Clinical trial NCT05492877: An Efficacy and Safety Study of Mitiperstat (AZD4831) (MPO Inhibitor) vs Placebo in the Treatment of Moderate to Severe COPD.
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Mitiperstat
AZD4831
Myeloperoxidase
MPO
Myeloperoxidase inhibitor
COPD
Chronic Obstructive Pulmonary Disease
Lung function
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2022-08-09
Enrollment: 381
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomised to receive either Mitiperstat (AZD4831) or placebo.
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

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) \< 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.

Primary outcomes:
measure: 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.
timeFrame: From baseline to up to 24 weeks
Secondary outcomes:
measure: To assess the pharmacokinetics (PK) of mitiperstat (AZD4831) in patients with moderate to severe COPD.
timeFrame: Baseline and week 12 (or at early discontinuation visit due to rash)
measure: To assess the PK of mitiperstat (AZD4831) in patients with moderate to severe COPD
timeFrame: Baseline and week 12 (or at early discontinuation visit due to rash)
measure: To evaluate the effect of mitiperstat (AZD4831) as compared to placebo on the time to first moderate or severe exacerbation.
timeFrame: From baseline to up to week 24
measure: 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.
timeFrame: From baseline to week 12
measure: To assess the effect of mitiperstat (AZD4831) compared to placebo on respiratory symptoms in patients with moderate to severe COPD.
timeFrame: From baseline to week 12 and week 24
measure: To assess the effect of mitiperstat (AZD4831) compared to placebo on respiratory symptoms in patients with moderate to severe COPD.
timeFrame: From baseline to week 12 and week 24
measure: To assess the effect of mitiperstat (AZD4831) compared to placebo on respiratory symptoms in patients with moderate to severe COPD.
timeFrame: From baseline to week 12 and week 24
measure: To assess the effect of mitiperstat (AZD4831) compared to placebo in disease impact in patients with moderate to severe COPD.
timeFrame: From baseline to Week 12
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Research Site
state: California
city: Clearwater
country: United States
facility: Research Site
state: Florida
city: DeLand
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
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state: Florida
city: Tampa
country: United States
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state: Florida
city: Winter Park
country: United States
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state: Florida
city: Chicago Ridge
country: United States
facility: Research Site
state: Illinois
city: Ann Arbor
country: United States
facility: Research Site
state: Michigan
city: Chesterfield
country: United States
facility: Research Site
state: Missouri
city: Saint Charles
country: United States
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state: Missouri
city: New Windsor
country: United States
facility: Research Site
state: New York
city: Gastonia
country: United States
facility: Research Site
state: North Carolina
city: Kernersville
country: United States
facility: Research Site
state: North Carolina
city: New Bern
country: United States
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state: North Carolina
city: Columbus
country: United States
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state: Ohio
city: Choctaw
country: United States
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state: Oklahoma
city: Fort Mill
country: United States
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state: South Carolina
city: Amarillo
country: United States
facility: Research Site
state: Texas
city: Buenos Aires
country: Argentina
facility: Research Site
city: Buenos Aires
country: Argentina
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city: Buenos Aires
country: Argentina
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city: Córdoba
country: Argentina
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city: Ranelagh
country: Argentina
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city: San Fernando
country: Argentina
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city: Dupnitsa
country: Bulgaria
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city: Haskovo
country: Bulgaria
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city: Pernik
country: Bulgaria
facility: Research Site
city: Ruse
country: Bulgaria
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city: Sofia
country: Bulgaria
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city: Stara Zagora
country: Bulgaria
facility: Research Site
city: Stara Zagora
country: Bulgaria
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city: Vratsa
country: Bulgaria
facility: Research Site
city: Calgary
country: Canada
facility: Research Site
state: Alberta
city: St Charles Borromee
country: Canada
facility: Research Site
state: Quebec
city: Trois-Rivières
country: Canada
facility: Research Site
state: Quebec
city: Quebec
country: Canada
facility: Research Site
city: Quebec
country: Canada
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city: Aalborg
country: Denmark
facility: Research Site
city: Hvidovre
country: Denmark
facility: Research Site
city: København NV
country: Denmark
facility: Research Site
city: Næstved
country: Denmark
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city: Odense C
country: Denmark
facility: Research Site
city: Vejle
country: Denmark
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Frankfurt
country: Germany
facility: Research Site
city: Immenhausen
country: Germany
facility: Research Site
city: Koblenz
country: Germany
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city: Landsberg
country: Germany
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city: Leipzig
country: Germany
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city: Marburg
country: Germany
facility: Research Site
city: Witten
country: Germany
facility: Research Site
city: Foggia
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Sassari
country: Italy
facility: Research Site
city: Siena
country: Italy
facility: Research Site
city: Verona
country: Italy
facility: Research Site
city: Culiacán
country: Mexico
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city: Guadalajara
country: Mexico
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city: Monterrey
country: Mexico
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city: Monterrey
country: Mexico
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city: Veracruz
country: Mexico
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city: Zapopan
country: Mexico
facility: Research Site
city: Groningen
country: Netherlands
facility: Research Site
city: Veldhoven
country: Netherlands
facility: Research Site
city: Bielsko-Biała
country: Poland
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city: Chęciny
country: Poland
facility: Research Site
city: Karczew
country: Poland
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city: Kraków
country: Poland
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city: Ksawerów
country: Poland
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city: Staszów
country: Poland
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city: Szczecin
country: Poland
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city: Warszawa
country: Poland
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city: Cape Town
country: South Africa
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city: Durban
country: South Africa
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city: Durban
country: South Africa
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city: Tygervalley
country: South Africa
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city: Vereeniging
country: South Africa
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city: Granada
country: Spain
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city: Madrid
country: Spain
facility: Research Site
city: Merida
country: Spain
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city: Málaga
country: Spain
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city: Santander
country: Spain
facility: Research Site
city: Adana
country: Turkey
facility: Research Site
city: Ankara
country: Turkey
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city: Istanbul
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Izmir
country: Turkey
facility: Research Site
city: Mersin
country: Turkey
facility: Research Site
city: Bradford
country: United Kingdom
facility: Research Site
city: Cambridge
country: United Kingdom
facility: Research Site
city: Cottingham
country: United Kingdom
facility: Research Site
city: Dundee
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
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city: London
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Nottingham
country: United Kingdom
facility: Research Site
city: Rotherham
country: United Kingdom
facility: Research Site
city: Wakefield
country: United Kingdom
facility: Research Site
city: York
country: United Kingdom
facility: Research Site
Study officials:
References: