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
March 17, 2022
Primary Contact Information
For more information on this trial, visit clinicaltrials.gov.
For more information and to contact the study team: