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Clinical trial

Study to Evaluate Dupilumab Monotherapy in Pediatric Patients With Peanut Allergy

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Last updated:10th Mar 2021
Status: Active, not recruiting
Identifier: NCT03793608
Study to Evaluate 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

Study Type: Interventional (Clinical Trial)
Actual Enrollment: 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Efficacy and Safety of Dupilumab Monotherapy in Pediatric Patients With Peanut Allergy
Actual Study Start Date: March 12, 2019
Actual Primary Completion Date: February 19, 2021
Estimated Study Completion Date: May 27, 2021

- Experimental: Dupilumab

Category Value
Study type(s) Interventiona
Actual enrolment 25
Actual Study start date 12 March 2019
Estimated Study Completion Date 27 May 2021

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