Phase 1b2 Study of EP-104GI Safety and Effectiveness in Adults with Eosinophilic Esophagitis

What this Trial Is About

Researchers are evaluating the safety, effectiveness, and how the body processes EP-104GI, an extended-release fluticasone propionate injectable suspension, in adults with eosinophilic esophagitis EoE. This Phase 1b2 study aims to understand the local effects of EP-104GI on disease activity using endoscopic and tissue assessments. About 160 participants will be enrolled across dose escalation and randomized dose optimization phases to identify recommended doses and assess outcomes. Participants will receive EP-104GI or a matching vehicle control through submucosal injections during an esophagogastroduodenoscopy EGD procedure at the baseline dosing visit. The dose escalation phase will enroll 27 to 33 participants in different dose cohorts, while the randomized phase will assign about 120 participants to one of two dose levels or vehicle control. Those on vehicle control may switch to EP-104GI after 24 weeks if eligible. Additional substudies may include extended pharmacokinetic follow-up. During the study, participants will attend 8 to 10 visits over approximately 52 weeks, with some having up to 4 extra visits extending to 108 weeks. They will undergo 3 to 5 EGD procedures with biopsies to monitor disease changes and safety. Blood and urine samples will be collected for laboratory tests and drug level measurement. Questionnaires will track symptoms like difficulty swallowing and pain when swallowing. Safety and physical health will be regularly assessed throughout the trial.

A Trial to Evaluate EP-104GI in Adults With Eosinophilic Esophagitis (EoE).