PALISADE Follow-on Study (ARC004)

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.

This is an international, multicenter, open-label, 2-arm follow-on study of the safety, tolerability, and efficacy of AR101 in peanut-allergic individuals who have completed the ARC003 study. This study will explore alternative dosing regimens during extended maintenance with AR101.

Key Inclusion Criteria:

* Completion of the ARC003 study
* Written informed consent and/or assent from subjects/guardians as appropriate
* Use of effective birth control by sexually active female subjects of child-bearing potential

Key Exclusion Criteria:

* Early discontinuation from the ARC003 study
* Meets any longitudinally applicable ARC003 study exclusion criteria
* (Group 2 only) Failure to tolerate ≥ 443 mg cumulative of peanut protein with no or mild symptoms in the ARC003 study Exit DBPCFC
* Any other condition that, in the opinion of the Investigator, precludes participation for reasons of safety