This study is researching an experimental drug called dupilumab (called "study drug"). The study is focused on children with active eosinophilic esophagitis (EoE; an inflammatory disease of the esophagus) which impacts feeding and nourishment. The aim of the study is to see how safe, tolerable, and effective the study drug is when given for 24 weeks to children with active EoE. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
20
Administered as defined in the protocol
Phoenix Childrens Hospital
Phoenix, Arizona, United States
RECRUITINGGI Care for Kids LLC
Atlanta, Georgia, United States
RECRUITINGWeill Cornell Medicine
New York, New York, United States
RECRUITINGUniversity of North Carolina, Bioinformatics Building
Chapel Hill, North Carolina, United States
RECRUITINGUniversity of Virginia
Charlottesville, Virginia, United States
RECRUITINGIncidence of treatment-emergent Serious Adverse Events (SAEs)
Time frame: Up to 24 Weeks
Incidence of Treatment-Emergent Adverse Events (TEAEs) leading to permanent discontinuation of study treatment
Time frame: Up to 24 Weeks
Incidence of treatment-emergent Adverse Event of Special Interest (AESIs)
Time frame: Up to 24 Weeks
Incidence of TEAEs
Time frame: Up to 24 Weeks
Proportion of patients achieving peak esophageal intraepithelial eosinophil count of ≤6 eosinophils per high power field (eos/hpf) (400×)
Time frame: At Week 24
Proportion of patients achieving peak esophageal intraepithelial eosinophil count of <15 eos/hpf (400×)
Time frame: At Week 24
Percent change in peak esophageal intraepithelial eosinophil count (eos/hpf)
Time frame: Baseline to Week 24
Change in body weight for age percentile
Time frame: Baseline up to Week 24
Concentrations of functional dupilumab in serum
Time frame: Baseline up to Week 24
Incidence of Anti-Drug Antibody (ADA) to dupilumab
Time frame: Up to Week 36
Titer of ADA to dupilumab
Time frame: Up to Week 36
Incidence of Neutralizing Antibody (NAb) to dupilumab
Time frame: Up to Week 36
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