An Efficacy and Safety Study of Mitiperstat (AZD4831) (MPO Inhibitor) vs Placebo in the Treatment of Moderate to Severe COPD.
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Registration Number
- NCT05492877
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 381
Inclusion Criteria:<br><br> - Provision of informed consent.<br><br> - Participants must be deemed as high risk of exacerbations as defined by: >= 1<br> moderate or severe exacerbation in the previous 24 months; or frequent productive<br> cough; or post-bronchodilator (BD) forced expiratory volume in the first second<br> (FEV1) < 50% predicted.<br><br> - Participants must be 40-80 years of age inclusive, at the time of signing informed<br> consent form (ICF).<br><br> - Participants who have a confirmed primary diagnosis of moderate to severe COPD.<br><br> - Participants who are current or ex-smokers with a tobacco history of = 10<br> pack-years.<br><br> - Participants who have a documented stable regimen of triple therapy or dual therapy<br> for<br><br> = 3 months prior to enrolment.<br><br> - Body mass index within the range 18 to 40 kg/m2 (inclusive).<br><br>Exclusion Criteria:<br><br> - As judged by the investigator, any evidence of any active medical or psychiatric<br> condition or other reason (at SV1 [screening] and SV3 [pre-dose]) which in the<br> investigator's opinion makes it undesirable for the participant to participate in<br> the study.<br><br> - Current diagnosis of asthma or past diagnosis of asthma which persisted beyond the<br> age of 25 years.<br><br> - Clinically important pulmonary disease other than COPD.<br><br> - Any other clinically relevant abnormal findings on physical examination, laboratory<br> testing including haematology, coagulation, serum chemistry, or urinalysis; or chest<br> CT scan at screening or randomisation, which in the opinion of the investigator or<br> medical monitor may compromise the safety of the participant in the study or<br> interfere with evaluation of the study intervention or reduce the participant's<br> ability to participate in the study.<br><br> - History of a clinically significant infection (viral, bacterial, or fungal; defined<br> as requiring systemic antibiotics, antiviral, or antifungal medication for > 7 days)<br> within 4 weeks prior to SV3 (Day 1) (including unexplained diarrhoea) or clinical<br> suspicion of infection at time of dosing.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method To assess the pharmacokinetics (PK) of mitiperstat (AZD4831) in patients with moderate to severe COPD.;To assess the PK of mitiperstat (AZD4831) in patients with moderate to severe COPD;To evaluate the effect of mitiperstat (AZD4831) as compared to placebo on the time to first moderate or severe exacerbation.;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.;To assess the effect of mitiperstat (AZD4831) compared to placebo on respiratory symptoms in patients with moderate to severe COPD.;To assess the effect of mitiperstat (AZD4831) compared to placebo on respiratory symptoms in patients with moderate to severe COPD.;To assess the effect of mitiperstat (AZD4831) compared to placebo on respiratory symptoms in patients with moderate to severe COPD.;To assess the effect of mitiperstat (AZD4831) compared to placebo in disease impact in patients with moderate to severe COPD.