Phase 2
Completed N=381
An Efficacy and Safety Study of Mitiperstat (AZD4831) (MPO Inhibitor) vs Placebo in the Treatment of Moderate to Severe COPD.
Source: ClinicalTrials.gov NCT05492877 ↗Enrolled (actual)
381
Serious AEs
9.5%
Results posted
Aug 2025
Primary outcomePrimary: 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. — 125; 125 Participants — p=0.599
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
125; 125 | 0.599 |
| SECONDARY To Assess the PK of Mitiperstat (AZD4831) in Patients With Moderate to Severe COPD |
1.292 | — |
| SECONDARY To Assess the Pharmacokinetics (PK) of Mitiperstat (AZD4831) in Patients With Moderate to Severe COPD. |
38.786 | — |
| SECONDARY To Evaluate the Effect of Mitiperstat (AZD4831) as Compared to Placebo on the Time to First Moderate or Severe Exacerbation. |
53; 44 | — |
| SECONDARY 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. |
-0.049; -0.031 | — |
| SECONDARY To Assess the Effect of Mitiperstat (AZD4831) Compared to Placebo on Respiratory Symptoms in Patients With Moderate to Severe COPD. |
0.16; 0.15; 0.11; -0.17 | — |
| SECONDARY To Assess the Effect of Mitiperstat (AZD4831) Compared to Placebo on Respiratory Symptoms in Patients With Moderate to Severe COPD. |
0.16; 0.15; 0.11; -0.17 | — |
| SECONDARY To Assess the Effect of Mitiperstat (AZD4831) Compared to Placebo in Disease Impact in Patients With Moderate to Severe COPD. |
-1.25; -3.05; -2.64; -3.48 | — |
| SECONDARY Change From Baseline to Week 12 in Total COPD Assessment Test (CAT) |
-1.2; -1.2 | — |
Eligibility 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) 7 days) within 4 weeks prior to SV3 (Day 1) (including unexplained diarrhoea) or clinical suspicion of infection at time of dosing.
Data sourced from ClinicalTrials.gov (NCT05492877). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.