Current Environment:

Summary

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.

Conditions

Peanut Allergy

Recruitment Status

Completed

Detailed Description

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.

Eligibility Criteria

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

Intervention

Intervention Type

Intervention Name

Biological

AR101

Phase

Phase 3

Gender

All

Minimum Age

4 Years

Maximum Age

55 Years

Download Date

March 17, 2022

Principal Investigator

N/A

Primary Contact Information

For more information on this trial, visit clinicaltrials.gov.

Contact

For more information and to contact the study team: