CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 243 enrolled
Drug / intervention
AR101biological
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.

Search/NCT03337542
NCT03337542Phase 3Completed
CompareCT.gov

Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children, Active Treatment Arm Open-Label Extension Study (RAMSES OLE)

Aimmune Therapeutics, Inc.·interventional·Posted Nov 9, 2017·Updated Nov 2, 2021

In Brief

A Phase 3 clinical trial evaluating AR101 for Peanut Allergy. Completed, enrolled 243 participants across 60 sites in 2 countries.

Detailed Summary

This study is enrolling participants by invitation only. This is an open-label, safety extension study for subjects who participated in the ARC007 study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeanut Allergy
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedNov 9, 2017
Enrollment StartOct 18, 2017
Primary CompletionSep 20, 2019
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 8.6 years ago

Interventions

AR101biological

AR101