AZD6793 for Chronic obstructive pulmonary disease (COPD)

Inclusion criteria

• {"criterion_text":"- Participant must be ≥40 years of age at the time of signing the informed consent.\n- Documented primary diagnosis of moderate to very severe COPD for at least 12 months prior to enrolment.\n- 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.\n- Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations in the 12 months prior to screening\n- Documented stable regimen of inhaled triple maintenance therapy or inhaled dual maintenance therapy for ≥ 3 months prior to screening.\n- CAT score ≥ 10 at Visit 1.\n- Current or ex-smokers with a cigarette smoking history of ≥ 10 pack-years.\n- Participants who are clinically stable and free from an exacerbation of COPD for 4 weeks prior to Visit 1 and remain exacerbation free at Visit 3 (randomisation).\n- Negative pregnancy test at Visit 1 and Visit 3 for Women Of Child-Bearing Potential (WOCBP)."}

Exclusion criteria

• {"criterion_text":"- 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).\n- Radiological findings suggestive of a respiratory disease other than COPD that is significantly contributing to the participant’s respiratory symptoms\n- 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.\n- Significant left heart failure (ie, NYHA class III and IV or LVEF < 40% on echocardiogram or cardiac MRI.\n- 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.\n- Pulmonary arterial hypertension, either idiopathic or due to connective tissue or thromboembolic disease.\n- History of another underlying condition that predisposes the participant to infections.\n- History of ulcerative colitis, Crohn’s disease, or microscopic colitis diagnosed by either a gastroenterologist or by histopathology.\n- Abnormal laboratory findings (ALT or AST, TBL, Hb, WBC < LLN, neutrophil count, estimated glomerular filtration rate, platelet count)\n- Participants with evidence of active liver disease and/or evidence of chronic liver disease.\n- Participants with history of HIV infection or who test positive for HIV.\n- History of lung volume reduction surgery\n- Current or history of malignancy within 5 years before the screening visit."}

Primary endpoints

• {"endpoint_text":"- Annualised rate of moderate or severe COPD exacerbations","definition_or_measurement_approach":"Annualised rate of moderate or severe COPD exacerbations; (endpoint expressed as annualised rate of exacerbations). Severe exacerbation is defined in the protocol as an exacerbation resulting in hospitalization or death due to COPD."}

Secondary endpoints

• {"endpoint_text":"- Time to first moderate or severe COPD exacerbation: *Annualised rate of COPD exacerbations associated with emergency room visits, urgent care visits, or hospitalizations. *Annualised rate of severe COPD exacerbations. A severe exacerbation is defined as an exacerbation resulting in hospitalization or death due to COPD.","definition_or_measurement_approach":"Time-to-event analysis for time to first moderate or severe COPD exacerbation; annualised rates of exacerbations associated with emergency/urgent care visits or hospitalisations. Severe exacerbation defined as resulting in hospitalisation or death due to COPD."}
• {"endpoint_text":"- * Annualised rate of COPDCompEx events. * Time to first COPDCompEx event.","definition_or_measurement_approach":"Annualised rate and time-to-first event for COPDCompEx composite endpoint as specified in protocol."}
• {"endpoint_text":"- * Change from baseline in pre-bronchodilator (BD) FEV1 at Week 12 and Week 24. * Change from baseline in post-BD FEV1 at Week 12 and Week 24.\"","definition_or_measurement_approach":"Change from baseline in pre- and post-bronchodilator FEV1 measured by spirometry at Week 12 and Week 24."}
• {"endpoint_text":"- Change from baseline over 24 weeks in each of the following: -\t- Breathlessness, Cough and Sputum Scale (BCSS) total score. - COPD Assessment Test (CAT) total score - St George's Respiratory Questionnaire (SGRQ) total and domain scores.","definition_or_measurement_approach":"Patient-reported outcome instruments (BCSS, CAT, SGRQ) measured at baseline and through 24 weeks; change from baseline analysed."}
• {"endpoint_text":"- AZD6793 plasma concentrations at specific timepoints.","definition_or_measurement_approach":"Pharmacokinetic sampling to determine AZD6793 plasma concentrations at protocol-specified timepoints."}
• {"endpoint_text":"- Safety and tolerability evaluations as assessed by AEs, SAEs, AESis (X-ray confirmed pneumonia, serious infections, herpes zoster infections, severe COVID-19 infections, haematology events [anaemia, neutropenia, thrombocytopaenia], skin and hair depigmentation events during skin examinations) vital signs, physical examinations, clinical laboratory assessments (clinical chemistry, male reproductive hormones, haematology, and urinalysis), and ECGs","definition_or_measurement_approach":"Safety assessed by collection and evaluation of adverse events (AEs), serious adverse events (SAEs), AESIs (including specified events), vital signs, physical examinations, laboratory tests (clinical chemistry, haematology, urinalysis, male reproductive hormones) and ECGs."}

Methods

• Site-level recruitment arrangements (K1 documents) — country-specific K1 recruitment arrangements documents are provided for participating countries.
• Printed recruitment materials: posters and pamphlets (K2 recruitment materials / patient posters) for use at clinic sites.
• General advertisement text / lay ad text (K2 Recruitment Material General Ad Text) for public advertising.
• Digital recruitment and pre-screening tools (e.g., Velocity Clinical Research pre-screening tool documents referenced in recruitment materials).
• Third-party patient recruitment support referenced (e.g. James Lind Care recruitment material noted in documents).

Spain

Earliest CTIS Part Ii Submission Date

28-08-2025

Latest Decision Or Authorization Date

02-12-2025

Processing Time Days

96

Number Of Participants

25

Greece

Earliest CTIS Part Ii Submission Date

25-06-2025

Latest Decision Or Authorization Date

27-11-2025

Processing Time Days

155

Number Of Participants

40

Bulgaria

Earliest CTIS Part Ii Submission Date

26-08-2025

Latest Decision Or Authorization Date

25-11-2025

Processing Time Days

91

Number Of Participants

36

Germany

Earliest CTIS Part Ii Submission Date

27-08-2025

Latest Decision Or Authorization Date

26-11-2025

Processing Time Days

91

Number Of Participants

72

Denmark

Earliest CTIS Part Ii Submission Date

29-08-2025

Latest Decision Or Authorization Date

07-11-2025

Processing Time Days

70

Number Of Participants

22

Hungary

Earliest CTIS Part Ii Submission Date

27-08-2025

Latest Decision Or Authorization Date

26-11-2025

Processing Time Days

91

Number Of Participants

40

Italy

Earliest CTIS Part Ii Submission Date

25-08-2025

Latest Decision Or Authorization Date

10-11-2025

Processing Time Days

77

Number Of Participants

24

Poland

Earliest CTIS Part Ii Submission Date

03-09-2025

Latest Decision Or Authorization Date

14-12-2025

Processing Time Days

102

Number Of Participants

55

Primary sponsor

Full Name

AstraZeneca AB

Organisation Type

Pharmaceutical company

Country Of Registered Address

Sweden