Phase 3 Asthma 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 understand the study and are willing to sign a consent form agreeing to take part
• People aged 18 to 80 years old (male or female) who weigh at least 40 kg
• People who have been diagnosed with asthma for at least one year
• People whose lung function test result (measured before using a bronchodilator inhaler) is at or below 80% of what would normally be expected for someone of their age and size
• People who have had a positive breathing test showing their airways respond to a bronchodilator, either at the screening visit or within the past 24 months
• People who have been taking a medium-to-high dose inhaled corticosteroid (a type of preventer inhaler) combined with at least one other asthma control medicine for at least 3 months, and whose treatment dose has stayed the same for at least 1 month before joining
• People whose asthma control score on a standard questionnaire (ACQ-6) is 1.5 or higher, indicating asthma is not well controlled
• People who have had at least one severe asthma attack in the past 12 months, but have not had a severe attack in the 30 days immediately before joining
• People who took their usual asthma controller medicines at least 80% of the time during the screening period
• People who are willing to use highly effective contraception from the time of signing the consent form until 3 months after the last dose of the study treatment

Who may not be able to join:

• People who have a lung condition other than asthma, such as COPD, that affects their lung function (as decided by the trial doctor)
• People who have a condition other than asthma that raises their eosinophil (a type of white blood cell) count, such as a parasitic worm infection, that is not being treated or is not responding to treatment
• People who have been treated with biologic medicines or medicines that suppress the immune system for an autoimmune or inflammatory condition within the past 8 weeks or 5 half-lives of the medicine (whichever is longer)
• People with a known or suspected history of a weakened immune system, including a history of serious or unusual infections, even if those infections have since cleared up
• People with a history of any cancer
• People with a serious or poorly controlled health condition that the trial doctor believes could affect the study results, such as severe neurological disease, a history of serious mental illness, or poorly controlled diabetes
• People who have an active infection or a recent acute infection that required systemic anti-infection treatment, from 4 weeks before joining up until the point of being assigned to a treatment group
• People with a history of serious heart or cardiovascular disease, or who have a clinically significant abnormal result on a 12-lead ECG (heart tracing) during screening
• People who had major surgery requiring general anaesthesia or a hospital stay of more than one day within the 8 weeks before signing the consent form
• People who have received a biologic medicine used for the same type of treatment purpose within 4 months or 5 half-lives (whichever is longer) before signing the consent form
• People who have taken part in another clinical trial of a drug or medical device within the past 3 months, or who are still within a follow-up period or within 5 half-lives of a trial drug from a previous study (whichever is longer)
• People who received immunoglobulin or blood products within 30 days before signing the consent form
• People who have been treated with systemic corticosteroids (steroid medicines taken by mouth or injection) for a reason other than asthma, from 8 weeks before signing the consent form up until being assigned to a treatment group
• People who received a live or weakened (attenuated) vaccine within 3 months before signing the consent form
• People who started allergy desensitisation therapy within 3 months before signing the consent form
• People who had a bronchial thermoplasty procedure (a procedure done inside the airways) within the past 12 months
• People who currently smoke, people who quit smoking less than 6 months ago, or people who quit more than 6 months ago but have a smoking history of more than 10 pack-years
• People whose blood tests at screening show active or past hepatitis B infection (with detectable virus), hepatitis C infection (with detectable virus), HIV, or syphilis
• People whose liver enzyme levels (AST or ALT) are more than twice the upper limit of normal, or whose creatinine level (a measure of kidney function) is more than 1.5 times the upper limit of normal, at screening
• People who are allergic to or cannot tolerate any ingredients in the study medicine (CM326 injection) or the placebo, or who have a history of severe drug allergy or anaphylactic shock
• People who have consumed heavy amounts of alcohol within 3 months before screening
• People with a history of drug abuse within the 5 years before signing the consent form
• People who are pregnant, breastfeeding, or who have a positive pregnancy test at screening
• People whom the trial doctor believes have any other condition that may prevent them from completing the study (confirm with trial site)

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