Study to Evaluate Dupilumab Monotherapy in Pediatric Patients With Peanut Allergy

May 17, 2022 updated by: Regeneron Pharmaceuticals

A Study to Evaluate the Efficacy and Safety of 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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Hamilton, Ontario, Canada, L8S 1G5
        • Regeneron Investigational Site
      • Toronto, Ontario, Canada, M5G 1X8
        • Regeneron Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H3T 1C5
        • Regeneron Investigational Site
    • California
      • Mountain View, California, United States, 94305
        • Regeneron Investigational Site
    • Florida
      • Tampa, Florida, United States, 33612
        • Regeneron Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Regeneron Investigational Site
    • Michigan
      • Ypsilanti, Michigan, United States, 48197
        • Regeneron Investigational Site
    • New York
      • Bronx, New York, United States, 10461
        • Regeneron Investigational Site
      • Great Neck, New York, United States, 11021
        • Regeneron Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • Patient has a clinical history of allergy to peanuts or peanut-containing foods (symptom[s] of reaction due to exposure).
  • Experience dose-limiting symptoms at or before the challenge dose of peanut protein on screening DBPCFC conducted in accordance with Practical Issues in Allergology, Joint United States/European Union Initiative (PRACTALL) guidelines. And not experiencing dose limiting symptoms to placebo
  • Serum IgE to peanut of ≥10 kilo units (kUA)/L and/or a SPT to peanut ≥8 mm compared to a negative control
  • Patients/legal guardians must be trained on the proper use of the epinephrine autoinjector device to be allowed to enroll in the study
  • Patients with other known food allergies must agree to eliminate these other food items from their diet so as not to confound the safety and efficacy data from the study

Key Exclusion Criteria:

  • Any previous exposure to marketed dupilumab or dupilumab in a clinical trial
  • Member of the clinical site study team or his/her immediate family
  • History of other chronic disease (other than asthma, AD, or allergic rhinitis) requiring therapy
  • History of frequent or recent severe, life-threatening episode of anaphylaxis or anaphylactic shock as defined by more than 3 episodes of anaphylaxis within the past year and/or an episode of anaphylaxis within 60 days of screening DBPCFC
  • History of eosinophilic gastrointestinal disease
  • History of eosinophilic granulomatosis with polyangiitis
  • Severe, unstable asthma at time of enrollment or any patient with Forced Expiratory Volume in 1 Second (FEV1) <80% of predicted or asthma control questionnaire (ACQ)>1.5
  • Use of systemic corticosteroids within 2 months prior to screening

Note: Other protocol Inclusion/Exclusion Criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dupilumab
Open label weight base subcutaneous (SC) injection every two (Q2) weeks.
Dupilumab weight-based dosing will be administered subcutaneously (SC) in a single-use, pre-filled syringe every two weeks (Q2W)
Other Names:
  • Dupixent
  • REGN668
  • SAR231893
  • IL4R

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. Participants were considered to have passed the DBPCFC if they did not experience any objective Grade 1 reaction. Percentage of participants treated with dupilumab who passed the DBPCFC with at least 444 mg (cumulative) peanut protein at Week 24 was reported.
At Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Cumulative Tolerated Dose (Log Transformed) of Peanut Protein During a DBPCFC at Weeks 24 and 36
Time Frame: Weeks 24 and 36
Change from baseline in cumulative tolerated dose (log transformed) of peanut protein during a DBPCFC at Week 24 and Week 36 was reported.
Weeks 24 and 36
Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 444 mg (Cumulative) Peanut Protein at Week 36
Time Frame: At Week 36
Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. Participants were considered to have passed the DBPCFC if they did not experience any objective Grade 1 reaction. Only participants treated with dupilumab who passed at least 444 mg (cumulative) peanut challenge at Week 24 were eligible for Week 36 DBFC.
At Week 36
Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 1044 mg (Cumulative) Peanut Protein at Week 24
Time Frame: At Week 24
Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. Participants were considered to have passed the DBPCFC if they did not experience any objective Grade 1 reaction. Percentage of participants treated with dupilumab who passed a DBPCFC with at least 1044 mg (cumulative) peanut protein at Week 24 was reported.
At Week 24
Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 1044 mg (Cumulative) Peanut Protein at Week 36
Time Frame: At Week 36
Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. Participants were considered to have passed the DBPCFC if they did not experience any objective Grade 1 reaction. Only participants treated with dupilumab who passed at least 444 mg (cumulative) peanut challenge at Week 24 were eligible for Week 36 DBFC.
At Week 36
Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 2044 mg (Cumulative) Peanut Protein at Week 24
Time Frame: At Week 24
Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. Participants were considered to have passed the DBPCFC if they did not experience any objective Grade 1 reaction. Percentage of participants treated with dupilumab who passed a DBPCFC with at least 2044 mg (cumulative) peanut protein at Week 24 was reported.
At Week 24
Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 2044 mg (Cumulative) Peanut Protein at Week 36
Time Frame: At Week 36
Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. Participants were considered to have passed the DBPCFC if they did not experience any objective Grade 1 reaction. Only participants treated with dupilumab who passed at least 444 mg (cumulative) peanut challenge at Week 24 were eligible for Week 36 DBFC.
At Week 36
Percent Change From Baseline in Peanut-specific Immunoglobulin E (sIgE) at Weeks 4, 8, 12, 16, 24, and 36
Time Frame: Weeks 4, 8, 12, 16, 24, and 36
Percent change from baseline in sIgE at Weeks 4, 8, 12, 16, 24, and 36 was reported.
Weeks 4, 8, 12, 16, 24, and 36
Change From Baseline in Titrated Skin Prick Test (SPT) Measured by Average Wheal Size Area Under the Curve (AUC) After Peanut Allergen Stimulation at Different Concentrations at Weeks 4, 12, 24, and 36
Time Frame: Weeks 4, 12, 24, and 36
The titrated SPT is the skin testing for atopic response at different concentrations of peanut extract with saline as negative control and histamine as positive controls. Wheal size induced by peanut extract at each concentration was calculated as average of largest diameter and perpendicular midpoint diameter. The AUC for titrated SPT was calculated using the mean wheal diameter versus the concentration at which the wheal diameter was measured, which was then normalized to concentration. Change from baseline in titrated SPT as measured by average wheal size AUC after peanut allergen stimulation at different concentrations at Weeks 4, 12, 24, and 36 was reported.
Weeks 4, 12, 24, and 36
Percentage of Participants With Grade 2 or Above Allergic Reactions During the DBPCFC at Week 24
Time Frame: At Week 24
Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. Percentage of participants with Grade 2 (Moderate) or above allergic reactions during the DBPCFC at Week 24 was reported.
At Week 24
Percentage of Participants Who Used Epinephrine as a Rescue Medication During the DBPCFC at Week 24
Time Frame: At Week 24
Percentage of participants who used Epinephrine as a rescue medication during the DBPCFC at Week 24 was reported.
At Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2019

Primary Completion (Actual)

February 19, 2021

Study Completion (Actual)

May 12, 2021

Study Registration Dates

First Submitted

January 2, 2019

First Submitted That Met QC Criteria

January 2, 2019

First Posted (Actual)

January 4, 2019

Study Record Updates

Last Update Posted (Actual)

May 19, 2022

Last Update Submitted That Met QC Criteria

May 17, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • R668-ALG-1702
  • 2018-003133-15 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All IPD that underlie results in a publication

IPD Sharing Time Frame

Individual de-identified participant data will be made available once the indication has been approved by a regulatory body, if there is participant consent and there is not a reasonable likelihood of participant re-identification.

IPD Sharing Access Criteria

Qualified researchers may request access to study documents (including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan) that support the methods and findings reported in a manuscript. Individual de-identified participant data will be made available once the indication has been approved by a regulatory body, if there is participant consent and there is not a reasonable likelihood of participant re-identification.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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