Study to Evaluate Dupilumab Monotherapy in Pediatric Patients With Peanut Allergy
Condition: Peanut Allergy
MeSH terms: Hypersensitivity; Peanut Hypersensitivity
Intervention: Dupilumab
Intervention description: Dupilumab weight-based dosing will be administered subcutaneously (SC) in a single-use, pre-filled syringe every two weeks (Q2W)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No

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
    

Eligibility 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