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
NCT06851559 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2026-04-28
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.
Conditions
- Eosinophilic Esophagitis
Interventions
- DRUG
-
Vonoprazan
Vonoprazan will be administered orally as a tablet
- DRUG
-
Placebo will be administered orally as tablet
Sponsors & Collaborators
-
Phathom Pharmaceuticals, Inc.
lead INDUSTRY
Principal Investigators
-
Medical Director · Phathom Pharmaceuticals
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-30
- Primary Completion
- 2026-12-31
- Completion
- 2027-03-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
A Study to Evaluate Vonoprazan in Children Who Have Symptomatic Gastroesophageal Reflux Disease
NCT06106022 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Efficacy and Safety of Vonoprazan Compared to Placebo for Relief of Heartburn in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease (NERD)
NCT05195528 ·Status: COMPLETED ·Phase: PHASE3
-
EoE RCT Fluticasone and Omeprazole vs Fluticasone Alone
NCT03781596 ·Status: UNKNOWN ·Phase: PHASE4
-
Efficacy and Safety of Dexlansoprazole MR on Maintaining Healing in Subjects With Healed Erosive Esophagitis
NCT00255164 ·Status: COMPLETED ·Phase: PHASE3
-
A Trial to Evaluate EP-104GI in Adults With Eosinophilic Esophagitis (EoE).
NCT05608681 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Fluticasone Versus Esomeprazole to Treat Eosinophilic Esophagitis
NCT00895817 ·Status: COMPLETED ·Phase: NA
-
Efficacy and Safety of Oral Once-Daily Vonoprazan (TAK-438) in Participants With Erosive Esophagitis
NCT02388724 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Vonoprazan in Adolescents With Symptomatic Gastroesophageal Reflux Disease
NCT05343364 ·Status: COMPLETED ·Phase: PHASE1
-
Predictors of Proton Pump Inhibitor (PPI) Response in Eosinophilic Esophagitis
NCT01479231 ·Status: WITHDRAWN ·Phase: PHASE1/PHASE2
-
An Open-Label Trial of Losartan Potassium in Participants With Eosinophilic Esophagitis (EoE)
NCT03029091 ·Status: COMPLETED ·Phase: PHASE2
-
Indonesian Study of Vonoprazan Vs Esomeprazole in Erosive Esophagitis
NCT06720610 ·Status: NOT_YET_RECRUITING ·Phase: PHASE4
-
Vonoprazan Study of Investigating the Effect on Sleep Disturbance Associated With Reflux Esophagitis- Exploratory Evaluation
NCT03116841 ·Status: COMPLETED ·Phase: PHASE4
-
The Frequency of Eosinophilic Esophagitis in Patients With Heartburn That is Refractory to Proton Pump Inhibitors
NCT01404832 ·Status: TERMINATED ·Phase: PHASE4
-
Allergy Immunotherapy in the Management of Eosinophilic Esophagitis
NCT01685034 ·Status: WITHDRAWN ·Phase: NA
-
A Study to Investigate the Efficacy and Tolerability of ESO-101 in Patients With Eosinophilic Esophagitis
NCT04849390 ·Status: COMPLETED ·Phase: PHASE2
-
Comparison of Esomeprazole to Aerosolized, Swallowed Fluticasone for Eosinophilic Esophagitis
NCT00123656 ·Status: COMPLETED ·Phase: PHASE2
-
Improvement in Bronchial Asthma in Patients With Extraesophageal Reflux After Acid Suppression
NCT00234117 ·Status: COMPLETED ·Phase: NA
-
The Role Of Gastroesophageal Reflux Disease (GERD) in Eosinophilic Esophagitis
NCT00728481 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Efficacy and Safety of Dexlansoprazole MR Compared to Placebo on Maintaining Healing in Subjects With Healed Erosive Esophagitis
NCT00321737 ·Status: COMPLETED ·Phase: PHASE3
-
Testing Effectiveness of Losartan in Patients With EoE With or Without a CTD
NCT01808196 ·Status: COMPLETED ·Phase: PHASE2
-
Effect of Dupilumab on the Muscle Function of the Esophagus (food Pipe) in Participants with Eosinophilic Esophagitis (EoE)
NCT06665971 ·Status: RECRUITING ·Phase: PHASE4
-
Dupilumab for Eosinophilic Esophagitis With Severe Strictures
NCT06352073 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE4
-
Effectiveness of Vonoprazan vs Omeprazole as Empiric Therapy for Gastroesophageal Reflux Disease (GERD) Patients Without Alarm Features
NCT04028466 ·Status: TERMINATED ·Phase: PHASE4
-
Safety and Tolerability Study of Oral EUR-1100 to Treat Eosinophilic Esophagitis
NCT01386112 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Proof of Concept Study of OC000459 in Eosinophilic Esophagitis
NCT01056783 ·Status: COMPLETED ·Phase: PHASE2