Trials / Completed
CompletedNCT03736447
Peanut Oral Immunotherapy Study of Early Intervention for Desensitization
Peanut Oral Immunotherapy Study of Early Intervention for Desensitization (POSEIDON)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 146 (actual)
- Sponsor
- Aimmune Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 1 Year – 3 Years
- Healthy volunteers
- Not accepted
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
This is a Phase 3, randomized, double-blind, placebo-controlled study conducted at 14 study sites in North America and 9 in Europe to evaluate 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | AR101 powder provided in capsules & sachets | Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol |
| BIOLOGICAL | Placebo powder provided in capsules & sachets | Study product formulated to contain only inactive ingredients for use as defined in the protocol |
Timeline
- Start date
- 2018-12-27
- Primary completion
- 2022-07-05
- Completion
- 2022-07-05
- First posted
- 2018-11-09
- Last updated
- 2023-03-02
- Results posted
- 2023-03-02
Locations
23 sites across 4 countries: United States, France, Germany, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03736447. Inclusion in this directory is not an endorsement.