Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Regeneron Pharmaceuticals
With
Sanofi
Age
6–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Study to Evaluate Dupilumab Monotherapy in Pediatric Patients With Peanut Allergy
