Phase 2 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:

• Adults aged 18 to 75 years, of any gender, who weigh at least 40 kg (approximately 88 lbs)
• People who have been diagnosed with bronchial asthma for at least 1 year, and who have also been diagnosed with allergic asthma
• People who have had at least one asthma flare-up in the year before the screening visit, where the flare-up required steroid tablets or injections for at least 3 days, or a significant increase in inhaled steroids for at least 3 days
• People who had a positive breathing test (bronchial dilation test) either at screening or within the 2 years before screening
• People who have had at least one positive allergy test — either a skin prick test or a blood test for specific allergy antibodies (IgE) — within the 12 months before joining the trial
• People who have been using a medium to high dose of inhaled corticosteroids (a type of inhaled preventer medication) for at least 8 weeks before screening, and have kept the same dose for at least 4 weeks before joining, while their asthma remains only partly controlled or uncontrolled (confirmed by a standard asthma control score of 19 or below)
• People who are also using at least one other asthma controller medication (such as a long-acting reliever inhaler, or certain other prescribed asthma medicines) and have been on a stable dose for at least 4 weeks before joining
• People whose lung function test (FEV1) shows a result between 40% and 80% of what would normally be expected for someone of their age and size
• People who are not planning to become pregnant and who agree to use effective contraception during the trial and for 6 months after the last dose of the study treatment
• People who are willing and able to sign a consent form, complete assessment questionnaires, use a peak flow meter at home, keep a daily diary, and attend all scheduled visits

Who may not be able to join:

• People who have a known allergy to the study drug, its ingredients, or the comparator medicine Xolair® (omalizumab)
• People who have other lung or breathing conditions besides asthma — such as COPD, a fungal lung condition (ABPA), or bronchiectasis — that the trial doctor considers may affect safety or results
• People who have serious or poorly controlled conditions affecting the liver, kidneys, digestive system, heart, brain or blood vessels, blood, urinary system, hormones, nervous system, or immune system
• People who have had a significant infection in the 4 weeks before joining, which the trial doctor considers could affect the results
• People who have had major surgery in the 4 weeks before joining, or who have planned surgery during the trial period
• People who have had a parasitic infection in the 6 months before joining
• People who have been diagnosed with cancer in the 5 years before screening
• People whose blood or other laboratory test results during screening are significantly abnormal in a way the trial doctor considers unsuitable for participation
• People who test positive for HIV, syphilis, hepatitis B, or hepatitis C at screening (with some specific exceptions — confirm with the trial site)
• People who currently smoke, who have quit smoking within the last 6 months, or who have a smoking history of 10 or more pack-years (for example, 1 pack per day for 10 years, or equivalent)
• People who have used a biological medicine (such as a monoclonal antibody, including any experimental biological treatment) within 3 months before screening, or within 5 half-lives of that medicine, whichever is longer
• People who have taken immune-suppressing medicines or high-dose steroid tablets for conditions like rheumatoid arthritis, inflammatory bowel disease, or lupus within 8 weeks before screening, or within 5 half-lives of that medicine, whichever is longer
• People who have undergone allergen immunotherapy (desensitisation treatment) within 3 months before screening
• People who have received a live vaccine or intravenous immunoglobulin within 4 weeks before screening
• People who have taken part in another drug clinical trial within 3 months before screening, or within 5 half-lives of the trial drug, whichever is longer
• People who have had a history of drug misuse, substance misuse, or excessive alcohol use in the year before screening
• People who are pregnant or breastfeeding
• People whom the trial doctor considers unsuitable for any other reason

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