Status:

RECRUITING

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

Lead Sponsor:

AstraZeneca

Conditions:

Chronic Obstructive Pulmonary Disease (COPD)

Eligibility:

All Genders

40+ years

Phase:

PHASE2

Brief Summary

This Phase IIb dose-ranging study will evaluate the efficacy and safety of 3 different doses of AZD6793 compared with placebo tablets in participants with moderate to very severe chronic obstructive p...

Detailed Description

A Multicentre, Parallel-group, Phase IIb, Randomised, Double-blind, Placebo-controlled, 4-Arm, 24-Week Study to Evaluate the Efficacy and Safety of AZD6793 Tablets in Adult Participants with Moderate ...

Eligibility Criteria

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.

Key Trial Info

Start Date :

June 27 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

November 5 2027

Estimated Enrollment :

1160 Patients enrolled

Trial Details

Trial ID

NCT07082738

Start Date

June 27 2025

End Date

November 5 2027

Last Update

March 17 2026

Active Locations (363)

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Page 1 of 91 (363 locations)

1

Research Site

Birmingham, Alabama, United States, 35205

2

Research Site

Glendale, Arizona, United States, 85306

3

Research Site

Phoenix, Arizona, United States, 85027

4

Research Site

Phoenix, Arizona, United States, 85044

A Study to Investigate the Effect of AZD6793 in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease | DecenTrialz