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Oral Desensitization to Peanut in Peanut Allergic Children and Adults Using CPNA Peanut OIT Safety Follow-On Study

Peanut Allergy Clinical Trial

Official title:
Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen (CPNA) Peanut Oral Immunotherapy (OIT) Safety Follow-On Study

Clinical Trial 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.

Clinical Trial Description

This phase 2, open-label, follow-on, multicenter study was designed to gather additional information on the safety, tolerability, and efficacy of oral desensitization with AR101 in subjects who participated in study ARC001 (NCT01987817) as follows: - Group 1 (ARC001 placebo): Subjects who received placebo in study ARC001 - Group 2 (ARC001 AR101): Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001 All subjects will receive daily oral dosing of peanut OIT (oral immunotherapy) in the form of Characterized Peanut Allergen (CPNA). Study Duration - 12-90 weeks before reaching the Extended Maintenance Phase. All Subjects may continue Extended Maintenance Phase until CPNA becomes commercially available or the study is terminated. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02198664
Study type Interventional
Source Aimmune Therapeutics, Inc.
Contact
Status Completed
Phase Phase 2
Start date August 27, 2014
Completion date January 4, 2018
View Details
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