drugset / Trial / NCT02198664

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

NCT02198664

Phase 2 Completed 47 enrolled Aimmune Therapeutics, Inc.
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2014-08-27
Primary completion
2018-01-04
Completion
2018-01-04

Drugs

EvaluationDrugModalityDoseRoute
Subject AR101 Protein / enzyme biologic 0.5 mg Oral
Subject AR101 Protein / enzyme biologic 1 mg Oral
Subject AR101 Protein / enzyme biologic 10 mg Oral
Subject AR101 Protein / enzyme biologic 100 mg Oral
Subject AR101 Protein / enzyme biologic 300 mg Oral
Subject AR101 Protein / enzyme biologic 475 mg Oral
Subject AR101 Protein / enzyme biologic 1000 mg Oral

Indications