A study to investigate the effect of AZD6793 in participants with moderate to very severe chronic obstructive pulmonary disease

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AstraZeneca AB

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

29 Sep 2025 → ongoing

Decision date (initial)

2025-09-29

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

AstraZeneca AB

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Dose response

To evaluate the effect of AZD6793 as compared to placebo on the rate of moderate or severe COPD exacerbations

Secondary objectives 6

1. To evaluate the effect of AZD6793 as compared to placebo on COPD exacerbations;
2. To evaluate the effect of AZD6793 as compared to placebo on COPDCompEx events;
3. To evaluate the effect of AZD6793 as compared to placebo on measures of lung function;
4. To evaluate the effect of AZD6793 compared to placebo on symptoms and HRQoL;
5. To assess the pharmacokinetics (PK) of AZD6793 in participants with COPD;
6. To assess the safety and tolerability of AZD6793 as compared to placebo in participants with moderate to very severe COPD;

Conditions and MedDRA coding

Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

Study design 3 periods

Regulatory references

Scientific advice from competent authorities

AstraZeneca AB

Plan to share IPD

Yes

IPD plan description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared. AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment https://vivli.org/. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Participant must be ≥40 years of age at the time of signing the informed consent.
2. Documented primary diagnosis of moderate to very severe COPD for at least 12 months prior to enrolment.
3. 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.
4. Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations in the 12 months prior to screening
5. Documented stable regimen of inhaled triple maintenance therapy or inhaled dual maintenance therapy for ≥ 3 months prior to screening.
6. CAT score ≥ 10 at Visit 1.
7. Current or ex-smokers with a cigarette smoking history of ≥ 10 pack-years.
8. 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).
9. Negative pregnancy test at Visit 1 and Visit 3 for Women Of Child-Bearing Potential (WOCBP).

Exclusion criteria 13

1. 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).
2. Radiological findings suggestive of a respiratory disease other than COPD that is significantly contributing to the participant’s respiratory symptoms
3. 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.
4. Significant left heart failure (ie, NYHA class III and IV or LVEF < 40% on echocardiogram or cardiac MRI.
5. 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.
6. Pulmonary arterial hypertension, either idiopathic or due to connective tissue or thromboembolic disease.
7. History of another underlying condition that predisposes the participant to infections.
8. History of ulcerative colitis, Crohn’s disease, or microscopic colitis diagnosed by either a gastroenterologist or by histopathology.
9. Abnormal laboratory findings (ALT or AST, TBL, Hb, WBC < LLN, neutrophil count, estimated glomerular filtration rate, platelet count)
10. Participants with evidence of active liver disease and/or evidence of chronic liver disease.
11. Participants with history of HIV infection or who test positive for HIV.
12. History of lung volume reduction surgery
13. Current or history of malignancy within 5 years before the screening visit.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Annualised rate of moderate or severe COPD exacerbations

Secondary endpoints 6

1. 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.
2. * Annualised rate of COPDCompEx events. * Time to first COPDCompEx event.
3. * 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."
4. Change from baseline over 24 weeks in each of the following: - - Breathlessness, Cough and Sputum Scale (BCSS) total score. - COPD Assessment Test (CAT) total score - St George's Respiratory Questionnaire (SGRQ) total and domain scores.
5. AZD6793 plasma concentrations at specific timepoints.
6. 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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AstraZeneca AB

Sponsor organisation

AstraZeneca AB

Address

-

City

Sodertalje

Postcode

151 85

Country

Sweden

Scientific contact point

Organisation

AstraZeneca AB

Contact name

AstraZeneca Clinical Study Information Center

Public contact point

Organisation

AstraZeneca AB

Contact name

AstraZeneca Clinical Study Information Center

Locations

8 EU/EEA countries · 82 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Urgent safety measures 1 · Art. 54 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 71 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

9 submissions — initial application plus substantial / non-substantial modifications