At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 175 enrolled
Drug / intervention
AR101 powder provided in capsules & sachets +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
AR101 Trial in Europe Measuring Oral Immunotherapy Success in Peanut Allergic Children (ARTEMIS)
In Brief
A Phase 3 clinical trial evaluating AR101 powder provided in capsules & sachets and Placebo powder provided in capsules & sachets for Peanut Allergy. Completed, enrolled 175 participants across 18 sites in 7 countries.
Detailed Summary
The purpose of this study is to demonstrate the efficacy and safety of AR101 through oral immunotherapy (OIT) in peanut-allergic children.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeanut Allergy
CountriesFrance, Germany, Ireland, Italy, Spain, Sweden, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
Enrollment StartJun 2017
First PostedJun 2017
Primary CompletionFeb 2019
TodayJul 2026
First PostedJun 28, 2017
Enrollment StartJun 12, 2017
Primary CompletionFeb 15, 2019
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 9.0 years ago
Interventions
AR101 powder provided in capsules & sachetsbiological
Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol
Placebo powder provided in capsules & sachetsother
Study product formulated to contain only inactive ingredients for use as defined in the protocol