Recruiting
Phase 2

AZD6793

Sponsor:

AstraZeneca

Code:

NCT07082738

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

AZD6793

Placebo

Study Details

Brief summary:

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Study ID

NCT07082738

Start date

Jun 27, 2025

Status verified date

Aug, 2026

Completion date

Nov 5, 2027

Anticipated

Primary completion date

Nov 5, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

987 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose 1 of AZD6793

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

experimental: Dose 2 of AZD6793

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

placebo comparator: Matching Placebo

Approximately 290 participants will be randomized to receive Matching Placebo

Interventions

AZD6793

Oral dosage

Placebo

Oral dosage

Primary outcome measure

  • Annualised rate of moderate or severe COPD exacerbations [ Time Frame: From baseline up to 24 Weeks ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

Recruiting

Birmingham, Alabama, United States, 35205

Research Site

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Phoenix, Arizona, United States, 85027

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Phoenix, Arizona, United States, 85044

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Phoenix, Arizona, United States, 85051

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Los Angeles, California, United States, 90017

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Newport Beach, California, United States, 92663

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Norco, California, United States, 92860

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Tustin, California, United States, 92780

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Brandon, Florida, United States, 33511

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Cape Coral, Florida, United States, 33990

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Clearwater, Florida, United States, 33756

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Clearwater, Florida, United States, 33765

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Lake City, Florida, United States, 32055

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Miami, Florida, United States, 33125

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Miami, Florida, United States, 33155

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Miami, Florida, United States, 33173

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Miami, Florida, United States, 33175

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Miami, Florida, United States, 33182

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Miami Lakes, Florida, United States, 33016

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Naples, Florida, United States, 34102

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Ocala, Florida, United States, 34471

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Ormond Beach, Florida, United States, 32174

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Plantation, Florida, United States, 33324

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Sarasota, Florida, United States, 34239

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Tamarac, Florida, United States, 33321

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Tampa, Florida, United States, 33606

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Tampa, Florida, United States, 33607

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Winter Park, Florida, United States, 32789

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Suwanee, Georgia, United States, 30024

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Zachary, Louisiana, United States, 70791

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Baltimore, Maryland, United States, 21201

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Baltimore, Maryland, United States, 21224

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Burlington, Massachusetts, United States, 01805

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Farmington Hills, Michigan, United States, 48336

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Garden City, Michigan, United States, 48135

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Grand Rapids, Michigan, United States, 49546

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Chesterfield, Missouri, United States, 63005

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Hannibal, Missouri, United States, 63401

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St Louis, Missouri, United States, 63110

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St Louis, Missouri, United States, 63141

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Missoula, Montana, United States, 59808

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Mount Kisco, New York, United States, 10549

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New Bern, North Carolina, United States, 28562

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Cleveland, Ohio, United States, 44106

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Marion, Ohio, United States, 43302

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Oklahoma City, Oklahoma, United States, 73104

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Tulsa, Oklahoma, United States, 74133

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Medford, Oregon, United States, 97504

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Portland, Oregon, United States, 97202

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Camp Hill, Pennsylvania, United States, 17011

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DuBois, Pennsylvania, United States, 15801

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Philadelphia, Pennsylvania, United States, 19114

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Philadelphia, Pennsylvania, United States, 19140

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Pittsburgh, Pennsylvania, United States, 15213

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Scottdale, Pennsylvania, United States, 15683

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Smithfield, Pennsylvania, United States, 15478

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Lancaster, South Carolina, United States, 29720

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Spartanburg, South Carolina, United States, 29303

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Rapid City, South Dakota, United States, 57702

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Chattanooga, Tennessee, United States, 37421

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Franklin, Tennessee, United States, 37067

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Boerne, Texas, United States, 78006

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Dallas, Texas, United States, 75254

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Denison, Texas, United States, 75020

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El Paso, Texas, United States, 79902

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Houston, Texas, United States, 77008

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Kingwood, Texas, United States, 77339

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Lewisville, Texas, United States, 75067

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Mansfield, Texas, United States, 76063

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McKinney, Texas, United States, 75069

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Colchester, Vermont, United States, 05446

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Norfolk, Virginia, United States, 23504

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Williamsburg, Virginia, United States, 23188

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Morgantown, West Virginia, United States, 26505

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Madison, Wisconsin, United States, 53715

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Edmonton, Alberta, Canada, T6G 2G3

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Winnipeg, Manitoba, Canada, R3L 1Z5

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Truro, Nova Scotia, Canada, B2N 1L2

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Ajax, Ontario, Canada, L1S 2J5

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Burlington, Ontario, Canada, L7N 3V2

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Guelph, Ontario, Canada, N1H 6J2

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Hamilton, Ontario, Canada, L8L 5G4

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Stoney Creek, Ontario, Canada, L8G 2V6

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Québec, Quebec, Canada, G1V 4G5

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Saint-Charles-Borromée, Quebec, Canada, J6E 2B4

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Sherbrooke, Quebec, Canada, J1H 5N4

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Trois-Rivières, Quebec, Canada, G8T 7A1

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Trois-Rivières, Quebec, Canada, G9A 4P3

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Victoriaville, Quebec, Canada, G6P 3Z8

Research Site

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Saskatoon, Saskatchewan, Canada, S7N 0W8

More Information

Sponsor

AstraZeneca

Last update posted

Aug 11, 2026

Last verified

Aug, 2026

Keywords

  • COPD
  • Moderate COPD
  • Severe COPD
  • Very Severe COPD
  • chronic obstructive pulmonary disease
  • AZD6793
  • IRAK4 Inhibitor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-08-11.