This is a multi-center, open-label, follow-on study to gather additional information on the safety and tolerability of oral desensitization with CPNA in the subjects who participated in ARC001.
This phase 2, open-label, follow-on, multicenter study was designed to gather additional information on the safety, tolerability, and efficacy of oral desensitization with AR101 in subjects who participated in study ARC001 (NCT01987817) as follows: * Group 1 (ARC001 placebo): Subjects who received placebo in study ARC001 * Group 2 (ARC001 AR101): Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001 All subjects will receive daily oral dosing of peanut OIT (oral immunotherapy) in the form of Characterized Peanut Allergen (CPNA). Study Duration - 12-90 weeks before reaching the Extended Maintenance Phase. All Subjects may continue Extended Maintenance Phase until CPNA becomes commercially available or the study is terminated.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
47
Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)
Arkansas Children's Hospital
Little Rock, Arkansas, United States
UC San Diego
San Diego, California, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Mount Sinai Medical Center
New York, New York, United States
Number of Participants With Treatment-related Adverse Events and Dosing Symptoms Occurring With Peanut OIT Over a Protracted Treatment Period Comprising at Least 18 Months
TEAEs are any event starting during or after the active treatment period. If a subject has multiple occurrences of TEAEs, the subject is presented once in the respective subject count (n).
Time frame: Up to 90 weeks
The Proportion of Subjects Who Tolerated at Least 300 mg (443 mg) and 600 mg (1043 mg Cumulative) Peanut Protein With no More Than Mild Symptoms During the Up-dosing DBPCFC
Time frame: Up to 36 weeks
The Proportion of Subjects Who Tolerated at Least 300 mg (443 mg), 600 mg (1043 mg Cumulative), and 1000 mg Peanut Protein (2043 mg Cumulative) With no More Than Mild Symptoms During the Maintenance DBPCFC.
Time frame: Up to 60 weeks.
Change From Baseline in the Single Highest Tolerated Dose of Peanut Protein
The single highest tolerated dose of peanut protein with no more than mild symptoms during the up-dosing DBPCFC and the change from baseline was evaluated for the ARC001 placebo completer population. The single highest tolerated dose of peanut protein with no more than mild symptoms during the maintenance DBPCFC and the change from up-dosing DBPCFC was evaluated for each group (ARC001 AR101 and ARC001 placebo) and overall for the food challenge completer population.
Time frame: Up to 60 weeks (Up to 36 weeks for up-dosing; up to 24 weeks for maintenance)
Number of Participants Who Tolerated Maximum Dose of Peanut Protein With no More Than Mild Symptoms Maximum Dose of Peanut Protein Tolerated
The maximum dose of peanut protein tolerated with no more than mild symptoms during the up-dosing and maintenance DBPCFCs
Time frame: Up to 60 weeks (Up to 36 weeks for up-dosing; up to 24 weeks for maintenance)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of North Carolina Chapel HIll
Chapel Hill, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Medical Center Dallas
Dallas, Texas, United States
Change in Peanut-specific IgE From Baseline and Up-dosing to Extended Maintenance
Time frame: Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks)
Change in Peanut-specific IgG4 From Baseline and Up-dosing to Extended Maintenance
Time frame: Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks)
Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter and Peanut Erythema/Flare From Baseline and Up-dosing to Extended Maintenance
Time frame: Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks)
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC
Maximum severity of symptoms that occurred at each challenge dose of peanut protein for all subjects during up-dosing DBPCFC
Time frame: Up to 36 weeks for up-dosing
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC
Maximum severity of symptoms that occurred at each challenge dose of peanut protein for all subjects during maintenance DBPCFC
Time frame: Up to 60 weeks (Up to 36 weeks for up-dosing; up to 24 weeks for maintenance)
Change in Physician Global Assessment, Disease Activity as Measured on a 100 mm Visual Analogue Scale (VAS) From Baseline and Up-dosing to Extended Maintenance.
A 100-mm Visual Analog Scale (VAS) was used by the investigators for the Physician Global Assessment of disease activity as a marker for safety. The investigator was to assign a single integrated overall disease activity score ranging from 0 to 100 mm. Zero indicated no disease activity and 100 indicated very severe disease activity.
Time frame: Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks)