Study to Evaluate Dupilumab Monotherapy in Pediatric Patients With Peanut Allergy

NCT ID: NCT03793608

Last Updated: 2022-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-12
• Study Completion Date: 2021-05-12

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

Conditions

Peanut Allergy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dupilumab

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

Group Type: EXPERIMENTAL

Dupilumab

Intervention Type: DRUG

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

Interventions

Dupilumab

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

Intervention Type: DRUG

Other Intervention Names

REGN668; IL4R; Dupixent; SAR231893

Eligibility Criteria

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

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

Regeneron Investigational Site

Mountain View, California, United States

Regeneron Investigational Site

Tampa, Florida, United States

Regeneron Investigational Site

Indianapolis, Indiana, United States

Regeneron Investigational Site

Ypsilanti, Michigan, United States

Regeneron Investigational Site

Great Neck, New York, United States

Regeneron Investigational Site

The Bronx, New York, United States

Regeneron Investigational Site

Hamilton, Ontario, Canada

Regeneron Investigational Site

Toronto, Ontario, Canada

Regeneron Investigational Site

Montreal, Quebec, Canada

Countries

United States; Canada

References

Chinthrajah RS, Sindher SB, Nadeau KC, Leflein JG, Spergel JM, Petroni DH, Jones SM, Casale TB, Wang J, Carr WW, Shreffler WG, Wood RA, Wambre E, Liu J, Akinlade B, Atanasio A, Orengo JM, Hamilton JD, Kamal MA, Hooper AT, Patel K, Laws E, Mannent LP, Adelman DC, Ratnayake A, Radin AR. Dupilumab as an Adjunct to Oral Immunotherapy in Pediatric Patients With Peanut Allergy. Allergy. 2025 Mar;80(3):827-842. doi: 10.1111/all.16420. Epub 2024 Dec 14.

Reference Type: DERIVED

PMID: 39673367 (View on PubMed)

Ghelli C, Costanzo G, Canonica GW, Heffler E, Paoletti G. New evidence in food allergies treatment. Curr Opin Allergy Clin Immunol. 2024 Aug 1;24(4):251-256. doi: 10.1097/ACI.0000000000000999. Epub 2024 May 30.

Reference Type: DERIVED

PMID: 38814736 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2018-003133-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

R668-ALG-1702

Identifier Type: -

Identifier Source: org_study_id