Study to Evaluate Dupilumab Monotherapy in Pediatric Patients With Peanut Allergy
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
Arm:
- 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 |