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 aged 12 or older at the time of signing the consent form (in some countries, only adults aged 18 or older may be eligible, depending on local rules).
• People who have had a formal asthma diagnosis from a doctor for at least 2 years, confirmed according to recognised medical guidelines.
• People who have had at least 2 asthma attacks (exacerbations) in the past 3 years, with at least 1 occurring in the past year — where each attack required steroid treatment for at least 3 days, despite already using a combination inhaler (low to medium dose).
• People who have been using a low to medium dose combination inhaler (ICS/LABA) for at least 12 months, with no changes to that treatment in the 3 months before screening.
• Women who are not pregnant or breastfeeding, and who either cannot become pregnant or are using a highly effective form of contraception (with a failure rate below 1%) starting at least 14 days before the first dose and continuing for at least 35 weeks after the last dose (confirm specific contraceptive requirements with the trial site).
• Women of childbearing potential who have a negative pregnancy test at specific visits as required by the trial.
• People who show signs of a specific type of asthma (called "Type 2 high") based on blood test results showing elevated eosinophil levels (a type of immune cell), with specific thresholds that the trial site will assess — or elevated eosinophils at a lower level combined with either a high exhaled nitric oxide reading or a confirmed diagnosis of nasal polyps.
• People who are able to give informed consent and are willing to follow the trial requirements.

Who may not be able to join:

• People who have had 3 or more asthma attacks in the past year before the first visit.
• People who are currently taking daily oral steroids or high-dose combination inhalers for asthma.
• People who have had asthma for more than 20 years.
• People who have another significant lung condition in addition to asthma, such as bronchiectasis, pulmonary fibrosis, a current lung infection, lung cancer history, emphysema, or chronic bronchitis.
• People who have other conditions that can cause elevated eosinophil levels in the blood, such as Eosinophilic Granulomatosis with Polyangiitis or eosinophilic esophagitis.
• People who had an asthma attack within 4 weeks before screening.
• People who have had a parasitic infection within the 6 months before screening, unless it has been fully treated and resolved.
• People with a known immune system deficiency, such as HIV (unless the immune issue is solely related to steroid use for asthma).
• People who currently have cancer, or whose cancer has been in remission for less than 12 months before screening.
• People with significant uncontrolled conditions affecting the heart, kidneys, liver, nervous system, digestive system, blood, hormones, or other body systems.
• People who currently have a diagnosis of vasculitis (inflammation of blood vessels).
• People who have previously received any approved or investigational biologic treatment (a type of medication made from living cells, including monoclonal antibodies).
• People with a history of alcohol misuse or substance abuse within the 2 years before starting the trial.
• People who currently smoke, people who vape, or former smokers with a heavy smoking history (20 pack-years or more — calculated by the trial site).
• People with a known allergy or intolerance to biologic medicines or to any ingredient in the study drug (depemokimab).
• People who are pregnant or breastfeeding.
• People who have a known history of not following prescribed asthma treatment or medical advice.
• People whose blood tests, urine tests, or other screening results show clinically significant abnormalities, as assessed by the trial doctor.
• People with certain liver test results above specified thresholds (including elevated ALT or bilirubin levels), or those with cirrhosis or unstable liver or bile duct disease — specific thresholds will be assessed by the trial site (confirm with trial site if Gilbert's syndrome applies).
• People whose heart trace (ECG) shows certain abnormalities in electrical timing, assessed using a specific measurement called QTcF — thresholds will be evaluated by the trial site.
• People whose asthma medication dose or routine changed during the lead-in period before randomisation.

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