An Efficacy and Safety Study of AZD4831 (MPO inhibitor) vs placebo in the treatment of moderate to severe COPD. - CRESCENDO

Study identifier:D6582C00001

ClinicalTrials.gov identifier:NCT05492877

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

Official Title

A Phase 2a Randomised, Double Blind, Placebo Controlled, Parallel Arm, Multi-Centre Study to Evaluate the Efficacy and Safety of AZD4831 in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Medical condition

Chronic obstructive pulmonary disease (COPD)

Phase

Phase 2

Healthy volunteers

Study drug

AZD4831

Sex

All

Actual enrollment

288

Study type

Interventional

Age

40 Years - 80 Years

Date

Study Start Date: 14 Nov 2022

Estimated Primary Completion Date: 13 May 2024

Estimated Study Completion Date: 13 May 2024

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jan 2023 by AstraZeneca

Collaborators

Inclusion and exclusion 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

- Participants with a positive diagnostic lateral flow test for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) at Study Visit 1 (SV1) or Study Visit 3 (SV3).
- Participants with a significant Coronavirus Disease 2019 (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.
- 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.

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Arms	Assigned Interventions
Placebo Comparator: Placebo Approximately 144 participants will be randomised to receive placebo.	Other: Placebo Oral dosage, once daily. Other Name: N/A
Experimental: AZD4831 Approximately 144 participants will be randomised to receive AZD4831.	Drug: AZD4831 Oral dosage, once daily. Other Name: N/A

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]