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 @ 11:31 PM
Ignite Modification Date:
2025-12-24 @ 11:31 PM
NCT ID:
NCT06103656
Eligibility Criteria:
Inclusion Criteria:
* 6 through 40 years
* At least one of the following for each of the 3 study allergens: serum immunoglobulin E (IgE) \>4000 U/L or skin -prick test \>6mm
* dose limiting symptoms at a cumulative dose of \<=444 mg protein for 3 allergens as screening double-blind, placebo-controlled food challenge
* use of an effective method of contraception by females of child-bearing potential
* ability to ingest oat or corn with no allergic reaction
Exclusion Criteria:
* If baked milk or egg are tolerated (assessed by clinical report), then milk or egg may not be included as a study allergen
* Any disorder in which epinephrine is contraindicated such as coronary artery disease, uncontrolled hypertension, and serious ventricular arrhythmias
* History of other chronic disease requiring therapy (other than asthma, atopic dermatitis, or rhinitis)
* History of eosinophilic gastrointestinal disease
* Current participation in any other interventional study
* Investigational drug use within 90 days
* Subject is on build-up phase of any allergen immunotherapy (prior to maintenance dosing)
* Current uncontrolled moderate to severe asthma as defined by:
* Forced Expiratory Volume-1 (FEV1) value \<80% predicted or any clinical features of moderate or severe persistent asthma baseline severity (as defined by the 2007 NHLBI Guidelines) and greater than high daily doses of inhaled corticosteroids (as defined for children and adults using dosing tables from the 2007 NHLBI Guidelines).
* Use of steroid medications in the following manners: history of daily oral steroid dosing for \>1 month during the past year, having 1 burst or steroid course within the past 6 months, or having \>1 burst oral steroid course within the past 12 months.
* Asthma requiring \>1 hospitalization in the past year for asthma or \>1 Emergency Department (ED) visit in the past 6 months for asthma.
* Use of systemic steroid medications (Intravenous, Intramuscular or oral) for indications other than asthma for \> 3 weeks within the past 6 months
* Inability to discontinue antihistamines for the initial day of escalation, skin testing or DBPCFC
* Use of Xolair® (omalizumab) within the past 6 months
* Known sensitivity to Xolair® (omalizumab) or to the class of study drugs
* Body weight more than 90 kg, or subjects with weight-IgE combination that yields a dose requirement greater than 600 mg dosing
* Use of beta-blockers (oral), Angiotensinogen converting enzyme (ACE) inhibitors, angiotensin-receptor blockers or calcium channel blockers
* Pregnancy or lactation
* Inability to swallow placebo capsules
* Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the subject's ability to comply with study requirements
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
40 Years
Study:
NCT06103656
Study Brief:
Protocol Section:
NCT06103656