A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Dupilumab in Adult Patients with Active Eosinophilic Esophagitis
ID Number 15-1067Principal Investigator(s)
Department(s) or Division(s)
The Elliot and Roslyn Jaffe Food Allergy Institute
This is a multi-center study of dupilumab in adult patients with active eosinophilic esophagitis (EoE). EoE signs and symptoms are thought to be driven by the presence of activated eosinophils in the esophagus. The symptoms can consist of vomiting, abdominal or chest pain, heartburns, and difficulty swallowing. While the cause of EoE is poorly understood, there is growing evidence that inflammation results from an allergic type response to food allergens.
Dupilumab is a type of investigational agent called a “monoclonal antibody.” An antibody is a special kind of protein that the immune system normally makes to fight bacteria and viruses. This study is being done to evaluate the effect of dupilumab on relieving EoE symptoms and reducing esophageal inflammation in adults. Since this is the first study in which Dupilumab will be used to help patients with EoE, it is placebo-controlled. This means that half of the patients participating in this study will receive Dupilumab, and the other half will receive a placebo (a solution that looks like the study medication but does not contain any medication). Dupilumab is not yet approved by government agencies, such as the US Food and Drug Administration (FDA) and European Regulatory Authorities.
Patients may qualify to take part in this study if they are between the ages of 18-65 and have been diagnosed with EoE. Participation in this study will consist of three months of weekly dosing visits (with the option to self-administer at home for certain visits) followed by four monthly follow up visits in clinic. In addition to study visits, participants will be asked to complete a series of symptom questionnaires to determine if Dupilumab is helping to improve symptoms associated with EoE.
Mary Ellen Riffle
Recruiting Patients: Yes