Phase 2 COPD Trial, Recruiting

Written by an AI model from the 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 understand the study and are willing to sign a consent form agreeing to take part.
• People aged 40 to 85 years old (male or female) at the time of signing the consent form.
• People who weigh at least 40 kg.
• People who have been diagnosed with COPD for at least 12 months.
• People whose breathing test results (taken after using a bronchodilator inhaler) show a specific pattern of reduced airflow, within a range the trial defines (confirm with trial site).
• People who have been on a stable COPD medication plan for at least 3 months before the screening visit, with no dose changes for at least 1 month before screening.
• People who have had at least 2 moderate flare-ups, or at least 1 severe flare-up, of their COPD in the year before screening.
• People whose COPD Assessment Test (CAT) score is 10 or higher, indicating a noticeable impact of COPD on daily life.
• People whose blood test at screening shows a certain level of a type of white blood cell called eosinophils (at or above a set threshold).
• People who currently smoke, have a history of at least 10 pack-years of smoking, or have been exposed to smoke from burning materials such as wood or biomass fuels for 10 or more years.
• People who are willing to use highly effective contraception from the time of signing consent until 3 months after their last dose of the study treatment.

Who may not be able to join:

• People who currently have, or have previously been diagnosed with, asthma (either alone or alongside COPD).
• People who have a significant lung disease other than COPD, such as scarring of the lungs, pulmonary hypertension, bronchiectasis, active tuberculosis, or other conditions that can raise eosinophil levels in the blood.
• People who have a serious uncontrolled health condition that could affect the study results, such as severe neurological disease, a history of serious mental illness, major heart disease, poorly controlled diabetes, certain irregular heart rhythms, or specific abnormalities on a heart tracing test.
• People with a history of cancer.
• People with a known or suspected history of a weakened immune system, or who have unusually frequent, long-lasting, or recurring infections.
• People who have been treated with biologic medicines or medicines that suppress the immune system for an autoimmune or inflammatory condition within approximately 8 weeks (or 5 half-lives, whichever is longer) before signing consent.
• People with severe heart failure (a specific advanced stage), uncontrolled high blood pressure in the lungs, or signs of right-side heart failure.
• People who have had a heart attack, unstable chest pain, or stroke within 6 months before signing the consent form.
• People who have had a parasitic infection in the 24 weeks before signing consent that has not been treated or has not responded to standard treatment.
• People who have had a moderate or severe COPD flare-up in the 4 weeks before signing consent up until the point of being assigned to a treatment group.
• People who have had an active infection requiring antibiotic or antiviral treatment (taken by mouth or injection) in the 4 weeks before signing consent up until the point of being assigned to a treatment group.
• People who have had major surgery within 8 weeks before signing consent, or who have planned surgery requiring general anaesthesia or an overnight hospital stay during the study period.
• People who have had a lung removal surgery or lung volume reduction surgery for COPD within 12 months before screening, or who have such surgery planned.
• People who need oxygen therapy for more than 15 hours per day as a medical necessity, or who need a specific type of breathing machine (BiPAP) for a build-up of carbon dioxide in the blood.
• People who have recently started (within 4 weeks before screening) an active pulmonary rehabilitation programme. (Note: people already in the maintenance phase of rehabilitation may still be eligible — confirm with trial site.)
• People who have been taking steroid tablets or injections (not including skin creams, eye drops, or nasal sprays) in the 4 weeks before signing consent up until being assigned to a treatment group, except for short courses of 7 days or less used for non-immune-related allergic conditions.
• People taking a certain type of antibiotic called a macrolide (for example, azithromycin) unless they have been on a stable dose for more than 3 months before screening and plan to continue throughout the study.
• People taking a medication called roflumilast (a PDE-4 inhibitor) unless they have been on a stable dose for at least 3 months and plan to continue at that dose throughout the study.
• People who have received certain biological treatments — including omalizumab (within 130 days before consent) or other specific biologic medicines targeting immune pathways relevant to this trial (within 3 months or 5 half-lives before consent, whichever is longer).
• People who have taken part in another clinical trial of a drug or medical device within 3 months before signing consent, or who are still within the follow-up period or active drug period of another study.
• People who have received intravenous immunoglobulin or blood products within 30 days before signing consent.
• People who have received certain traditional Chinese medicines, ethnic medicines, or natural medicines approved for COPD treatment within 4 weeks before being assigned to a treatment group.
• People who have received a live or weakened (attenuated) vaccine within 3 months before signing consent, or who plan to receive one during the study period.
• People whose screening blood test comes back positive for HIV or for a specific bacterial infection (Treponema pallidum) that requires treatment.
• People with certain active or inadequately managed hepatitis B or hepatitis C virus infections, based on specific blood test results at screening (confirm with trial site for exact criteria).
• People whose liver enzyme levels (AST or ALT) or kidney function marker (creatinine) are significantly above the normal range on blood tests at screening.
• People who are pregnant, breastfeeding, or have a positive pregnancy test at screening.
• People who have a known allergy or intolerance to any component of the study drug (CM326 injection) or the placebo, or who have a history of a severe allergic reaction or anaphylactic shock to any medicine.
• People with a history of drug or substance misuse within 5 years before signing the consent form.
• People who have taken less than 70% of their usual prescribed COPD medications during the screening phase of the trial.
• People who, in the opinion of the trial doctor, have any other condition that may prevent them from completing the study.

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