Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2025-12-24 @ 2:28 PM
NCT ID:
NCT05062759
Eligibility Criteria:
Inclusion Criteria:
* Documented physician-diagnosed asthma for at least 12 months prior to Visit 1.
* Morning pre-bronchodilator FEV1 (Forced expiratory volume) of \> 50% predicted normal value at Visit 1 or Visit 2.
* Body weight ≥ 40 kg.
* For women of childbearing potential, a negative urine pregnancy test is required prior to administration of study intervention at Visit 3.
* Must have 'not well-controlled' asthma.
Exclusion Criteria:
* Clinically important pulmonary disease other than asthma.
* Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment.
* Life-threatening asthma
* History of cancer.
* Allergy to eggs, if egg based influenza vaccine will be administered.
* History of anaphylaxis to any biologic therapy.
* Current smokers or participants with smoking history ≥ 10 pack-years and participants using vaping products, including electronic cigarettes. Former smokers with a smoking history of \< 10 pack-years and users of vaping or e-cigarette products must have stopped for at least 6 months prior to Visit 1 to be eligible.
* History of alcohol or drug abuse within 12 months prior to the date of informed consent.
* Major surgery within 8 weeks prior to Visit 1 or planned surgical procedures during the conduct of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
21 Years
Study:
NCT05062759
Study Brief:
Protocol Section:
NCT05062759