CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 146 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.

Search/NCT03736447
NCT03736447Phase 3Completed

Peanut Oral Immunotherapy Study of Early Intervention for Desensitization (POSEIDON)

Aimmune Therapeutics, Inc.·interventional·Posted Nov 9, 2018·Updated Mar 2, 2023

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 146 participants across 23 sites in 4 countries.

Detailed Summary

The purpose of this study is to determine the efficacy and safety of AR101 in peanut-allergic children aged 1 to \< 4 years.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeanut Allergy
CountriesFrance, Germany, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedNov 9, 2018
Enrollment StartDec 27, 2018
Primary CompletionJul 5, 2022
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 7.6 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 & sachetsbiological

Study product formulated to contain only inactive ingredients for use as defined in the protocol