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A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study in Pediatric Subjects With Peanut Allergy to Evaluate the Efficacy and Safety of Dupilumab as Adjunct to AR101 (Peanut Oral Immunotherapy)
Primary objective is to assess whether dupilumab as adjunct to AR101 compared to placebo improves desensitization at the completion of up-dosing, defined as an increase in the proportion of participants who pass a post up-dosing double-blind placebo-controlled food challenge (DBPCFC) at visit 16. Secondary objectives are: * To assess whether dupilumab as adjunct to AR101 compared to placebo improves desensitization at the completion of up-dosing, defined as an increase in the cumulative tolerated dose (log transformed) of peanut protein during a post up-dosing DBPCFC at visit 16 * To assess whether dupilumab as (indefinite \[continuously\]) adjunct to AR101 compared to placebo maintains desensitization, defined as an increase in the proportion of participants who pass a post maintenance DBPCFC at visit 22 * To assess whether dupilumab as (limited \[previously\]) adjunct to AR101 compared to placebo maintains desensitization, defined as an increase in the proportion of participants who pass a post maintenance DBPCFC at visit 22 * To evaluate the safety and tolerability of dupilumab as adjunct to AR101 compared to placebo * To assess the effect of dupilumab (compared to placebo) as adjunct to AR101 on the change in peanut-specific Immunoglobulin E (sIgE), Immunoglobulin G (IgG), Immunoglobulin G4 (IgG4), and peanut-specific IgG4/IgE ratio * To assess if dupilumab increases the tolerability of AR101 as measured by the daily symptoms (electronic diary \[e-diary\]) during the up-dosing phase
Age
6 - 17 years
Sex
ALL
Healthy Volunteers
No
Regeneron Investigational Site
Birmingham, Alabama, United States
Regeneron Investigational Site
Tucson, Arizona, United States
Regeneron Investigational Site
Little Rock, Arkansas, United States
Regeneron Investigational Site
Los Angeles, California, United States
Regeneron Investigational Site
Los Angeles, California, United States
Regeneron Investigational Site
Mission Viejo, California, United States
Regeneron Investigational Site
Mountain View, California, United States
Regeneron Investigational Site
Rolling Hills Estates, California, United States
Regeneron Investigational Site
Denver, Colorado, United States
Regeneron Investigational Site
Washington D.C., District of Columbia, United States
Start Date
October 3, 2018
Primary Completion Date
October 16, 2020
Completion Date
July 23, 2021
Last Updated
February 7, 2024
148
ACTUAL participants
Dupilumab
DRUG
Placebo matching dupilumab
DRUG
AR101
DRUG
Lead Sponsor
Regeneron Pharmaceuticals
Collaborators
NCT03835767
NCT04222491
NCT04511494
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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