Real-World Peanut Allergy Study with subject completed questionnaires.

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 200

Inclusion Criteria

1. Aged 4 to 17 years, inclusive, at screening
2. Written informed consent from subjects, as appropriate per local requirements, and legal
guardian/parent (or both parents where required by local authorities) of subjects who are
minors.
3. Written assent from subjects who are minors, as appropriate per local requirements
4. Written informed consent from the parent/caregiver who will complete relevant questionnaires during the study
5. History of physician-diagnosed immunoglobulin (Ig) E-mediated peanut allergy that includes the onset of characteristic signs and symptoms of allergy within 2 hours of known oral exposure to peanut or peanut-containing food. In general, characteristic signs and symptoms of IgE-mediated allergic reactions are objective and affect the target organs of skin, gastrointestinal (GI) tract, upper/lower respiratory tract, cardiovascular system, or a combination of target organs
6. Mean wheal diameter on SPT to peanut = 8 mm greater than the negative saline control at screening
7. Serum IgE to peanut of = 14 kUA/L at screening
8. For sexually active females of childbearing potential, use of a highly effective method of birth control, defined as one that results in a low failure rate (ie, < 1% per year) when used consistently and correctly
Are the trial subjects under 18? yes
Number of subjects for this age range: 200
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1. Uncertain clinical diagnosis of peanut allergy
2. History of severe or life-threatening anaphylaxis or anaphylactic shock within 60 days before screening
3. History of eosinophilic esophagitis (EoE); other eosinophilic GI disease; chronic, recurrent, or severe gastroesophageal reflux disease (GERD); symptoms of dysphagia (eg, difficulty swallowing, food getting stuck”); or recurrent GI symptoms of any etiology
4. History of a mast cell disorder including systemic mastocytosis, urticaria pigmentosa, chronic idiopathic or chronic physical urticaria beyond simple dermatographism (eg, cold urticaria, cholinergic urticaria), and hereditary or idiopathic angioedema
5. Severe persistent asthma
6. Mild or moderate asthma (criteria steps 1-4; NHLBI, 2007) that is uncontrolled or difficult to control
7. History of high-dose corticosteroid medication use (eg, > 3 days at 1-2 mg/kg of prednisone or equivalent)
8. History of chronic disease (except asthma, atopic dermatitis, or allergic rhinitis) that is or is at significant risk of becoming unstable or requiring a change in a chronic therapeutic regimen, including malignancies within 5 years before screening and autoimmune diseases
9. History of cardiovascular disease including uncontrolled or inadequately controlled hypertension
10. Use of beta-blockers (oral), angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, calcium channel blockers, or tricyclic antidepressants
11. Unable to discontinue antihistamines 5 half-lives of the medication before the SPT, first day of dose escalation, and food challenges
12. Lack of an available palatable vehicle food to which the subject is not allergic
13. Allergy to oat
14. Use of any therapeutic antibody or any immunomodulatory therapy (including immunosuppressive medications) except aeroallergen or venom immunotherapy used in the maintenance phase within 6 months before screening

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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