PALISADE Follow-on Study (ARC004)

ID#: NCT02993107

Age: 4 - 55 years

Gender: All

Healthy Subjects: No

Study Phase: Phase 3

Recruitment Status: Recruiting

Start Date: December 01, 2016

End Date: December 01, 2020

Contact Information:
Jerome G. Pinkett, MBA

The purpose of this study is to demonstrate the safety, tolerability, and efficacy of AR101 through characterized oral desensitization immunotherapy (CODIT) in peanut-allergic children and adults who have completed the ARC003 study.


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

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