Brief 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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_2

Timeline

Completed

Started Mar 2019

Geographic Reach

2 countries

9 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.2 years study duration

First Submitted

Initial submission to the registry

January 2, 2019

Completed

2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2019

Completed

2 months until next milestone

Study Start

First participant enrolled

March 12, 2019

Completed

1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2021

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2021

Completed

1 year until next milestone

Results Posted

Study results publicly available

May 19, 2022

Completed

Last Updated

May 19, 2022

Status Verified

May 1, 2022

Enrollment Period

1.9 years

First QC Date

January 2, 2019

Results QC Date

February 16, 2022

Last Update Submit

May 17, 2022

Conditions

Peanut Allergy

Outcome Measures

Primary Outcomes (1)

Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 444 mg (Cumulative) Peanut Protein 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 Outcomes (10)

Change From Baseline in Cumulative Tolerated Dose (Log Transformed) of Peanut Protein During a DBPCFC at Weeks 24 and 36
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
At Week 36
Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 1044 mg (Cumulative) Peanut Protein at Week 24
At Week 24
Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 1044 mg (Cumulative) Peanut Protein at Week 36
At Week 36
Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 2044 mg (Cumulative) Peanut Protein at Week 24
At Week 24
+5 more secondary outcomes

Study Arms (1)

Dupilumab

EXPERIMENTAL

Open label weight base subcutaneous (SC) injection every two (Q2) weeks.

Drug: Dupilumab

Interventions

DupilumabDRUG

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

Also known as: REGN668, IL4R, Dupixent, SAR231893

Dupilumab

Eligibility Criteria

Age6 Years - 17 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.