Phase 2 COPD Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are between 40 and 75 years old (inclusive)
• People who have been diagnosed with COPD by a doctor for at least 1 year before the screening visit
• People who have had at least 2 moderate COPD flare-ups, or at least 1 severe COPD flare-up, in the 12 months before the screening visit
• People whose COPD is rated as moderate to severe, based on specific breathing test results measured after using a bronchodilator (confirm with trial site for exact test values)
• People with a Body Mass Index (BMI) — a measure of weight relative to height — between 16 and 32 kg/m²
• People who currently smoke, or who used to smoke, with a total smoking history of at least 10 pack-years (a way of measuring how much someone has smoked over time)
• People who have been on a stable, standard COPD controller medication for at least 3 months before screening, with no dose changes in the last month before screening

Who may not be able to join:

• People who have been diagnosed with asthma, either currently or in the past
• People who have a condition called Alpha-1 Antitrypsin Deficiency
• People with a history of other significant lung diseases besides COPD, such as sarcoidosis, interstitial lung disease, bronchiectasis, cystic fibrosis, constrictive bronchiolitis, severe pulmonary hypertension, or other active lung conditions
• People who require long-term oxygen therapy (more than 15 hours per day), mechanical ventilation, or breathing support devices such as CPAP or NIPPV for sleep apnea
• People who have had a lung removal surgery, or lung volume reduction surgery within the 12 months before screening, or who are planning to have lung volume reduction surgery during the study
• People who are currently in the active phase of a pulmonary rehabilitation program, or who are scheduled to start one within 4 weeks of screening
• People who have an untreated upper or lower respiratory tract infection during the screening period
• People who have had a moderate to severe COPD flare-up within 4 weeks before screening or during the screening period
• People who have had any infection requiring hospitalisation for 24 hours or more, or who were treated with antibiotics (by mouth, injection, or drip) within 4 weeks before screening or during the screening period
• People who have been treated with oral, injected, or intramuscular corticosteroids at doses higher than 10 mg per day of prednisone (or equivalent) within 4 weeks before starting study medication
• People who have had a heart attack or unstable chest pain (angina) within the 12 months before screening, or moderate to severe heart failure within the 6 months before screening
• People with a history of serious heart rhythm problems, or risk factors for them, such as structural heart disease, a family history of unexplained sudden death, or a condition called long QT syndrome
• People who have had a mini-stroke (transient ischemic attack) or stroke within 6 months before screening
• People with unstable heart or blood vessel conditions, such as a blood clot in the lungs or legs within the 6 months before screening, that the research team believes could affect safety or study results
• People with a known active tuberculosis infection or active nontuberculous mycobacterial infection (people with a positive TB blood test result may still be eligible if the investigating doctor determines the infection is inactive — confirm with trial site)
• People who test positive for HIV, or who have active hepatitis B or hepatitis C infections based on specific blood test results, or who test positive for syphilis
• People with an active autoimmune disease (such as rheumatoid arthritis, lupus, multiple sclerosis, or inflammatory bowel disease), or who are currently receiving immunosuppressive therapy for an autoimmune condition
• People with any active cancer, or a history of cancer, unless a low-grade cancer (such as certain skin cancers or early-stage cervical changes) was considered fully treated at least 5 years before screening
• People who have received a live attenuated vaccine (a type of vaccine made from a weakened live virus or bacteria) within 4 weeks before screening or during the screening period
• People who have received certain biologic medications (such as omalizumab, dupilumab, or anti-IL-5 therapies) within 3 months before screening
• People who have taken part in another clinical trial or received an experimental treatment within 3 months before screening, or within 5 half-lives of that treatment, whichever is longer
• People with a significant abnormality on a heart tracing (ECG) test, such as a prolonged QTc interval (above 450 ms for men, or above 470 ms for women), that the investigator considers relevant to the study
• People with significantly elevated liver enzyme levels (ALT or AST at 2 or more times the normal upper limit) or elevated bilirubin (1.5 or more times the normal upper limit) on blood tests
• People with reduced kidney function, specifically an eGFR below 60 mL/min/1.73m² on blood tests
• People with any serious medical condition or significant abnormal test result that the investigator believes could affect safety or the ability to complete the study
• People with a history of alcohol or substance misuse within the 12 months before screening
• People with a known history of severe allergic reactions to any biologic medicine, or known allergy to any ingredient in the study drug
• Women who are pregnant or breastfeeding, or women of childbearing age who have a positive pregnancy test at screening
• People considered unsuitable for the trial for any reason, as determined by the investigator

Important: Always verify eligibility with the trial site directly before applying.