At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 506 enrolled
Drug / intervention
AR101 +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.
Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children Ages 4 to 17 Years (RAMSES)
In Brief
A Phase 3 clinical trial evaluating AR101 and Placebo for Peanut Allergy. Completed, enrolled 506 participants across 67 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeanut Allergy
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedApr 2017
Enrollment StartMay 2017
Primary CompletionAug 2018
Study CompletionSep 2018
TodayJul 2026
First PostedApr 24, 2017
Enrollment StartMay 8, 2017
Primary CompletionAug 31, 2018
Study CompletionSep 23, 2018
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 9.2 years ago
Interventions
AR101biological
AR101 powder provided in capsules
Placebobiological
Placebo powder provided in capsules