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 @ 4:59 AM
Ignite Modification Date:
2025-12-25 @ 4:59 AM
NCT ID:
NCT04872218
Eligibility Criteria:
Inclusion Criteria:
* Male or female subjects 14 to 50 years old at screening visit
* History of IgE mediated allergy to peanut protein
* ImmunoCAP IgE level \> 50 kU/L for peanut;
* Total IgE level \< 5000 kU/L
* Willing to comply to all study requirements during participation in the study;
Exclusion Criteria:
* Previous adverse reactions to abatacept;
* Known hypersensitivity to abatacept or any of its components;
* Patients at risk of sepsis, such as immunocompromised or HIV positive;
* Patient undergoing a treatment with any other biologic agent;
* Uncontrolled asthma;
* Unstable angina, significant arrhythmia, uncontrolled hypertension, chronic sinusitis, or other chronic or immunological diseases that, in the judgment of the investigator, might interfere with the evaluation, administration of the test drug or pose additional risk to the subject (e.g., gastrointestinal or gastroesophageal disease, chronic infections, scleroderma, hepatic and gallbladder disease, chronic non-allergic pulmonary disease);
* Current users of oral, intramuscular, or intravenous corticosteroids, tricyclic antidepressants or beta-blocker
* Concurrent/prior use of immunomodulatory therapy (within 6 months);
* A diagnosis of eosinophilic esophagitis, eosinophilic colitis, or eosinophilic gastritis;
* Pregnant or breastfeeding women;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
50 Years
Study:
NCT04872218
Study Brief:
Protocol Section:
NCT04872218