Actively Recruiting
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
Led by Phathom Pharmaceuticals, Inc. · Updated on 2026-04-28
80
Participants Needed
41
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant is 18 years of age or older at consent.
- Able to understand and follow the study requirements including completing an electronic diary.
- Signed informed consent and any required privacy authorization.
- Peak eosinophil count of at least 15 eosinophils per high-power field in at least 2 of 3 esophageal levels from biopsies.
- Four or more days with dysphagia episodes recorded in the electronic diary in the 2 weeks before treatment.
- Stable diet for at least 6 weeks before screening and expected to remain stable during the study.
- Female participants of childbearing potential agree to use adequate contraception from consent signing until 4 weeks after last dose.
You will not qualify if you...
- Currently on a pure liquid diet.
- Documented erosive esophagitis at screening endoscopy.
- Other known causes of esophageal eosinophilia such as hypereosinophilic syndrome or eosinophilic granulomatosis with polyangiitis.
- Diagnosis of eosinophilic gastritis, duodenitis, jejunitis, ileitis, proctitis, or colitis.
- Presence of Barrett's esophagus longer than 1 cm or dysplastic changes.
- History of achalasia, Crohn's disease, ulcerative colitis, or celiac disease.
- Known active Helicobacter pylori infection.
- Significant structural esophageal conditions or history of esophageal surgery.
- Recent gastric or duodenal ulcers or significant gastrointestinal bleeding within 4 weeks.
- Esophageal strictures that cannot be passed with an 8-10 mm endoscope or requiring dilation.
- Use of PPIs or PCABs within 2 months prior to screening.
- Use of topical or systemic corticosteroids or dupilumab within specified timeframes before screening.
- Use of investigational drugs within 30 days or biologics within 3 months prior to screening.
- Use or anticipated use of immunomodulatory therapy except allergy therapy.
- Study site employees or their immediate family members.
- History of hypersensitivity or allergies to vonoprazan or its components.
- History of substance abuse or regular alcohol use within 12 months.
- Pregnancy, lactation, or planning pregnancy during study and 4 weeks after.
- Significant medical conditions that may affect safety or study results.
- History or treatment of malignancy within 5 years except certain skin or cervical cancers.
- HIV/AIDS or positive for hepatitis B or active hepatitis C infection.
- Zollinger-Ellison syndrome or other gastric acid hypersecretory conditions.
- Hospitalization or surgery scheduled during study or recent major surgery.
- Moderate to severe liver impairment or severe kidney impairment.
- Abnormal liver enzymes or creatinine levels above specified limits.
- Refractory to prior PPI therapy as judged by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 41 locations
1
Preferred Research Partners, Inc
Little Rock, Arkansas, United States, 72211
Actively Recruiting
2
GW Research, Inc
Chula Vista, California, United States, 91910
Actively Recruiting
3
Southern California Research Institute Medical Group
Los Angeles, California, United States, 90045
Active, Not Recruiting
4
Rocky Mountain Gastroenterology
Lakewood, Colorado, United States, 80228
Actively Recruiting
5
Western States Clinical Research, Inc.
Wheat Ridge, Colorado, United States, 80033
Actively Recruiting
6
Connecticut Clinical Research Institute
Bristol, Connecticut, United States, 06010
Actively Recruiting
7
Nature Coast Clinical Research
Inverness, Florida, United States, 34452
Actively Recruiting
8
Encore Borland-Groover Clinical Research
Jacksonville, Florida, United States, 32256
Actively Recruiting
9
International Center for Research
Tampa, Florida, United States, 33614
Actively Recruiting
10
Gastroenterology Associates of Central Georgia, LLC
Macon, Georgia, United States, 31201
Actively Recruiting
11
Treasure Valley Medical Research
Boise, Idaho, United States, 83706
Actively Recruiting
12
Grand Teton Research Group
Idaho Falls, Idaho, United States, 83404
Actively Recruiting
13
Northwestern Medicine Digestive Health Center
Chicago, Illinois, United States, 60611
Actively Recruiting
14
GI Alliance - Gurnee
Gurnee, Illinois, United States, 60031
Actively Recruiting
15
Combined Gastro, LLC
Lafayette, Louisiana, United States, 70503
Actively Recruiting
16
Tandem Clinical Research GI, LLC
Marrero, Louisiana, United States, 70072
Actively Recruiting
17
Woodholme Gastroenterology Associates
Glen Burnie, Maryland, United States, 21061
Actively Recruiting
18
Boston Specialists
Boston, Massachusetts, United States, 02111
Actively Recruiting
19
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
20
Huron Gastroenterology Associates
Ypsilanti, Michigan, United States, 48197
Actively Recruiting
21
Advanced Research Institute
Reno, Nevada, United States, 89511
Actively Recruiting
22
Weill Cornell Medicine, New York Presbyterian Hospital
New York, New York, United States, 10065
Actively Recruiting
23
UNC Clinical & Translational Research Center
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
24
GCGA Physicians, LLC dba/Gastro Health Research
Cincinnati, Ohio, United States, 45219
Actively Recruiting
25
Great Lakes Gastroenterology Research LLC
Mentor, Ohio, United States, 44060
Actively Recruiting
26
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
27
Galen Medical Group - Galen Digestive Health
Chattanooga, Tennessee, United States, 37404
Actively Recruiting
28
Quality Medical Research
Nashville, Tennessee, United States, 37211
Actively Recruiting
29
GI Alliance
Cedar Park, Texas, United States, 78613
Actively Recruiting
30
The Hospitals of Providence Memorial Campus
El Paso, Texas, United States, 79902
Actively Recruiting
31
Texas Digestive Specialists
Harlingen, Texas, United States, 78550
Actively Recruiting
32
Houston Endoscopy and Research Center
Houston, Texas, United States, 77079
Actively Recruiting
33
Research Physicians Network, LLC
Houston, Texas, United States, 77089
Actively Recruiting
34
Biopharma Informatic, LLC
McAllen, Texas, United States, 78503
Actively Recruiting
35
Pearland Physicians
Pearland, Texas, United States, 77581
Actively Recruiting
36
Gastroenterology Research of San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
37
Texas Gastro Consultants
Tomball, Texas, United States, 73375
Actively Recruiting
38
Care Access - Ogdon
Ogden, Utah, United States, 84403
Actively Recruiting
39
Advanced Research Institute
Ogden, Utah, United States, 84405
Actively Recruiting
40
Advanced Research Institute
Sandy City, Utah, United States, 84070
Actively Recruiting
41
Blue Ridge Medical Research
Lynchburg, Virginia, United States, 25402
Actively Recruiting
Research Team
P
Phathom Medical Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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