Reusel

Researchers are evaluating the safety, effectiveness, and how the body processes EP-104GI, an extended-release fluticasone propionate formulation, in adults with eosinophilic esophagitis (EoE). This Phase 1b/2 trial aims to understand how EP-104GI affects the disease by assessing symptoms, tissue changes, and local effects within the esophagus. Approximately 160 adults aged 18 to 75 will participate, including dose escalation groups and a randomized dose optimization phase comparing two doses of EP-104GI to a matching vehicle control. Participants will receive EP-104GI or vehicle control through an injection during an esophagogastroduodenoscopy (EGD) procedure at the start of the study. Dose escalation involves small groups receiving increasing doses to evaluate safety over 52 weeks. The dose optimization phase will randomly assign about 120 participants to either of two EP-104GI doses or vehicle control, with some eligible to switch to EP-104GI after 24 weeks. The study includes up to 10 visits over about a year, with some participants in an extended pharmacokinetics sub-study having up to 4 more visits over 108 weeks. Throughout the study, participants will undergo several EGDs with esophageal biopsies at specified times, provide blood and urine samples for lab tests and drug level measurements, and complete questionnaires about swallowing symptoms. Researchers will monitor adverse events, physical exams, body weight, and cortisol levels. The main outcomes include safety, drug levels, and changes in esophageal tissue inflammation and disease activity, with careful safety monitoring during the entire participation period.