Clinical trial NCT04056299: Oral Immunotherapy for Desensitization in Children, Adolescents, and Young Adults With Hen Egg Allergy
Official title: Phase 2 Study of AR201 Oral Immunotherapy for Desensitization in Children, Adolescents, and Young Adults With Hen Egg Allergy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
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
Lead sponsor: Aimmune Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-08-14
Enrollment: 15
Sex: ALL
Minimum age (years): 4
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2:1 randomization
Primary purpose: TREATMENT

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.

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 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 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

Primary outcomes:
measure: 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)
timeFrame: 9-12 months
Secondary outcomes:
measure: Number of Participants by Maximum Dose Achieved With no or Mild Symptoms at Exit DBPCFC
timeFrame: 9-12 months
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: Rolling Hills Estates
country: United States
facility: Peninsula Research Associates
state: California
city: San Diego
country: United States
facility: Allergy & Asthma Medical Group and Research Center, A.P.C
state: California
city: San Jose
country: United States
facility: Allergy & Asthma Associates of Santa Clara Valley Research Center
state: California
city: Walnut Creek
country: United States
facility: Allergy and Asthma Clinical Research dba Bay Area Allergy
state: California
city: Marietta
country: United States
facility: Atlanta Allergy & Asthma Clinic, PA
state: Georgia
city: Eagle
country: United States
facility: Idaho Allergy LLC, dba Idaho Allergy and Research
state: Idaho
city: White Marsh
country: United States
facility: Chesapeake Clinical Research, Inc.
state: Maryland
city: Minneapolis
country: United States
facility: Clinical Research Institute Inc
state: Minnesota
city: Ocean City
country: United States
facility: Atlantic Research Center, LLC
state: New Jersey
city: Seattle
country: United States
facility: Seattle Allergy & Asthma Research Institute dba ASTHMA, Inc. Clinical Research Center
state: Washington
Study officials:
affiliation: Aimmune Therapeutics, Inc.
name: Director of Regulatory Affairs
role: STUDY_CHAIR
References: