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
PHASE3
Gender
ALL
Min Age
4 Years
Max Age
55 Years
Download Date
2022-03-17
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: