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)
- Conditions
- Chronic Obstructive Pulmonary DiseaseCOPD10024967
- Registration Number
- NL-OMON53515
- Lead Sponsor
- Astra Zeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 25
1. Participant must be 40 to 80 years of age inclusive, at the time of signing
the ICF.
2. Participants who have a confirmed primary diagnosis of moderate to severe
COPD as per GOLD criteria (FEV1/FVC < 0.7, and post-BD FEV1 >= 25% predicted).
3. Participants who are current or ex-smokers with a tobacco history of >= 10
pack-years.
4. Participants must be deemed at high risk of exacerbations as defined by any
one of the following:
a) a documented history of >= 1 moderate or severe AECOPD requiring systemic
corticosteroids and/or antibiotics for at least 3 days* duration or
hospitalization for reason of AECOPD in the 24 months prior to screening,
b) frequent productive cough (over the past 3 months coughed at least several
days a week and phlegm (sputum) is brought up at least several days a week), or
c) post-BD FEV1 < 50% predicted.
5. Participants who have a documented stable regimen of triple therapy (ICS +
LABA + LAMA) or dual therapy (ICS + LABA or LABA + LAMA) for >= 3 months prior
to enrolment.
6. Participants who are clinically stable and free from an exacerbation of COPD
for 1 month prior to SV1 (screening) and prior to Day 1.
7. Participants who are at least 70% compliant with each of the following:
morning e-Diary, evening e-Diary, and PEF measurements during the 14 days
preceding SV3 based on the e-Diary.
8. Body mass index within the range 18 to 40 kg/m2 (inclusive).
9. Male or female of non-childbearing potential.
- Participants with a significant 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. This includes but is not limited to:
(a) Diabetes mellitus,
(b) History of left heart failure
(c) Unstable angina, acute coronary syndrome/acute myocardial infarction or
coronary intervention with percutaneous coronary intervention/coronary artery
bypass graft within 6 months, arrhythmia requiring treatment, or cardiomyopathy.
(d) Clinically significant aortic stenosis.
(e) Systemic hypertension
(f) Pulmonary arterial hypertension,
-Current diagnosis of asthma
-Clinically important pulmonary disease other than COPD
-Known history of allergy or reaction to any component of the study
intervention formulation, including hereditary fructose intolerance.
- Any other clinically relevant abnormal findings on physical examination,
laboratory testing including hematology, coagulation, serum chemistry, or
urinalysis; or recent lung imaging prior to randomization,
-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
diarrhea) or clinical suspicion of infection at time of dosing.
-History of ANCA positive vasculitis or ANCA positive skin disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary objective; To evaluate the effect of AZD4831 as compared to placebo on<br /><br>the time to first COPDCompEx event in participants with moderate to severe COPD.<br /><br>Primary Endpoint: time to first COPDCompEx event.</p><br>
- Secondary Outcome Measures
Name Time Method