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

Primary Purpose

Hen Egg Allergy

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

AR201 powder

Placebo powder

About this trial

This is an interventional treatment trial for Hen Egg Allergy focused on measuring 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

Eligibility Criteria

4 Years - 26 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arkansas Children's Hospital
Peninsula Research Associates
Allergy & Asthma Medical Group and Research Center, A.P.C
Allergy & Asthma Associates of Santa Clara Valley Research Center
Allergy and Asthma Clinical Research dba Bay Area Allergy
Atlanta Allergy & Asthma Clinic, PA
Idaho Allergy LLC, dba Idaho Allergy and Research
Chesapeake Clinical Research, Inc.
Clinical Research Institute Inc
Atlantic Research Center, LLC
Seattle Allergy & Asthma Research Institute dba ASTHMA, Inc. Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

AR201 powder

Placebo powder

Arm Description

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

Subjects were randomized to placebo arm of AIME01 and administered placebo for approximately 6 months, followed by maintenance placebo for approximately 12 weeks.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

NCT ID

NCT04056299

First Posted

August 12, 2019

Last Updated

February 28, 2022

Sponsor

Aimmune Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04056299

Brief Title

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

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Terminated

Why Stopped

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.

Study Start Date

August 20, 2019 (Actual)

Primary Completion Date

December 16, 2020 (Actual)

Study Completion Date

December 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Aimmune Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

2:1 randomization

Masking

ParticipantCare ProviderInvestigator

Masking Description

Double-Blinded

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AR201 powder

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo powder

Arm Type

Placebo Comparator

Arm Description

Subjects were randomized to placebo arm of AIME01 and administered placebo for approximately 6 months, followed by maintenance placebo for approximately 12 weeks.

Intervention Type

Biological

Intervention Name(s)

AR201 powder

Intervention Description

AR201 powder (Hen Egg allergen formulation) provided in capsules

Intervention Type

Biological

Intervention Name(s)

Placebo powder

Intervention Description

Placebo powder provided in capsules

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

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

Time Frame

9-12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

26 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Director of Regulatory Affairs

Organizational Affiliation

Aimmune Therapeutics, Inc.

Official's Role

Study Chair

Facility Information:

Facility Name

Arkansas Children's Hospital

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72202

Country

United States

Facility Name

Peninsula Research Associates

City

Rolling Hills Estates

State/Province

California

ZIP/Postal Code

90274

Country

United States

Facility Name

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

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Allergy & Asthma Associates of Santa Clara Valley Research Center

City

San Jose

State/Province

California

ZIP/Postal Code

95117

Country

United States

Facility Name

Allergy and Asthma Clinical Research dba Bay Area Allergy

City

Walnut Creek

State/Province

California

ZIP/Postal Code

94598

Country

United States

Facility Name

Atlanta Allergy & Asthma Clinic, PA

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060-8950

Country

United States

Facility Name

Idaho Allergy LLC, dba Idaho Allergy and Research

City

Eagle

State/Province

Idaho

ZIP/Postal Code

83616

Country

United States

Facility Name

Chesapeake Clinical Research, Inc.

City

White Marsh

State/Province

Maryland

ZIP/Postal Code

21162

Country

United States

Facility Name

Clinical Research Institute Inc

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55402

Country

United States

Facility Name

Atlantic Research Center, LLC

City

Ocean City

State/Province

New Jersey

ZIP/Postal Code

07712

Country

United States

Facility Name

Seattle Allergy & Asthma Research Institute dba ASTHMA, Inc. Clinical Research Center

City

Seattle

State/Province

Washington

ZIP/Postal Code

98115

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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