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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
388
AR101 powder provided in capsules \& sachets
Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE)
Percentage of subjects ages 4-17 with at-least 1 TEAE, including serious adverse events, during the overall study period. The percentage of subjects reporting at least 1 TEAE by maximum reported severity is also presented using the 5-point CTCAE severity grading scale. All safety evaluations were conducted using the safety population (all subjects who received at least 1 dose of AR101 during ARC004), age 4-17 years. Safety data are presented for group 1 (former placebo) and Group 2 data are divided into columns for cohort 1 (QD), cohort 2 (overall), cohort 3A (QD), and cohorts 3B and 3C (overall).
Time frame: Up to 126 weeks
Percentage of Subjects Ages 4-17 Responding to Each Challenge Dose at Exit DBPCFC (Double-blind, Placebo-controlled Food Challenge)
The percentage of subjects who tolerated each the of 300 mg, 600 mg, 1000 mg, or 2000 mg challenge doses with no more than mild symptoms at exit DBPCFC. Analyses based on DBPCFCs used the completer population (age 4-17 years).
Time frame: Up to 126 weeks
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Banner University of Arizona Medical Center
Tucson, Arizona, United States
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Allergy & Asthma Associates of Southern California
Mission Viejo, California, United States
Sean N. Parker Center for Allergy Research at Stanford University Packard-El Camino Hospital
Mountain View, California, United States
Peninsula Research Associates, Inc.
Rolling Hills Estates, California, United States
Allergy & Asthma Medical Group and Research Center, APC
San Diego, California, United States
Rady Children's Hospital, San Diego
San Diego, California, United States
University of California, San Francisco
San Francisco, California, United States
UCLA Medical Center, Santa Monica
Santa Monica, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
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