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

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ClinicalTrials.gov Identifier: NCT04056299
Recruitment Status : Recruiting
First Posted : August 14, 2019
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Aimmune Therapeutics, Inc.

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.

Condition or disease Intervention/treatment Phase
Hen Egg Allergy Biological: AR201 Powder Biological: Placebo powder Phase 2

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 will be conducted at approximately 15 sites in the United States.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2:1 randomization
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Double-Blinded
Primary Purpose: Treatment
Official Title: Phase 2 Study of AR201 Oral Immunotherapy for Desensitization in Children, Adolescents, and Young Adults With Hen Egg Allergy
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Active Comparator: AR201 powder (Hen Egg Allergen formulation)
Subjects will be randomized to active arm of AIME01 and will be administered IP (AR201) in escalating doses for approximately 6 months, followed by a maintenance dose for approximately 12 weeks
Biological: AR201 Powder
AR201 powder provided in capsules (Hen Egg allergen formulation)

Placebo Comparator: Placebo powder
Subjects will be randomized to placebo arm of AIME01 and will be administered escalating doses of IP (placebo) for approximately 6 months, followed by a maintenance dose for approximately 12 weeks
Biological: Placebo powder
Placebo powder provided in capsules




Primary Outcome Measures :
  1. Efficacy of AR201 in a CODIT regimen in hen egg-allergic subjects aged 4 to 26 years, inclusive, assessed by single highest tolerated dose of at least 1000 mg dried egg white protein in a DBPCFC [ Time Frame: 9-12 months ]

Secondary Outcome Measures :
  1. Safety and tolerability of AR201 [ Time Frame: 9-12 months ]
    2. Efficacy of AR201 assessed by single highest tolerated dose of dried egg white protein in a DBPCFC



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 26 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04056299


Contacts
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Contact: Ellen Ashley +1-650-396-3295 medicalinformation@aimmune.com

Locations
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United States, California
Peninsula Research Associates Recruiting
Rolling Hills Estates, California, United States, 90274
Allergy and Asthma Clinical Research Recruiting
Walnut Creek, California, United States, 94598
United States, Idaho
Idaho Allergy, LLC dba Idaho Research Recruiting
Eagle, Idaho, United States, 83616
Sponsors and Collaborators
Aimmune Therapeutics, Inc.
Investigators
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Study Director: Ellen Ashley Aimmune Therapeutics

Additional Information:
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Responsible Party: Aimmune Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04056299     History of Changes
Other Study ID Numbers: AIME01
First Posted: August 14, 2019    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aimmune Therapeutics, Inc.:
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
Additional relevant MeSH terms:
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Hypersensitivity
Egg Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate
Immunologic Factors
Physiological Effects of Drugs