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
Phathom Pharmaceuticals, Inc.
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * The participant is ≥18 years of age at the time of informed consent signing. * In the opinion of the investigator or subinvestigators, the participant is capable of understanding and complying with protocol requirements, including completion and compliance with the electronic diary. The diary must be completed on at least 11 of the last 14 days in the 2 weeks prior to Visit 2 (Day -1). * The participant signs and dates a written informed consent form (ICF) and any required privacy authorization prior to the initiation of any study procedures. * The participant has a peak…
Interventions
- DrugVonoprazan
Vonoprazan will be administered orally as a tablet
- DrugPlacebo
Placebo will be administered orally as tablet
Locations (41)
- Preferred Research Partners, IncLittle Rock, Arkansas
- GW Research, IncChula Vista, California
- Southern California Research Institute Medical GroupLos Angeles, California
- Rocky Mountain GastroenterologyLakewood, Colorado
- Western States Clinical Research, Inc.Wheat Ridge, Colorado
- Connecticut Clinical Research InstituteBristol, Connecticut