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:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-25 @ 2:21 AM
NCT ID:
NCT03469934
Eligibility Criteria:
Inclusion Criteria:
* Participants with a confirmed clinical diagnosis of eosinophilic asthma
* History of diagnosis of eosinophilic asthma
* Severe asthma diagnosed according to the Global Initiative for Asthma (GINA) 2016
* Body mass index (BMI) of 18 to 38 kilograms per squared meters (kg/m\^2) (inclusive) and total body weight \> 50 kg (110 pounds)
* Women of childbearing potential must have a negative serum pregnancy test at screening and be willing to use highly effective methods of contraception throughout the study
* Male participants must be willing to use effective methods of contraception during the entire study period.
* Participant must be on high dose inhaled corticosteroids (ICS) plus long-acting beta-2-agonists (LABA)
* Willing and able to comply with the study protocol requirements
* Have the ability to read and understand the study procedures and can communicate meaningfully with the Investigator and staff
Exclusion Criteria:
* Have concomitant medical condition(s) which may interfere with the Investigator's ability to evaluate the participant's response to the investigational product (IP)
* Have experienced severe life threatening anaphylactic reactions
* Have received any IP within a period of 3 months or 5 half lives of an IP
* Have received high dose systemic corticosteroids
* Have received treatment with biologics, such as mepolizumab or omalizumab, within 3 months or 5 half lives (whichever is longer) before screening
* Abnormal electrocardiogram (ECG) assessment at screening
* Uncontrolled hypertension, or acute ischemic cardiovascular diseases
* If female, is pregnant or lactating, or intend to become pregnant during the study period
* History (or suspected history) of alcohol or substance abuse within 2 years before screening
* Any comorbidity that the Investigator believes is a contraindication to study participation
* Have any other physical, mental, or medical conditions which, in the opinion of the Investigator, make study participation inadvisable or could confound study assessments
* Planned surgery during the study or 30 days before screening
* History of malignancy within 5 years, except non melanoma skin cancer which has been fully treated with no current active disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03469934
Study Brief:
Protocol Section:
NCT03469934