Loading clinical trials...

Oral Immunotherapy for Desensitization in Children, Adolescents, and Young Adults With Hen Egg Allergy | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

NCT04056299•Aimmune Therapeutics, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

4 - 26 years

Sex

ALL

Healthy Volunteers

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

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

Locations (11)

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

Key Dates

Start Date

August 20, 2019

Primary Completion Date

December 16, 2020

Completion Date

December 28, 2020

Last Updated

March 10, 2022

Enrollment

ACTUAL participants

Conditions

Hen Egg Allergy

Interventions

AR201 powder

BIOLOGICAL

Placebo powder

BIOLOGICAL

Efficacy and Safety of Egg Ladders in Children With IgE-Mediated Hen's Egg Protein Allergy

NCT07040111

Food AllergyEgg Allergy+1 more

View study

COMPLETEDNA

Tolerance to Baked Goods in Allergic Children

NCT06998225

Cow Milk Protein AllergyHen Egg Allergy

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 10, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions