Last updated on August 2019

A Study to Evaluate the Efficacy and Safety of Dupilumab Monotherapy in Pediatric Patients With Peanut Allergy


Brief description of study

The primary objective of the study is to assess whether dupilumab as compared to placebo improves peanut protein tolerability, defined as an increase in 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 compared to placebo improves peanut tolerability, defined as an increase in the cumulative tolerated dose (log transformed) of peanut protein during a DBPCFC

• To evaluate the safety and tolerability of dupilumab treatment compared to placebo in peanut allergic patients

• To evaluate the effects of treatment (dupilumab vs placebo) on the levels of peanut-specific Immunoglobulin E (IgE)

• To evaluate the treatment effect of dupilumab vs. placebo 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

 

Clinical Study Identifier: TX227895

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