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

NCT04056299 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: AIME01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 11

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.

Conditions

Hen Egg Allergy

Keywords

CODIT™ (characterized oral desensitization immunotherapy™); Hen Egg Allergic Children; Desensitization; AR201; Allergy; Hen Egg Allergy; Characterized Hen Egg Allergen; Oral Immunotherapy; CHEA (Characterized Hen Egg Allergen); Food Allergy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Participants by Maximum Dose Achieved With no or Mild Symptoms at Exit DBPCFC

  9-12 months

Study Arms (2)

AR201 powder

ACTIVE COMPARATOR

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

Placebo powder

PLACEBO COMPARATOR

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

Interventions

AR201 powder BIOLOGICAL

AR201 powder (Hen Egg allergen formulation) provided in capsules

AR201 powder

Placebo powder BIOLOGICAL

Placebo powder provided in capsules

Placebo powder

Eligibility Criteria

• Age: 4 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aimmune Therapeutics, Inc.: lead

Study Sites (11)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

Peninsula Research Associates

Rolling Hills Estates, California, 90274, United States

Location

Allergy & Asthma Medical Group and Research Center, A.P.C

San Diego, California, 92123, United States

Location

Allergy & Asthma Associates of Santa Clara Valley Research Center

San Jose, California, 95117, United States

Location

Allergy and Asthma Clinical Research dba Bay Area Allergy

Walnut Creek, California, 94598, United States

Location

Atlanta Allergy & Asthma Clinic, PA

Marietta, Georgia, 30060-8950, United States

Location

Idaho Allergy LLC, dba Idaho Allergy and Research

Eagle, Idaho, 83616, United States

Location

Chesapeake Clinical Research, Inc.

White Marsh, Maryland, 21162, United States

Location

Clinical Research Institute Inc

Minneapolis, Minnesota, 55402, United States

Location

Atlantic Research Center, LLC

Ocean City, New Jersey, 07712, United States

Location

Seattle Allergy & Asthma Research Institute dba ASTHMA, Inc. Clinical Research Center

Seattle, Washington, 98115, United States

Location

MeSH Terms

Conditions

Hypersensitivity; Food Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases; Hypersensitivity, Immediate

Results Point of Contact

• Title: Director of Regulatory Affairs
• Organization: Aimmune Therapeutics, Inc.

RegulatoryAffairs@aimmune.com

650-409-5164

Study Officials

• Director of Regulatory Affairs

  Aimmune Therapeutics, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-Blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 2:1 randomization

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: August 14, 2019
• Study Start: August 20, 2019
• Primary Completion: December 16, 2020
• Study Completion: December 28, 2020
• Last Updated: March 10, 2022
• Results First Posted: February 28, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)