Hen Egg Allergy Clinical Trial
Official title:
Phase 2 Study of AR201 Oral Immunotherapy for Desensitization in Children, Adolescents, and Young Adults With Hen Egg Allergy
| Verified date | February 2022 |
| Source | Aimmune Therapeutics, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 15 |
| Est. completion date | December 28, 2020 |
| Est. primary completion date | December 16, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 4 Years to 26 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Idaho Allergy LLC, dba Idaho Allergy and Research | Eagle | Idaho |
| United States | Arkansas Children's Hospital | Little Rock | Arkansas |
| United States | Atlanta Allergy & Asthma Clinic, PA | Marietta | Georgia |
| United States | Clinical Research Institute Inc | Minneapolis | Minnesota |
| United States | Atlantic Research Center, LLC | Ocean City | New Jersey |
| 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 | Seattle Allergy & Asthma Research Institute dba ASTHMA, Inc. Clinical Research Center | Seattle | Washington |
| United States | Allergy and Asthma Clinical Research dba Bay Area Allergy | Walnut Creek | California |
| United States | Chesapeake Clinical Research, Inc. | White Marsh | Maryland |
| Lead Sponsor | Collaborator |
|---|---|
| Aimmune Therapeutics, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Number of Participants by Maximum Dose Achieved With no or Mild Symptoms at Exit DBPCFC | 9-12 months |