A Study to Investigate the Effect of AZD6793 in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (PRESTO)

AstraZeneca

Status and phase: Enrolling; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: AZD6793; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07082738

D7860C00006

Details and patient eligibility

About

This Phase IIb dose-ranging study will evaluate the efficacy and safety of 2 different doses of AZD6793 compared with placebo tablets in participants with moderate to very severe chronic obstructive pulmonary disease.

Full description

A Multicentre, Parallel-group, Phase IIb, Randomised, Double-blind, Placebo-controlled, 3-Arm, 24-Week Study to Evaluate the Efficacy and Safety of AZD6793 Tablets in Adult Participants with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (PRESTO)

Approximately 350 sites globally will participate in this study. Approximately 970 participants will be randomized to AZD6793 or Placebo. Following CSP V.3.0, participants will be randomized in a 1:1:1 ratio of two doses of AZD6793 vs Placebo.

Enrollment: 987 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant must be ≥40 years of age at the time of signing the informed consent.
• Documented primary diagnosis of COPD for at least 12 months prior to enrolment.
• Pre-BD FEV1/FVC < 0.7 at Visit 1 and pre- and post-BD FEV1/FVC < 0.7, and post-BD FEV1 ≥ 25% to < 80% of predicted normal at Visit 2.
• Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations in the 12 months prior to screening.
• Documented stable regimen of inhaled triple maintenance therapy or inhaled dual maintenance therapy for ≥ 3 months prior to screening.
• CAT score ≥ 10 at Visit 1.
• Current or ex-smokers with a cigarette smoking history of ≥ 10 pack-years.
• Participants who are clinically stable and free from an exacerbation of COPD for 4 weeks prior to Visit 1 and are also exacerbation free for at least 4 weeks (28 days) prior to Visit 3 (randomisation).
• Negative pregnancy test at Visit 1 and Visit 3 for Women Of Child-Bearing Potential (WOCBP).

Exclusion criteria

• Clinically important pulmonary disease other than COPD (eg, asthma [current diagnosis per GINA or other accepted guidelines], active pulmonary infection, clinically significant bronchiectasis when bronchiectasis is the predominant diagnosis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha-1 antitrypsin deficiency or primary ciliary dyskinesia).
• Radiological findings suggestive of a respiratory disease other than COPD that is significantly contributing to the participant's respiratory symptoms.
• Any unstable disorder, including, but not limited to, CV, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric disorder, major physical and/or cognitive impairment.
• Significant left heart failure.
• Unstable angina, acute coronary syndrome/acute myocardial infarction or coronary intervention with percutaneous coronary intervention/coronary artery bypass graft within 6 months of randomisation, uncontrolled arrhythmia, or cardiomyopathy, clinically significant aortic stenosis, or signs of pulmonary oedema or volume overload.
• Pulmonary arterial hypertension, either idiopathic or due to connective tissue or thromboembolic disease.
• History of another underlying condition that predisposes the participant to infections.
• History of ulcerative colitis, Crohn's disease, or microscopic colitis diagnosed by either a gastroenterologist or by histopathology.
• Abnormal laboratory findings.
• Participants with evidence of active liver disease and/or evidence of chronic liver disease.
• Participants with history of HIV infection or who test positive for HIV.
• History of lung volume reduction surgery.
• Current or history of malignancy within 5 years before the screening visit.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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987 participants in 3 patient groups, including a placebo group

Dose 1 of AZD6793

Experimental group

Description:

Approximately 290 participants will be randomized to receive Dose 1 of AZD6793

Treatment:

Drug: AZD6793

Dose 2 of AZD6793

Experimental group

Description:

Approximately 290 participants will be randomized to receive Dose 2 of AZD6793

Treatment:

Drug: AZD6793

Matching Placebo

Placebo Comparator group

Description:

Approximately 290 participants will be randomized to receive Matching Placebo

Treatment:

Other: Placebo