CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 47 enrolled
Drug / intervention
AR101 - Peanut protein capsulebiological
Likely dose
AR101 - Peanut protein capsule 475 mgfrom 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/NCT02198664
NCT02198664Phase 2Completed
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Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen (CPNA) Peanut Oral Immunotherapy (OIT) Safety Follow-On Study

Aimmune Therapeutics, Inc.·interventional·Posted Jul 24, 2014·Updated Nov 9, 2021

In Brief

A Phase 2 clinical trial evaluating AR101 - Peanut protein capsule for Peanut Allergy. Completed, enrolled 47 participants across 8 sites.

Detailed Summary

This is a multi-center, open-label, follow-on study to gather additional information on the safety and tolerability of oral desensitization with CPNA in the subjects who participated in ARC001.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeanut Allergy
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 24, 2014
Enrollment StartAug 27, 2014
Primary CompletionJan 4, 2018
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 11.9 years ago

Interventions

AR101 - Peanut protein capsulebiological

Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)