Oral Immunotherapy for Desensitization in Children, Adolescents, and Young Adults With Hen Egg Allergy
NCT ID: NCT04056299
Last Updated: 2022-03-10
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
15 participants
INTERVENTIONAL
2019-08-20
2020-12-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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AR201 powder
Subjects were randomized to active arm of AIME01 and administered AR201 in escalating doses for approximately 6 months, followed by a maintenance dose for approximately 12 weeks
AR201 powder
AR201 powder (Hen Egg allergen formulation) provided in capsules
Placebo powder
Subjects were randomized to placebo arm of AIME01 and administered placebo for approximately 6 months, followed by maintenance placebo for approximately 12 weeks.
Placebo powder
Placebo powder provided in capsules
Interventions
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AR201 powder
AR201 powder (Hen Egg allergen formulation) provided in capsules
Placebo powder
Placebo powder provided in capsules
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
4 Years
26 Years
ALL
No
Sponsors
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Aimmune Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Director of Regulatory Affairs
Role: STUDY_CHAIR
Aimmune Therapeutics, Inc.
Locations
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Arkansas Children's Hospital
Little Rock, Arkansas, United States
Peninsula Research Associates
Rolling Hills Estates, California, United States
Allergy & Asthma Medical Group and Research Center, A.P.C
San Diego, California, United States
Allergy & Asthma Associates of Santa Clara Valley Research Center
San Jose, California, United States
Allergy and Asthma Clinical Research dba Bay Area Allergy
Walnut Creek, California, United States
Atlanta Allergy & Asthma Clinic, PA
Marietta, Georgia, United States
Idaho Allergy LLC, dba Idaho Allergy and Research
Eagle, Idaho, United States
Chesapeake Clinical Research, Inc.
White Marsh, Maryland, United States
Clinical Research Institute Inc
Minneapolis, Minnesota, United States
Atlantic Research Center, LLC
Ocean City, New Jersey, United States
Seattle Allergy & Asthma Research Institute dba ASTHMA, Inc. Clinical Research Center
Seattle, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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AIME01
Identifier Type: -
Identifier Source: org_study_id
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