Status:
TERMINATED
Oral Immunotherapy for Desensitization in Children, Adolescents, and Young Adults With Hen Egg Allergy
Lead Sponsor:
Aimmune Therapeutics, Inc.
Conditions:
Hen Egg Allergy
Eligibility:
All Genders
4-26 years
Phase:
PHASE2
Brief Summary
To determine the efficacy and safety of AR201 in a characterized oral desensitization immunotherapy (CODIT™) regimen in hen egg-allergic subjects aged 4 to 26 years, inclusive.
Detailed Description
This is a phase 2, randomized, double-blind, placebo-controlled study of the efficacy and safety of AR201 in a CODIT regimen in hen egg-allergic subjects aged 4 to 26 years, inclusive. The study was c...
Eligibility Criteria
Inclusion
- Key
- Age 4 to 26 years, inclusive
- Written informed consent from subjects, as appropriate per local requirements, and parent/guardian
- Written assent from subjects who are minors, as appropriate per local requirements
- History of physician-diagnosed hen egg allergy
- Elevated egg specific IgE and/or mean wheal diameter on SPT to egg
- Experience dose-limiting symptoms at or before the 300 mg challenge dose of dried egg white protein on Screening DBPCFC
- Use of effective birth control by sexually active female subjects of childbearing potential
- Key
Exclusion
- History of severe or life-threatening anaphylaxis within 60 days before screening
- History of non-IgE mediated hen egg allergy such as food protein-induced enterocolitis syndrome (FPIES)
- 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 unknown etiology
- History of a mast cell disorder including systemic mastocytosis, urticaria pigmentosa, chronic idiopathic or chronic physical urticaria beyond simple dermatographism (e.g., cold urticaria, cholinergic urticaria), and hereditary or idiopathic angioedema
- History of chronic disease (except asthma, atopic dermatitis, or allergic rhinitis) which may require a change in immunosuppressive medication regimen or chronic corticosteroid use
- History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension
- Developing dose-limiting symptoms to placebo challenge during the Screening DBPCFC
- Having the same place of residence as another subject in the study
- Any other condition that, in the opinion of the Investigator, precludes participation for reasons of safety
Key Trial Info
Start Date :
August 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 28 2020
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04056299
Start Date
August 20 2019
End Date
December 28 2020
Last Update
March 10 2022
Active Locations (11)
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1
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
2
Peninsula Research Associates
Rolling Hills Estates, California, United States, 90274
3
Allergy & Asthma Medical Group and Research Center, A.P.C
San Diego, California, United States, 92123
4
Allergy & Asthma Associates of Santa Clara Valley Research Center
San Jose, California, United States, 95117