CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 388 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/NCT02993107
NCT02993107Phase 3Completed

Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE) Follow-on Study

Aimmune Therapeutics, Inc.·interventional·Posted Dec 15, 2016·Updated Mar 17, 2022

In Brief

A Phase 3 clinical trial evaluating AR101 for Peanut Allergy. Completed, enrolled 388 participants across 65 sites in 9 countries.

Detailed Summary

The purpose of this study is to demonstrate the safety, tolerability, and efficacy of AR101 through oral immunotherapy (OIT) in peanut-allergic children and adults who have completed the ARC003 study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeanut Allergy
CountriesCanada, Germany, Ireland, Italy, Netherlands, Spain, Sweden, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 15, 2016
Enrollment StartDec 29, 2016
Primary CompletionMay 31, 2019
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 9.5 years ago

Interventions

AR101biological

AR101 powder provided in capsules \& sachets