TerminatedNCT04056299Updated Mar 10, 2022Results posted

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

A Phase 2 interventional study of AR201 powder and Placebo powder in Hen Egg Allergy, sponsored by Aimmune Therapeutics, Inc.. Terminated at 11 sites in United States. Open to participants aged 4 Years to 26 Years. Per ClinicalTrials.gov, last updated 2022-03-10.

Sponsored by Aimmune Therapeutics, Inc. · Phase 2, Interventional, and Treatment

Why this study was terminated

The study was prematurely terminated by the Sponsor based on difficulties in meeting enrollment goals, especially during the COVID-19 pandemic, and not for reasons relating to any concerns regarding quality, safety, or efficacy.

Phase: Phase 2
Study type: Interventional
Enrollment: 15
Allocation: Randomized
Ages: 4 Years to 26 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Hen Egg Allergy

Browse trials for

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

Who can participate

Ages eligible: 4 Years to 26 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 15 participants (actual)

Study arms

Active comparator
AR201 powder
Subjects were randomized to active arm of AIME01 and administered AR201 in escalating doses for approximately 6 months, followed by a maintenance dose for approximately 12 weeks
Biological: AR201 powder
Placebo comparator
Placebo powder
Subjects were randomized to placebo arm of AIME01 and administered placebo for approximately 6 months, followed by maintenance placebo for approximately 12 weeks.
Biological: Placebo powder

Interventions

BiologicalAR201 powder
AR201 powder (Hen Egg allergen formulation) provided in capsules
BiologicalPlacebo powder
Placebo powder provided in capsules

What researchers measure

Primary outcomes

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)
Time frame: 9-12 months

Secondary outcomes

Number of Participants by Maximum Dose Achieved With no or Mild Symptoms at Exit DBPCFC
Time frame: 9-12 months

Results

Posted Feb 28, 2022

Participant flow

Participant flow — Overall Study
Milestone	AR201 Powder	Placebo Powder
Started	9	6
Completed	6	3
Not completed	3	3
Withdrew: Sponsor discontinued study	3	3

Outcome measures

PrimaryProportion 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)

Time frame:: 9-12 months
Reported as:: Count of participants · Participants

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)
Participants	AR201 Powder	Placebo Powder
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)	1	0

SecondaryNumber of Participants by Maximum Dose Achieved With no or Mild Symptoms at Exit DBPCFC

Time frame:: 9-12 months
Reported as:: Count of participants · Participants

Number of Participants by Maximum Dose Achieved With no or Mild Symptoms at Exit DBPCFC
Participants	AR201 Powder	Placebo Powder
None	0	0
1 mg	0	0
3 mg	0	0
10 mg	0	0
30 mg	0	0
100 mg	0	0
300 mg	2	0
600 mg	0	0
1000 mg	0	0
2000 mg	1	0
Did not have an exit DBPCFC	6	6

Adverse events

Collected over Approximately 9 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
AR201 Powder	0/9 (0%)	1/9 (11.1%)	9/9 (100%)
Placebo Powder	0/6 (0%)	0/6 (0%)	5/6 (83.3%)

Most frequent serious events

Most frequent serious events
Event	AR201 Powder	Placebo Powder
Subdural haematomaInjury, poisoning and procedural complications	1/9	0/6
HeadacheNervous system disorders	1/9	0/6

Most frequent other events

Showing 10 of 61

Most frequent other events
Event	AR201 Powder	Placebo Powder
Abdominal painGastrointestinal disorders	5/9	2/6
Abdominal pain upperGastrointestinal disorders	1/9	3/6
PruritusSkin and subcutaneous tissue disorders	3/9	3/6
UrticariaSkin and subcutaneous tissue disorders	4/9	2/6
NauseaGastrointestinal disorders	3/9	1/6
Oral pruritusGastrointestinal disorders	1/9	2/6
Tongue pruritusGastrointestinal disorders	1/9	2/6
HeadacheNervous system disorders	3/9	1/6
AsthmaRespiratory, thoracic and mediastinal disorders	1/9	2/6
VomitingGastrointestinal disorders	2/9	1/6

Baseline characteristics

Age, Continuous
Age, Continuous(years)	AR201 Powder	Placebo Powder	Total
Median	13.0 (6 to 23)	5.5 (4 to 12)	7.0 (4 to 23)

Sex: Female, Male
Sex: Female, Male(Participants)	AR201 Powder	Placebo Powder	Total
Female	5	3	8
Male	4	3	7

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	AR201 Powder	Placebo Powder	Total
Hispanic or Latino	1	0	1
Not Hispanic or Latino	8	6	14
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	AR201 Powder	Placebo Powder	Total
American Indian or Alaska Native	0	0	0
Asian	2	0	2
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	0	0	0
White	7	4	11
More than one race	0	0	0
Unknown or Not Reported	0	2	2

Region of Enrollment
Region of Enrollment(participants)	AR201 Powder	Placebo Powder	Total
United States	9	6	15

Study locations

11 sites

Arkansas Children's Hospital
Little Rock, Arkansas 72202, United States
Peninsula Research Associates
Rolling Hills Estates, California 90274, United States
Allergy & Asthma Medical Group and Research Center, A.P.C
San Diego, California 92123, United States
Allergy & Asthma Associates of Santa Clara Valley Research Center
San Jose, California 95117, United States
Allergy and Asthma Clinical Research dba Bay Area Allergy
Walnut Creek, California 94598, United States
Atlanta Allergy & Asthma Clinic, PA
Marietta, Georgia 30060-8950, United States
Idaho Allergy LLC, dba Idaho Allergy and Research
Eagle, Idaho 83616, United States
Chesapeake Clinical Research, Inc.
White Marsh, Maryland 21162, United States
Clinical Research Institute Inc
Minneapolis, Minnesota 55402, United States
Atlantic Research Center, LLC
Ocean City, New Jersey 07712, United States
Seattle Allergy & Asthma Research Institute dba ASTHMA, Inc. Clinical Research Center
Seattle, Washington 98115, United States

References and documents

Study documents

Study protocol · May 28, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT04056299
Lead sponsor: Aimmune Therapeutics, Inc.
Responsible party: Sponsor
First posted: Aug 14, 2019
Start date: Aug 20, 2019
Primary completion: Dec 16, 2020
Completion: Dec 28, 2020
Results posted: Feb 28, 2022
Last update: Mar 10, 2022

Study contacts

Director of Regulatory Affairs

study chair · Aimmune Therapeutics, Inc.

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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