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A Study to Evaluate the Efficacy and Safety of Dupilumab Monotherapy in Pediatric Patients With Peanut Allergy
The primary objective of the study is to assess the tolerability of peanut protein in pediatric patients (6-17 years old) treated with dupilumab monotherapy, in which tolerability is defined as the proportion of patients who safely pass a double-blind placebo-controlled food challenge (DBPCFC) at week 24. The secondary objectives are: * To determine whether dupilumab treatment improves peanut tolerability, defined as a change in the cumulative tolerated dose (log transformed) of peanut protein during a DBPCFC * To evaluate the safety and tolerability of dupilumab treatment in peanut allergic patients * To evaluate the effects of dupilumab treatment on the levels of peanut-specific Immunoglobulin E (IgE) * To evaluate the treatment effect of dupilumab on the average wheal size after a titrated skin prick test (SPT), as measured by area under curve (AUC) of the average wheal size induced by peanut extract at different concentrations * To assess the incidence of treatment-emergent anti-drug antibodies (ADA) to dupilumab in patients over time
Age
6 - 17 years
Sex
ALL
Healthy Volunteers
No
Regeneron Investigational Site
Mountain View, California, United States
Regeneron Investigational Site
Tampa, Florida, United States
Regeneron Investigational Site
Indianapolis, Indiana, United States
Regeneron Investigational Site
Ypsilanti, Michigan, United States
Regeneron Investigational Site
Great Neck, New York, United States
Regeneron Investigational Site
The Bronx, New York, United States
Regeneron Investigational Site
Hamilton, Ontario, Canada
Regeneron Investigational Site
Toronto, Ontario, Canada
Regeneron Investigational Site
Montreal, Quebec, Canada
Start Date
March 12, 2019
Primary Completion Date
February 19, 2021
Completion Date
May 12, 2021
Last Updated
May 19, 2022
25
ACTUAL participants
Dupilumab
DRUG
Lead Sponsor
Regeneron Pharmaceuticals
Collaborators
NCT03835767
NCT04222491
NCT04511494
Data Source & Attribution
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