Hen Egg AllergyPhase 2NCT04056299
Oral Immunotherapy for Desensitization in Children, Adolescents, and Young Adults With Hen Egg Allergy
A Phase 2 study testing AR201 powder in people with Hen Egg Allergy, run by Aimmune Therapeutics, Inc. at 11 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 4 to 26 years
- Conditions the study is for
- Hen Egg Allergy
- What is being tested?
- AR201 powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 11 sitesUnited States
- Study dates
- 20 Aug 2019to 28 Dec 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Idaho Allergy LLC, dba Idaho Allergy and Research
Eagle, Idaho, 83616
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Atlanta Allergy & Asthma Clinic, PA
Marietta, Georgia, 30060-8950
Clinical Research Institute Inc
Minneapolis, Minnesota, 55402
Atlantic Research Center, LLC
Ocean City, New Jersey, 07712
Peninsula Research Associates
Rolling Hills Estates, California, 90274
Allergy & Asthma Medical Group and Research Center, A.P.C
San Diego, California, 92123
Allergy & Asthma Associates of Santa Clara Valley Research Center
San Jose, California, 95117
Seattle Allergy & Asthma Research Institute dba ASTHMA, Inc. Clinical Research Center
Seattle, Washington, 98115
Allergy and Asthma Clinical Research dba Bay Area Allergy
Walnut Creek, California, 94598
Chesapeake Clinical Research, Inc.
White Marsh, Maryland, 21162
About this study
Official title: Phase 2 Study of AR201 Oral Immunotherapy for Desensitization in Children, Adolescents, and Young Adults With Hen Egg Allergy
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
- Hen Egg Allergy
- Being tested
- AR201 powder, Placebo powder
- 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
- Medical subject headings
- Hypersensitivity, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AR201 powderBiological
AR201 powder (Hen Egg allergen formulation) provided in capsules
Placebo powderBiological
Placebo powder provided in capsules
| Study group | Role | What they receive |
|---|---|---|
| AR201 powder | Active comparator | 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 Receives: Biological: AR201 powder |
| Placebo powder | Placebo comparator | Subjects were randomized to placebo arm of AIME01 and administered placebo for approximately 6 months, followed by maintenance placebo for approximately 12 weeks. Receives: Biological: Placebo powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 9-12 months
Secondary outcomes (1)
Number of Participants by Maximum Dose Achieved With no or Mild Symptoms at Exit DBPCFC
Measured: 9-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start20 Aug 2019
- Primary completion16 Dec 2020
- Study completion28 Dec 2020
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hen Egg AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2:1 randomization
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aimmune Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Director of Regulatory Affairs, Study chair, Aimmune Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04056299
- Sponsor's protocol ID
- AIME01
- Status last verified
- Feb 2022
- First submitted
- 12 Aug 2019
- Last updated
- 10 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of AR201 Oral Immunotherapy for Desensitization in Children, Adolescents, and Young Adults With Hen Egg Allergy
- ClinicalTrials.gov ID
- NCT04056299
- Acronym / sponsor ID
- AIME01
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Aimmune Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Aug 2019 (actual)
- Primary completion
- 16 Dec 2020 (actual)
- Study completion
- 28 Dec 2020 (actual)
- First posted
- 14 Aug 2019 (actual)
- Results
- Posted 28 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 2:1 randomization
| Arm | Type | Receives |
|---|---|---|
| AR201 powder | Active comparator | Biological: AR201 powderSubjects 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 |
| Placebo powder | Placebo comparator | Biological: Placebo powderSubjects were randomized to placebo arm of AIME01 and administered placebo for approximately 6 months, followed by maintenance placebo for approximately 12 weeks. |
Who may qualify
- Ages
- 4 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AR201 powderAR201 powder (Hen Egg allergen formulation) provided in capsules | Biological | AR201 powder |
| Placebo powderPlacebo powder provided in capsules | Biological | Placebo powder |
Primary outcome
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
1 secondary outcome
Number of Participants by Maximum Dose Achieved With no or Mild Symptoms at Exit DBPCFC
Time frame: 9-12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Hen Egg Allergy
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Food Allergy, Egg Allergy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Director of Regulatory Affairs study chair
Aimmune Therapeutics, Inc.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AR201 powder in people with Hen Egg Allergy, run by Aimmune Therapeutics, Inc. at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: 9-12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2022; AzTrials last refreshed its copy on 8 Nov 2026.