Peanut Oral Immunotherapy Study of Early Intervention for Desensitization (POSEIDON)
Peanut Oral Immunotherapy Study of Early Intervention for Desensitization (POSEIDON)
Brief Summary:
The purpose of this study is to determine the efficacy and safety of AR101 in peanut-allergic children aged 1 to < 4 years.
Detailed Description:
To determine the efficacy and safety of AR101 in a characterized oral desensitization immunotherapy (CODIT™) regimen compared with placebo in peanut-allergic children aged 1 to < 4 years.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 132 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: Peanut Oral Immunotherapy Study of Early Intervention for Desensitization (POSEIDON)
Actual Study Start Date: December 27, 2018
Estimated Primary Completion Date: November 2020
Estimated Study Completion Date: November 2021
Arm:
- Active Comparator: AR101 powder (Peanut allergen formulation)
- Placebo Comparator: Placebo powder
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 132 |
| Actual Study start date | 27 December 2018 |
| Estimated Study Completion Date | 01 November 2021 |