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A Phase 2, Randomized, Double-Blind, Multi-Center Study in Adult Subjects With Eosinophilic Esophagitis (EoE) to Evaluate the Safety and Efficacy of Vonoprazan 20 mg Compared to Placebo After 12 Weeks and to Evaluate the Safety and Efficacy of Vonoprazan 20 mg Up to 24 Weeks
The primary objective of this study is to assess the efficacy of vonoprazan 20 mg once daily (QD) compared to placebo QD in the number of participants with a peak eosinophilic histologic response \<15 eosinophils per high-power field (eos/hpf) after 12 weeks of therapy.
Details
| Lead sponsor | Phathom Pharmaceuticals, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | RECRUITING |
| Enrolment | 80 |
| Start date | 2025-10-30 |
| Completion | 2027-03 |
Conditions
- Eosinophilic Esophagitis
Interventions
- Vonoprazan
- Placebo
Primary outcomes
- Number of Participants at Week 12 Achieving Peak Esophageal Intraepithelial Eosinophil Count <15 eos/hpf. — Week 12
Countries
United States