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

• Status: Not yet recruiting
• Trial end date: 2024-04-12
• Target enrollment: 0
• Participant gender: All

Summary

This is a research study to evaluate the efficacy and safety of the investigational drug AZD4831 in adult participants with chronic obstructive pulmonary disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca

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:

• Participants with a positive diagnostic lateral flow test for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) at Study Visit 1 (SV1) or Study Visit 3 (SV3).

• Participants with a significant Coronavirus Disease 2019 (COVID-19) illness within 6 months of enrolment.

• 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.