Does your child have eosinophilic esophagitis (EoE)?
Study ID: STU 2019-0556
Children’s Health℠ is conducting a clinical research study that is currently looking for children ages 12 to 18 who have been diagnosed with eosinophilic esophagitis (EOE) to test if an investigational subcutaneous injection called dupilumab will be safe and effective in treating EoE. Dupilumab is FDA-approved for moderate to severe asthma and atopic dermatitis (eczema) age 12 and up, but has not previously been studied in this age group for EoE.
What are we studying? We are evaluating the efficacy and safety of dupilumab adolescent patients with EoE.
Why it is important? Current treatment options of EoE are very limited. There is no FDA-approved treatment for EoE available currently.
What do we hope to accomplish? Evaluate the safety and effect of dupilumab on relieving EoE symptoms and reducing esophageal inflammation in adolescents.
Who can participate? (Additional criteria to be met prior to participation)
Adolescents between ages 12-18 years old
Adolescents that have been diagnosed with eosinophilic esophagitis by biopsy or a doctor
Adolescents who are willing to undergo an endoscopy procedure and allow the doctor to obtain biopsy samples from the esophagus, stomach and small intestine, as indicated.
Adolescents who are willing to receive an investigational subcutaneous (SQ) injection for eosinophilic esophagitis and are willing to participate for about 18 months (about 20 visits)
Who cannot participate? (Additional exclusion criteria to be reviewed prior to participation)
Those who are pregnant or breastfeeding
Those who have certain gastrointestinal disorders
Those who have a history of bleeding disorders
Those who are hepatitis B and HIV positive
What will you be asked to do? Participants will be asked to have a parent/guardian give investigational subcutaneous injections of dupilumab or placebo for EoE. There is a 2/3 chance of receiving dupilumab vs placebo for the first half of the study. For the second half of the study ALL participants will recieve dupilumab. Participants will be asked to undergo 3 endoscopy procedures which include obtaining biopsies of esophagus, stomach and small intestine, as indicated. Other assessments include vital signs, blood draws, EKG and physical examinations.