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Study to Evaluate Dupilumab Monotherapy in Pediatric Patients With Peanut Allergy

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ClinicalTrials.gov Identifier: NCT03793608
Recruitment Status : Recruiting
First Posted : January 4, 2019
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:

The primary objective of the study is to assess whether dupilumab as compared to placebo improves peanut protein tolerability, defined as an increase in 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 compared to placebo improves peanut tolerability, defined as an increase in the cumulative tolerated dose (log transformed) of peanut protein during a DBPCFC
  • To evaluate the safety and tolerability of dupilumab treatment compared to placebo in peanut allergic patients
  • To evaluate the effects of treatment (dupilumab vs placebo) on the levels of peanut-specific Immunoglobulin E (IgE)
  • To evaluate the treatment effect of dupilumab vs. placebo 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

Condition or disease Intervention/treatment Phase
Peanut Allergy Drug: Dupilumab Drug: placebo matching dupilumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
Estimated Primary Completion Date : August 13, 2020
Estimated Study Completion Date : November 10, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
Drug Information available for: Dupilumab

Arm Intervention/treatment
Experimental: Arm A - placebo matching dupilumab Drug: placebo matching dupilumab
Placebo matching dupilumab is prepared in the same formulation without the addition of protein

Experimental: Arm B - dupilumab Drug: Dupilumab
Dupilumab will be administered subcutaneously (SC) in a single-use, pre-filled glass syringe every two weeks (Q2W)




Primary Outcome Measures :
  1. Proportion of patients treated with dupilumab vs placebo that pass a Double-blind, placebo-controlled food challenge (DBPCFC) with low-dose (cumulative) peanut protein [ Time Frame: At Week 24 ]

Secondary Outcome Measures :
  1. Proportion of patients treated with dupilumab vs placebo that pass a DBPCFC with low-dose (cumulative) peanut protein [ Time Frame: At Weeks 12 and 36 ]
  2. Proportion of patients treated with dupilumab vs placebo that pass a DBPCFC with mid-dose (cumulative) peanut protein [ Time Frame: At Weeks 12, 24 and 36 ]
  3. Proportion of patients treated with dupilumab vs placebo that pass a DBPCFC with high-dose (cumulative) peanut protein [ Time Frame: At Weeks 12, 24 and 36 ]
  4. Change in the cumulative tolerated dose (log transformed) of peanut protein during a DBPCFC in peanut allergic patients treated with dupilumab vs placebo [ Time Frame: From Baseline to Weeks 12, 24 and 36 ]
  5. Percent change in peanut-specific Immunoglobulin E (sIgE) [ Time Frame: From Baseline To Weeks 4, 8, 12, 24 and 36 ]
  6. Change in titrated SPT as measured by the average wheal size AUC after peanut allergen stimulation at different concentrations [ Time Frame: From Baseline To Weeks 4, 12, 24 and 36 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • 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 ≥24 kilo units (kU)/L and/or a SPT to peanut ≥10 mm compared to a negative control
  • Participants/caregivers must be trained on the proper use of the epinephrine autoinjector device to be allowed to enroll in the study
  • Participants 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03793608


Contacts
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Contact: Clinical Trials Administrator 844-734-6643 clinicaltrials@regeneron.com

Locations
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United States, California
Regeneron Investigational Site Recruiting
Mountain View, California, United States, 94305
United States, Florida
Regeneron Investigational Site Recruiting
Tampa, Florida, United States, 33612
United States, Michigan
Regeneron Investigational Site Recruiting
Ypsilanti, Michigan, United States, 48197
United States, New York
Regeneron Investigational Site Recruiting
Bronx, New York, United States, 10461
Canada, Ontario
Regeneron Investigational Site Recruiting
Hamilton, Ontario, Canada, L8S 1G5
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals

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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03793608     History of Changes
Other Study ID Numbers: R668-ALG-1702
2018-003133-15 ( EudraCT Number )
First Posted: January 4, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All IPD that underlie results in a publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
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.
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.
URL: https://errs.regeneron.com/external

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypersensitivity
Peanut Hypersensitivity
Immune System Diseases
Nut and Peanut Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs