Study to Evaluate Dupilumab Monotherapy in Pediatric Patients With Peanut Allergy

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	6 Years - 17 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03793608
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Regeneron Pharmaceuticals
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Clinical Trial Management
Principal Investigator Affiliation	Regeneron Pharmaceuticals
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Active, not recruiting
Countries	Canada, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Peanut Allergy

Arms & Interventions

Arms

Experimental: Dupilumab

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

Interventions

Drug: - Dupilumab

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Regeneron Investigational Site, Mountain View, California

Status

Address