This is a competitive renewal of CEGIR UAI117804. In this renewal application, NU will participate in 3 parts: The Pilot Demonstration Program, Clinical Trial 1 and Clinical Trial 2. They are described as follows:The Pilot/Demonstration Clinical Research Projects Program will support research projects that encourage the development of new ideas concerning eosinophilic esophagitis, eosinophilic gastritis, eosinophilic gastroenteritis and eosinophilic colitis. Projects will be selected by their likelihood to develop new models and ideas that will improve the way researchers, healthcare providers, and patients understand these diseases and to develop better treatments.The proposed clinical research projects have been developed in partnership with patient advocacy groups with the objective of answering immediately important questions concerning the understanding and treatment of the rare diseases eosinophilic esophagitis, eosinophilic gastritis, eosinophilic gastroenteritis and eosinophilic colitis.Over the course of Clinical Trial 1, a total of 1,050 patients from all sites is expected to be followed. To meet this number of patients (including individuals that drop out), each site should enroll at least 16 patients, including four that have each of the following diseases: eosinophilic esophagitis, eosinophilic gastritis, eosinophilic gastroenteritis and eosinophilic colitis.Over the course of Clinical Trial 2, a total of 40 patients from all sites is expected to be enrolled. Each site should enroll 4 or more patients during years 2-4 of the project. The central aim of this study is to conduct a proof of principle trial testing the hypothesis that dupilumab will safe and effective for reducing eosinophilia and a Th2 gene profile in eosinophilic gastritis. This proof-of-principle study aims to provide mechanistic evidence that type 2 immunity is essential in the pathogenesis of eosinophilic esophagitis.
|Effective start/end date||9/17/19 → 8/31/24|
- Cincinnati Children's Hospital Medical Center (309364 (CT2)//5U54AI117804-07)
- National Institute of Allergy and Infectious Diseases (309364 (CT2)//5U54AI117804-07)