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

Last updated: April 27, 2026
Sponsor: Phathom Pharmaceuticals, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Esophageal Disorders

Heartburn (Pediatric)

Heartburn

Treatment

Vonoprazan

Placebo

Clinical Study ID

NCT06851559
EoE-201
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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 capableof understanding and complying with protocol requirements, including completion andcompliance with the electronic diary. The diary must be completed on at least 11 ofthe 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 anyrequired privacy authorization prior to the initiation of any study procedures.

  • The participant has a peak eosinophil count of at least 15 eos/hpf [X 400] from atleast 2 of the 3 esophageal levels on screening endoscopy as measured in at least 6biopsies, at least 2 each from the proximal, mid, and distal segments of theesophagus based on central reading.

  • The participant has 4 or more days with dysphagia episodes documented via electronicdiary in the 2 weeks prior to Visit 2 (Day -1).

  • The participant must remain on a stable diet for at least 6 weeks prior to theScreening Period and is expected to remain on a stable diet during the course of thestudy; stable diet is defined as not initiating new elimination diets orreintroducing previously eliminated foods.

  • A female participant of childbearing potential who is or may be sexually active witha non-sterilized male partner agrees to routinely use adequate contraception fromthe signing of informed consent until 4 weeks after the last dose of study drug.

Exclusion

Exclusion Criteria:

  • The participant is on a pure liquid diet.

  • The participant has documented erosive esophagitis at the screening endoscopy.

  • The participant has other known causes of esophageal eosinophilia or either of thefollowing conditions: hypereosinophilic syndrome, or eosinophilic granulomatosiswith polyangiitis (Churg-Strauss Syndrome).

  • The participant has a documented diagnosis of eosinophilic gastritis, duodenitis,jejunitis, ileitis, proctitis, or colitis.

  • The participant has endoscopic Barrett's esophagus (>1 cm of columnar-linedesophagus) or dysplastic changes in the esophagus.

  • The participant has a history of achalasia, Crohn's disease, ulcerative colitis, orceliac disease.

  • The participant has a known active Helicobacter pylori infection.

  • The participant has any other clinically significant structural conditions affectingthe esophagus, including: esophageal varices, viral or fungal infection, and historyof radiation therapy, radiofrequency ablation, endoscopic mucosal resection,cryotherapy to the esophagus, caustic or physiochemical trauma (includingsclerotherapy or esophageal variceal band ligation), or esophageal surgery.

  • The participant has a history of surgery or non-EoE endoscopic intervention, such asgastric bypass, fundoplication, gastric sleeve, or a history of gastric or duodenalsurgery (except endoscopic removal of benign polyps).

  • The participant has gastric ulcer(s) or duodenal ulcer(s) within 4 weeks before thefirst dose of study drug.

  • The participant has had clinically significant upper or lower gastrointestinalbleeding within 4 weeks prior to the Screening Period.

  • The participant has esophageal stricture(s) unable to be passed with an 8 to 10 mmendoscope, clinically requires dilation, or has a history of dilation within the 3months prior to the Screening Period.

  • Use of prescription or non-prescription PPIs or PCABs within 2 months prior to theScreening Period.

  • Use of swallowed topical corticosteroid or budesonide oral suspension for EoE within 2 months prior to the Screening Period.

  • Use of systemic corticosteroid for any condition within 3 months prior to theScreening Period.

  • Use of inhaled or nasal glucocorticoids within 3 months prior to the ScreeningPeriod, except stable dose for at least 3 months prior to the Screening Period forany condition (should not be changed during the study).

  • Use of dupilumab within 3 months prior to the Screening Period.

  • The participant has received any investigational compound within 30 days or anyinvestigational biologic within 3 months prior to the start of the Screening Period (including those in post-marketing studies) or vonoprazan in a clinical trial at anytime. A participant who has been screen failed from another clinical study and whohas not been dosed may be considered for enrollment in this study.

  • The participant has used immunomodulatory therapy within 3 months prior to theScreening Period or anticipates using immunomodulatory therapy during the study (except for any ongoing regimen of allergy therapy).

  • The participant is a study site employee, an immediate family member, is in adependent relationship with a study site employee who is involved in the conduct ofthis study (eg, spouse, parent, child, sibling), or who may have consented underduress.

  • The participant has a history of hypersensitivity or allergies to vonoprazan (including the formulation excipients: D-mannitol, microcrystalline cellulose,hydroxypropyl cellulose, ascorbic acid, fumaric acid, croscarmellose sodium,magnesium stearate, hypromellose, macrogol 8000, titanium oxide, or red ferricoxide). Skin testing may be performed according to local standard practice toconfirm hypersensitivity.

  • The participant has a history of alcohol abuse, illegal drug use, drug addiction orregularly consumes alcohol within the 12 months prior to the Screening Period (basedon self-report). Participants must have a negative urine drug screen fornon-prescribed medications at screening. Participants taking prescription drugs willbe allowed. Occasional, recreational use of cannabis is allowed. However,participants with a cannabis use disorder (eg, frequent use, functional-socialimpairment, withdrawal symptoms) per the opinion of the investigator should beexcluded.

  • The participant is taking any excluded medications or treatments listed in theprotocol.

  • If female, the participant is pregnant, lactating, or intending to become pregnantbefore, during, or within 4 weeks after participating in this study, or intending todonate ova during such time period.

  • The participant has a history or clinical manifestations of significant centralnervous system, cardiovascular, pulmonary, metabolic, other gastrointestinal,urological, endocrine, or hematological disease that, in the opinion of theinvestigator, would confound the study results or compromise participant safety.

  • The participant has a history of malignancy (including MALToma) or has been treatedfor malignancy within 5 years prior to the start of the Screening Period (Visit 1).The participant may be included in the study if he/she has recovered from cutaneousbasal cell carcinoma or cervical carcinoma in situ.

  • The participant has acquired immunodeficiency syndrome or human immunodeficiencyvirus infection, or tests positive for the hepatitis B surface antigen, hepatitis Cvirus (HCV) antibody, or HCV-ribonucleic acid (RNA). However, participants who testpositive for HCV antibody but negative for HCV-RNA are permitted to participate.

  • The participant has Zollinger-Ellison syndrome or other gastric acid hypersecretoryconditions.

  • The participant requires hospitalization or has surgery scheduled during the courseof the study or has undergone major surgical procedures within 30 days prior to theScreening Period.

  • The participant has moderate to severe hepatic impairment (Child-Pugh Class B andChild-Pugh Class C).

  • The participant has severe renal impairment (estimated glomerular filtration rate <30 mL/min).

  • The participant has any of the following abnormal laboratory test values at thestart of the Screening Period:

  1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 × theupper limit of normal (ULN) or total bilirubin >2 × ULN (except participantswith Gilbert Syndrome).

  2. Creatinine levels: >2 mg/dL (>177 μmol/L)

  • The participant is refractory to prior PPI therapy as judged by the investigator.

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Vonoprazan
Phase: 2
Study Start date:
October 30, 2025
Estimated Completion Date:
March 31, 2027

Connect with a study center

  • Preferred Research Partners, Inc

    Little Rock, Arkansas 72211
    United States

    Active - Recruiting

  • Preferred Research Partners, Inc

    Little Rock 4119403, Arkansas 4099753 72211
    United States

    Site Not Available

  • GW Research, Inc

    Chula Vista, California 91910
    United States

    Active - Recruiting

  • Southern California Research Institute Medical Group

    Los Angeles, California 90045
    United States

    Site Not Available

  • GW Research, Inc

    Chula Vista 5336899, California 5332921 91910
    United States

    Site Not Available

  • Southern California Research Institute Medical Group

    Los Angeles 5368361, California 5332921 90045
    United States

    Site Not Available

  • Rocky Mountain Gastroenterology

    Lakewood, Colorado 80228
    United States

    Active - Recruiting

  • Western States Clinical Research, Inc.

    Wheat Ridge, Colorado 80033
    United States

    Active - Recruiting

  • Rocky Mountain Gastroenterology

    Lakewood 5427946, Colorado 5417618 80228
    United States

    Site Not Available

  • Western States Clinical Research, Inc.

    Wheat Ridge 5443948, Colorado 5417618 80033
    United States

    Site Not Available

  • Connecticut Clinical Research Institute

    Bristol, Connecticut 06010
    United States

    Active - Recruiting

  • Connecticut Clinical Research Institute

    Bristol 5282835, Connecticut 4831725 06010
    United States

    Site Not Available

  • Nature Coast Clinical Research

    Inverness, Florida 34452
    United States

    Active - Recruiting

  • Encore Borland-Groover Clinical Research

    Jacksonville, Florida 32256
    United States

    Active - Recruiting

  • International Center for Research

    Tampa, Florida 33614
    United States

    Active - Recruiting

  • Nature Coast Clinical Research

    Inverness 4159786, Florida 4155751 34452
    United States

    Site Not Available

  • Encore Borland-Groover Clinical Research

    Jacksonville 4160021, Florida 4155751 32256
    United States

    Site Not Available

  • International Center for Research

    Tampa 4174757, Florida 4155751 33614
    United States

    Site Not Available

  • Gastroenterology Associates of Central Georgia, LLC

    Macon, Georgia 31201
    United States

    Active - Recruiting

  • Gastroenterology Associates of Central Georgia, LLC

    Macon 4207400, Georgia 4197000 31201
    United States

    Site Not Available

  • Treasure Valley Medical Research

    Boise, Idaho 83706
    United States

    Active - Recruiting

  • Grand Teton Research Group

    Idaho Falls, Idaho 83404
    United States

    Active - Recruiting

  • Treasure Valley Medical Research

    Boise 5586437, Idaho 5596512 83706
    United States

    Site Not Available

  • Grand Teton Research Group

    Idaho Falls 5596475, Idaho 5596512 83404
    United States

    Site Not Available

  • Northwestern Medicine Digestive Health Center

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • GI Alliance - Gurnee

    Gurnee, Illinois 60031
    United States

    Active - Recruiting

  • Northwestern Medicine Digestive Health Center

    Chicago 4887398, Illinois 4896861 60611
    United States

    Site Not Available

  • GI Alliance - Gurnee

    Gurnee 4894861, Illinois 4896861 60031
    United States

    Site Not Available

  • Combined Gastro, LLC

    Lafayette, Louisiana 70503
    United States

    Active - Recruiting

  • Tandem Clinical Research GI, LLC

    Marrero, Louisiana 70072
    United States

    Active - Recruiting

  • Combined Gastro, LLC

    Lafayette 4330145, Louisiana 4331987 70503
    United States

    Site Not Available

  • Tandem Clinical Research GI, LLC

    Marrero 4332628, Louisiana 4331987 70072
    United States

    Site Not Available

  • Woodholme Gastroenterology Associates

    Glen Burnie, Maryland 21061
    United States

    Active - Recruiting

  • Woodholme Gastroenterology Associates

    Glen Burnie 4356188, Maryland 4361885 21061
    United States

    Site Not Available

  • Boston Specialists

    Boston, Massachusetts 02111
    United States

    Active - Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Boston Specialists

    Boston 4930956, Massachusetts 6254926 02111
    United States

    Site Not Available

  • Huron Gastroenterology Associates

    Ypsilanti, Michigan 48197
    United States

    Active - Recruiting

  • Huron Gastroenterology Associates

    Ypsilanti 5015688, Michigan 5001836 48197
    United States

    Site Not Available

  • Advanced Research Institute

    Reno, Nevada 89511
    United States

    Active - Recruiting

  • Advanced Research Institute

    Reno 5511077, Nevada 5509151 89511
    United States

    Site Not Available

  • Weill Cornell Medicine, New York Presbyterian Hospital

    New York, New York 10065
    United States

    Active - Recruiting

  • UNC Clinical & Translational Research Center

    Chapel Hill, North Carolina 27514
    United States

    Active - Recruiting

  • UNC Clinical & Translational Research Center

    Chapel Hill 4460162, North Carolina 4482348 27514
    United States

    Site Not Available

  • GCGA Physicians, LLC dba/Gastro Health Research

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • Great Lakes Gastroenterology Research LLC

    Mentor, Ohio 44060
    United States

    Active - Recruiting

  • GCGA Physicians, LLC dba/Gastro Health Research

    Cincinnati 4508722, Ohio 5165418 45219
    United States

    Site Not Available

  • Great Lakes Gastroenterology Research LLC

    Mentor 5162645, Ohio 5165418 44060
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • University of Pennsylvania

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Site Not Available

  • Galen Medical Group - Galen Digestive Health

    Chattanooga, Tennessee 37404
    United States

    Active - Recruiting

  • Quality Medical Research

    Nashville, Tennessee 37211
    United States

    Active - Recruiting

  • Galen Medical Group - Galen Digestive Health

    Chattanooga 4612862, Tennessee 4662168 37404
    United States

    Site Not Available

  • Quality Medical Research

    Nashville 4644585, Tennessee 4662168 37211
    United States

    Site Not Available

  • GI Alliance

    Cedar Park, Texas 78613
    United States

    Active - Recruiting

  • The Hospitals of Providence Memorial Campus

    El Paso, Texas 79902
    United States

    Active - Recruiting

  • Texas Digestive Specialists

    Harlingen, Texas 78550
    United States

    Active - Recruiting

  • Houston Endoscopy and Research Center

    Houston, Texas 77079
    United States

    Active - Recruiting

  • Research Physicians Network, LLC

    Houston, Texas 77089
    United States

    Active - Recruiting

  • Biopharma Informatic, LLC

    McAllen, Texas 78503
    United States

    Active - Recruiting

  • Pearland Physicians

    Pearland, Texas 77581
    United States

    Active - Recruiting

  • Gastroenterology Research of San Antonio

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Texas Gastro Consultants

    Tomball, Texas 73375
    United States

    Active - Recruiting

  • GI Alliance

    Cedar Park 4679867, Texas 4736286 78613
    United States

    Site Not Available

  • The Hospitals of Providence Memorial Campus

    El Paso 5520993, Texas 4736286 79902
    United States

    Site Not Available

  • Texas Digestive Specialists

    Harlingen 4696233, Texas 4736286 78550
    United States

    Site Not Available

  • Houston Endoscopy and Research Center

    Houston 4699066, Texas 4736286 77079
    United States

    Site Not Available

  • Research Physicians Network, LLC

    Houston 4699066, Texas 4736286 77089
    United States

    Active - Recruiting

  • Biopharma Informatic, LLC

    McAllen 4709796, Texas 4736286 78503
    United States

    Site Not Available

  • Pearland Physicians

    Pearland 4718097, Texas 4736286 77581
    United States

    Site Not Available

  • Gastroenterology Research of San Antonio

    San Antonio 4726206, Texas 4736286 78229
    United States

    Site Not Available

  • Texas Gastro Consultants

    Tomball 4737094, Texas 4736286 73375
    United States

    Site Not Available

  • Advanced Research Institute

    Ogden, Utah 84405
    United States

    Active - Recruiting

  • Care Access - Ogdon

    Ogden, Utah 84403
    United States

    Active - Recruiting

  • Advanced Research Institute

    Sandy City, Utah 84070
    United States

    Active - Recruiting

  • Advanced Research Institute

    Ogden 5779206, Utah 5549030 84405
    United States

    Active - Recruiting

  • Care Access - Ogdon

    Ogden 5779206, Utah 5549030 84403
    United States

    Site Not Available

  • Advanced Research Institute

    Sandy City 5781061, Utah 5549030 84070
    United States

    Site Not Available

  • Blue Ridge Medical Research

    Lynchburg, Virginia 25402
    United States

    Active - Recruiting

  • Blue Ridge Medical Research

    Lynchburg 4771075, Virginia 6254928 25402
    United States

    Site Not Available

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