Study to Evaluate Dupilumab Monotherapy in Pediatric Patients With Peanut Allergy
Status:
Completed
Trial end date:
2021-05-12
Target enrollment:
Participant gender:
Summary
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