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

Phase 2 Study of AR201 Oral Immunotherapy for Desensitization in Children, Adolescents, and Young Adults With Hen Egg Allergy

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.

Study Overview

• Status: Terminated
• Conditions: Hen Egg Allergy
• Intervention / Treatment: Biological: AR201 powder; Biological: Placebo powder

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Arkansas Children's Hospital
  • California
    • Rolling Hills Estates, California, United States, 90274
      • Peninsula Research Associates
    • San Diego, California, United States, 92123
      • Allergy & Asthma Medical Group and Research Center, A.P.C
    • San Jose, California, United States, 95117
      • Allergy & Asthma Associates of Santa Clara Valley Research Center
    • Walnut Creek, California, United States, 94598
      • Allergy and Asthma Clinical Research dba Bay Area Allergy
  • Georgia
    • Marietta, Georgia, United States, 30060-8950
      • Atlanta Allergy & Asthma Clinic, PA
  • Idaho
    • Eagle, Idaho, United States, 83616
      • Idaho Allergy LLC, dba Idaho Allergy and Research
  • Maryland
    • White Marsh, Maryland, United States, 21162
      • Chesapeake Clinical Research, Inc.
  • Minnesota
    • Minneapolis, Minnesota, United States, 55402
      • Clinical Research Institute Inc
  • New Jersey
    • Ocean City, New Jersey, United States, 07712
      • Atlantic Research Center, LLC
  • Washington
    • Seattle, Washington, United States, 98115
      • Seattle Allergy & Asthma Research Institute dba ASTHMA, Inc. Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 26 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key 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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Biological: AR201 powder; AR201 powder (Hen Egg allergen formulation) provided in capsules
Placebo Comparator: 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.	Biological: Placebo powder; Placebo powder provided in capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: Aimmune Therapeutics, Inc.
• Investigators: Study Chair: Director of Regulatory Affairs, Aimmune Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2019
• Primary Completion (Actual): December 16, 2020
• Study Completion (Actual): December 28, 2020

Study Registration Dates

• First Submitted: August 12, 2019
• First Submitted That Met QC Criteria: August 12, 2019
• First Posted (Actual): August 14, 2019

Study Record Updates

• Last Update Posted (Actual): March 10, 2022
• Last Update Submitted That Met QC Criteria: February 28, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Allergy; Desensitization; Food Allergy; Oral Immunotherapy; CODIT™ (characterized oral desensitization immunotherapy™); Hen Egg Allergic Children; AR201; Hen Egg Allergy; Characterized Hen Egg Allergen; CHEA (Characterized Hen Egg Allergen)
• Additional Relevant MeSH Terms: Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Egg Hypersensitivity
• Other Study ID Numbers: AIME01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No