MedTrace Logo

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

NCT04056299 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2022-03-10

Study results available
· View outcomes & findings →

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.

Conditions

  • Hen Egg Allergy

Interventions

BIOLOGICAL

AR201 powder

AR201 powder (Hen Egg allergen formulation) provided in capsules

BIOLOGICAL

Placebo powder

Placebo powder provided in capsules

Sponsors & Collaborators

  • Aimmune Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Director of Regulatory Affairs · Aimmune Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
26 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-20
Primary Completion
2020-12-16
Completion
2020-12-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04056299 on ClinicalTrials.gov