Oral Immunotherapy for Desensitization in Children, Adolescents, and Young Adults With Hen Egg Allergy
Oral Immunotherapy for Desensitization in Children, Adolescents, and Young Adults With Hen Egg Allergy
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 will be conducted at approximately 30 sites in the United States.
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
Actual Study Start Date: August 20, 2019
Estimated Primary Completion Date: March 1, 2021
Estimated Study Completion Date: March 1, 2021
Arm:
- Active Comparator: AR201 powder (Hen Egg Allergen formulation)
- Placebo Comparator: Placebo powder
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 84 |
| Actual Study start date | 20 August 2019 |
| Estimated Study Completion Date | 01 March 2021 |