A Trial Evaluating EP-104IAR in Adults With Eosinophilic Esophagitis
Status:
Not yet recruiting
Trial end date:
2023-09-01
Target enrollment:
Participant gender:
Summary
An open-label, dose-escalation study to explore the safety, tolerability and pharmacokinetics
of EP-104IAR in adults with eosinophilic esophagitis (EoE). Endoscopic and histologic
assessments will also be evaluated to understand the local effects of EP-104IAR on
eosinophilic EoE disease activity.
The study will evaluate up to 8 doses of EP-104IAR (4 mg to 40 mg) in cohorts of 3 to 6
participants per cohort. If all planned cohorts are evaluated, or cohorts need to be
repeated, up to 24 participants could be enrolled.
The study involves 7 site visits spread over approximately 18 weeks.
All participants will receive active study drug (EP-104IAR), The study drug will be
administered by qualified personnel during an esophagogastroduodenoscopy (EGD) procedure at
the Baseline/Dosing visit.
Safety will be assessed throughout the study. Blood and urine samples will be collected at
site visits for laboratory assessments and to measure plasma levels of EP-104IAR.
Participants will complete questionnaires to assess symptoms of dysphagia and odynophagia and
will undergo 3 EGDs with esophageal biopsies at the Baseline/Dosing Visit, and at 4 and 12
weeks post dose.