Primary Investigator: Gary W. Falk, MD, MS
Research Coordinator: Maureen DeMarshall
A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis
The main purpose of this study is to evaluate the effect of dupilumab on relieving EoE symptoms and reducing esophageal inflammation in adults and adolescents.
1) Less than 18
2) A documented diagnosis of EoE by endoscopic biopsy prior to screening, as demonstrated by intraepithelial eosinophilic infiltration (peak cell count greater than 15 eos/hpf) from at least one esophageal region and performed after at least 8 weeks of treatment with a high-dose PPI regimen.
3) At least 2 episodes of dysphagia (with intake of solids) per week in the 4 weeks prior to screening.
1) History of achalasia, Crohn's Disease, ulcerative colitis, celiac disease, and prior esophageal surgery.
2) Any esophageal stricture unable to be passed with a standard, diagnostic, 9 to 10 mm upper endoscope or any critical esophageal stricture that requires dilation at screening.
3) Treatment with swallowed topical corticosteroids within 8 weeks prior to baseline.