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

AstraZeneca381 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

381

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Mitiperstat (AZD4831)DRUG

Oral dosage, once daily.

PlaceboOTHER

Oral dosage, once daily.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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.

Time frame: From baseline to up to 24 weeks

Secondary Outcomes

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

Measurement of Time to Reach Maximum Plasma Concentration (Tmax) at pre-randomisation (baseline visit) and week 12.

Time frame: At week 12

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

Measurement of Maximum Plasma Concentration (Cmax) at pre-randomisation (baseline visit) and week 12.

Time frame: At week 12

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

A COPD exacerbation was considered moderate if it required treatment with systemic corticosteroids and/or antibiotics for at least 3 days or resulted in emergency room visit\< 24 hours requiring intensive treatment; and did not result in hospitalization or death. A COPD exacerbation was considered severe if it resulted in hospitalization (defined as an inpatient admission ≥ 24 hours in the hospital, an observation area, the emergency department, or other equivalent healthcare facility depending on the country and healthcare system) or death due to COPD.

Data from ClinicalTrials.gov

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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

Chicago Ridge, Illinois, United States

Research Site

Ann Arbor, Michigan, United States

Research Site

Chesterfield, Missouri, United States

...and 91 more locations