Study to Evaluate Dupilumab Monotherapy in Pediatric Patients With Peanut Allergy

Regeneron Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Peanut Allergy

Treatments

Drug: Dupilumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT03793608

R668-ALG-1702

2018-003133-15 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment

25 patients

Sex

All

Ages

6 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion and 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