Trials / Completed
CompletedNCT03126227
Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children (RAMSES)
Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children Ages 4 to 17 Years (RAMSES)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 506 (actual)
- Sponsor
- Aimmune Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 4 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
This is a multicenter, randomized, double-blind, placebo-controlled safety study of AR101 using the characterized oral desensitization immunotherapy (CODIT™) regimen in peanut-allergic children.
Detailed description
The primary objective is to assess the safety and tolerability of AR101 when used in a CODIT™ regimen for approximately 6 months in peanut-allergic children children aged 4 to 17 years, inclusive.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | AR101 | AR101 powder provided in capsules |
| BIOLOGICAL | Placebo | Placebo powder provided in capsules |
Timeline
- Start date
- 2017-05-08
- Primary completion
- 2018-08-31
- Completion
- 2018-09-23
- First posted
- 2017-04-24
- Last updated
- 2021-11-02
- Results posted
- 2021-11-02
Locations
67 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03126227. Inclusion in this directory is not an endorsement.