Oral Immunotherapy for Desensitization in Children, Adolescents, and Young Adults With Hen Egg Allergy

Phase 2

Terminated

• Conditions: Hen Egg Allergy
• Interventions: Biological: AR201 powder; Biological: Placebo powder

• Registration Number: NCT04056299
• Lead Sponsor: Aimmune Therapeutics, Inc.

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 conducted at 8 sites in the United States.

Study Timeline

• Study First Submitted: 2019-08-12
• Study First Submitted QC: 2019-08-12
• Study First Posted: 2019-08-14
• Study Start: 2019-08-20
• Primary Completion: 2020-12-16
• Study Completion: 2020-12-28
• Status Verified: 2022-02
• Results First Submitted: 2022-02-03
• Results First Submitted QC: 2022-02-03
• Results First Posted: 2022-02-28
• Last Update Submitted: 2022-02-28
• Last Update Posted: 2022-03-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AR201 powder	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
Placebo powder	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.

Primary Outcome Measures

Name	Time	Method
Proportion of Subjects Tolerating a Single Highest Dose of at Least 1000 mg Dried Egg White Protein With no More Than Mild Symptoms at the Exit Double-blind Placebo Controlled Food Challenge (DBPCFC)	9-12 months

Secondary Outcome Measures

Name	Time	Method
Number of Participants by Maximum Dose Achieved With no or Mild Symptoms at Exit DBPCFC	9-12 months

Trial Locations

Locations (11)

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

Arkansas Children's Hospital; 🇺🇸 Little Rock, Arkansas, United States