7811: An Open-Label Study Of Zemaira (Alpha 1-Trypsin Inhibitor) In Subjects With Eosinophilic Esophagitis

For Diseases

• Eosinophilic Esophagitis (EoE)

Background

This study is being conducted to determine whether the study drug Zemaira is safe and effective in adults with eosinophilic esophagitis (EoE). In this study, Zemaira is considered an experimental drug because it has not been approved by the US Food and Drug Administration (FDA) to treat EoE. Zemaira is approved by the FDA for the treatment of Alpha1-proteinase inhibitor deficiency but not eosinophilic esophagitis. We want to see how people with EoE feel while taking this drug and if Zemaira accumulates in the esophagus and reduces the activity of proteins that contribute to impaired barrier in patients with EoE.

About this Study

This study is an open label treatment study where all patients receive Zemaira.

Your participation in this study may last up to approximately 32 weeks including the screening period (up to 12 weeks), open label study treatment period (~8 weeks), and a follow-up period (12 weeks). During screening, 1 – 2 clinic visits may be required. During the open label treatment period, clinic visits are every week for a total of 8 visits. The follow-up period consists of 1 telephone visit at ~32 weeks. Clinics visits will take 2 – 4 hours. Standard of care endoscopy visits will also occur in the screening period and after 8 weeks of treatment and take up to 4 hours.

You may be asked to complete the following assessments and procedures that are specific to research:

• Questions about symptoms
• Intravenous infusions of the study treatment
• Physical exam, vitals, pulse oximetry, height, and weight
• Blood and urine sample collections
• Medical history collections; and answer health-related questions

Additionally, as part of your standard of care, two endoscopy visits will occur and additional research biopsies from the esophagus will be taken.

Targeted Enrollment

To be eligible to participate, you must:

• Be 18 to 70 years old
• Be diagnosed with Eosinophilic Esophagitis (EoE)
• Have symptoms of EoE
• Have failed to adequately respond to other treatments for EoE

You are not eligible to participate if you have:

• Gastrointestinal disorders such as Crohn’s disease, inflammatory bowel disease, Celiac disease or eosinophilic gastritis, colitis, or enteritis.
• IgA deficiency
• Hypereosinophilic syndrome
• Initiation, discontinuation or change in the dosage regimen of the following medications within 8 weeks prior to the screening endoscopy:
  • Proton pump inhibitors (PPIs)
  • Leukotriene inhibitors
  • Nasal and/or inhaled corticosteroids

How to Join

The sites listed on the right side of this page are participating in the study.