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

A Phase IIa Randomised, Double Blind, Placebo Controlled, Parallel Arm, Multi-Centre Study to Evaluate the Efficacy and Safety of Mitiperstat (AZD4831), for 12-24 Weeks, in Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) - CRESCENDO

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-002441-18-NL

Enrollment

288

Registered

2022-10-26

Start date

2022-12-05

Completion date

Unknown

Last updated

2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease (COPD) MedDRA version: 21.1 Level: PT Classification code 10009033 Term: Chronic obstructive pulmonary disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Product Name: Mitiperstat (AZD4831) film-coated tablet 5 mg Product Code: Mitiperstat (AZD4831) Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Not available CAS Number: 1933460-19-5 Curr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Confirmed primary diagnosis of moderate to severe COPD as per FEV1/FVC =65 years) yes F.1.3.1 Number of subjects for this age range 144

Exclusion criteria

Exclusion criteria: 1. Current diagnosis of asthma or past diagnosis of asthma which persisted beyond the age of 25 years 2. Active malignancy requiring treatment (with the exception of basal cell or squamous cell carcinomas of the skin and stable prostate cancer) 3. Evidence of untreated active TB: Participants currently receiving treatment for active TB may be considered after completion of an appropriate course of therapy. 4. Change in smoking status in 12 weeks prior to enrolment or intention to change smoking status between enrolment and end of follow-up. 5. Current diagnosis of hyperthyroidism, uncontrolled hypothyroidism (including but not limited to TSH = 10 mIU/mL), or any clinically significant thyroid disease. 6. Participant who is going to start or finish intensive COPD rehabilitation program at anytime during study period. Participants can be recruited immediately following the completion of their COPD rehabilitation program.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the effect of mitiperstat (AZD4831) as compared to placebo on the time to first COPDCompEx event in patients with moderate to severe COPD.;Secondary Objective: - 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 COPD exacerbation. - To assess the effects of mitiperstat (AZD4831) as compared to placebo on post-BD FEV1 in patients with moderate to severe COPD. - To assess the effect of mitiperstat (AZD4831) compared with placebo on respiratory symptoms in patients with moderate to severe COPD. - To assess the effect of mitiperstat (AZD4831) compared with placebo on disease impact in patients with moderate to severe COPD.;Primary end point(s): Time to first COPDCompEx event. COPDCompEx events include changes in COPD symptoms, lung function testing, COPD exacerbations, study dropout due to lack of efficacy, and use of reliever medication.;Timepoint(s) of evaluation of this end point: Not applicable as this is an event driven endpoint.	—

Measure

Time frame

Main Objective: To evaluate the effect of mitiperstat (AZD4831) as compared to placebo on the time to first COPDCompEx event in patients with moderate to severe COPD.;Secondary Objective: - 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 COPD exacerbation. - To assess the effects of mitiperstat (AZD4831) as compared to placebo on post-BD FEV1 in patients with moderate to severe COPD. - To assess the effect of mitiperstat (AZD4831) compared with placebo on respiratory symptoms in patients with moderate to severe COPD. - To assess the effect of mitiperstat (AZD4831) compared with placebo on disease impact in patients with moderate to severe COPD.;Primary end point(s): Time to first COPDCompEx event. COPDCompEx events include changes in COPD symptoms, lung function testing, COPD exacerbations, study dropout due to lack of efficacy, and use of reliever medication.;Timepoint(s) of evaluation of this end point: Not applicable as this is an event driven endpoint.

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Secondary

Measure	Time frame
Secondary end point(s): - Plasma mitiperstat (AZD4831) concentration-time profiles during the intervention and follow-up periods, and PK parameters. - Time to first COPD exacerbation event. - Change from baseline in post-BD FEV1 after 12 weeks. - Change from baseline in EXACT, BCSS score, and cough VAS at Week 12 and Week 24. - Change from baseline in Total CAT measured in clinic at Week 12. - Safety and tolerability evaluations using AEs, SAEs, AESIs (skin reactions, including maculopapular rash, and infections, including pneumonia), vital sign measures, clinical laboratory assessments (clinical chemistry, haematology, and urinalysis), and ECG.;Timepoint(s) of evaluation of this end point: - To assess the PK of mitiperstat (AZD4831) in patients with moderate to severe COPD (timepoint not applicable) - To evaluate the effect of mitiperstat (AZD4831) as compared to placebo on the time to first moderate or severe COPD exacerbation (timepoint not applicable) - To assess the effects of mitiperstat (AZD4831) as compared to placebo on post-BD FEV1 in patients with moderate to severe COPD (week 12) - To assess the effect of mitiperstat (AZD4831) compared with placebo on respiratory symptoms in patients with moderate to severe COPD (week 12 and week 24) - To assess the effect of mitiperstat (AZD4831) compared with placebo on disease impact in patients with moderate to severe COPD (week 12)	—

Measure

Time frame

Secondary end point(s): - Plasma mitiperstat (AZD4831) concentration-time profiles during the intervention and follow-up periods, and PK parameters. - Time to first COPD exacerbation event. - Change from baseline in post-BD FEV1 after 12 weeks. - Change from baseline in EXACT, BCSS score, and cough VAS at Week 12 and Week 24. - Change from baseline in Total CAT measured in clinic at Week 12. - Safety and tolerability evaluations using AEs, SAEs, AESIs (skin reactions, including maculopapular rash, and infections, including pneumonia), vital sign measures, clinical laboratory assessments (clinical chemistry, haematology, and urinalysis), and ECG.;Timepoint(s) of evaluation of this end point: - To assess the PK of mitiperstat (AZD4831) in patients with moderate to severe COPD (timepoint not applicable) - To evaluate the effect of mitiperstat (AZD4831) as compared to placebo on the time to first moderate or severe COPD exacerbation (timepoint not applicable) - To assess the effects of mitiperstat (AZD4831) as compared to placebo on post-BD FEV1 in patients with moderate to severe COPD (week 12) - To assess the effect of mitiperstat (AZD4831) compared with placebo on respiratory symptoms in patients with moderate to severe COPD (week 12 and week 24) - To assess the effect of mitiperstat (AZD4831) compared with placebo on disease impact in patients with moderate to severe COPD (week 12)

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Countries

Argentina, Bulgaria, Canada, Denmark, Germany, Italy, Mexico, Netherlands, Poland, South Africa, Spain, Turkey, United Kingdom, United States

Contacts

Public ContactClinical Study Information Center

AstraZeneca

Information.Center@astrazeneca.com1877240 9479

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026