Status:
COMPLETED
Study to Evaluate Dupilumab Monotherapy in Pediatric Patients With Peanut Allergy
Lead Sponsor:
Regeneron Pharmaceuticals
Collaborating Sponsors:
Sanofi
Conditions:
Peanut Allergy
Eligibility:
All Genders
6-17 years
Phase:
PHASE2
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 pr...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
March 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 12 2021
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03793608
Start Date
March 12 2019
End Date
May 12 2021
Last Update
May 19 2022
Active Locations (9)
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1
Regeneron Investigational Site
Mountain View, California, United States, 94305
2
Regeneron Investigational Site
Tampa, Florida, United States, 33612
3
Regeneron Investigational Site
Indianapolis, Indiana, United States, 46202
4
Regeneron Investigational Site
Ypsilanti, Michigan, United States, 48197