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NCT04056299 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Aimmune Therapeutics.

Terminated
Registry status
Phase 2
Development phase
15
Enrollment target

NCT04056299: Clinical Trial Phase 2 study, sponsored by Aimmune Therapeutics.

NCT04056299 is a Phase 2 study that was terminated before completion, run by Aimmune Therapeutics. The registered enrollment target is 15 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04056299, a Phase 2 study, was terminated before completion, sponsored by Aimmune Therapeutics.

TERMINATED
Registry status
Phase 2
Development phase
15 participants
Enrollment target

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.

Interventions

  • BIOLOGICAL AR201 powder
  • BIOLOGICAL Placebo powder

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2019-08-20
Est. Completion 2020-12-28
Phase Phase 2
Aimmune Therapeutics

10 total trials

Why NCT04056299 stopped before completion

NCT04056299 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).

The record links to 0 conditions, and to 2 interventions - of which AR201 powder is the first listed.

NCT04056299 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04056299 about?

NCT04056299 is a clinical study titled "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.

What is the current status of trial NCT04056299?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2019-08-20. Estimated completion is 2020-12-28.

What interventions are being tested in trial NCT04056299?

The interventions under investigation include: AR201 powder (BIOLOGICAL), Placebo powder (BIOLOGICAL).

Who is sponsoring clinical trial NCT04056299?

This trial is sponsored by Aimmune Therapeutics, which has 10 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04056299's enrollment target sits among peer trials

15 1919th of 2000 higher than 60 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04056299, the US trial registry maintained by the National Library of Medicine. NCT04056299 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.