PL (8); ES (5); TU (6); GB (12); BU (8); AR (6); US (19); CA (5); IT (5); ME (6)