Clinical trial NCT03793608: Study to Evaluate Dupilumab Monotherapy in Pediatric Patients With Peanut Allergy
Official title: A Study to Evaluate the Efficacy and Safety of Dupilumab Monotherapy in Pediatric Patients With Peanut Allergy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Peanut Allergy
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2019-01-04
Enrollment: 25
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 444 mg (Cumulative) Peanut Protein at Week 24
timeFrame: At Week 24
Secondary outcomes:
measure: Change From Baseline in Cumulative Tolerated Dose (Log Transformed) of Peanut Protein During a DBPCFC at Weeks 24 and 36
timeFrame: Weeks 24 and 36
measure: Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 444 mg (Cumulative) Peanut Protein at Week 36
timeFrame: At Week 36
measure: Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 1044 mg (Cumulative) Peanut Protein at Week 24
timeFrame: At Week 24
measure: Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 1044 mg (Cumulative) Peanut Protein at Week 36
timeFrame: At Week 36
measure: Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 2044 mg (Cumulative) Peanut Protein at Week 24
timeFrame: At Week 24
measure: Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 2044 mg (Cumulative) Peanut Protein at Week 36
timeFrame: At Week 36
measure: Percent Change From Baseline in Peanut-specific Immunoglobulin E (sIgE) at Weeks 4, 8, 12, 16, 24, and 36
timeFrame: Weeks 4, 8, 12, 16, 24, and 36
measure: Change From Baseline in Titrated Skin Prick Test (SPT) Measured by Average Wheal Size Area Under the Curve (AUC) After Peanut Allergen Stimulation at Different Concentrations at Weeks 4, 12, 24, and 36
timeFrame: Weeks 4, 12, 24, and 36
measure: Percentage of Participants With Grade 2 or Above Allergic Reactions During the DBPCFC at Week 24
timeFrame: At Week 24
measure: Percentage of Participants Who Used Epinephrine as a Rescue Medication During the DBPCFC at Week 24
timeFrame: At Week 24
Other outcomes:
Locations:
city: Mountain View
country: United States
facility: Regeneron Investigational Site
state: California
city: Tampa
country: United States
facility: Regeneron Investigational Site
state: Florida
city: Indianapolis
country: United States
facility: Regeneron Investigational Site
state: Indiana
city: Ypsilanti
country: United States
facility: Regeneron Investigational Site
state: Michigan
city: Bronx
country: United States
facility: Regeneron Investigational Site
state: New York
city: Great Neck
country: United States
facility: Regeneron Investigational Site
state: New York
city: Hamilton
country: Canada
facility: Regeneron Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Regeneron Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Regeneron Investigational Site
state: Quebec
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: