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 @ 7:36 PM
Ignite Modification Date:
2025-12-24 @ 7:36 PM
NCT ID:
NCT03201003
Eligibility Criteria:
Key Inclusion Criteria:
* Age 4 to 17 years, inclusive
* Clinical history of allergy to peanuts
* Serum SPT ≥ 3 mm greater than control and/or psIgE ≥ 0.35 kUa/L
* Dose limiting symptoms after consuming a single dose of peanut protein ≤ 300 mg
* Written informed consent from the subject's parent/guardian
* Written assent from the subject as appropriate (per local regulatory requirements)
* Use of effective birth control by sexually active female subjects of childbearing potential
Key Exclusion Criteria:
* History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension
* History of severe asthma (NHLBI criteria steps 5 or 6), or mild to moderate asthma (2007 NHLBI criteria steps 1-4) that is uncontrolled or difficult to control
* History of severe or life threatening episode of anaphylaxis or anaphylactic shock within 60 days of screening
* History of eosinophilic esophagitis (EoE), other eosinophilic gastrointestinal disease, chronic, recurrent, or severe gastroesophageal reflux disease (GERD), symptoms of dysphagia or recurrent gastrointestinal symptoms of undiagnosed etiology
* History of a mast cell disorder, including mastocytosis, urticaria pigmentosa, chronic idiopathic or chronic physical urticaria beyond simple dermatographism (e.g., cold urticaria, cholinergic urticaria), and hereditary or idiopathic angioedema
* Any other condition that, in the opinion of the Investigator, precludes participation for reasons of safety
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
17 Years
Study:
NCT03201003
Study Brief:
Protocol Section:
NCT03201003