Phase 3 Asthma 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 are able to understand the study and are willing to sign a consent form agreeing to take part
• People aged between 12 and 75 years old (male or female) who weigh at least 40 kg
• People who have been diagnosed with asthma for at least 1 year, where the diagnosis meets recognised international asthma guidelines (GINA 2022)
• People whose lung function test (measuring how much air they can breathe out forcefully) shows a result of 80% or less of the expected normal value, measured at both the screening and baseline appointments
• People who have had a positive "reversibility" breathing test — meaning their lung function improved by at least 12% (and at least 200 mL) after using a reliever inhaler — either at screening or within the past 24 months
• People who have been taking a medium-to-high dose inhaled corticosteroid (a preventer inhaler) combined with at least one other controller medication for at least 3 months before joining, and whose treatment has been stable for at least 1 month before joining
• People whose asthma control score (ACQ-5) is 1.5 or higher at both the screening and baseline visits, indicating poorly controlled asthma
• People who have had at least one serious asthma attack in the 12 months before joining (but not within the 1 month immediately before joining), with at least one of those attacks occurring while on medium-to-high dose preventer inhaler treatment
• People (and their partners) who have no plans to have children and who agree to use highly effective contraception from the time of signing consent until 3 months after the last dose of the study drug

Who may not be able to join:

• People who have received a biological medicine used to treat asthma or a similar condition within the 6 months before joining
• People who have been treated with biological medicines or strong immune-suppressing medicines for an autoimmune or inflammatory disease within approximately 8 weeks (or 5 half-lives of that medicine, whichever is longer) before joining
• People who have received immunoglobulin or blood products within the 30 days before joining
• People who have taken oral or injected corticosteroids (steroid tablets or injections — not nasal sprays, eye drops, or inhaled steroids) in the 4 weeks before joining up until the time of being assigned to a treatment group
• People who have received a live or weakened (attenuated) vaccine within 3 months before joining, or who plan to receive one during the study
• People who started allergen desensitisation (allergy immunotherapy) within 3 months before joining
• People who have had a procedure called bronchial thermoplasty (a treatment applied to the airways) within the 12 months before joining
• People who currently smoke, who stopped smoking less than 6 months ago, or who stopped smoking more than 6 months ago but have a smoking history of more than 10 pack-years
• People who have been diagnosed with chronic obstructive pulmonary disease (COPD) or another lung condition that may affect lung function, as assessed by the trial doctor
• People who have had an active or acute infection requiring antibiotic or antiviral treatment in the 4 weeks before joining up until the time of being assigned to a treatment group
• People with a known or suspected history of a weakened immune system, including a history of serious or unusual infections, or who experience infections that are unusually frequent, long-lasting, or recurring
• People with a history of cancer, unless: they had basal cell skin cancer, a localised skin squamous cell cancer, or cervical carcinoma in situ and completed curative treatment at least 12 months before joining; or they had another type of cancer and completed curative treatment at least 5 years before joining
• People with serious or uncontrolled medical conditions that the trial doctor believes could affect the study results — including severe neurological disease, a history of serious mental illness, major heart disease, poorly controlled diabetes, certain heart rhythm abnormalities, or other significant health conditions
• People who have had major surgery within 8 weeks before joining, or who plan to have surgery requiring general anaesthesia or a hospital stay of more than 1 day during the study
• Women who are pregnant, breastfeeding, or who have a positive pregnancy test at screening
• People who test positive for HIV or syphilis at screening
• People with chronic hepatitis B or hepatitis C infection
• People with abnormal liver or kidney function results above specified laboratory thresholds (confirm with trial site)
• People who have a high eosinophil count (a type of white blood cell) caused by a condition other than asthma — for example, a parasitic worm infection — that has not been adequately treated or has not responded to treatment
• People who are allergic or sensitive to any ingredient in the study drug (CM310 injection) or placebo, or who have a history of severe allergic reactions or anaphylactic shock to medicines
• People who have taken part in another clinical trial of a medicine or medical device within 3 months before joining, or who are still within a follow-up period or 5 half-lives of a trial drug from a previous study (whichever is longer)
• 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 joining
• People whom the trial doctor considers unsuitable for any other reason — for example, if completing the study safely may not be possible

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