Study to Evaluate Dupilumab Monotherapy in Pediatric Patients With Peanut Allergy

Part of paid clinical trials in Mountain View, California.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT03793608
Phase
PHASE2
Status
Completed

Conditions

  • Peanut Allergy

Eligibility Criteria

Sex
ALL
Age
6 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Dupilumab — DRUG
    Dupilumab weight-based dosing will be administered subcutaneously (SC) in a single-use, pre-filled syringe every two weeks (Q2W)

Study Details

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

Key Dates

Start date
Mar 12, 2019
Status verified
May 2022
Primary completion
Feb 19, 2021
Completion
May 12, 2021

Study Design

Enrollment
25 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dupilumab
    Open label weight base subcutaneous (SC) injection every two (Q2) weeks.

Primary Outcome Measure

Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 444 mg (Cumulative) Peanut Protein at Week 24 [ Time Frame: At Week 24 ]

Locations (6)

FacilityCityStateZIPSite coordinators
Regeneron Investigational SiteMountain ViewCalifornia94305-
Regeneron Investigational SiteTampaFlorida33612-
Regeneron Investigational SiteIndianapolisIndiana46202-
Regeneron Investigational SiteYpsilantiMichigan48197-
Regeneron Investigational SiteGreat NeckNew York11021-
Regeneron Investigational SiteThe BronxNew York10461-

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Regeneron Investigational Site· Mountain View, CARegeneron Investigational Site· Tampa, FLRegeneron Investigational Site· Indianapolis, INRegeneron Investigational Site· Ypsilanti, MIRegeneron Investigational Site· Great Neck, NYRegeneron Investigational Site· The Bronx, NY

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