Trials / Completed
CompletedNCT03201003
ARTEMIS Peanut Allergy In Children
AR101 Trial in Europe Measuring Oral Immunotherapy Success in Peanut Allergic Children (ARTEMIS)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 175 (actual)
- Sponsor
- Aimmune Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 4 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to demonstrate the efficacy and safety of AR101 through oral immunotherapy (OIT) in peanut-allergic children.
Detailed description
This is a European, multicenter, double-blind, randomized, placebo-controlled 2-arm study of the efficacy and safety of AR101 in peanut-allergic children.
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 |
| OTHER | Placebo powder provided in capsules & sachets | Study product formulated to contain only inactive ingredients for use as defined in the protocol |
Timeline
- Start date
- 2017-06-12
- Primary completion
- 2019-02-15
- Completion
- 2019-02-15
- First posted
- 2017-06-28
- Last updated
- 2021-08-03
- Results posted
- 2021-08-03
Locations
18 sites across 7 countries: France, Germany, Ireland, Italy, Spain, Sweden, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03201003. Inclusion in this directory is not an endorsement.