A Phase 2, Randomized, Double-Blind, Multi-Center Study in Adults With Eosinophilic Esophagitis to Evaluate Vonoprazan 20 mg Compared to Placebo After 12 Weeks and Up to 24 Weeks

What this Trial Is About

Researchers are evaluating vonoprazan, a drug taken once daily at 20 mg, in adults with eosinophilic esophagitis (EoE), a condition characterized by a high number of eosinophils in the esophagus. The study aims to compare vonoprazan to a placebo to see how many participants achieve a peak eosinophil count below 15 eosinophils per high-power field after 12 weeks of treatment. This phase 2, randomized, double-blind study is sponsored by Phathom Pharmaceuticals, Inc. and involves adult participants who meet specific clinical and diagnostic criteria for EoE. Participants are randomly assigned to receive either vonoprazan 20 mg daily for 12 weeks followed by an additional 12 weeks at the same dose, or placebo for 12 weeks followed by 12 weeks of vonoprazan 20 mg daily. The study is conducted across multiple centers and includes a double-blind design to compare the safety and efficacy of vonoprazan against placebo initially and then evaluate continued treatment effects up to 24 weeks. During the trial, participants will be monitored through various assessments including esophageal biopsies to measure eosinophil counts, electronic diaries documenting dysphagia episodes, and endoscopic scoring for EoE severity. The main outcome is the number of participants achieving reduced eosinophil levels at week 12. Secondary assessments include changes in dysphagia days, endoscopic reference scores, and eosinophil counts from baseline to week 12. Safety and adherence will be tracked throughout the study period, with participant involvement expected for up to 24 weeks.

A Study in Adult Participants With EoE to Evaluate Vonoprazan 20 mg Compared to Placebo After 12 Weeks and to Evaluate Vonoprazan 20 mg Up to 24 Weeks