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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 4 Years - 26 Years
Gender All
More Inclusion & Exclusion Criteria

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 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04056299
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Aimmune Therapeutics, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Ellen Ashley
Principal Investigator Affiliation Aimmune Therapeutics
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Active, not recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Hen Egg Allergy
Study Website: View Trial Website
Additional Details

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 will be conducted at approximately 30 sites in the United States.

Arms & Interventions

Arms

Active Comparator: AR201 powder (Hen Egg Allergen formulation)

Subjects will be randomized to active arm of AIME01 and will be administered IP (AR201) in escalating doses for approximately 6 months, followed by a maintenance dose for approximately 12 weeks

Placebo Comparator: Placebo powder

Subjects will be randomized to placebo arm of AIME01 and will be administered escalating doses of IP (placebo) for approximately 6 months, followed by a maintenance dose for approximately 12 weeks

Interventions

Biological: - AR201 Powder

AR201 powder provided in capsules (Hen Egg allergen formulation)

Biological: - Placebo powder

Placebo powder provided in capsules

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Clinical Research Center of Alabama, LLC, Birmingham, Alabama

Status

Address

Clinical Research Center of Alabama, LLC

Birmingham, Alabama, 35209

Scottsdale, Arizona

Status

Address

Medical Research of Arizona, a division of Allergy, Asthma and Immunology Associates, Ltd.

Scottsdale, Arizona, 85251

Arkansas Children's Hospital, Little Rock, Arkansas

Status

Address

Arkansas Children's Hospital

Little Rock, Arkansas, 72202

Peninsula Research Associates, Rolling Hills Estates, California

Status

Address

Peninsula Research Associates

Rolling Hills Estates, California, 90274

San Diego, California

Status

Address

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

San Diego, California, 92123

San Jose, California

Status

Address

Allergy & Asthma Associates of Santa Clara Valley Research Center

San Jose, California, 95117

Allergy and Asthma Clinical Research, Walnut Creek, California

Status

Address

Allergy and Asthma Clinical Research

Walnut Creek, California, 94598

Asthma and Allergy Associates, PC, Colorado Springs, Colorado

Status

Address

Asthma and Allergy Associates, PC

Colorado Springs, Colorado, 80907

Allergy Associates of the Palm Beaches, North Palm Beach, Florida

Status

Address

Allergy Associates of the Palm Beaches

North Palm Beach, Florida, 33408

Atlanta, Georgia

Status

Address

Children's Healthcare of Atlanta - Center for Advanced Pediatrics

Atlanta, Georgia, 30329

Atlanta Allergy & Asthma Clinic, PA, Marietta, Georgia

Status

Address

Atlanta Allergy & Asthma Clinic, PA

Marietta, Georgia, 30060-8950

Idaho Allergy LLC, dba Idaho Research, Eagle, Idaho

Status

Address

Idaho Allergy LLC, dba Idaho Research

Eagle, Idaho, 83616

Sneeze, Wheeze, & Itch Associates, LLC, Normal, Illinois

Status

Address

Sneeze, Wheeze, & Itch Associates, LLC

Normal, Illinois, 61761

Chesapeake Clinical Research, Inc., White Marsh, Maryland

Status

Address

Chesapeake Clinical Research, Inc.

White Marsh, Maryland, 21162

Ann Arbor, Michigan

Status

Address

University of Michigan Allergy Specialty Clinic and Food Allergy Clinic

Ann Arbor, Michigan, 48106

Clinical Research Institute Inc, Minneapolis, Minnesota

Status

Address

Clinical Research Institute Inc

Minneapolis, Minnesota, 55402

Atlantic Research Center, LLC, Ocean City, New Jersey

Status

Address

Atlantic Research Center, LLC

Ocean City, New Jersey, 07712

Clackamas, Oregon

Status

Address

Portland Clinical Research dba Columbia Asthma and Allergy

Clackamas, Oregon, 97015

North Charleston, South Carolina

Status

Address

National Allergy and Asthma Research, LLC.

North Charleston, South Carolina, 29420

Seattle, Washington

Status

Address

Seattle Allergy & Asthma Research Institute

Seattle, Washington, 98115

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