FARE Clinical Trial Finder

Simplify your search for a clinical trial and help researchers discover new therapies. The FARE Clinical Trial Finder links patients with food allergy and healthy, non-patient volunteers to actively recruiting food allergy studies.

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 - 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 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 15 sites in the United States.

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.

Seattle, Washington

Status

Recruiting

Address

Seattle Allergy & Asthma Research Institute

Seattle, Washington, 98115

Atlantic Research Center, LLC, Ocean City, New Jersey

Status

Recruiting

Address

Atlantic Research Center, LLC

Ocean City, New Jersey, 07712

Clinical Research Institute Inc, Plymouth, Minnesota

Status

Recruiting

Address

Clinical Research Institute Inc

Plymouth, Minnesota, 55441

Idaho Allergy LLC, dba Idaho Research, Eagle, Idaho

Status

Recruiting

Address

Idaho Allergy LLC, dba Idaho Research

Eagle, Idaho, 83616

Atlanta Allergy & Asthma Clinic, PA, Marietta, Georgia

Status

Recruiting

Address

Atlanta Allergy & Asthma Clinic, PA

Marietta, Georgia, 30060-8950

Allergy and Asthma Clinical Research, Walnut Creek, California

Status

Recruiting

Address

Allergy and Asthma Clinical Research

Walnut Creek, California, 94598

San Jose, California

Status

Recruiting

Address

Allergy & Asthma Associates of Santa Clara Valley Research Center

San Jose, California, 95117

San Diego, California

Status

Recruiting

Address

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

San Diego, California, 92123

Peninsula Research Associates, Rolling Hills Estates, California

Status

Recruiting

Address

Peninsula Research Associates

Rolling Hills Estates, California, 90274

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.