Pua E. Hopson, D.O.

Closed for Enrollment

• A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled 3-Part Phase 3 Study To Demonstrate The Efficacy And Safety Of Benralizumab In Patients With Eosinophilic Gastritis And/or Gastroenteritis (The HUDSON GI Study) Rochester, Minn.

  The purpose of this study is to compare the effect of benralizumab 30 mg every 4 weeks (Q4W) with placebo on histologic signs and gastrointestinal symptoms in patients with eosinophilic gastritis and/or gastroenteritis (Part A & B).

  The objectives of this study are to validate a patient-reported outcome (PRO) instrument for Eosinophilic gastritis and gastroenteritis (EG/EGE) while providing preliminary effectiveness and safety data (24-week Part A), to provide pivotal efficacy and safety data for EG/EGE for the registration of this indication (24-week Part B), and to provide long-term effectiveness and safety data of benralizumab (Part C) during an open label extension.

  Eosinophilic gastritis and gastroenteritis (EG/EGE) are inflammatory disorders characterized by eosinophilic infiltration of the stomach (EG) and/or duodenum (EGE) with a resultant significant burden of gastrointestinal symptoms (e.g., abdominal pain, nausea, and bloating).

• AN EXPLORATORY, MULTICENTER, RANDOMIZED, DOUBLE BLIND STUDY OF CLINICAL OUTCOMES, TOLERABILITY, AND SAFETY OF 2 DOSES OF ORAL PANTOPRAZOLE IN PEDIATRIC PARTICIPANTS AGED 1 TO 11 YEARS AND 12 TO 17 YEARS WHO REQUIRE MAINTENANCE THERAPY FOR HEALED EROSIVE ESOPHAGITIS Rochester, Minn.

  The purpose of this study is to explore the outcomes, tolerability and safety of 2 different doses of oral pantoprazole (full healing dose, half healing dose), assigned based upon weight, for the maintenance of healing of erosive esophagitis in pediatric participants aged 1 to 17 years with endoscopically-confirmed, healed erosive esophagitis.